Orac is the nom de blog of a (not so) humble pseudonymous surgeon/scientist with an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his miscellaneous verbal meanderings, but just barely small enough to admit to himself that few will. (Continued 
If there's one law that (most) supporters of science-based medicine detest and would love to see repealed, it's the Dietary Supplement and Health Act of 1994 (DSHEA). The reason is that this law, arguably more than almost anything else, allowed for the proliferation of supplements and claims made for these supplements that aren't based in science. In essence, the DSHEA created a new class of regulated entity called dietary supplements. At the same time, it liberalized the rules for information and claims that the supplement manufacturers can transmit to the public and while at the same time mostly tying the FDA's hands so that it can do almost nothing before supplements are marketed and it has a hard time effectively policing supplement safety after supplements are marketed. As I've pointed out before, the DSHEA in essence allows the use of the Quack Miranda Warning to make health claims for supplements as a "get out of jail free" card. Indeed, fellow ScienceBlogger PalMD has referred to the DSHEA as a travesty of a mockery of a sham.
Suffice it to say that the DSHEA of 1994 is a very bad law indeed. One thing it does is to make a distinction between food and medicine. While on its surface this is a reasonable distinction (after all, it wouldn't make a lot of sense to hold food to the same sorts of standards to which drugs are held), as implemented by the DSHEA this distinction has a pernicious effect in that it allows manufacturers to label all sorts of botanicals, many of which with pharmacological activity, as "supplements," and supplements, being defined as food and not medicine, do not require prior approval by the FDA before marketing.
In other words, when a supplement is marketed it's more or less the honor system. No registration with the FDA is required. After all, supplements are food, not medicine! In effect, the government can't really do anything unless problems are reported after the supplement is marketed. Even worse, the definition of "supplement" has become very broad, as Quackwatch points out:
DSHEA worsened this situation by increasing the amount of misinformation that can be directly transmitted to prospective customers. It also expanded the types of products that could be marketed as "supplements." The most logical definition of "dietary supplement" would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.
In other words, under the DSHEA, substances that are clearly not foods can be marketed as supplements, including herbs and other botanicals (the vast majority of which are marketed as having a beneficial medicinal effect and some of which contain chemicals that do act as drugs). As long as the manufacturer is careful not to make specific health claims, it's all good. In other words, a "nutritional support" statement claimed for a supplement must not be a "drug" claim; i.e., it must not claim that the supplement can be used for the treatment or prevention of a disease. Supplement manufacturers easily evade this requirement by making vaguer claims related to organs or systems, such as claiming that a product "boosts the immune system," "supports heart health," or something similar.
It is not an exaggeration to state that the DSHEA was the greatest boon to supplement manufacturers ever. In its wake, the supplement industry exploded, racking up huge increases in sales. Indeed, a recent GAO report estimated that the supplement industry has grown to a $23.7 billion industry in 2007. Moreover, so lax is the regulation of supplements that it took a very extreme and egregious act, namely the marketing of an industrial chelator as an "antioxidant" supplement for the treatment of autism, before the FDA finally acted. Over the years, supporters of science-based medicine and sound public policy have made efforts to alter or repeal the DSHEA. All have failed. Tom Harkin and Orrin Hatch are powerful patrons, and Utah is home to many supplement manufacturers, whose interests Hatch zealously defends. Indeed, when adulterated supplements manufactured in Utah caused Olympic athletes to test positive for banned drugs and the International Olympic Committee warned athletes to avoid banned supplements, particularly those manufactured in Utah, Hatch leapt to the defense of the supplement manufacturers.
The latest to try to reform the DSHEA is, of all people, Senator John McCain (R-AZ). Those of you who, like me, peruse NaturalNews.com from time to time for the entertainment value may have noticed that the forces of woo have been lining up against McCain. For instance, Ethan Huff wrote a hysterical screed entitled McCain bill threatens access to vitamins and supplements:
Senator John McCain (R-Arizona) has introduced a new bill called The Dietary Supplement Safety Act (DSSA) of 2010 (S. 3002), that, if enacted, would severely curtail free access to dietary supplements. Cosponsored by Senator Byron Dorgan (D-North Dakota), the bill would essentially give the FDA full control over the supplement industry.
Ethan writes that as though it would be a bad thing. He continues:
DSSA would mandate that all supplement companies register with the Secretary of Health and Human Services (HHS), which oversees the FDA. Any company that refuses to register and comply with HHS would be subject to hefty fines, the classification of its products as "adulterated", and their removal from the market. The new system would burden manufacturers with significant new costs that would cause supplement prices to increase. A new taxpayer-funded bureaucracy would also be created to conduct inspections and oversee compliance.
Ethan writes that as though it would be a bad thing for all supplement companies to be registered and subject to inspection.
Unfortunately, a mere month after announcing the DSSA of 2010, Senator McCain has ignominiously withdrawn his support from the bill. Orrin Hatch prevailed in protecting the supplement industry and made public a letter written to McCain in the wake of a conversation they apparently had last week. Big supplement had won, and McCain's mavericky-ness is apparently not so mavericky when confronting its power. But what was the DSSA? Why did the supplement industry see it as such a threat, so much so that it brought all its influence to bear to get John McCain to bravely, bravely run away?
Let's go back in time a mere five weeks ago, shall we?
On February 3, 2010 Senator McCain gave a speech announcing new legislation that he was introducing, the Dietary Supplement Safety Act of 2010:
Like many of you, I am looking forward to watching the Super Bowl this Sunday and the Winter Olympics later this month. However, a little over a year ago the NFL suspended six players, including two players from one of the teams competing this Sunday, for violating the league's anti-doping policy. Several of the players were surprised that they tested positive for a banned substance because they used a dietary supplement they believed to be safe and legal.It is for precisely this reason that today Senators Dorgan and I are proud to introduce the Dietary Supplement Safety Act of 2010. All Americans should know the exact ingredients of any dietary supplement they use and the FDA must have the tools necessary to ensure the safety of dietary supplements.
This legislation would require dietary supplement manufactures to register with the FDA and fully disclose the ingredients contained in the supplement. Surveys have found that a majority of dietary supplement users believe the FDA approves the safety of dietary supplements prior to market introduction. However, that is not the case. In fact, dietary supplement manufacturers' advertised claims of safety and effectiveness are not reviewed or approved by the FDA.
The complete text of the bill can be found here. Perhaps the most promising aspect of the McCain-Dorgan Bill was that it would provide the FDA with mandatory recall authority if a supplement is found to be unsafe or harmful, and this appears to be the part of the bill that got Ethan Huff so hot and bothered that he referred to it as the power to "arbitrarily pull supplements from the market" if the FDA "believes it has 'reasonable probability' that there may be a problem."
Which seems eminently reasonable to me. After all, why should supplements be different from food, which the FDA has the power to recall if there is a problem?
Part of the reason that the government could do little about, for example, ephedra, which it took the FDA over a decade to be able to ban, despite multiple deaths linked to supplements containing it. Perhaps the most notorious death attributed to ephedra-containing supplements was that of Steve Bechler, a pitcher for the Baltimore Orioles, who died of heat strokefollowing a spring training workout in 2003. The medical examiner found that ephedra toxicity played a "significant role" in Bechler's sudden death. Sad to say that cleaning up sports seems to be the primary motivation behind Senator McCain's decision to take on the DSHEA, rather than protecting the public at large, but, whatever his motivation, it is good to see a legislator trying to make some corrections to the abomination of a travesty that is the DSEA of 1994. Indeed, as long as 6 years ago, McCain appeared to get it:
McCain voted for DSHEA, the 1994 law that gutted the federal government's authority to oversee supplements -- and that triggered the explosive growth in the sale of everything from horny goat weed to bee feces. But he says: "I'm not satisfied at all. The bill I voted for, frankly, I was not as aware of it as I should have been."Now McCain would like to force makers of supplements or any substance that affects the human body to test their products before bringing them to market. Given that the supplement manufacturers have huge political influence in Congress -- they can mobilize millions of loyal customers, and they have a powerful patron in Sen. Orrin Hatch, R-Utah -- that's not likely to happen.
Prophetic words, even six years ago.
The DSSA, whose future is very unclear now, has a number of good features. One part that I like is that the DSSA mandates that all adverse events be reported to the FDA, including non-serious ones. As mentioned by Senator McCain, it also includes expanded power for the FDA to issue cease distribution and notification order requiring that the manufacturer cease sales and marketing of the supplement in question. It also provides a mechanism for a hearing within ten days for the manufacturer to defend itself against the charges. After the hearing, the FDA may then issue a formal recall if it finds adequate evidence that the supplement is unsafe. While it is true that the DSHEA does currently allow the FDA to ban supplements, it does not, as I understand it, give the FDA the power to issue a rapid order to cease distribution or to mandate a recall this quickly, nor does it require supplement manufacturers to register with the FDA. All in all, it is a welcome modification of a very bad law. Although it does not go far enough, it is a bill that supporters of science-based medicine should support.
Not surprisingly, it's not just the woo-meisters at NaturalNews.com who are utterly opposed to the DSSA. The supplement industry immediately expressed its displeasure with the bill right from the day it was anounced. For example, the Council for Responsible Nutrition (CRN) was fast to respond to Senator McCain's press conference. In a bit of denialist double-speak that would make tobacco manufacturers blush, the CRN had the audacity to claim that requiring the reporting of all adverse events, not just serious ones, would not do anything to protect consumers. Even more Orwellian, the CRN actually claimed with (apparently) a straight face that the supplement industry had lobbied to "increase the regulation under which the supplement industry operates" and to "increase funding for the FDA's enforcement efforts." It supports a different bill, the Senate Food and Drug Administration Food Safety and Modernization Act (S.510), sponsored by Senator Richard Durbin (D-IL).
My reading of Durbin's bill is that, although it too has a number of good features, it does not really address the supplement industry other than as a byproduct of regulating the food industry. Durbin's bill concentrates primarily on sanitation, and adulteration, the inspection of food manufacturing facilities, and regulation of imported food. Indeed, it appears to be primarily an agricultural bill to regulate food safety, and it says nothing about supplements explicitly. Of course, given that the law considers supplements food, supplements would fall under the law, but the law doesn't really look as though it would actually do much about supplements. Certainly, it would not require supplement manufacturers to report all adverse events and it would not address structure-function claims made by manufacturers under the protective umbrella of the Quack Miranda Warning. The GAO report on supplement regulation of about a year ago may have been part of the impetus for the Durbin Bill. (The DSHEA is so bad that even those predisposed to loose regulation of supplements appear to recognize that there is enough of a problem with the law that it needs some modification.) However, the GAO report was fairly anemic in its criticisms and suggested reforms, and the Durbin bill is certainly at best a baby step towards more careful regulation of supplments.
No wonder the supplement industry likes the Durbin bill better than the McCain bill. S.510 would do little or nothing to reform the DSHEA, and that's exactly how the supplement industry likes it. Indeed, founder executive director of the American Botanical Council, Mark Blumenthal, essentially said as much when he argued that a new law isn't necessary, claiming that all that is necessary is "robust enforcement" of the DSHEA. That is, of course, laughable, because even if the DSHEA were enforced to the letter, the problem would remain, namely that the FDA can do almost nothing about harmful supplements until after harm has been done and can do almost nothing about deceptive health claims made by supplement manufacturers. Again, that's just the way the supplement industry likes it. Indeed, the record of the supplement industry has been to push for the passage of the DSHEA, which weakened the FDA's authority to protect the public against dangerous supplements, and to fight every substantive effort to fix that travesty of a law.
