Impact and Limits of the Constitutional Deregulation of Health Claims on Foods and Supplements: From Dementia to Nuts to Chocolate to Saw Palmetto

Abstract:     
The lower courts have recognized that the constitutional protections for commercial speech permit food supplements to make health claims with disclaimers even though the claim does not comply with regulatory requirements for agency approval and scientific support. An example of a health claim is a claim that vitamins may reduce the risk of cancer. The court found that the marketer has to permit agency review of the disclaimers in advance, and that the agency could preclude a claim if the agency could show consumers would be deceived even with disclaimers.

On remand, FDA issued guidance on the type of disclaimer suitable for claims in light of the scientific support for the claim. The guidance makes it possible to consider in a concrete setting the adequacy of disclaimers to prevent consumer confusion on scientific matters that affect health. The guidance ranks the support by grades such as B, C or D and indicates a suitable disclaimer. Unfortunately, the FDA guidance did not provide for the use of the letter grade in the disclaimer on the label for the product, the type of information most likely to help consumers in understanding the strength or weakness of the claim. Lastly, the article examines a court decision finding that commercial speech did not permit a disease treatment claim with disclaimers for the non-food supplement saw palmetto. The court found disease treatment claims to be illegal without FDA approval, under the first step of the Central Hudson test, making the use of disclaimers to prevent deception irrelevant. While safety factors may also explain the result, it is notable that the courts have found a way to draw lines that allow Congress to establish mandatory testing and approval requirements for some drug claims.

Number of Pages in PDF File: 40

Keywords: Commercial speech, commercial free speech, FDA and the constitution, health claims on foods, health claims on supplements

Accepted Paper Series