The End of Supplements in America?

T he Federal Trade Commission (FTC) has announced that it will require two random-controlled human trials (RCTs) for any health-related claim that is permitted without such trials under the Dietary Supplement Health and Education Act of 1994. This includes structure/function claims, currently the principal way for consumers to know what a nutritional supplement does, and for what it can be used. And that’s two RCTs for each product!

If the FTC if allowed to proceed, nothing will be able to be said on a supplement label or in any promotional material for that product. This will be the end of supplements in America as we know it, and only billion dollar companies will be able to “compete.” The costs to a company, such as Life Enhancement, would amount to a minimum of $200,000 for each two RCTs or $28,600,000 or more to qualify its products, while suspending income. Egad! That’s a nearly impossible undertaking for any supplement company.

Yet before the FTC can adopt or enforce such new policies, it is required by law to go through the rulemaking process, and fortunately, that process is even more difficult whenever a new policy is controversial, such as the topic of health claims, for which Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) clearly won the day. Perhaps that is why FTC is ignoring that law.

The FTC would have been granted this authority through the Waxman amendment to the “Financial Reform” bill, but Congress was persuaded to drop it and that amendment was defeated. But shockingly, the FTC is just going ahead as if the amendment had passed and they had undergone the necessary rulemaking process to amend their regulations.

The good news is that Durk Pearson & Sandy Shaw, and the Alliance for Natural Health, as co-plaintiffs, have filed a Petition for Rulemaking before the FTC. The co-plaintiffs allege the following:

  • The FTC lacks jurisdiction to enforce the Federal Food, Drug, and Cosmetic Act

  • The FTC’s two clinical trial requirement violates the First Amendment standard in Pearson v. Shalala

  • The FTC cannot violate the Constitution in consent orders

  • The FTC’s new policies chill protected speech

A principal concern is that the FTC’s new policies apply to the industry as a whole. Thus, fear of enforcement of the FTC’s new policies is chilling protected speech, which will reduce access to important health-related information.

Also good news, the co-plaintiffs are being represented by renowned constitutional law attorney Jonathan Emord, of Emord & Associates.

The petition demands the FTC to stop implementation immediately, and to follow the rulemaking process. Also, only the FDA can legally regulate health claims, and thus by usurping the FDA’s regulatory authority, the FTC opens itself up for Pearson v. Shalala to be applied. This landmark legal precedent says that the FDA cannot impose prior restraints on free speech. The petition argues that if the FTC imposes FDA-specific regulations, then it must also abide by the Pearson precedent. Otherwise we have a blatant regulatory end-run around a federal court decision.

These aggressive tactics by the FTC have generated fear among smaller companies of FTC reprisal and expensive investigations, leading many away from making any claims, including truthful and legally allowed structure/function claims, hence leaving consumers in the dark.

If you want to be involved, contact the FTC and ask the agency to grant the petition. For more information, go to www.anh-usa.org. Act now before it’s too late.

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