In fact, if you want the attitude of supplement manufacturers encapsulated, just look at the reaction of attorney Jonathan W. Emord, a flack for the supplement industry:
Emord said a requirement to report non-serious adverse events was "laughable"."If it is not serious why bother?" he wondered, noting 'seriousness' had not been defined. "Is it when the vitamin bottle drops to the floor and the cat eats every one?"
Of course, I could point out that the FDA does define serious adverse events. Basically an SAE is a complication that is either life-threatening or require hospitalization and requires mandatory reporting. Even then, there was no guarantee that an adverse event due to a supplement would be reported because often such events are not linked to various supplements that people take. However, there are quite a few adverse events that might not fall under the FDA's definition of "serious" that are significant, and there is currently no requirement that these be reported.
When I first heard about the McCain-Dorgan bill, I had a bad feeling about it. Not only is the supplement industry quite powerful in certain key states, but powerful legislators like Orrin Hatch are totally in its pockets. Meanwhile, Senator Tom Harkin (D-IA) is a believer and the primary force behind the creation of the pseudoscientific monstrosity in the heart of the NIH known as NCCAM. Almost instantly after the bill was introduced, not just the supplement manufacturers went on the attack, but "health freedom" wingnuts such as the AAPS, which posted an attack on McCain on its TakeBackMedicine.com website, even going so far as to post what appear to be outright lies about the bill, such as:
Until now, supplement producers have also been allowed to market a "new dietary ingredient", that is, one not sold as a supplement prior to 1994, if it has been "in the food supply as an article used for food in a form not chemically altered." McCain's bill also wipes this out. If passed, supplement producers would have to prove the safety of the ingredient to the satisfaction of the FDA even if the item has been in food for millennia. This is a big change. But McCain still insists that it isn't a new regulatory structure. Need we add that the FDA almost never agrees that a supplement has been proven safe? The Agency wants full drug trials, but who can afford to pay for full drug trials on a non-patentable substance? Are we going to end up paying $100 for a supplement tablet?
On another article, the AAPS's "friends" at the Alliance for Natural Health write:
Why not simply require that supplements be brought through the FDA's drug approval process? Wouldn't that create a level playing field?That is probably the argument that Senator McCain has been sold. But it is a completely false argument. The FDA drug approval process costs as much as a billion dollars. It is not economically feasible to spend such vast sums on substances that are not protected by patent, and natural substances cannot legally be patented.
This is utter nonsense, but typical of the attacks being made by quack apologists against this bill. It's a fabrication and a straw man argument. Nothing I could find in the text of the DSSA would require full scale drug trials for supplements, much less for foodstuff that have been used for millennia. The closest I could find was Section 2 (d), subtitled "Maintaining Substantiation File," which mandates:
Any person submitting information to the Secretary under subsection (a) shall create and maintain a scientifically reasonable substantiation file relating to the claim that the dietary ingredient or dietary supplement will reasonably be expected to be safe. The substantiation file shall be prepared and maintained in such form and manner as the Secretary may prescribe and shall be available for review and inspection by the Secretary upon request.
Again, I fail to see what is so unreasonable about this. Basically, all this requires is that the manufacturer be able to document scientifically that its supplement can reasonably be expected to be safe. In fact, I would argue that it does not go far enough. Again, the DSSA does not do much of anything about deceptive and undocumented structure-function claims.
What probably led McCain to back off from the DSSA is a confluence of factors, not the least of which is that he is facing a strong primary challenge from the right in Arizona this year. Being seen as too willing to increase government regulation was almost certainly hurting him. Then, of course, there was the power of "big supplement." It should not be forgotten that Arizona is one of a handful of epicenters of quackery in the United States. There are a lot of people in Arizona who use supplements and, being very woo-friendly, are likely to be fairly easily frightened by lies about "taking away your vitamins" being thrown about.
In the end, although I briefly had a burst of hope that maybe--just maybe--this time would be different and that some substantive correction would be made to the travesty that is the DSHEA. Unfortunately, the forces arrayed against the DSSA were just too strong. Look next for Tom Harkin to put the finger on Byron Dorgan to kill the bill. He'll succeed, too.
Medicine & Health
Politics
Comments
You make many good points about the excesses of the supplement industry.
However, it is important to remember that the true purpose of regulation is to limit competition, not protect the public.
Who stands to benefit the most should new regulations pass?
Posted by: DayOwl | March 8, 2010 8:12 AM
Consumers?
Posted by: JohnV | March 8, 2010 8:30 AM
@DayOwl:
You're right. Traffic safety regulations limit my right to compete in drag races on neighborhood streets. Pollution regulations limit my right to compete with my neighbors to see who has the fittest genes. Financial regulations limit my right to compete with the bank to see who can wield fine print with more deadly effect. Insurance company regulations limit my right to compete with nature, red in tooth and claw. Police department regulations limit my right to compete mano-a-mano with well-armed police officers at their whim.
On second thought, surely you're a troll.
Posted by: madder | March 8, 2010 8:42 AM
However, it is important to remember that the true purpose of regulation is to limit competition, not protect the public.
Well, that depends on what's in the regulation, doesn't it?
Instead of lazily and minslessly assuming that all regulations have a bad purpose (without even mentioning specifics), why not make a little more effort to distinguish regs that limit competition from those that protect the public?
Posted by: Raging Bee | March 8, 2010 8:46 AM
Says who (other than DayOwl)? And if it is sometimes true due to the messy nature of our representative democracy, does it really matter if it limits competition somewhat in the supplement market as long as the products on store shelves are safer and consumers actually know what's in them?
Posted by: Gus Snarp
| March 8, 2010 8:53 AM
What, if anything, would this exclude? It should cover everything from opium (a botanical) to bacon (I could be easting it to increase protein intake).
Posted by: Andreas Johansson
| March 8, 2010 9:43 AM
Ah, so it is the NHRA who is behind all the local traffic laws. Those bastards.
Posted by: Pablo | March 8, 2010 9:50 AM
When Senator McCain gave his reasons for introducing this unnecessary bill, he was either being very disengenuous, or else he was simply ignorant of current law.
1. McCain said he wants to protect atheletes from inadvertantly taking adulterated supplements. But it is already a violation of federal law to adulterate a supplement with a drug (like a steroid). Under President Obama, the FDA is finally pursuing felony prosecutions of companies who market adulterated supplements. Here’s one example:
http://www.nytimes.com/2010/01/21/business/21steroids.htm
2. McCain says consumers should know exactly what ingredients are in their supplements. But this is precisely what the FDA's Good Manufacturing Practices already require:
"manufacturers must evaluate the identity, purity, quality, strength, and composition of dietary supplements." All documentation must be shown to FDA agents when they inspect each manufacturing facility (which the FDA is in the process of doing).
3. McCain's bill would require mandatory reporting of all adverse events, even minor ones. But the FDA already requires mandatory reporting of serious adverse events for dietary supplements. Minor adverse event reporting would certainly generate extra paperwork for supplement companies and the FDA. Does McCain really think it would contribute to greater safety?
4. McCain's bill would require annual registration of supplement manufacturing facilities and give the FDA mandatory recall authority for dietary supplements. But the Senate's Food Safety bill, S.510, already has both these provisions. Supplements have always been regulated as foods, even before DSHEA. So when S.510 requires all producers of food products to comply with these two provisions, supplement companies are included automatically. They would be excluded only if there is language specifically exempting supplements (there is not). S.510 has bipartisan support, and is expected to pass sometime this year.
Other provisions in McCain's bill could result in the banning of some, if not many products (and potencies), which have been safely consumed for years. It is possible this was McCain's real agenda: not to make supplements safe (they already are), but to take choice away from consumers and restrict access to many supplements.
Posted by: Jeff | March 8, 2010 9:54 AM
Orrin Hatch is the best buddy the supplement industry has ever had.
Not only did he push through DSHEA and help vastly increase sales of products making all sorts of undocumented claims, his family and associates have also benefited.
His son became a partner in a lobbying firm working on behalf of Big Supplement (a.k.a. Big Placebo) and Orrin has actually said that he'd have no problem talking to his son about the firm's clients. All very cosy - and of course Natural News has nice cosy relationships with the industry, as Mike Adams
shills forinterviews supplement dealers, and drums up sponsors for his site while shrilly warning about government regulation that might put a dent in his ad revenue.It's not surprising that McCain is backing off efforts to regulate supplements. He's facing a serious challenge in Arizona from the far right, which could label him further as a Big Government advocate and gain traction with tea partiers and Ron Paul groupies.
Posted by: Dangerous Bacon | March 8, 2010 9:58 AM
"Big Supplement Lashes Out?" What is this? Ironic jape? Simple nutbaggery? It's true that in a democracy, with its declared commitment to personal liberty, individual freedom of choice will tend to cover a broad range. Obviously Orac is mortally opposed to this right. Need we note that most drugs and therapeutic substances have originated as herbals in the hands of local healers? The pharmaceutical industry has teams combing the world in search of these natural substances so they can put them under patent, and under this exclusive control, rake in more tens of billions of dollars. An essential part of their strategy is to outlaw your access to the natural substance itself. If these outfits could purport to add something "new" to air, patent the air, and charge you for it, they would. Orac's screed should be read as a pure theoretical statement for totalitarian monopoly capitalism.
Posted by: My Body | March 8, 2010 9:58 AM
@My Body
Yes. And then they spend millions testing them to make sure that they are safe. Please point me to the pre-clinical and clinical trials of dietary supplements to ensure that they are safe before they go to market.
Posted by: Todd W. | March 8, 2010 10:19 AM
What about pharmacists? They would be a good group to mobilize against DSEA I think. I talk to them about the vast array of quackery all around them and they don't like it, but say it is out of their control.
On second thought, the misinformation about the value of supplements is so vast that it is probably not going to change; kind of like fighting religion.
Posted by: Anthro | March 8, 2010 10:19 AM
DayOwl is almost right, but he/she has this warped view where Big Pharma is crushing Big Supplement under its boot. The problem with DSHEA is that, indeed, it undermines competition by allowing supplements to be rushed to market and then advertised using deceptive claims, while it's "competition" from the pharmaceutical industry has much tighter restrictions.
@My Body: Your apparently libertarian position would at least be logically consistent IF you also support the legalization of all drugs, and the elimination of the FDA approval process for pharmaceuticals. After all, should individuals have the freedom to choose whatever pharmaceuticals or recreational drugs they want, completely unfettered by government regulation. Right?
Posted by: James Sweet | March 8, 2010 10:25 AM
Why yes, it's a riff on... oh sorry you're still talking.
No. You were right the first time... it's a riff on the Big Pharma that woomeisters so often blame for things.
Unfortunately you're probably a drive by troll without any facts to back up your claims, but I may as well note that you claim "most drugs and therapeutic substances have originated as herbals in the hands of local healers", and "An essential part of their strategy is to outlaw your access to the natural substance itself".
While the first is believable, (though may well be bullshit), the second sounds like a bunch of nonsense. Can you name any of these substances that Big Pharma has 'outlawed'? Or is that just paranoid ramblings with nothing to back it up? I'm interested to know.
p.s. It's better not to refer to a well written and sourced article as a 'screed' when writing an unsourced unparagraphed rant (AKA a screed).
