FTC Released a Guide Health Products Compliance Guidance (December 2022)

FTC Guidance on Advertising of Health-Related Products

December 2022

The Federal Trade Commission (“FTC”) has released updated guidance on health products, replacing its 1998 document on dietary supplements. This new guidance aims to help advertisers ensure that their claims about health-related products are truthful, not misleading, and backed by scientific evidence. The update reflects insights gained from over 200 cases involving misleading advertising of various health products, including dietary supplements, OTC drugs, and health apps.

The FTC's primary goal is to prevent unfair or deceptive acts in advertising, ensuring that marketers provide accurate information about the benefits and safety of health products. The framework is grounded in Sections 5 and 12 of the FTC Act, which emphasize two main principles: advertising must be truthful and not misleading, and advertisers must have adequate substantiation for all objective claims before dissemination.

Definition of Deceptive Advertising. A deceptive ad contains material misrepresentations or omissions likely to mislead reasonable consumers. The level of substantiation required depends on the product and claim type but claims about health benefits typically need competent scientific evidence.

Scope of Advertising. The term "advertising" encompasses a wide range of marketing techniques beyond traditional media, including: Packaging and labeling, Promotional materials, Digital content and social media, Press releases and interviews, and Events and presentations.

Liability and Responsibility. All participants in marketing—including product marketers, agency staff, and even individual corporate officers—can be held liable for deceptive practices. It’s crucial for everyone involved to understand and apply FTC advertising principles.

Enforcement and Remedies. The FTC can pursue various remedies for deceptive advertising, such as: Stopping false claims and mandating truthful marketing, Requiring corrective advertising or specific disclosures, and Seeking financial penalties or consumer refunds for harm caused.

The guide outlines the FTC and the Food and Drug Administration (“FDA”) jointly overseeing the marketing of dietary supplements, foods, drugs, and other health-related products. They coordinate their regulatory efforts through the FDA-FTC Liaison Agreement, which outlines their respective responsibilities. The FDA is primarily responsible for claims made in product labeling, such as packaging and promotional materials at the point of sale. The FTC is responsible for claims in advertising across all formats.

The FTC and the FDA both mandate truthful and accurate marketing for dietary supplements and health-related products, but there are significant differences in their legal frameworks and approaches.

The guide provides guidance on how its laws apply to the advertising of dietary supplements and health-related products. The process of compliance involves identifying claims and ensuring adequate scientific substantiation. The guide describes the two-step process for compliance of Identifying Claims and Interpreting Ad Meaning.

A. Identifying Claims and Interpreting Ad Meaning.

1. Identifying Express and Implied Claims. Marketers must recognize both direct and indirect claims made through their advertisements. Advertisers must identify all claims made in their marketing materials, including those that are directly stated (express) and those suggested (implied). The focus is on how reasonable consumers interpret the overall advertisement, rather than the marketer's intent.

2. Consumer Perspective. The determination of claims relies on consumer understanding. Marketers should consider the "net impression" of the ad, taking into account all elements, such as text and visuals.

3. When to Disclose Qualifying Information. Advertisements must disclose material information that would affect consumer understanding, particularly regarding health benefits or safety risks.

4. Clear and Conspicuous Disclosure. If a claim requires a disclosure to avoid deception, it must be presented clearly and prominently, both visually and audibly if applicable. Disclosures should be noticeable and easy to understand to effectively inform consumers.

B. Substantiating Claims. This includes the nature of the product, and the type of claims affect the level of substantiation required. Factors include the benefits of truthful claims, costs of substantiation, consequences of false claims, and expert opinions on reasonable substantiation.

1. Ads that Refer to a Specific Level of Support. Claims must be supported by the evidence level stated. Marketers must substantiate any claims they make about the amount, type, or strength of scientific evidence supporting their products. This includes meeting the basic requirement for objective claims about safety or efficacy.

2. The Amount and Type of Evidence. Reliable scientific evidence is essential, with randomized controlled trials being the gold standard. There must be competent and reliable scientific evidence. Other study types can include: epidemiological studies, animal and in vitro studies, anecdotal evidence, and public health recommendations.

3. The Quality of the Evidence. Factors like control groups, randomization, double blinding, and statistically significant results must be present to support claims.

4. The Totality of the Evidence. Claims should be consistent with the broader body of evidence, avoiding selective presentation of data. Studies must not be evaluated in isolation; advertisers should consider all relevant research on the claimed benefit. This means assessing the overall consistency of findings across multiple studies. Variations in study outcomes must be investigated. Factors like dosage, administration method, and population differences can explain these inconsistencies. When multiple studies exist, advertisers should prioritize those with more reliable methodologies and acknowledge the strengths and weaknesses of each.

5. The Relevance of the Evidence to the Specific Product and Claim. Research must directly relate to the product and its marketed benefits. Advertisers must ensure that the studies they cite are relevant to their specific product and the benefits they advertise. Key considerations include: dosage and formulation of the advertised product, ingredient composition compared to the study, administration method used in the study, relevance of tested outcomes to the advertised benefits, and characteristics of the study population versus the target audience.

C. Other Advertising Issues.

1. Claims Based on Consumer Testimonials or Expert Endorsements. Endorsements must be truthful and substantiated just like direct claims. Testimonials must represent the honest opinions of endorsers, but advertisers must also have evidence to back up implied claims about a product's effectiveness.

2. Claims Based on Traditional Use. These must also be backed by scientific evidence, and misleading implications should be avoided.

3. Use of the DSHEA Disclaimer in Advertising. While this disclaimer is required for labeling, it doesn't mitigate deceptive claims in advertising.

4. Mischaracterizations of FDA Approval. Marketers must accurately represent the FDA’s role and not imply approval of claims that haven’t been authorized.

5. Third-Party Literature. While the FTC doesn’t regulate third-party materials directly, marketers are responsible for how these materials are used in advertising.

The FTC emphasizes the importance of substantiation, clarity, and honesty in health-related advertising. Marketers must ensure that all claims—whether made directly or through testimonials, traditional uses, or third-party literature—are substantiated with reliable scientific evidence, both to comply with FTC standards and to avoid misleading consumers. Key steps include assessing consumer interpretation of ads and reviewing the scientific backing for each claim thoroughly.

 

For more information, see here:  https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance

 

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