To the members of the Federal Trade Commission: 

 

We write to express our concerns about FTC's Randomized Clinical Trial (RCT) requirement for all ‘health-related’ claims. The Federal Trade Commission was created in 1914 to fight monopolies and protect competition; the FTC Act also requires that advertising be truthful and not misleading. We fully support this mission. However, the current RCT policy protects pharmaceuticals, not consumers. 

 

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA) to ensure access to dietary supplements and herbal remedies. DSHEA found that supplements are foods, not drugs, and don’t need pre-market approval (PMA). PMA exists because new drug molecules are relatively unknown. PMA has required drug safety testing since 1938, and drug efficacy testing since 1962. But PMA also created a monopoly (FDA) and oligopoly (Big Pharma) that results in predatory pricing: Americans pay twice as much per capita for drugs and healthcare, yet our results are worse than other wealthy nations, and drug safety problems persist. In DSHEA, Congress recognized that foods, vitamins, and medicinal herbs have been part of the food supply for many years, and don’t need PMA testing, though substantiation is required for specific types of claims. 

 

Most supplements and herbal formulas can’t be patented, and are competitively produced by many suppliers. They are formulated and combined in different ways for the convenience and needs of different people. In the thirty years since DSHEA, the supplement market has grown from $4 billion to over $60 billion. Remarkably, about 75% of Americans choose supplements—about as many as those who use over-the-counter or prescription drugs. Yet drugs average over 2 million Serious Adverse Event Reports (hospitalization, permanent injury or death) every year; food-borne illness causes 128,000 hospitalizations and 3000 deaths; in 2023, the FDA CAERS database provides records of 3450 serious adverse events related to dietary supplements. Clearly, Congress’ trust in the relative safety of supplements was well placed. And while no product works for everyone, consumers continue to choose these products in a free and competitive market, and don’t need insurance to afford them. 

 

Against this backdrop, the FTC policy wants multiple RCTs (the PMA drug standard) for all “health-related” claims (a much broader scope), and on complete products, rather than individual ingredients. This means formulators can’t rely on published science; can’t sell without expensive testing; and have to start over for any change to a formula—even minor improvements. This is costly and burdensome, especially to small businesses, and makers of complex traditional formulas. It vastly increases the cost of innovation. And since clinical trials are mostly conducted by medical clinics, research hospitals, and contract research organizations, this policy puts alternative medicine products at the mercy of the PMA drug industry, contrary to FTC’s statutory mission to protect free markets and competition. It also violates DSHEA findings §2(13) regarding “unreasonable regulatory barriers.”

 

The FTC Act has no substantiation requirement; nor has the FTC established one by rule. Requiring RCT evidence for all claims, even those that are already truthful and not misleading, shifts the burden of proof, makes the seller guilty until proven innocent, and violates both due process and equal protection. The current RCT policy is more harmful and unjustified than the false claims it hopes to address—the cure is worse than the disease. 

 

For these reasons, we respectfully request that the FTC enforce the FTC Act as written. An RCT is not the only competent and reliable evidence. Both the FTC Act and DSHEA suggest a case-by-case approach that allows traditional use, ethnobotany, post-marketing observation, user experience, and other evidence. Claims that are truthful and not misleading don’t need further scrutiny or burden. 

 

Respectfully submitted by:

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