Posted by: Ender | March 8, 2010 10:42 AM
Another great post by Orac. And another tragic failure to reform the system. Orac, is there anything that we, normal citizens, can do to prevent the bill from being killed? Is there anything at all that can be done? Feels bad to know that some people are being abused with pseudo-science. Feels even worse to know you're only a spectator and can't change the course of events.
Posted by: Marc | March 8, 2010 10:43 AM
"Need we note that most drugs and therapeutic substances have originated as herbals in the hands of local healers?"
We could note this but we would be wrong.
It is likely true that a large proportion of prescription and OTC drugs have a basis in substances derived from "natural" compounds (i.e. in plants, molds etc.), but not that they were used by herbalists and then got appropriated and patented by Big Ol' Nasty Pharma.
No one is trying to "outlaw your access to the natural substance itself". What is being questioned is the ability to make money by selling products using unproven and false health claims.
"Health Freedom" is the battle cry of supplement pushers, whose idea of freedom is to be able to sell you whatever junk they want by any means possible.
Posted by: Dangerous Bacon | March 8, 2010 10:47 AM
@Marc
Write to your senators. I wrote to mine, as well as to a senator from my home state, even though I'm no longer a constituent.
Posted by: Todd W. | March 8, 2010 10:49 AM
The belief in the value of supplements is a religion as is the belief that if it is natural it must be safe.
Posted by: Militant Agnostic | March 8, 2010 10:50 AM
Ah, I see the libertarian "health freedom" supplement defenders have arrived. This ought to be fun.
Of course, the most hilarious thing about these guys is that they apparently don't realize that big supplement is being bought up by big pharma. Many of the supplements protected by the DSHEA are now manufactured by subsidiaries of big pharma. Pharmaceutical executives know an excellent profit opportunity when they see one, and supplements are perfect for them: Low overhead, none of that pesky pre-approval testing that new drugs require and that costs hundreds of millions of dollars, no worries about patents running out, etc.
Posted by: Orac | March 8, 2010 10:53 AM
Can you name any of these substances that Big Pharma has 'outlawed'? Or is that just paranoid ramblings with nothing to back it up? I'm interested to know.
By 2005 Bio-Stratum, a drug company, had discovered that pyridoxamine, a unique form of vitamin B6 could be an effective treatment for advanced kidney-disease caused by diabetes. For years Pyridoxamine had been available as a safe, affordable, unpatented dietary supplement. Bio-Stratum prevailed upon the FDA to ban the sale of Pyridoxamine as a dietary supplement so it could be marketed as a drug. In future this beneficial, naturally-occurring form of B6 will be available only to severely ill diabetics as an overpriced prescription drug.
DSHEA has at least some protections against drug companies turning natural ingredients into drugs. It prohibits a dietary supplement using any ingredient “authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food” If S.3002 became law Pyridoxamine would be only the beginning. There is already a prescription form of Omega-3 fish oil. It costs about seven times more than the same amount of Omega-3 fish oil you can buy as a dietary supplement. What if the FDA was given arbitrary power to ban omega-3 supplements?
S.3002 would eliminate the protections contained in DSHEA. If S.3002 passes, ANY supplement could be banned arbitrarily, including those which have been safely consumed for years. McCain's bill would mandate that every dietary supplement would have to go through a brand-new process of FDA review (yet to be defined) in order to remain on store shelves. The FDA would then decide which supplements it thinks are appropriate for consumers to buy; these would appear on a "list of accepted ingredients". Supplements drawn entirely from food and long-established supplements or supplement potencies could be banned arbitrarily.
Posted by: Jeff | March 8, 2010 11:01 AM
Would the DSSA affect all the autism "cures" and chelation therapy?
They are classified a suppliments aren't they?
Posted by: alareth
| March 8, 2010 11:03 AM
@Jeff #19:
So what you're saying is that pyridoxamine is a drug.
What are the side effects of pyridoxamine? What dose provides efficacy with acceptable safety? Are there any groups for which pyridoxamine is contraindicated?
Or should anybody be able so sell something they call pyridoxamine, free of inspection, and without having to disclose any other ingredients? Should they be allowed to sell their preparation absent those safeguards?
Posted by: madder | March 8, 2010 11:14 AM
No, alareth, it would not affect all of them. Some of them are supplements, some are homeopathic drugs (which are a category all on their own), and some of them are actual drugs being used off-label (such as the chelator EDTA, FDA approved only for the treatment of acute lead poisoning, and the drug Lupron, FDA approved for treatment of precocious puberty). It pretty much runs the gamut.
Posted by: Calli Arcale | March 8, 2010 11:17 AM
@Jeff
If a drug company can petition FDA to ban a supplement due to patent rights they establish for their product under DSHEA, how, exactly, would DSSA make that easier? What specific provisions of DSSA enable "arbitrary" banning of supplements?
From my reading of it, it would require that supplements prove that they are safe for consumption before they are marketed. It grants no special privileges to drug makers (who already own many supplement companies, as Orac pointed out).
It would be a new process for the supplement makers - actually showing that their product is safe for consumption before people actually start taking it. Wow. What a concept. That may result in a number of products disappearing from shelves if they either are not safe or if the maker decides they don't want to spend the money on such testing.
But, if you want things like ephedra to slip on by. Or OSR#1. By all means, support Hatch and the supplement makers. It's so comforting to know that Big
Snake OilSupplement has dedicated supporters.Posted by: Todd W. | March 8, 2010 11:18 AM
Fuck, but I hate healthfreedom nuts. They're all 'Ah kin inject mahself full of tincture-o-frogs'-legs if'n ah want and ah kin pump mah kids full a' sorbic acid 'cuz it's a free country and ah got the right to be a fuckin' dunce!'
Posted by: Katharine | March 8, 2010 11:22 AM
Did anyone actually EXPECT John McCain to do anything right?
The dude's a Republican who finished last in his class at the Naval Academy. If that doesn't make him an idiot, I don't know what does.
Posted by: Katharine | March 8, 2010 11:24 AM
People have this image of John McCain as some great and wise Republican equalizer.
He's not. He just occasionally gets a wild hair up his arse and does things that just coincidentally are the right thing to do.
Posted by: Katharine | March 8, 2010 11:26 AM
Jeff:
One notes that it is difficult for the FDA to recall or ban even industrial chelators, just as long as the manufacturer calls them "supplements":
http://scienceblogs.com/insolence/2010/01/pumping_autistic_children_full_of_an_ind.php
Yes, it took a case this egregious before the FDA thought it could act.
In any case, Jeff appears to be parroting the exact propaganda line of the supplement industry.
As for Jeff's constant parroting of the word "arbitrary," I say this to him:
"Arbitrary." You keep using that word. I do not think it means what you think it means.
Posted by: Orac | March 8, 2010 11:27 AM
What Todd W. said, basically.
How does 'you must prove it safe' translate into 'big pharma will be able to patent it more easily'?
and on the Pyridoxamine issue, I don't have time to read up on it more fully now but "The FDA verdict, delivered on January 12, reasoned that the ingredient was authorized for investigation as a new drug before it was ever marketed as a dietary supplement - so it's 'supplement' use was actually predated by its investigation as a drug and that's why they ruled. Nothing to do with outlawing natural products we've used for years, and therefore completely unrelated to any Omega3 oil worries.
Posted by: Ender | March 8, 2010 11:30 AM
I suspect all of Gary Null's "millions"(sic)of loyal followers,shocked by the information about DSSA on his website, put the squeeze on McCain(illustrating how grass-roots political activism works!).Similarly, Null, Adams,health freedom fighters and their cadres of lawyers have been carping about "Codex Alimentarius" for years,"Stop it or we'll end up like *Europe*(shudder) or *Canada*!" Their usual spiel goes something like this:"In *Europe*,you can't freely buy large amounts of high dosage vitamin C, B complex,Omega 3's,NAC,( - recites nearly endless list of supplements- )You'll have to get a prescription from a doctor!!!" Which would obviously feel like a threat to someone who takes (or recommends and sells) vitamin C at 5000+ mg. a day and myriad combinations of supplements "essential"(sic) to nutrition.The next thing you know, the FDA might try to interfere with "brave maverick" herbalists like Greg Caton(see NaturalNews) and his marvelous, magical anti-cancer slave, Cansema... wait, they already did that.
Posted by: Denice Walter | March 8, 2010 11:43 AM
The whole problem with the libertarian-freedom-to-ingest-whatever-we-want position is that libertarianism can only work with a fully informed populace. If anyone is allowed to make any claim about anything it wants, then no one can make an informed choice, and is subject to marketing.
An important role of the FDA is to hold companies responsible for what they say and claim, to make sure they are telling the truth.
The irony to me is that, if I am reading it right, this would be the purpose of the McCain bill - to require companies to provide full disclosure about what they are selling.
I admit that I don't really have a problem with the selling of non-FDA approved substances, but they would have to be marketed honestly, and prominently display the results of testing, but this would also apply to supplements just as much. If the libertarians really want a free for all and to have everything available, then that has to happen with full disclosure of information so that the populace can make an informed decision.
The FDA is currently holding drugs to that standard, and beyond. I want the government to do the same thing with supplements.
It's not restricting the free market at all, it is making sure it is an honest market. Yes, I know the argument that "the market will weed out the bad seeds," but I'm not willing to let that happen when people's lives are at stake. I may have to turn in my libertarian membership card, but I draw the line at allowing companies to harm people as long as they can make a buck at it.
Posted by: Pablo | March 8, 2010 11:43 AM
Just a quick note to those who would argue against DSSA or any other sort of regulation for supplements. Take a look at pre-1906 drug regulation, when anyone could come out with any concoction they could dream up and claim all manner of health benefits for it, all without any evidence that it was effective or even safe. That is the current state of supplement regulation, more or less.
In short, supplement regulation is about 104 years out of date.
Posted by: Todd W. | March 8, 2010 12:04 PM
There's a good account of Colliers' Magazine's war on patent medicines and resulting governmental actions at Quackwatch, as well as a history of snake oil salesmen and their methods of deception.
Posted by: Denice Walter | March 8, 2010 12:26 PM
I'm on the side of "health freedom," I guess, in that people should be able to take most drugs as they wish.
But this DEMANDS good labeling of risks. The makers of the drugs and supplements don't necessarily need to "prove it safe," because "safe" is such a vague terms. All drugs have side effects; if we are lucky they also have benefits.
So the supplement makers should do studies and trials and accurately describe the risks. The amount of study needed is debatable, but in general the more people that use the supplement the more study it should receive. If only a few thousand people are buying vitamin Z, a small study will suffice. If tens of millions are taking it, then there should be continuing studies, even going up to the level of being randomized double-blind placebo-controlled comparisons, paid for by the supplement makers. And I don't think we're anywhere near this level of transparency.
I'm aware that my viewpoint may be proved wrong. Sometimes consumers simply don't make the right choices even when given good information. If liberty needs to take a back seat to public health, there are times that can be done (although I would prefer it to happen at the state level).
Posted by: Dan Weber | March 8, 2010 12:41 PM
Also don't forget addiction... One could be fully informed, yet still unable to make a reasoned choice due to dependence issues.
There is some appeal in the pure libertarian position here, though I don't condone it. However, what these trolls are pitching is not a pure libertarian position. Their position is, libertarianism for Big Supplement, heavy regulation for legitimate pharmaceuticals. While the pure libertarian position holds some superficial appeal, the libertarianism-only-for-our-side position just makes you an asshole.
Posted by: James Sweet | March 8, 2010 12:47 PM
Glad to see Quackwatch getting a shout-out. It's a good site with good information, to which you should refer your friends and family - especially the ones heading down woo highway. You may also want to subscribe to the weekly email from NCAHF, the unfortunately named Consumer Health Digest, a name shared by a woo site.
