Wellness Professionals Should Be Familiar with the Federal Trade Commission Health Products Compliance Guidance

Wellness Professionals Should Be Familiar with the Federal Trade Commission Health Products Compliance Guidance

In December 2022, the Federal Trade Commission (FTC) issued a document entitled Health Products Compliance Guidance. Any wellness professional, whether you are a health coach, functional medicine provider, integrative health provider, holistic health provider, naturopathic doctor, chiropractor, or wellness business owner, should understand the FTC guidance. This is particularly true for those wellness providers who sell products such as dietary supplements, essential oils, diet plans, certain foods, or other products that can provide health benefits.

It should be noted that the FTC works in cooperation with the Food and Drug Administration (FDA). The FDA governs health product labeling, including the package, product inserts, and other promotional materials available at the point of sale. The FTC, on the other hand, governs advertising in all its forms, not just health product labeling.

Here is a quick summary of the FTC guidance:

  1. It Applies to Everyone. The guidance applies to anyone who markets health-related products. You don’t have to be a certain type of professional with a certain type of credential to be subject to this guidance. If you sell health-related products, you should comply with the guidance or face consequences (discussed below).
  2. Claims Need to be Truthful and Substantiated. To stay out of trouble with the FTC and the Food and Drug Administration (FDA), wellness professionals who market health-related products, including dietary supplements, must make sure their advertising meets both of these requirements:
    1. The advertising must be truthful and not misleading; and
    2. The claims about the product must be substantiated with reliable evidence.
  3. Substantiation Applies to Both Express and Implied Claims. The need to substantiate product claims about health benefits applies to both express claims as well as suggested or reasonably implied claims. Here’s an example of an express claim and an implied claim, according to the FTC:
    1. Express claim example: A herbal supplement claims that the product boosts the immune system to help maintain a healthy nose and throat during the winter.
    2. Implied claim example: The herbal supplement ad features the name “Cold Away” and includes images of people sneezing and coughing. These images likely convey to consumers that the product helps prevent colds, even though the advertisement does not specifically say that.

For both express and implied claims, the FTC guidance states that substantiation should consist of “competent and reliable scientific evidence” through “tests, analyses, research, or studies that: 1) have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; and 2) are generally accepted in the profession to yield accurate and reliable results.” See FTC Guidance, at 12. The FTC Guidance document provides numerous examples of what constitutes good evidence to back up health-related claims.

  1. Advertising Can Occur in a Variety of Formats. The FTC’s guidance applies to advertising on your website, in brochures, in social media and influencer marketing, in media appearances, things you say at trade shows or conferences, as well as indirectly through other people.
  2. Consequences for Violating FTC Law Can be Severe. Violating the FTC rules can result in the following types of penalties:
    1. A cease and desist order;
    2. A mandate that you make certain disclosures or engage in corrective advertising (which could cost significant money);
    3. An outright ban from engaging in certain advertising;
    4. Consumer refunds;
    5. Other financial penalties.
  3. Disclaimers Are Not Enough. For those wellness professionals who believe adding a disclaimer to their advertisement about the health product, such as “this product is not intended to diagnose, treat, cure or prevent any disease,” the FTC guidance states that such disclaimers won’t necessarily protect you from violating FTC rules. If your advertisement still makes untrue or unsubstantiated claims, whether express or implied, about a health product, the disclaimer won’t save you. The FTC could still impose penalties.

This is just a quick summary of the contents from the 40-page FTC guidance document. Hopefully it prompts you to pay attention to your health product advertising and perhaps enlist the help of an experienced wellness lawyer, such as those at the Center for Health and Wellness Law, LLC. You can reach us via our quick contact form or by phone at (608) 579-1267 to schedule your initial consultation today.

Alternatively, if you are a wellness professional who would like to be more in tune with various wellness law requirements, please consider taking the Mastering Workplace Wellness Laws course through the National Wellness Institute/Wellness Compliance Institute. This course aims to help you identify compliance red flags, including those involving FTC/FDA compliance. Knowing the boundaries of what you can and can’t do as a wellness professional can help you practice more confidently and save yourself a lot of expense and headache.

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