Ashish Talati, Partner

June 10, 2011

2 Min Read
The Product Claims Legal Checklist

The Federal Trade Commission (FTC) along with the Food and Drug Administration (FDA), has been cracking down on dietary supplement companies for allegedly overselling the health benefits of their products.

Since neither the FDA nor FTC does not require companies to vet claims with the agency before using them in commerce, it is critical for companies to make sure all their product claims are fully substantiated. Federal and state government enforcement of consumer protection laws and other regulations is only part of the legal risk. Private action lawsuits brought by plaintiffs' attorneys and public interest groups are on the rise and they pose equal if not greater legal risk.

How can companies avoid and/or minimize their legal exposure? The following can help.

  • ·         All label, labeling, and advertising claims should be reviewed by legal counsel with expertise in FDA/FTC regulations.

  • ·         Adequately evaluate the clinical research and literature on individual ingredients and ideally on the product as a whole. ONLY use claims that are substantiated with competent and reliable scientific evidence in the dosage range of the product.

  •           Always consider the number of studies, the type of studies (ideally human), quality of studies [# of participants, double-blind, placebo controlled], relevance of studies [same formulation, additional ingredients, route of administration]), and other negative findings/totality of the evidence.

  •          Avoid relying on animal or in-vitro studies unless the claim is qualified to reflect the limitation.

  •          Testimonials or personal experiences are not considered as substantiation.

  •          Keep a binder or file with all of the studies and/or literature used to substantiate product claims.

  •          Ensure all claims are phrased in “structure/function” language and that no express or implied disease claims are being made. Websites not only help sell product but also help the agencies to review claims from the comfort of their office.

  •          Subscribe to FDA warning letters notification e-mails and other industry sources to stay abreast of the latest enforcement priorities.

  •          Advertising claims based solely on traditional use should be crafted in a way to avoid the implication that the product has been scientifically evaluated for efficacy. Historical use should be documented.

  •          Avoid claims that, if unfounded, could present a substantial safety risk.

  •          Avoid claims that could lead consumers to forgo treatments or to self-medicate for serious conditions.

  •          Third-party literature can be a very effective tool if used correctly. To minimize risk it should be reviewed by legal counsel prior to its use in marketing.

  •          Understand the difference between puffery (subjective claims that cannot be proven true or false) and deceptive (objective) claims. Avoid making objective claims that cannot be scientifically substantiated.

  •          A disclaimer cannot cure a deceptive claim.

  •          Consider getting expert letters on substantiation especially for “grey” claims to minimize risk.

By following these guidelines, companies can avoid FDA/FTC scrutiny as well exorbitant costs associated with reviewing, restructuring and redrafting product claims and reconditioning of products already marketed. 

About the Author(s)

Ashish Talati

Partner, Amin Talati Wasserman LLP

Ashish Talati is a partner with Amin Talati Wasserman LLP. He primarily counsels clients on matters of regulatory compliance, helping them anticipate and address regulatory issues in their day-to-day business operations and strategic planning. He is considered a leading authority in the areas of generally recognized as safe (GRAS) requirements and new dietary ingredients.

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