Posted by: TGAP Dad
| March 8, 2010 12:56 PM
@Pablo: The irony to me is that, if I am reading it right, this would be the purpose of the McCain bill - to require companies to provide full disclosure about what they are selling.
By law every supplement bottle must have a "supplement facts" panel on the label. All ingredients must be disclosed. Verifying this information is one the purposes of the FDA's Good Manufacturing Practices: "Manufacturers must evaluate the identity, purity, quality, strength, and composition of dietary supplements. All documentation must be shown to FDA agents when they inspect each manufacturing facility" (which the FDA is in the process of doing).
I may have to turn in my libertarian membership card, but I draw the line at allowing companies to harm people as long as they can make a buck at it.
John McCain tried to persuade us that supplements are unsafe, even lethal. In fact dietary supplements have the strongest record of safety of any class of products regulated by the FDA. Food kills more people than supplements. The American Association of Poison Control Centers just released their annual report for 2008. According to the AAPCC, for all of that year there were no deaths from any kind of dietary supplement. Of course this does not include illegal dietary supplements like OSR#1, or any supplement adulterated with a drug.
@Ender: It's DSHEA that allows drug companies to petition the FDA that a supplement be banned only if they can prove it was being investigated as a drug before being marketed as a supplement. DSSA would eliminate even this protection along with other key provisions of DSHEA.
The "accepted list of ingredients" provision of DSSA gives no criteria for what would make an ingredient "acceptable". The FDA could decide, at its own discretion, what supplements could be marketed, which would be banned, and which could be marketed only as drugs. The process sure sounds arbitrary to me.
Posted by: Jeff | March 8, 2010 1:04 PM
http://www.ourcivilisation.com/medicine/usamed/deaths.htm
Seriously?
At worst the supplement is bad science and quackery, at best it provides a compliment to the our current medical systems failings. All one has to do is look up statistics on Iatrogenic causes of death (as the link above has done) and one would say that the possibility of AER with supplements is provably lower than that of aspirin let alone the entire myriad of pharmacies patients have in their own home.
I work in the industry and I hear all kinds of crazy pseudo-scientific mumbo jumbo all the time. And yes it is like a religion to some people. However for the most part many of these companies and health food stores were started by individuals who having a medical conditions that had no allopathic treatment options available to the them decided to go the alternative and less proven path. And they found success. I could go on about how naive customers, store managers etc are and how predatory and unscrupulous manufacturers can be is a recipe for disaster. But if it is so potentially bad why are we not seeing higher AER's not that the FDA has mandated AER reporting by manufacturers. Will time tell? I would hope that a group of scientists who look at data could put their reservations and prejudices behind them and find serious problems in not only the supplement industry, but in the medical industry as well. I find the paranoia of consumers, who claim that they have a cure for cancer, they just aint sharing it as ludicrous as the sky is falling and people are dying from taking fish oil (perhaps you doubt the research, so why not read a couple hundred out of the thousands of studies on omega-3's http://omega-research.com/research.php?catid=5 )
this headline pleases me to no end
F.D.A. Cracks Down on Nestlé and Others Over Health Claims on Labels
Posted by: Clay | March 8, 2010 1:25 PM
@Clay
There are no regulations compelling the reporting of adverse events for supplements, like there are for drugs. Even with drugs, the adverse events are under-reported. So, just how many adverse events are reported every year for supplements? How many people who have adverse events actually attribute it to the supplement?
For example, if a supplement causes, say, cardiac problems after two months of continuous use, how likely is it that the patient or their treating physician will link it to the supplement? In particular, there are other factors that may be pointed to instead: genetic risk, lifestyle, other meds/products, etc.
Posted by: Todd W. | March 8, 2010 1:37 PM
1. Sounds like we have a homeopath who believes in magic water. The "allopathic" gives it away. Allopathy's been dead for centuries. Homeopaths just haven't updated their rhetoric after they out-competed other quacks.
2. Finding success? How do they measure it? Anecdotes? You do realize that referencing anecdotes is inherently an act of cherry picking, right? Good science involves removing bias, and cherry picking only serves to add selection bias.
3. Iatrogenic deaths? Malpractice is not a failure of science, it's a failure of infrastructure and implementation. Medicine is also about managing risks to get benefits. Given the large number of people involved, some are going to be unlucky, unfortunately. The altie crowd, however, spends a lot of time denying the existence of risk ("all natural means it's safe!") and trying to justify minimizing the effort they need to prove a benefit. They think of the public as a herd of guinea pigs, and that The Almighty Market will sort out any problems without any effort on their part.
Posted by: Bronze Dog | March 8, 2010 1:46 PM
I think Jeff is stretching a wee bit when he tries to demonstrate safety of dietary supplements via some annual report from the American Association of Poison Control Centers.
Both the FDA and consumer organizations have repeatedly demonstrated the occurrence of serious injuries and death from poorly regulated supplements.
Just recently there was an uproar over the development of renal failure and cancer in a British woman who was given a Chinese herbal supplement for a chronic skin rash. The product in question apparently included one or more herbs containing aristolochic acid, which has been implicated in other cases as a highly toxic and carcinogenic agent. Yet you can find a U.S.-based supplement company selling an herbal mixture under the same name, with one component identified as "Caulis aristolochiae manshuriensis", marketed as good for quelling "sthenic fire in the liver and gallbladder meridians".
It's hard to defend the ability of companies to sell this sort of stuff as "health freedom" - unless you've either swallowed industry propaganda* or are profiting from such sales.
*interesting how people who complain the loudest about the Big Pharma-Medical Establishment Conspiracy are generally the first to fall for the "health freedom" protests and bogus claims of the supplement industry.
Posted by: Dangerous Bacon | March 8, 2010 1:47 PM
My view on "Health Freedom": It's a euphemism for "caveat emptor": Let the buyer beware. If you don't have the expertise to recognize the dangers, well, you're not a good enough Ayn Randian Marty Stu to survive in the world, and deserve what's coming to you for being weak.
Posted by: Bronze Dog | March 8, 2010 1:53 PM
Did I miss something? Did the FDA actually act on this egregious use of the DSHEA? I was under the impression that the FDA's last "act" in this farce was to send a strongly worded letter and that they had taken no further action.
Please tell me that I'm wrong.
Prometheus
Posted by: Prometheus | March 8, 2010 2:04 PM
Actually, I think you're right. The action that the FDA took was simply to send a nasty letter telling them not to do it again.
Posted by: Orac | March 8, 2010 2:17 PM
Strangely enough, the supplibertarians never seem to harp on patent laws, which are where some legitimate claims might actually be laid at the feet of Big Pharma. While the base for patent laws actually make sense (in that they encourage the investment necessary for research), the actual application of those laws is often abused (most often by companies that tweak a formula or release new test results in a manner meant to extend the life of a patent beyond the baseline).
Instead, the supplibs focus entire on attempts to sensibly regulate supplements in the first place. Makes me wonder how many supplements are, themselves, patented.
Posted by: Freemage | March 8, 2010 2:24 PM
Given all the advertisements I've heard where they've touted "patented" as if it were a guarantee of efficacy, I'd say lots.
Posted by: Bronze Dog | March 8, 2010 2:47 PM
So, where are the pure libertarians? They usually show up about now, claiming we don't need the FDA at all. I actually had a libertarian tell me that if we abolished the FDA, independent laboratories would open to fill the gap and take over testing.
Posted by: Alexis | March 8, 2010 2:56 PM
Bronze Dog: Note, however, that it's easy to say something is patented. You can say it even if it is not really patented. Most people won't bother to look it up. (Well, regulators would, but the only one that would apply in this case would be the FTC, and they're only going to check if someone else does first and then makes a complaint.) It's a lot like claiming that your overpriced Vitamins C & A supplement is clinically proven; if nobody checks, you can get away with it for a long time, and it makes it look more important.
Posted by: Calli Arcale | March 8, 2010 3:20 PM
One of the more vacuous claims by the pro-supplement crowd is that Big Pharma will ignore the ancient tribal wisdoms about the curative properties of suchandsuch root or whathaveyou flowers because they wouldn't be able to patent the results and therefore won't be able to make gobs of money in the process.
This claim is refuted in 1.2 seconds on Google, where the term "patented herbal supplement" (in quotes) get almost 21 thousand results. 12K for "patented herbal remedy"... It's trivial to find dozens of hundreds of hits on the The United States Patent and Trademark Office site for searches of a similar vein.
Posted by: Scientizzle | March 8, 2010 3:29 PM
To piggyback Calli Arcale, even if you make outrageously false claims, and get caught, a letter of reprimand from the FDA is hardly likely to mess up the bottom line. Would be nice if the 'teeth' would draw a little blood.
Posted by: MikeMa
| March 8, 2010 3:40 PM
@ Scientizzle: speaking of vacuous claims by the pro-supplement crowd, here's another:"If you take a pharmaceutical, you'll need to take it for the *rest of your life*(you might even become addicted!!!)" unlike herbs and supplements that you....just keep taking (or else you'll need pharmaceuticals! or the improvements you've enjoyed will disappear, etc.)Seriously. And I won't even *start* about cost!
Posted by: Denice Walter | March 8, 2010 4:00 PM
Scientizzle - Someone also patented basmati rice, until they got caught. Legally, you may not patent a plant or traditional combination of plants for a use that has been previously published. You can patent a unique preparation of a plant, e.g., a novel extraction method. You can patent an extract marketed for a novel use - if you are the first person ever to discover that X plant might be good for Y disease, you can protect the right to market the extract with that claim, if your investors are deluded enough to think that any number of trials will ever get the FDA to approve it as a drug that can make disease claims. And you can patent a novel combination of plant extracts that together have a particular bioactivity. Nothing you do can give you the right to patent the use of peppermint tea for stomachache.
Dangerous Bacon - the FDA, which has the right to ban genuinely dangerous botanicals, banned the sale of all aristolochic acid-containing botanicals several years ago. The product you link to is blatantly illegal on those grounds (unless, of course, it actually contains magnolia rather than aristolochia - then it would just be illegal under the DSHEA and GMP requirements that products be correctly identified and not adulterated). Have you considered trying to call this to the attention of the FDA? If they do not take action against this vendor, either for lack of interest or lack of manpower, one rather doubts that they will have the interest and manpower to respond to endless kerfuffles over the availability of one supplement after another with no proven safety risk. (Or do some people think that it would require less manpower just to enforce a total ban on all herbs not sold in a McCormick bottle?)
Posted by: jane | March 8, 2010 4:11 PM
Just what would make that a "deluded" belief, given how many drugs have gone through precisely that process of being originally found in a plant, isolated/refined, subjected to proper clinical trials, and approved?
It has apparently escaped your notice that requiring such "supplements" to be registered with the FDA would allow blocking such to be easier and take less resources.
Posted by: Scott | March 8, 2010 4:23 PM
@Todd W.: Unfortunately, I live in Canada for now since I'm going to a Canadian university. I don't know how much water a letter from some guy holding American citizenship but living in another country would hold. I did, however, tell my friends back in the States to do this. Now, technically, I also hold Canadian citizenship. I wonder if putting pressure on the American embassy in Canada would help. But then again, I'm not sure about this. Usually, the embassy is used to seek political asylum, not for this type of complaint.
