Dietary Supplement Claims: Avoid FDA Enforcement Crosshairs

Dietary Supplement Claims: Avoid FDA Enforcement Crosshairs

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    Dietary supplement claims are the focus of today’s video: when you want to market a dietary supplement product, what are the basic FDA rules that you need to follow?

    By the end of today’s video, you’ll know the essential rules of the road for dietary supplement claims and how to avoid, for the most part, FDA cross hairs.

    I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group.  Over the years, we’ve represented many, many, many dietary supplement companies with their various claims. Dietary supplement companies are perhaps our favorite returning clients because they always have innovative nutraceuticals, and are looking to make edgy claims that pack a marketing punch, without running afoul of FDA legal tripwires.

    Here are 15 bullet points containing some critical legal rules, as well as tips and recommendations for those companies and clients that are marketing dietary supplements:

    1. A dietary supplement can only make structure/function claims, not disease claims.
    2. A dietary supplement company must be able to substantiate each and every claim.
    3. If you have a new dietary ingredient, you must submit an NDI or New Dietary Ingredient notification to FDA.
    4. All marketing materials, including social media sites, should be reviewed by legal counsel for FDA and FTC compliance.
    5. A dietary supplement manufacturer must submit a notification to FDA no later than 30 days after the first marketing of the product that Company is making the structure/function statement, in accordance with 21 CFR Section 101.93(a).
    6. Any kind of explicit or implicit comparison to a drug for can raise FDA enforcement scrutiny.
    7. FDA and FTC, the Federal Trade Commission, work in tandem to regulate false and misleading advertising.
    8. FTC has warned about deceptive advertising in the context of implied promises to consumers of likely results, i.e. the implication that other consumers will achieve similar results
    9. If you intend to market the Product as a dietary supplement, then avoid comparing the Product to prescription drugs or to medical or surgical procedures.
    10. All statements must be substantiated—that is, proven by competent and reliable scientific evidence.
    11. Asserting a mechanism of action suggests that the product acts like a drug, in targeting physiological, biochemical, or other pathways to address a given condition, and raises substantiation issues. Even though you might like to talk about a mechanism of action because it makes the claim sounds more scientific, this puts you on dangerous territory, as FDA could conclude you’re marketing a drug.
    12. Here are some examples of claims that could create substantiation issues: “scientifically proven,” “clinically proven,” and “proven to work.”
    13. FTC has rules about consumer testimonials and expert endorsements. Before marketing using testimonials, have your marketing reviewed by an FDA lawyer familiar with these legal rules. If your expert receives financial compensation from your company, this has to be disclosed.
    14. You may want to consider using focus groups to assess (and create evidence about) what the average consumer believes about the product, based on the claim.
    15. Some clients also include disclaimers or qualifying language such as additional disclosures about mechanism of action and to diminish any consumer perception that the product could have a drug effect or drug mechanism of action.

    Thanks for watching. If you still have questions about your dietary supplement products and claims you can make, click on the link below,, to send us a message or book an appointment. Here’s to the success of your dietary supplement venture, we look forward to speaking with you soon.


    • I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.

      Richard Freedland
      Richard Freedland GRAMedical, CEO
    • Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.

      James Riviezzo
      James Riviezzo Practice On Your Terms

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