Can FTC Substantiation Requirements Take Down Your Healthcare Product?

Can FTC Substantiation Requirements Take Down Your Healthcare Product?

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In today’s video, we describe how FTC substantiation rules can make or break the marketing you can make for your health and wellness product.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve advised over a thousand healthcare industry clients on healthcare and FDA legal issues, including many companies with medical devices, dietary supplements, cosmetics, and OTC drugs.

And so, we understand the pickle these dietary supplement and cosmetics manufacturers—you—are in when the choice is whether to follow all the rules, quite literally and slavishly to the ends of the Earth; or, take a chance with super-aggressive claims.

Today we’ll educate you on three points:

  1. How FTC substantiation rules shape your marketing claims, and how paying attention to these rules can keep you out of the regulatory crosshairs.
  2. How to balance compliance vs. your need and desire for profit, without losing your shirt one way or another.
  3. What kinds of claims can make or break you if enforcement takes an interest.

First how FTC substantiation rules can make a huge difference in your market share.

In a previous video, we talked about how FTC, like FDA, requires that claims for health and wellness products be substantiated, or supported by evidence.  We also noted that the standard for health and wellness is much higher than for advertising other products in general.

For most products, the FTC requires that the company have a “reasonable basis” for the claims.

For a health and wellness product, the FTC requires “competent and reliable scientific evidence.”  This is much more than a “reasonable basis.”  Typically, the FTC requires clinical trials.

Second, how to balance compliance vs. revenue.  This is a bit tricky.  On one hand, the more aggressive your claims, the bigger your sales and revenue.  And the more you are “100% compliant,” the smaller your market share. So, what do you do?

We counsel our health and wellness clients with sensitivity to their needs, interests, desires, and marketing oomph, and also with respect to the laws, regulations, and policy guidance documents that require close attention.

Third, how to stay clear from FDA or FTC regulatory tripwires.

FTC tells us that it pays the most attention to certain kinds of claims.  These include:

  • Claims about human health or safety (for example, that the product reduces the risk of a certain disease).
  • Claims that consumers could not easily evaluate on their own (for example, a claim that risks are reduced by a certain percentage).
  • Claims that are deceptive because of “fine print,” or because the ad does not have sufficient qualifying language, or because the claim is simply exaggerated or unproven.

The next thing you need to know is that having a disclaimer, such as “results may vary,” doesn’t necessarily solve your FTC issue.

Anyone who has a health and wellness product on the market needs to understand these nuanced rules in order to gain market share without triggering FDA or FTC enforcement.

Thanks for watching.  Here’s to the success of your healthcare 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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