Posted by: Marc | March 8, 2010 5:17 PM
Scott - You have changed the topic to single-compound pharmaceutical drugs, of which many indeed have been derived from medicinal plants. I am talking about the use of a multi-compound plant extract as a drug in the legal sense, i.e., something marketed and prescribed to treat a "disease" (again, as legally defined). Some plants contain no single compound that offers the same combination of safety and efficacy as the whole plant, so for consumers it will always be the whole botanical or nothing. Until recently, it was legally impossible even to seek FDA approval for such extracts. Now, it is just virtually impossible, as botanical drugs are technically allowable but the agency really, really does not like them. Companies have spent millions of dollars on studies and gotten nowhere. Would a Big Pharma company spend hundreds of millions to, say, convince the FDA that hawthorn really does treat angina? They'd be crazy to, because while they'd then have legal exclusivity to market hawthorn *with a health claim*, they couldn't actually charge very much for it or you and I could just plant the stuff in our backyard and duplicate the product ourselves.
It has apparently escaped YOUR notice that the manufacturer or importer of the supplement you criticize is ALREADY violating the law. I am not sure why you assume that those who are ignoring every other regulation would line up to register their crappy internet-marketed supplements. It's rather like the assumption that if we banned guns, the professional criminals would all turn theirs in.
Posted by: jane | March 8, 2010 5:44 PM
@jane
Citations, please, for these claims. For the first sentence, please cite the relevant law or regulation. For the second, please cite some evidence (e.g., relevant regulations, FDA guideances, etc.). For the final sentence, a citation of a company spending the money, the studies they produced and the responses from FDA in response to their applications.
Posted by: Todd W. | March 8, 2010 6:11 PM
"...botanical drugs are technically allowable but the agency really, really does not like them. Companies have spent millions of dollars on studies and gotten nowhere."
Aside from the nonsense of the FDA supposedly being biased against botanical drugs (guess they screwed up by letting taxol slip by them, huh?), drug companies have spent billions of dollars over the years investigating all sorts of potential pharmaceuticals in vain - that's the nature of drug research.
"Would a Big Pharma company spend hundreds of millions to, say, convince the FDA that hawthorn really does treat angina? They'd be crazy to, because while they'd then have legal exclusivity to market hawthorn *with a health claim*, they couldn't actually charge very much for it or you and I could just plant the stuff in our backyard and duplicate the product ourselves."
They seem to have made out OK over the years selling digoxin for heart failure even though "you or I could just plant (digitalis) in our backyard and duplicate the product ourselves". If hawthorn ever proves to have a practical beneficial effect for treating heart disease, it'll probably involve some purified extract that has a dependable, reproducible effect on cardiac function that can be safely taken by patients. (Then, the alties will drop it like a hot potato, or whine about how the Magickal Goodness of Hawthorn has been lost by not using the Whole Herb As God Intended).
It does not make sense for DSHEA supporters to deride the FDA for being toothless but simultaneously deny them the regulatory power and funding to protect Americans from charlatans in the supplement industry.
Posted by: Dangerous Bacon | March 8, 2010 6:49 PM
@Todd- They actually are required to.
how feasible that is and or accurate is up to debate, but the law is on the books and has been. So please stop arguing that supplements are not regulated. What would be accurate is that they are treated more like food than they are drugs, unless a manufacturer or distributor begins to make drug like claims, in which that case the FDA has seized warehouses etc full of these new "drugs'.
http://www.qualitydigest.com/inside/fda-compliance-news/nsf-keeping-pace-fda-gmp-regulations
The new version of NSF/ANSI Standard 173: Dietary Supplements contains revisions to Section 8 GMP requirements that reference the new FDA requirements for dietary supplement GMPs and the Adverse Event Reporting (AER) requirements that went into effect in December 2007. The NSF American National Standard is used to evaluate and analyze dietary supplements to ensure that they don’t contain undeclared ingredients or unacceptable levels of contaminants such as pesticides and heavy metals.
Part of DSHEA required the FDA to Implement these standards. It took the FDA almost 14 years. Which I don't doubt that the certain segments of the supplement industry fought, as it would require them to clean up their act, no different than say what is going on with Toyota.
Posted by: clay | March 8, 2010 7:07 PM
@Bronze Dog
No I am not a homeopath fan, nor user. Maybe you should read my post again and refute some of it based on scientific fact not ASSumptions. I agree with you on anecdotal reports. But I don't have evidence to counter the claims of a owner of a health food store who: spent 60 days in a hospital bed in 1967, suffered from Celiac Sprue and had no objective or subjective improvements until he began to try supplementing with certain vitamins, minerals and herbs, and dietary modification. Now I could GUESS, but that isn't very scientific either. And in reality science has bridged the gaps on how many disease states are related to a nutritional deficiency. This is not a claim that vitamins, fats etc are cure alls or even drugs. If that was the case enriched wheat flour would be a drug as it prevents pellagra, beri beri, spina bifida and iron deficiency. Through in some Iodized salt into the recipe and it prevents goiter. Does this mean that supplements are panacea's? Hell no, not even close. Given how much processed junk food and Americans eat though, it's not a bad idea to take a low mg content multi and cover bases if one isn't willing to eat plant matter, fish and get exercise. Do you need some references to a healthy diet and it's effect on certain disease states?
Like I said, I work in the industry and I am sick of the woo factor. Yet the overwhelming BELIEF here is that there is no science behind ANY supplementation . Tell that to all the children who had their risk of developing Nyctanopia in impoverished countries via treatment with half a pill of retinoids every 6 months. Because I know you have already formed an incorrect opinion on my stance, I must reiterate, companies that break the law need to be severely punished for providing false hope to ill individuals.
Also your apologetic attitude towards what could be argued is the Number 1 if not certainly the number 4 killer in america is our current medical system. Yes medical malpractice plays a role, and due to the shear volume one would assume there to be a higher level. What good is the science if it doesn't take into account the real world where we live, where bias does exist? Flexibility in medical practice could actually save lives, unfortunately neither side wants to give an inch, instead their is hyperbole and name calling. How does this benefit those consumers who wish to get educated when scientists sit here and yell quackery while at the same time prestigious research centers explore the role of nutrients in health and degenerative disease. Harvard to name but one.
From http://www.medterms.com/script/main/art.asp?articlekey=10981
Allopathy is not dead, the term is.
Allopathy: The system of medical practice which treats disease by the use of remedies which produce effects different from those produced by the disease under treatment. MDs practice allopathic medicine.
The term "allopathy" was coined in 1842 by C.F.S. Hahnemann to designate the usual practice of medicine (allopathy) as opposed to homeopathy, the system of therapy that he founded based on the concept that disease can be treated with drugs (in minute doses) thought capable of producing the same symptoms in healthy people as the disease itself.
Posted by: clay | March 8, 2010 7:41 PM
Anyone know anything about "K2"? I saw an article about it on Alter.net, that some states were about to make it illegal. I had never heard of it before, but it's supposed to have effects like cannabinol. So of course, I googled it and ordered some. Sheese! $39 for 3 grams!
Also note: I am not the Clay who posted earlier on this thread.
Posted by: Clay | March 8, 2010 7:59 PM
In the real world flexibility in medical practice seems to work out as MDs offering such risky quack treatments as hyperbaric chambers for autism, chelation therapy for cardiovascular disease, autism or anything else they can think of, encouraging people to avoid vaccination, massive overdoses of vitamins (which the doctor just happens to sell) that give you expensive urine, Reiki, accupuncture, homepathy and so on. How is that going to save lives.
As for nutrition - what a massive strawman you have set up there.
Posted by: Militant Agnostic | March 8, 2010 8:00 PM
@Militant Agnostic
Flexible, not to be confused with a contortionist and Not to be confused with quackery.
As bronze dog once said, does the earth end at florida? Look no further than Italy where they give fish oil in conjunction with drugs after a heart attack and have seen a reduction in mortality. Where they say it is almost criminal not to provide omega-3's. Or would you like the world of leading lipids researchers. http://www.issfal.org.uk/index.php/lipid-matters-mainmenu-8/issfal-policy-statements-mainmenu-9/23-issfal-policy-statement-3?showall=1
Quit lumping me in with ideas I have not espoused. I don't speak on behalf of charlatans, nor defend them. Maybe we should sit down for coffee and have a civilized debate of our ideas, because facts are salient and unarguable. Here is a simple one, Mg is needed for the creation of ATP and the cleaving of the Phosphate group off the ATP in the production of energy which forms ADP. different enzymes, both dependent on Mg.
So do americans consume sufficient Mg? Well what about this..http://stroke.ahajournals.org/cgi/content/full/29/2/411
One has to look at this in a long term picture, how does intake/excretion occur and how does it effect disease states. Well from the late 60's to the present day, low dietary magnesium has been linked to a higher incidence of cardiovascular disease. Does this mean that if you take Dr Pills brand XXX mega Magnesium you'll be protected from such events? No. In fact I pointed out that lower mg content is better for one simple reason, it raises tissue stores without disturbing blood levels so much that your kidneys excrete the excess.
I'm just curious as to what you think the Human body has been made of. Does diet in no way effect health, or the structure, if so please explain rickets from A lack of cholecalciferol or a bow legged syndromes associated with excessive phosphorus:calcium dietary intakes.
Posted by: clay | March 8, 2010 8:28 PM
Just of note Clay, narcotic laws include derivatives of known restricted substances. If K2 is like THC then purchasing K2 could be considered a felony. If you have also been following the war on drugs has gone up a notch recently with some pretty extreme constitutional violations committed for the sake of acquiring a stash. The health dietary supplement promotors here seem to be missing one of the main original points. If it is a food then go right ahead and sell it, if it is a medicine than it should first be proven safe then be proven effective. However, it isn't as if any diet is ever deficient in vitamin echinacea which really is what we are arguing about.
As per Jeff's "Of course this does not include illegal dietary supplements like OSR#1, or any supplement adulterated with a drug." That is the other main point. If supplements are not registered with the FDA, are manufactured outside the US, or frankly are created in some Joe's basement and sold through websites we don't really know what is in it. The burden of the research and investigation is then on the tax payers not the producers of said supplements.
Posted by: MS3 | March 8, 2010 9:19 PM
K2? Wait, what? I knew skiers can be obsessive, but why would anyone want to make K2 skiesM illegal?
Posted by: Chris | March 8, 2010 9:32 PM
@Clay:
http://lmgtfy.com/?q=site%3Ascienceblogs.com+K2+marijuana
Posted by: Otto | March 8, 2010 9:44 PM
We do not need government regulating vitamins, minerals, and herbs. The FDA can kiss our ass.
If you do not like to take supplements, then do not take them. However, do not force your will against those of us who do take supplements. If you wish to regualte something, how about regulating Vioxx. It's more dangerous than any herb sold on the market. Better yet, regulate the left wing supplment haters.
Turds beware, Dark Vader (Obama) has deceived you all.
I hope this evil scheme of McCains fails and fails miserablely and I sure as hell hope he gets beat in his upcoming election. He is a phony conservative and has betrayed the party, their values, their beliefs, and has joined Dark Vader (Obama) and the emperor (Rhambo deadfish) in the government takeover of every aspect of our individual soveriegnty and freedom. I hope all traitors get crushed in this election year.
Posted by: Darewimple | March 8, 2010 10:21 PM
Are you for real, Darewimple? Could you cram any more wingnut rhetoric into such a tiny bit of text? "Evil scheme of McCain's"? "Regulate left-wing supplement haters"? You really are hilarious. Best laugh I've had in a long time.
