If there’s one law that (most) supporters of science-based medicine detest and would love to see repealed, it’s the Dietary Supplement and Health Act of 1994 (DSHEA).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.