“Consumption of antioxidant vitamins in the amounts contained in this product may reduce the risk of certain kinds of cancer.” If this exact statement were to appear on a dietary supplement label with no disclaimer from the FDA, who would it hurt? Would you and I, health consumers be put at risk as the FDA has insisted time and again? Or, rather, would it be the bottom line of pharmaceutical companies that would be at risk? Sorry, but I sometimes enjoy stating the obvious. But let’s be realistic it’s almost impossible to imagine how any of us would suffer a threat to our health from the claim above or from the absence of the FDA disclaimer.
If you’re like me, you’ve got a dozen or more supplements at home that carry a notice that the ingredients have not been evaluated by the FDA. Personally, this disclaimer doesn’t affect me in the least. But for the many consumers who come across this disclaimer for the first time, this statement is often interpreted as a warning. And that’s exactly how the FDA and the pharmaceutical companies want consumers to feel: warned away.
But the days of the FDA disclaimer may be numbered, side-tracked — finally — by the First Amendment, compliments of the Supreme Court.
Winding legal road
Last week the FDA published a notice in the Federal Register, titled “Request for comment on First Amendment Issues.” The agency is seeking comments from the public to determine if its product labeling and advertising restrictions are constitutional. (Anyone who cares to weigh in on this topic has until July 30, 2002, to submit comments, and responses to those comments must be received by September 13, 2002.)
In the notice, the agency said, “Recent case law has emphasized the need for not imposing unnecessary restrictions on speech.” Which is a coy way of saying that recent case law – the direct result of lawsuits brought against the FDA – has focused on the agency’s long-standing policy to restrict freedom of speech.
So far, the decisions of various courts have placed the legal burden on the FDA to prove that claims made by the manufacturers of dietary supplements are false. Throughout the legal process, the FDA has maintained that its primary mission is to protect the public health, which overrides all concerns about First Amendment issues. Fortunately, this argument has not held water in any of the cases, including the case that went before the Supreme Court.
In the most recent ruling in April, the Supreme Court ruled 5 to 4 that the FDA could not block pharmacists from advertising drugs reformulated from bulk supplies. The agency claimed that its ban prevented pharmacists from disseminating false information. A majority of the justices were not swayed, recognizing the language of commercial transaction as “commercial speech,” which is entitled to First Amendment protection as long as it’s truthful and not misleading.
Who serves public health?
The critical response to the FDA notice has been mixed. Some consumer groups (such as the Center for Science in the Public Interest) believe public health will be harmed if the claims on supplement labels are not regulated. But clearly, the public health is harmed when consumers are driven away from the positive healthy effects of hundreds of supplements that are proven to be effective.
Are there snake oil salesmen out there who would mislead consumers? Of course – there always have been and there always will be. That’s why consumers have the responsibility to be diligent about educating themselves when they choose any pharmaceutical or dietary supplement.
Without getting into the constitutionality of the agencies or the benefit of their existence, the simple fact is that the FDA has long overstepped its regulatory bounds by enforcing this misguided disclaimer at all. If anyone is charged with protecting consumers from false claims, it’s the Federal Trade Commission. The FDA’s mandate is to evaluate the safety and effectiveness of pharmaceuticals, foods, cosmetics, etc. So who does it protect when it takes the unnecessary step of requiring labels to carry this disclaimer? Not the health of the taxpayers. It protects the giant drug companies who stand to lose millions if more and more consumers choose to improve their health with supplements and reduce their need for high priced pharmaceuticals.
Voices of many
So is the FDA now prepared to budge on its long-standing labeling policy – after numerous court challenges and losses? Absolutely not. If the agency is genuinely considering a specific policy change, it wasn’t outlined it in the Federal Register notice. Furthermore, this comment was included: “FDA will continue to regulate commercial speech as part of its mandate. In particular, FDA intends to defend the act (Federal Food, Drug, and Cosmetic Act) against any constitutional challenges.” To me, that sounds like an agency ready to step up the battle.
Whatever its intentions, there’s no doubt that this is a rare opportunity for opinions to be heard. Whether you’re a First Amendment scholar or simply a concerned citizen, your comments are important. HSI will be submitting a comment, and I urge you to do so as well.
If you would like to read the entire FDA notice, you can access the Federal Register online at http://www.gpo.gov. From there you’ll find a link to the Federal Register. In its notice, the FDA sets forth 9 questions that are not meant to be exhaustive, but rather a jumping off point. They encourage the public to address these and/or other related questions. You can submit comments by going to http://www.fda.gov/dockets/ecomments.
Has the FDA seen the light? They have – and it’s not to their liking. Will they give in and give up this self-appointed regulatory power they seized many years ago? Certainly not without a sustained fight. But what matters right now is that all of us have a chance to add our voices and have our say in what might eventually prove to be a turning point in the deregulation of dietary supplements.
To Your Good Health,
Jenny Thompson
Health Sciences Institute
Sources:
“Request for comment on First Amendment Issues,” Federal Register, 5/16/02
Reuters Health, 5/15/02
“Challenging FDA Censorship,” Reasonline.com
Copyright 1997-2002 by Institute of Health Sciences, L.L.C.