Posted by: Orac | March 8, 2010 10:32 PM
Why does the far left hate groups want to regulate everything? Why are they so against the freedom that our founders laid out in the constitution. Free will and personal resposibility along with individual soveriegnty and the power to make personal decisions is what this country was founded on. You people are enslaving us with these regulations. We should regulate the left if anything. Look what you did to California. It could be the most independent wealthiest state in the union right now if if were not for the hippy communists who moved there, bred, and seized power. They turned California into a downgraded version of Cuba. It went from a pontential wealthy free state to a people's republic of whore, liars, beggars, cheats, frauds, sodomites, homos, and God haters. Sounds like the Soviet Union. It is the California model that for some reason the fasr left nuts want the rest of us to adhere to. I refuse to live in that hell. I am a soveriegn citizens with rights granted directly from God himself, instilled into the minds of the founding father and penned by them on paper in 1776. I still love the document that gives me individual freedom, choice, and the ability to fight back against government tyranny much like they themselves had to do. Entitlements bring slavery. regulation brings domination, and domination brng REVOLUTION. To hell with your regulations. We had enough already. Go regulate your farts. nevermind, the EPA alreadys want to do that in the name of the non-existant global warming that should be renamed global whining.
One of these days when Jesus returns with His immortal army merciless angels, they are going to kick the left's ass and I hope they let me watch. Like the song goes, WHAT A DAY OF REJOICING THAT WILL BE!
Posted by: Darewimple | March 8, 2010 10:46 PM
Now now Orac, remember that decent is the highest form of patriotic.
http://www.flickr.com/photos/unpossibles/3462246191/
Posted by: snerd | March 8, 2010 10:55 PM
Darewimple (may I call you Courageous Nun's Hat?), you have inspired in me a neogilsm: 'Poegarbl'
Posted by: snerd | March 8, 2010 11:01 PM
"may I call you Courageous Nun's Hat?),"
Sure. may I call you terd? You have inspired me to raise one hand and yell "ALL HEIL DARK VADER LORD OF THE HELLTHCARE MADANTE!!"
Posted by: Darewimple | March 8, 2010 11:11 PM
Nutty as a fruitcake...
Posted by: NJ | March 8, 2010 11:16 PM
@darewimple
How much noni soaked coral calcium have you been smoking?
Jesus was a liberal, get over it. He had a firm hand towards the rich, but loved the poor.
Posted by: clay | March 8, 2010 11:32 PM
The constitution was divinely-inspired? I haven't heard that one before.
Posted by: Patrick | March 9, 2010 12:21 AM
I call Poe on Darewimple.
Posted by: The Panic Man | March 9, 2010 12:25 AM
Dare le wimp, your raging impotence is palpable. You need to get out of the basement more often.
Posted by: Pareidolius | March 9, 2010 12:42 AM
@Darewimple:
"Why does the far left hate groups want to regulate everything?"
>> Ignorance of Marxist politics.
"Why are they so against the freedom that our founders laid out in the constitution. Free will and personal resposibility along with individual soveriegnty and the power to make personal decisions is what this country was founded on."
>> Nope. The country was founded mostly on land grabs from Indians and Mexicans and on slavery of Africans.
"You people are enslaving us with these regulations."
>> How funny. If you want to know what slavery means, read a history book about it or go into a Texan prison and speak with black inmates.
"We should regulate the left if anything."
>> Contradiction with the claim above that government should not be allowed to restrict anyone.
"Look what you did to California. It could be the most independent wealthiest state in the union right now if if were not for the hippy communists who moved there, bred, and seized power."
>> Independent and in the union? Contradiction.
"They turned California into a downgraded version of Cuba."
>> Which is exactly why California's GDP is higher than the cumulative GDP of Cuba and many others (years considered 2008-2009).
"It went from a pontential wealthy free state to a people's republic of whore, liars, beggars, cheats, frauds, sodomites, homos, and God haters."
>> So, basically a real-world version of Sodom and Gomorrah? Hardly. Prostitution is still illegal. Most of the liars, beggars, cheats, frauds could be found in Las Vegas, which is in Nevada. And one great thing about California is that they are as close to a secular state as one can get. Finally a state where I can yell "The very idea of God is bullshit!" and be answered "Dude!" As for sodomy, it's just fine, anal sex feels great when done right.
"Sounds like the Soviet Union. It is the California model that for some reason the fasr left nuts want the rest of us to adhere to."
>> Gross ignorance of international relations and Russian history. The Soviet Union was a totalitarian state, socialism/communism were only pretexts. And the "far left" probably hates the Californian model. They probably want a dictatorship of the proletariat or something similar.
"I refuse to live in that hell."
>> Not a problem. You can go live in other, more sinister, hells such as Kansas, where ID/Creationism is considered on par with Evolution.
"I am a soveriegn citizens with rights granted directly from God himself, instilled into the minds of the founding father and penned by them on paper in 1776."
>> Such as the right to make the grammar mistakes of a nine-year old. Also, how about this quote from George Washington: "The government of the United States is not in any sense founded on the Christian Religion."
"I still love the document that gives me individual freedom, choice, and the ability to fight back against government tyranny much like they themselves had to do."
>> And instead of being subject to government tyranny you shall be subject to corporate tyranny.
"Entitlements bring slavery. regulation brings domination, and domination brng REVOLUTION."
>> I'm sure that my political science teacher would fail me if I even joked about some BS like this.
"To hell with your regulations. We had enough already. Go regulate your farts. nevermind, the EPA alreadys want to do that in the name of the non-existant global warming that should be renamed global whining."
>> Ah, I see. This is in fact Ronald Reagan, back from the dead. The stance on climate change is also on par with Reagan's. And if you don't like our regulations, not a problem. Have fun ingesting everything you want, the Darwin Awards need more nominations.
"One of these days when Jesus returns with His immortal army merciless angels, they are going to kick the left's ass and I hope they let me watch. Like the song goes, WHAT A DAY OF REJOICING THAT WILL BE!"
>> Interesting theory. The Lord of the Rings meets the Bible meets Anarcho-Capitalism.
Posted by: Marc | March 9, 2010 1:13 AM
Damn I hope that's a poe. Otherwise, someone is in need of a hug.
Posted by: marty | March 9, 2010 1:42 AM
Poegarbl or Poearrhea? The possibilities just keep flowing.
Posted by: snerd | March 9, 2010 2:07 AM
wow, that guy really hates libs. I'm with clay, Jesus was the most famous liberal of all time. Not only that, he was a hippie too, what with not having a job, never showering, long hair and beard, promoting love and peace to all.
Disliked rich people, encouraged everyone to work together in communities (damn communist ;P)
Posted by: squargr | March 9, 2010 3:18 AM
When I asked "who stands to benefit the most from regulation?", my own assumption was that the bigger supplement companies would gain the most since new, expensive research & safety requirements would put the little companies out of business. If Big Pharma is buying up the supplement companies, new regulation is so much the better. They already have all the mechanisms in place.
I know that my deeply cynical nature is showing. Whenever someone starts pushing for regulation, I'm doubtful that they really have my best interests in mind. I'm more inclined to "follow the money". Consumers should ultimately benefit from tighter regulation, but I don't believe that's what gets it introduced as a bill in the first place. People with something significant to gain (profit or power) get it there.
@madder: Name calling really undermines your argument.
Posted by: DayOwl | March 9, 2010 8:35 AM
DayOwl, sure: it'll drive the small companies who can't afford to test their products for safety out of the market. I'd make the argument they shouldn't even be in the market anyway. If some company wants to sell you either placebo or really expensive urine pills (Vitamin C), by all means do it, but I'd like to know that they are safe and don't contain some industrial product.
Ideally, I'd like for the FDA to evaluate their health claims. That "Airborne" crap curing the common cold faster because it was "developed by a school teacher"? It is just a multivitamin. It doesn't do anything. While it is a relatively harmless waste of money, some of these "supplements" are not. Some are dangerous, don't list their contraindications, or even deadly. Those should be regulated.
If your product is going to make a medical claim, it should have to be evaluated in a proper double blind clinical study. If your product isn't going to make a medical claim, it should be evaluated to be safe and benign in a clinical study.
Posted by: smidget | March 9, 2010 9:51 AM
Todd W - if I paste links here, it'd get caught by the spam blocker, but in any case I'm under no more obligation than any other commenter here to do your Googling for you. People who demand "citations" for every single simple statement of historical fact are in my experience the least likely to actually read and accept any citations given.
Dangerous Bacon - Your ignorance is showing on several counts. Firstly, you cannot duplicate or surpass digoxin by growing digitalis in your back yard, because in this case the ability to exactly standardize the quantity of the drug greatly improves the risk-benefit ratio. With digitalis, if you don't have a lab to quantify the active ingredientS, you have to either take a pretty low, often suboptimal dose or risk overdose. Thus the drug-development model improved on the traditional remedy.
Secondly, by contrast, you seem unaware there have already been dozens of human clinical trials to show that hawthorn provides safe and effective relief in stage I and II heart failure - plus human studies to show, e.g., that it improves the heart's ejection fraction, plus animal and in vitro studies that have begun to elucidate the mechanisms by which it works. These studies have determined that the overall benefits CANNOT be narrowed down to one compound. If that fact offends your pharmaceutical sensibilities so greatly that you, should you develop this condition, would rather take a pro-arrhythmic single compound than an anti-arrhythmic botanical, you are free to do so. I am free to make the opposite choice, and I don't want to see Congress take that freedom away from me.
Posted by: jane | March 9, 2010 9:55 AM
@jane
One link will be allowed through, and I think two might still make it. Beyond that, spam filters will catch your comment and hold it up until Orac lets it through. But, unless you're linking to nudie sites or sites that contain computer viruses or trojan horses, it'll show up. You could also just post the title of the source, the author's name and other identifiers so people can find it, or post the URL in a cut-up format (e.g., www (dot) cdc (dot) gov).
Now, as to you providing your evidence vs. me looking it up. First, you made the claim; you need to back it up. Second, even if I googled around for stuff, I don't know which sources you are using to support your claim. I could find and read sites A, B, C, D and E, but you're using site Q. Finally, contrary to your experience with other individuals, I actually would read the links you provide. If you provide the links and I read them, I might be convinced. If you provide the links and I don't read them, at least everyone else who is reading this will be able to see upon what you are basing your claims.
The only thing you'll lose by posting your citations is a few seconds of extra time. Well, you might also lose credibility if your source is something like whale.to, Natural News or rense.
Posted by: Todd W. | March 9, 2010 10:08 AM
One of these days when Jesus returns with His immortal army merciless angels
Yeah. It's been - what - 2,000 years? Keep holding your breath. He's coming aaaaaaany day now. (eyeroll)
Posted by: Marcus Ranum | March 9, 2010 10:47 AM
@Jane
Funny, in my experience people who refuse to post their sources usually don't have any.
Posted by: JohnV | March 9, 2010 10:54 AM
Well, you will know not the hour or the day, and all that. ;-) (Though "merciless angels" -- is Darewimpl one of those "Left Behind" fans? I think snerd wins a few internets for calling that post "Poegarbl".)
Posted by: Calli Arcale | March 9, 2010 11:02 AM
@DayOwl:
I suspected that you may be a troll based on your flat claim that "the true purpose of regulation is to limit competition," as well as your definite statement that regulations such as the product-safety ones discussed here are not intended to benefit the public. I found your claim to be preposterous, and suspected that you did not really believe it. The generally accepted term for this behavior is "trolling." Your more moderate statement since then ("consumers should ultimately benefit from tighter regulation") shows that you are not a troll, but merely an unclear writer.
