FTC Issues New Guidance on Health-Related Claims to Replace the Dietary Supplements Advertising Guide

On December 20, 2022, the Federal Trade Commission (“FTC”) issued a new guidance document entitled Health Products Compliance Guidance. The publication updates and replaces FTC’s 1998 document, Dietary Supplements: An Advertising Guide for Industry. The new guidance broadly applies to all health-related claims, as opposed to only those made about dietary supplements, and reflects FTC cases and product innovations over the last two decades. The guidance includes a more detailed discussion of the amount and type of evidence needed to substantiate health-related claims through dozens of examples. While much of FTC’s guidance remains largely unchanged, this client alert highlights some notable changes and issues worth reemphasizing. The new guidance document reinforces the FTC’s continuing scrutiny of advertising for health-related products.

Competent and Reliable Scientific Evidence Standard

• FTC reiterates that health benefit claims must be substantiated by “competent and reliable scientific evidence.”
  • FTC defines “competent and reliable scientific evidence” to mean “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.”
  • The research must be “sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.”

RCTs needed?

• FTC states that as a general matter, the substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical trials (“RCTs”) to meet the competent and reliable scientific evidence standard.
• FTC does not require a specific number of RCTs to meet that standard; the quality of the research is more important than the quantity.
• That said, FTC believes that the replication of research in an independently-conducted study adds to the weight of the evidence and provides greater confidence in the validity of the initial results.
• FTC will accept high-quality epidemiologic evidence to substantiate a claim in limited cases where: 1) experts in the field consider it to be an acceptable substitute for RCTs; and 2) RCTs are not otherwise feasible.

“Experts in the Field” as Arbiters of Evidence Needed

• FTC enumerates a number of factors to determine the amount and type of substantiation required, including the type of product; the type of claim; the benefits of a truthful claim; the consequences of a false claim; and the amount of substantiation that experts in the field believe is reasonable.
• FTC gives great weight to accepted norms in the relevant fields of research and consults with experts in those fields.
  • As an example, FTC states that research supporting a claim about heart benefits would need to meet accepted norms of research in the field of cardiology.
• FTC also states that research that has not been through a rigorous peer-review process will be subject to greater scrutiny.

Need for Limitations or Qualifying Language

• To avoid being deceptive, an advertiser should disclose any significant limitations on a claimed benefit.
  • For example, a claim about the benefit of a multi-vitamin and mineral supplement to reduce fatigue should be limited so that consumers understand that only the small percentage of people who suffer from the mineral deficiency are likely to experience any reduction in fatigue from using the product.
• Advertisers should disclose negative long-term effects of consuming a product over an extended period if there is scientific data showing that such consumption presents serious risk.
• A product that may be utilized by consumers with a particular health condition should make a disclosure that the product is not intended to treat that health condition.
  • For example, FTC stated that an advertisement for nasal strips to reduce the sound of snoring should disclose that the nasal strips are not intended to treat sleep apnea. We find this example noteworthy because FTC reached this conclusion absent express or implied claims related to sleep apnea or any finding that a reasonable consumer would otherwise expect any product intended to treat snoring to also treat sleep apnea.
• FTC updated the standard for disclosures of qualifying information by specifying that “clear and conspicuous” means the disclosure is difficult to miss (i.e., easily noticeable) and easily understandable by ordinary consumers.
  • As compared to the previous guide, the guidance makes clear that if a claim requiring a disclosure is made both visually and audibly, the disclosure should be made both ways as well. If a claim is made only visually or only audibly, the disclosure should at least appear in the same way, but a simultaneous visual and audible disclosure is more likely to be clear and conspicuous.
• FTC continues to caution that it is difficult adequately to qualify a claim based on limited and still-emerging science to make clear to consumers the uncertain and limited nature of the support for the claim. FTC reemphasizes that vague qualifying terms, such as “may” or “helps,” are inadequate. Further, consumers are likely to interpret modifiers such as “promising,” “preliminary,” “initial,” or “pilot” as positive product attributes, rather than as substantial disclaimers about the limited evidence behind a claim.

