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Len MonheitToo Good To Be True?
17 May 2002
by Len Monheit, President & CEO, Natural Products Industry Center, Toronto, Ontario
© NPIcenter.com, reprinted with permission.

Amidst both praise and skepticism, the FDA is asking for public comment on how its actions and policies for advertising and labeling should be reevaluated after recent defeats involving First Amendment Freedom of Speech issues. This is potentially a wonderful opportunity for the dietary supplement industry and consumers to provide direct feedback, and given existing industry relations with the FDA, this opportunity can't be ignored. Supporters of the call to the public are eager to influence agency policy. Detractors fear a loosening of enforcement and FDA powers.

I can't help but wonder at what's going on behind the scenes and at the motivations behind this request. Especially with regulatory issues, things are rarely exactly as they seem, and this situation may be too good to be true. Could it be that the FDA, under new guidance and legal advice finally comprehends the implications of First Amendment defeats? Could it be that they understand that disclaimer clauses of several sentences are impractical on small labels? Could it be that the agency is coming to terms with limited enforcement resources, and that it doesn't want to wage futile war, fighting battles like Pearson versus Shalala over and over again? Or could it be that the FDA wants to alter its image to be more participative and guiding in its stance to regulate industry and advise consumers?

The sample questions the FDA has asked to launch the program do not indicate much in the way of objectives, at least at face value. Several relate to social behaviors including the effect of 'commercial speech' and FDA warnings on consumer behavior. I am sure this data exists and will be brought to the appropriate attention.

(See FDA's questions listed at FDA Seeks Public Comment on First Amendment Limits on Health Claims.)

The irony is that many within the FDA have held the agency to be above both law and public opinion in the enforcement of its mandates. For it to incorporate public opinion and socio-economic data into its policies now would be a drastic switch. But maybe the situation does call for drastic action. We continually hear the cry of 'inadequate resources' from regulatory agencies around the world attempting to fulfill their obligations. Cost recovery and fiscal reality has made an impact on many areas of government, and any way to reduce cost to allow an increased focus on strategic objectives on the part of agencies would be good -- or would it? Will the comments received change agency plans, or will the results support objectives already in place inside the agency? In fact, having been defeated on first amendment issues, what is the purpose behind a public comment period? If the lawmakers and enforcers have already decided that the FDA's stance runs contrary to constitutional law, what will public comment, and the interpretation of public comment, change?

Rakesh Amin, from the Chicago-based law firm of Weaver & Amin comments,

"The FDA needs to focus on policing and enforcing against companies making false or misleading claims rather than implementing more policies and regulations which the Supreme Court already has indicated treads on violating First Amendment commercial free speech rights and constitutes unconstitutional and illegal prior restraint of speech."

If so many feel FDA has been given its answer by the courts regarding Freedom of Speech, one can't help but ask how many scarce resources are going to be allocated to this PR campaign and whether this is the best use of FDA resources.

Although the sample FDA questions did not focus solely on dietary supplements, they did indicate attention placed on the different regulatory environments among supplements and food and drugs. Given negative comments made by FDA officials about the dietary supplements industry, it would not be surprising if part of the objective of the comment period was to open discussion about DSHEA and the perception that the dietary supplements industry is not properly regulated or that 'commercial speech' as presently interpreted in the courts is misleading to consumers.

Mr. Amin, whose firm has extensive experience in FDA and FTC law and regulations issues notes,

"The Food, Drug & Cosmetic Act, which includes DSHEA as an amendment, and Federal Trade Commission regulations prohibit false or misleading claims and labeling for any food, drug, and dietary supplement product including structure-function claims. The FDC Act also requires all foods and dietary supplements to be safe.

"Thus, the FDA already has ample ammunition to enforce against companies distributing unsafe products and/or making any type of false or misleading claim or in any way mislabeling a product. In other words, diligent FDA and related regulatory enforcement would benefit consumers much more than over-regulating."

Although this comment period is an opportunity to incorporate public opinion into regulatory policy, it's another example of where our industry needs to be alert for ulterior motives and a hidden agenda. The interpretation of the public comment will be critical; this industry needs to be vocal in order to protect itself.end-of-story

[How to submit your comments to FDA]




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