Posted by: madder | March 9, 2010 11:16 AM
Todd W.: Take a look at pre-1906 drug regulation, when anyone could come out with any concoction they could dream up and claim all manner of health benefits for it, all without any evidence that it was effective or even safe. That is the current state of supplement regulation, more or less.
Not true. Any new supplement is subject to the New Dietary Ingredient regulations. The FDA has rejected approximately 70% of all NDI applications since 1994, thus keeping many new supplements off the market. Companies don't have to prove effectiveness but they do have to provide evidence of safety.
There are clear rules about making claims for supplements. Yes there a few companies making false or exaggerated claims, but this requires adequate enforcement of existing laws, not more regulation. Many industry supporters have been demanding for years that the FDA take stronger enforcement action against rogue players:
http://www.nutraingredients-usa.com/Regulation/FDA-fails-to-deter-H1N1-fraud-claims-New-York-legal-expert
Posted by: Jeff | March 9, 2010 11:32 AM
In my experience people who demand specific sources for very general statements that would be noncontroversial to anyone who is informed on the subject are not going to benefit from being given sources. Okay, I am not a lawyer and am not going to do major research unless paid to. However, those who really wish to learn about this should start with the following:
1. Google "CDER botanical drug guidance 2004." This is FDA's new set of instructions on how, in theory, a company can get a botanical drug approved.
2. Google "FDA guidance UCM072112." This will lead you to a 1987-dated PDF, one of a small swarm of guidance documents related to New Drug Applications, which will give you some view of why FDA formerly just refused to consider botanicals as new drugs at all. Exhaustive pharmacokinetic details, and requisite studies of bioavailability, bioequivalence, etc., were required of every new drug application (and still are for novel single compounds). Many botanicals have dozens of active ingredients, some present only in small quantity and it is often impossible to identify all of them as such - much less to provide those many details of the pharmacokinetics for each and every one! A botanical simply could not meet this standard, no matter how well it had been proven to function in clinical trials.
Further, I have been told that FDA used to argue that a multicompound botanical would only be acceptable if the manufacturer could prove that every compound in the product independently contributed to activity - otherwise, as they saw it, those not so proven to be active should all be removed, an opinion apparently still in the minds of those people who call herbs "dirty" or "contaminated" drugs. Thus, in theory, if you wanted approval to put whole powdered material in a capsule, you'd have to prove that the cellulose and chlorophyll contributed to bioactivity. I am not taking the time to try to find a web page that mentions this attitude, but I find it plausible, since we are talking about an agency that during the same time period tried to outlaw ginseng as an "unapproved food additive" on the theory that the gelatin capsule was the "food" (google "FDA Alice in Wonderland" to find a federal judge's opinion of this).
3. Google "VeregenTM" or "Polyphenon E" to find the single botanical drug that has been approved during the last several years. This is a highly purified extract of green tea catechins, approved only for topical use on genital warts. You can get the same high-quality extract as a supplement for internal use. FDA approval came with a requirement for further studies of the "pharmacokinetics" of catechins absorbed through the mucosa - this for the extract of a plant that many people consume large quantities of daily, with resulting health benefits. (I have further heard that this product would likely not have been approved even for topical use had it not been a food plant, because of FDA's great discomfort with botanicals.)
4. You can google "Croton lechleri" to find an anti-diarrheal plant that a small company tried to get approved as a botanical drug. As I understand it, they shelled out for the biggest trials they could manage at FDA's request, then when the results were positive but they did not get a drug approval out of it, went bankrupt and had to restructure. The product is now available as a dietary supplement. IMHO, the combination of placebo-controlled trials and other use data show beyond a reasonable doubt that it does work. Fortunately, it works equally well whether it is called a "drug" or a "supplement."
Posted by: jane | March 9, 2010 12:05 PM
The DSHEA is just a safe harbor provision for those who want to make big money engaging in consumer fraud. Congress should feel shame that they betrayed their constitutuents this way.
Posted by: Free Lunch
| March 9, 2010 12:18 PM
jane, you did not make general statement, for one thing. And while this may come as a suprise to you, suggestions of what to plug into a search enginer ARE NOT CITATIONS.
Back your claims up or STFU.
Posted by: Natalie | March 9, 2010 12:24 PM
Posted by: Dan Weber | March 9, 2010 12:41 PM
Ah, there's the erudite answer when one's emotion-based dogma is threatened: "STFU."
I could go and get the web addresses for the FDA documents I cited, but why the hell should I? I already provided you the means of seeing those documents a lot faster than you would get to them if I pasted links that were then stuck in the spam filter for hours - and it is obvious that you would not have clicked on the links and looked at the documents anyway. It may come as a suRprise to you and certain others here that insults and tantrums do not make strangers work harder on your behalf.
Posted by: jane | March 9, 2010 12:41 PM
jane: "In my experience...noncontroversial to anyone who is informed on the subject...I have been told that...in theory...I find it plausible...I have further heard...As I understand it...IMHO...beyond a reasonable doubt..."
Forgive us if we are not impressed by your standards of evidence.
Posted by: Dangerous Bacon | March 9, 2010 12:55 PM
Because you care about convincing people of your argument, maybe?
Yes, that's actually why nobody wants to do your work and back up your own arguments for you.
Posted by: Calli Arcale | March 9, 2010 12:57 PM
Thank you for providing what you feel are citations that support your arguments. I will recap the arguments for which I requested citations:
None of the sources you provided establish that it was legally impossible to seek FDA approval for a botanical extract. As I said before, a proper citation to support this claim would be citing the particular law or regulation. It should be noted that FDA Guidances are not legally binding, but rather reflect the general opinion or attitude of the agency. A manufacturer does not need to follow such guidances, but it is generally recommended that they do.
I assume that the second guidance you cited is your basis for this claim, that the hurdles that all drugs need to go through are just too burdensome for botanical supplement makers. That guidance does not even mention botanicals, so it does not support any argument that "FDA doesn't like them". If the first guidance is what you're using to support your argument, my reading still finds that there is no inherent dislike of botanicals. In fact, give section III(B) and (C) a read. You'll see that botanical drug products require less stringent characterization than other drug products. In other words, the detail required is less than that required for other drugs. This guidance (PDF link) actually contradicts your opinion.
As support for this, I assume you are using the croton lechleri extract (developed by Shaman Pharmaceuticals) as your example? Shaman originally tried to market this as a supplement. However, they made the claim that it could "control diarrhea without causing constipation", which is a drug claim. Because they made that claim, they were subject to the regulations governing drugs, which meant they had to conduct clinical trials examining the PK/PD of the product, its safety profile, efficacy, etc. They were informed of this fact (PDF link). I was unable to find any other submission materials (their IND, NDA, etc.) for the company related to this product.
While it is unfortunate that the company went bankrupt, any company marketing a drug should conduct the necessary studies to show that their product is safe and effective, as well as show the ADME profile for the product. The purpose of all this is to ensure that drugs that reach the market are safe and effective.
You have, so far, failed to make your case that FDA "doesn't like" botanicals. You have not provided evidence that obtaining FDA approval for botanical products was not legal. I will agree that it is likely that companies have spent millions on studies and gotten nowhere, though I am, as yet, not convinced that the fault lies with FDA and the regulations, rather than with the companies.
Posted by: Todd W. | March 9, 2010 1:01 PM
@jane
I have a reply to you awaiting moderation due to multiple links. The short version is: you have not made your case. Take a look at my longer reply once Orac has approved it.
Posted by: Todd W. | March 9, 2010 1:04 PM
Nevermind. Looks like it was approved as I was writing my post saying that it was waiting approval.
Posted by: Todd W. | March 9, 2010 1:08 PM
It should be noted that FDA Guidances are not legally binding, but rather reflect the general opinion or attitude of the agency. A manufacturer does not need to follow such guidances, but it is generally recommended that they do.
Yes Todd W., FDA rules for new supplements are legally binding. See comment #89 which just got approved.
Because they made that claim, they were subject to the regulations governing drugs.
No. Since the company was trying to market a supplement, it was subject to regulations concerning supplement claims. See commenet #89.
Todd W. really does need to brush up on FDA rules governing supplements.
Posted by: Jeff | March 9, 2010 1:29 PM
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm072932.htm#ftnref2
Regarding qualified Health Claims.
II. The Agency's Consideration of a Qualified Health Claim
FDA has identified the following endpoints to use in identifying CHD risk reduction for purposes of a health claim evaluation for EPA and DHA omega-3 fatty acids: Coronary events (MI, ischemia), cardiovascular death, atherosclerosis, and high blood pressure. Artherosclerosis is the underlying cause of CHD, which can lead to the signs of CHD including coronary events (MI, ischemia) and cardiovascular death.[32] High blood pressure, serum total cholesterol, serum LDL-cholesterol, and serum HDL-cholesterol are considered as surrogate endpoints for CHD.[33] However, FDA concluded in its October 31, 2000 letter[34] that omega-3 fatty acids do not affect serum cholesterol levels (total, LDL, HDL). To evaluate the potential effects of EPA and DHA omega-3 fatty acid consumption on CHD risk, FDA considered coronary events (myocardial infarction (MI), ischemia), cardiovascular death, atherosclerosis, and high blood pressure as indicators or predictors of disease.
In considering the qualified health claim for EPA and DHA omega-3 fatty acid dietary supplements in October 2000, FDA focused on human data that had become available since FDA's 1991-93 review and on human studies that quantitatively measured or estimated the omega-3 fatty acid intakes in relation to a direct measure of CHD risk or a surrogate endpoint for CHD risk. Several, but not all, of the studies[35] that FDA had considered in its October 31, 2000 letter were submitted in the Wellness petition. Studies that have been published since that letter were also included in the petitions. For purposes of this review, FDA, in determining the scientific support for a relationship between EPA and DHA omega-3 fatty acid dietary supplements and CHD, focused on the more recent studies to determine whether these studies added any support to the scientific evidence that was used for the current qualified health claim for EPA and DHA omega-3 fatty acid dietary supplements. For purposes of determining whether there is a relationship between EPA and DHA omega-3 fatty acids from conventional foods and reduced risk of CHD, FDA determined whether the relevant studies cited in the petition, in addition to other relevant studies that the agency had already reviewed in its previous reviews support a qualified health claim.
Posted by: clay | March 9, 2010 1:57 PM
@Jeff
Go back and re-read what I said. I was talking about Guidances, which are a specific type of document. According to the FDA (emphasis added),
jane linked to two guidances. Those documents are not legally binding. The are recommendations, only. Eventually, guidance documents may become regulation, but only after publishing in the Federal Register and going through a lengthy administrative process to add them to the regulations, in which case, they will appear in the Code of Federal Regulations.
They were trying to market a supplement, but they made a disease claim. 21 CFR 101.93(g) covers disease claims. If a product makes a disease claim according to the definitions laid out in that section, then it is considered a drug, per the definition in 21 USC 321.
I'll admit I know more about drug and device regulations than supplements, but my knowledge still, apparently, amounts to more than you have.
Posted by: Todd W. | March 9, 2010 2:02 PM
Apparently when the FDA put something out saying that certain specific pharmacokinetic parameters MUST be provided for a new drug, they didn't really mean it? Yes indeed, the NEW botanical drug guidance relaxes formal requirements for botanical extracts relative to single-compound drugs. Until that happened, you simply could not get botanical drugs approved. Period. Perhaps some people would like us to think that nobody even tried to get a botanical drug approved for decades not because FDA wouldn't approve them, but because plants are so totally worthless - in that case, then, why is it that after the new botanical NDA rules came out they quickly received dozens of applications?
