BACKGROUND: A BAD, BAD LAW

One of the themes of this blog has been how, over the last couple of decades, the law has been coopted by forces supporting “complementary and alternative” medicine (CAM) in order to lend legitimacy to unscientific and even pseudoscientific medical nonsense. Whether it be $120 million a year being spent for the National Center for Complementary and Alternative Medicine (NCCAM) or attempts to insert provisions mandating that insurers in the government health care co-ops that would have been created by President Obama’s recent health care reform initiative (which at the moment seems to be pining for the fjords, so to speak), the forces who do not want pesky things like regulation to interfere with their selling of pseudoscience have been very successful. Arguably the crown jewel of their legislative victories came in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. Demonstrating that pseudoscience is a bipartisan affair, the DSHEA was passed, thanks to a big push from the man who is arguably the most powerful supporter of quackery in government and the man most responsible for the creation of the abomination that is NCCAM, Senator Tom Harkin (D-IA), along with his partner in woo, Senator Orrin Hatch (R-UT). It should be noted that Harkin happens to be the recipient of large contributions from supplement manufacturer Herbalife, demonstrating that big pharma isn’t the only industry that can buy legislation related to health.

Dr. Lipson has discussed the DSHEA before (calling it, in his own inimitable fashion, a “travesty of a mockery of a sham“) as has a certain friend of mine. Suffice it to say that the DSHEA of 1994 is a very bad law. 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:

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.

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, often accompanied by what Dr. Lipson has sarcastically referred to as the “quack Miranda warning“:

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

It doesn’t take too much searching to find supplement advertising that does claim to treat, cure, or prevent disease.

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:

…he [Hatch] has been unapologetic in his support for the supplement industry, having battled the FDA and other federal agencies over the regulation of vitamins, herbals, and other natural medicines for more than a decade…Hatch considers his 1994 law, DSHEA, a triumph on behalf of consumer health freedom. But a close look suggests that if anything, DSHEA (or the Hatch Act, as body builders call it) has left Americans “free” to serve as guinea pigs for a multibillion-dollar industry, much of which is built on a foundation of fraudulent claims, pyramid schemes, and lousy manufacturing practices.

We here at Science-Based Medicine have said much the same thing multiple times. Last week, I learned that yet another effort is being made to strengthen the DSHEA and close some of its loopholes. This effort comes in the form of a law under consideration, the Dietary Supplement Safety Act of 2010. It is a law proposed by, of all legislators, John McCain.

Can the Dietary Supplement Safety Act of 2010 fix the DSHEA?

On February 3, 2010 Senator John McCain (R-AZ) 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 is that it provides the FDA with mandatory recall authority if a supplement is found to be unsafe or harmful. 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.

The bill 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, the supplement industry is very much opposed to this bill. 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, at least not directly. Rather, it 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. No wonder the supplement industry likes it better than the McCain bill. S.510 would do little or nothing to reform the DSHEA, and that’s 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 nothing about harmful supplements until after the fact and or about deceptive health claims made by supplement manufacturers–again, which is 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.

I’m not a politician, nor am I a political blogger. I don’t know what the chances are that the DSSA will pass congress. I’m not very optimistic, though. For one thing, it’s being introduced by a Senator from the minority party, although Senator Byron Dorgan (D-ND) is a Democrat. More importantly, it’s likely to run into a buzzsaw of opposition, thanks to Senators Hatch and Harkin. On the other hand, the publicity of the Winter Olympics may help get this bill some traction, and the emphasis of athletes who have either been harmed or tested positive for banned substances, thanks to adulterated supplements. Still, my guess is that the bipartisan tag-team of woo, Senators Harkin and Hatch, will guarantee that the DSSA dies a quiet death. Hatch will do it for his campaign contributors in the supplement industry; Harkin will do it because he’s a true believer.

I’d love to be proven wrong, but doubt that I will be. After all, Senator McCain has been trying to tighten regulation of the supplement industry since 2004. For all the features it shares with the DSSA, I don’t think Durbin’s bill goes far enough because it doesn’t directly address supplements in a manner in which they need to be addressed to fix the DSHEA, and that is why I prefer the McCain bill at present. In fact, even the McCain bill doesn’t appear to go far enough in that it seems to leave the DSHEA largely intact in terms of what supplement manufacturers are allowed to say in their advertisements. Even so, the McCain-Dorgan bill strikes me as unlikely to pass unless there is a groundswell of public support for it, which is why I hope you will contact your Senators and tell them you support the bill and hope that they will support it too.

Whatever bill passes, the McCain or Durbin bill, as has been true for 16 years now, something needs to be done to fix the the DSHEA, or, as I like to call it, the Supplement Manufacturer’s Protection Act. As long as the DSHEA remains intact, it’s more or less the honors system for supplement manufacturers, and I don’t trust supplement manufacturers any more than many trust big pharma. In fact, in many cases, they are becoming one and the same. Big pharma recognizes profit potential when it sees it, and supplements can be marketed without all that pesky and expensive testing that are required for new drugs.