Studies on Ingredients v. Finished Products

• FTC states that a “clinically tested ingredient” claim on a product not only implies that the ingredient has a benefit but also that the product containing the ingredient confers that benefit. Because the product may contain other ingredients, an advertiser should consult with a qualified expert in the relevant field to determine whether experts in that field would generally require a clinical test of the product itself, rather than of the isolated ingredient, to confirm the benefit.
• Studies on individual ingredients may not be sufficient to substantiate a safety claim about a combination product containing two active ingredients because the ingredients together may affect the body differently than they do individually. An advertiser needs a study conducted on the product if that is what experts in the field would generally require to substantiate the claim.

Benefit Must Be Shown to be Clinically Relevant

• FTC continues to note that any statistically significant results must translate to a benefit that is clinically meaningful for consumers. Some results that are statistically significant may be too small to provide real consequences for consumer health.
• In evaluating the quality of a study, FTC will examine whether the study is of sufficient duration to show that the benefit will persist.

Traditional Use, Public Health Recommendations, Consumer Surveys

• Advertisements that describe the traditional or historic use of the product should be carefully qualified to avoid any misleading implications about the product’s efficacy or health-related benefits. A claim that suggests a health-related benefit in the absence of competent and reliable scientific evidence must clearly communicate the lack of scientific evidence. The disclosure should stand out and be in close proximity to the claim, perhaps incorporated into the claim.
  • FTC provides the following example of an appropriately qualified traditional use claim: An herbal tea makes the claim, “Ancient remedy used for centuries to aid digestion. There is no scientific evidence that it works.”
• FTC now states that advertisers should not rely on public health recommendations, such as advisories from a medical organization, for substantiation. Rather, advertisers should evaluate the science underlying the recommendations and its applicability to their products.
• FTC also continues to note that a claim for a dietary supplement approved under a foreign monograph does not constitute substantiation. The advertiser must independently evaluate the underlying research and any evidence that may contradict the monograph.
• FTC considers consumer survey results to be nothing more than a collection of anecdotal experiences and cannot adequately substantiate health-related claims.

Interaction Between FDA and FTC Jurisdiction

• The guidance notes that the FTC and Food and Drug Administration (“FDA”) continue to share jurisdiction over the marketing of dietary supplements, foods, drugs, devices, cosmetics and other health-related products under their Memorandum of Understanding (FDA-FTC Liaison Agreement). With certain exceptions (e.g., prescription drugs), FDA is primarily responsible for claims in labeling (i.e., product label, packaging, inserts, and promotional materials at point of sale) and FTC for claims in all forms of advertising.
• Unlike FDA, FTC makes no categorical distinctions between types of health-related products or claims. FTC applies the same substantiation standards to any health-related claim, regardless of whether FDA would consider it a health claim, a structure/function claim, or a drug claim, and whether, under FDA law, the product is considered a food, a supplement, or a drug.
• FTC explicitly states that the Dietary Supplement Health and Education Act of 1994 (DSHEA) has no effect on the FTC Act. Therefore, the DSHEA labeling disclaimer (i.e., FDA has not evaluated the claim . . .) is not required in other forms of advertising or marketing.
• The guidance reemphasizes that advertisers should not mischaracterize the extent to which a product or claim has been reviewed, authorized, or approved by FDA. This includes language or symbols that may be perceived by consumers to mean that FDA has reviewed, authorized, or approved the product or claim.

Scope

• The guidance notes the breadth of the term “advertising” subject to the substantiation standards, including claims and representations in packaging and labeling, promotional brochures or booklets, the internet and in other digital content, social media and influencer marketing, press releases, press interviews, or other media appearances, trade shows, conferences, and seminars, and even advertising indirectly through healthcare practitioners or other intermediaries.
• Anyone participating in deceptive marketing is potentially liable under FTC law, including individual owners and corporate officers of advertisers, expert endorsers, ad agencies, and retailers.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements and Advertising & Consumer Protection practices.