I admit that I am not a professional historian of drug regulations, and therefore, my knowledge of this subject is not complete. I am not capable of providing a complete dissertation on the FDA's internal politics during the last forty years. That doesn't mean that the FDA has spent all that time waiting with open arms to welcome any botanicals that have been shown to be effective by clinical trials (which include Croton lechleri). If you try to imply as much, I guarantee you that any remotely knowledgeable reader will laugh out loud, and will assume that everything else you say is equally distorted by ideology. Cheers.
Posted by: jane | March 9, 2010 2:06 PM
Posted by: MoM | March 9, 2010 2:13 PM
A quick bit of info for people regarding FDA information. There are several types of info you'll find covering food, drug and cosmetic products:
United States Code - This is the actual statutes passed by Congress. It carries the force of law.
Code of Federal Regulations - These are regulations created by various Federal agencies to enact and more clearly define what is in the USC. These carry the force of law.
Final Rule in the Federal Register - Once a Final Rule is published in the Federal Register, it becomes a regulation and is added to the CFR. These carry the force of law as of the published effective date.
Guidances - These are documents that represent the current interpretation of an agency about a particular law or regulation. They recommend what should be done. They do not carry the force of law.
Posted by: Todd W. | March 9, 2010 2:15 PM
Darewimple:
You are a whiny little baby. That is why you claim the political views you do, for they are the politics of whiny little self-centered hyper-entitled anti-intellectual hubristic dirty-diapered babies.
Posted by: BrianX
| March 9, 2010 3:49 PM
Also, I have to say I have never seen the big-L argument against regulation laid out so starkly before, so that people could glory in its blatant insanity, as DayOwl did in comment #1. Thank you, DayOwl, you've proven what conspiratorial lunatics you run with, and put in the simplest and bluntest terms why we shouldn't take anything they say seriously.
Posted by: BrianX
| March 9, 2010 3:58 PM
I have something to cry about.
http://canadafreepress.com/index.php/article/20823
------------
Me a whiny baby? What about the violent whiny asses protesting outside insurance companies demanding marxism replace the compnay when in fact they should be protesting the hospitals and doctors who made the price for the insurace to pay in the first place. If I were CEO of that company I would disperse those unpleasant assholes with a load of 12 guage bird shot. nohting lethal, but something to remember definitely. The insurance meployees should come out with firehoses, clubs, mace, and few maces (midevil style weapon) to beat back these marxists freaks. When they grow some balls and decide to fight back, I hope we can watch on pay per view. Better yet, you watch, I'll be the one shooting rotton eggs wth a wrist rocket at the mouth of the asshole protestors.
Posted by: Darewimple | March 9, 2010 7:05 PM
@Darewimple: There's no need to "protest" doctors and hospitals. Just boycott them. The Invisible Hand will take it from there.
Posted by: Otto | March 9, 2010 8:31 PM
Ugh
and of course my "progressive" radio station was celebrating this today.
Posted by: dfsparks | March 10, 2010 1:10 AM
I find it interesting that so much energy is involved in this debate. One side says that supplements are free of regulations, the other claims they are heavy handed on them. When the fact is the FDA has authority to remove any product that violates the laws that were written into law, and has done so numerous times.
I get that to many here it seems as though a vitamin or an herb can make a vague statement as long as it doesn't make a claim to cure, treat or prevent a disease. But if they do, well their are severe consequences, as there should be. One example as follows http://www.casewatch.org/fda/court/lane/lane.shtml
"The government’s request for a permanent injunction was based on the defendants’ demonstrated unwillingness to comply with the law. In 2002, Lane and his company settled an FTC case by agreeing to stop making unsubstaantiated claims and to pay penalties totaling $1 million."
But then we have the association of a vitamin as either causing a really expensive urine sample or a cure all to everything. As if there has been zero research on them or vice versa cure all in 1000's of mgs of a substance that humans only had a modicum of consumption in our history. Our undersatanding is closer to the middle, take magnesiotropic and calciatropic pathways, http://physiologyonline.physiology.org/cgi/content/full/23/1/32#F1
Supplements have to be Generally regarded as Safe. GRAS status is subject to FDA review. Salt had had its' GRAS status threatened by MD's since we know they greatly increase the RISK of CVD or CHD.
http://www.medpagetoday.com/Geriatrics/Hypertension/7540
Herbal concoctions. Well shit, thats a tough one, some herbs may be benign some beneficial and some toxic. Such as ephedra ( historical uses never saw it concentrated and combined with things like caffeine) "The RAND Corporation’s review of some 16,000 adverse-event reports revealed two deaths, four heart attacks, nine strokes, one seizure, and five psychiatric cases involving ephedra in which the records appeared thorough and no other contributing factors were identified." http://pn.psychiatryonline.org/content/39/3/24.full
compare that to OTC NSAIDS
By the Numbers – Impact of NSAID-associated GI side effects:
• An estimated 60 million Americans use NSAIDs regularly • It is estimated that more than 60 million Americans use NSAIDs regularly, resulting in clinically significant
upper GI events in one to two percent of users.7 • Over 80 percent of patients with serious GI complications have no prior symptoms or warning signals.8 • It is estimated that GI hemorrhages due to NSAID use account for approximately 60,000-120,000 hospital
admissions annually.9 • Though difficult to quantify, available reports suggest that deaths from NSAID-related GI events vary from
3,200 to more than 16,500 per year in the United States10,11 • Annual direct costs associated with NSAID toxicities are estimated at over two billion dollars.12
http://www.lindauerconsulting.com/HorizonTherapeutics/Risks.pdf
So apparently 2 deaths is heinous where as iatrogenic deaths, which very well could be the leading cause of death in this country, well hey thats just par the course. What makes one so much worse than the other, and please provide evidence to support your belief, because the facts don't support the supposed toxicity and lack of science behind supplementation. Anybody who thinks they can cure a disease with amino acids, herbs and minerals is not only deluded and naive, but misguided as well. Cures are rare in the medical community, but to say that you cant mitigate pain or improve the quality of life of an individual via complimentary methods (I include activities you don't have to pay for such as exercise and relation in this).
If somebody is practicing bad medicine or worse illegal medicine they should have the book thrown at them; the only thing worse than bad medicine is the cynical exploitation of somebodies hope for an improvement in health only to have it taken away with bad science.
http://www.nytimes.com/2010/03/04/health/04metalhip.html?ref=research
The cause and the scope of the problem are not clear. But studies in recent years indicate that in some cases the devices can quickly begin to wear, generating high volumes of metallic debris that is absorbed into a patient’s body. That situation can touch off inflammatory reactions that cause pain in the groin, death of tissue in the hip joint and loss of surrounding bone.
or
The May/June 2008 issue of The Journal of Orthopaedic Trauma published a report on “Low-energy femoral shaft fractures associated with alendronate use.” The authors reviewed records of 70 patients who had sustained low energy femur fractures. That means their femurs broke without any major stress. Rather they did little things such as walking or stepped off a curb and thus triggered the breaks. These weren’t young people, their average age was about 75. Of these 70 patients, 25 of them, a little over a third (36%), were taking Fosamax. Nineteen (76%) of those 25 patients demonstrated a simple, transverse fracture with a unicortical beak in an area of cortical hypertrophy. This is a rare and peculiar type of fracture. Only 1 patient of those not taking Fossamax (2%) had this kind of bone break. When the statistics were worked out, the numbers tell us that Fosamax use significantly increased risk of these fractures: the odds ratio was 139.33, 95% CI [19.0-939.4], P
0.0001). You can say those taking Fosamax were about 140 times more likely to get one of these rare fractures. It took about 7 years for this problem to occur. Those taking Fosamax less than 2.5 years were not at greater risk.
or just plain fraudulent research
http://www.the-scientist.com/blog/display/55823/
http://www.the-scientist.com/templates/trackable/display/article1.jsp?type=article&o;_url=article/display/55772&id;=55772
http://www.the-scientist.com/blog/display/55671/
And we can't forget the brit who made vaccinations become public enemy number one via false data.
Is DSHEA that bad? My opinion no, Oracs opinion Yes. Would McCains bill done anything new? Well if the local cop is refusing to do their job, making new laws for them to enforce won't guarantee that anything changes. That doesn't mean there are not good laws on the books, just that some people want to see them get tighter and others want them looser.
Posted by: clay | March 10, 2010 1:23 AM
clay: "So apparently 2 deaths is heinous where as iatrogenic deaths, which very well could be the leading cause of death in this country, well hey thats just par the course. What makes one so much worse than the other, and please provide evidence to support your belief"
A risk of death or serious injury resulting from use of a well-studied and medically effective treatment may be justifiable, especially if the alternative to no treatment is likely to be death or disability and the patient is informed of risks and benefits. But any deaths or serious injuries caused by taking ineffective quack remedies are unconscionable.
Get it now, clay?
And it's false that iatrogenic deaths are the leading cause of death in this country.
"Well if the local cop is refusing to do their job, making new laws for them to enforce won't guarantee that anything changes."
If you hamstring the "local" police force by denying it enforcement power and funding, it's foolish to blame it for not doing its job.
Posted by: Dangerous Bacon | March 10, 2010 12:31 PM
But any deaths or serious injuries caused by taking ineffective quack remedies are unconscionable.
What about the overwhelmingly negative reaction to McCain's bill? There were hundreds of thousands of messages sent to Congress in opposition to DSSA. These Americans consider supplements to be important for wellness and disease-prevention. And contrary to McCain's statements, supplements have an excellent track record of safety. According to data collected by the FDA and the American Association of Poison Control Centers, deaths from dietary supplements have been virtually non-existent over the last several years:
http://www.orthomolecular.org/resources/omns/v06n04.shtml
On the other hand we have these two eye-popping studies:
1. HealthGrades study: 52 percent lower chance of dying at top-rated hospitals
"Comparing the best hospitals in the country to the national average finds that there is a 52% lower risk of dying at the top-rated hospitals. When comparing the best to the worst that figure jumps to a 72% lower risk of dying in a top hospital. This discrepancy in care quality has been documented for the past decade and is not improving. We have 74,000 needless deaths a year due to inept care. Maybe health care reform should start in the hospitals."
2. The Risk of Death from Hospital Surgeries
"A near unbelievable report was published this week in the Archives of Internal Medicine. It showed that in 2006 48,000 Americans who went to a hospital for surgery were killed by infections acquired while at the hospital. This included many people who were generally healthy and having routine surgery. The cost to the health care system for this medical ineptitude was 8 billion dollars."
If you hamstring the "local" police force by denying it enforcement power and funding, it's foolish to blame it for not doing its job.
This article tells about the FDA's intentional non-enforcement of DSHEA. Some believe the current FDA has the same attitude, hoping an unregulated industry will hang itself:
http://www.naturalproductsinsider.com/articles/2009/09/the-history-future-of-the-dietary-supplement-health-education-act.aspx
It cannot be overstated what a radical change in supplement regulation is contained in DSSA. The "accepted list of ingredients" provision of DSSA gives no criteria for what would make an ingredient "acceptable". This would be left entirely up to FDA bureaucrats. DSSA would eliminate the protections in DSHEA concerning consumer access to supplements.
Posted by: Jeff | March 10, 2010 2:59 PM