On December 20, 2022, the Federal Trade Commission (“FTC”) announced its issuance of Health Products Compliance Guidance, which updates and replaces its previous 1998 guidance, Dietary Supplements: An Advertising Guide for Industry.  While the FTC notes that the basic content of the guide is largely left unchanged, this guidance expands the scope of the previous guidance beyond dietary supplements to broadly include claims made about all health-related products, such as foods, over-the-counter drugs, devices, health apps, and diagnostic tests.  This updated guidance emphasizes “key compliance points” drawn from the numerous enforcement actions brought by the FTC since 1998, and discusses associated examples related to topics such as claim interpretation, substantiation, and other advertising issues.

Identifying Claims and Interpreting Advertisement Meaning

The updated guidance first discusses how claims are identified and interpreted, including the difference between express and implied claims.  The updated guidance emphasizes that the phrasing and context of an advertisement may imply that the product is beneficial to the treatment of a disease, which in turn would require that the advertiser be able to substantiate the implied claim with competent and reliable scientific evidence, even if the advertisement contains no express reference to the disease.

In addition, the updated guidance provides examples of when advertisers are expected to disclose qualifying information, such as when a product is targeted to a small percentage of the population or contains potentially serious risks.  When the qualifying information is necessary to avoid deception, the updated guidance contains a discussion of what constitutes a clear and conspicuous disclosure of that qualifying information.  Specifically, the guidance states that a disclosure is required to be provided in the same manner as the claim (i.e., if the claim is made visually, the disclosure is required to be made visually).  A visual claim should stand out, and based on its size, contract, location, and length of time is appears, must be easily noticed, read, and understood.  An audible disclosure should be at a volume, speed, and cadence so as to be easily heard and understood.  On social media, the guidance states a disclosure should be “unavoidable,” which the FTC clarifies does not include hyperlinks.  The qualifying information should not include vague qualifying terms, such as that a product “may” have benefits or “helps” achieve a benefit.

Substantiating Claims

The updated guidance next lays out a number of factors used to determine the amount and type of substantiation that is required to constitute competent and reliable scientific evidence, such as the type of product and claim, the benefits of a truthful claim, the cost/feasibility of developing substantiation, the consequences of a false claim, and the amount of substantiation that experts in a field believe is reasonable.  The updated guidance states that the amount, type, or strength of support of evidence for the claim must be accurate (e.g., an advertisement should not suggest scientists have reached a consensus if that is not accurate).

The updated guidance emphasizes the use of randomized, controlled human clinical trials (“RCTs”), underscoring that RCTs are “the most reliable form of evidence and are generally the type of substantiation that experts would require for health benefit claims.”  According to the guidance, no specific number of RCTs is required to meet the standard for competent and reliable scientific evidence; the quality of the research is more important than the quantity.  The guidance also states that research should yield statistically significant results and be clinically meaningful.  In addition, statistically significant results that are a result of post hoc analysis may draw suspicion of data mining or “p-hacking.” On the other hand, the updated guidance suggests that epidemiological or observational studies are only acceptable in limited circumstances, namely where 1) experts in the field consider them to be an acceptable substitute; and 2) RCTs are not otherwise feasible.  Similarly, animal and in vitro studies, anecdotal evidence about individual experiences of consumers, and public health recommendations are described as insufficient to substantiate health claims. 

Other Advertising Issues

Lastly, the updated guidance discusses other common issues in health-related advertisements, including consumer testimonials and expert endorsements, claims based on alternative medicine, and claims about FDA approval.  Reinforcing the Endorsement Guides, the updated guidance emphasizes that advertisements portraying dramatic results cannot be cured by stating “results not typical”—rather, they must contain a clear disclosure about what a typical consumer can expect in the depicted circumstances.  Expert endorsers must have appropriate qualifications; according to an example in the updated guidance, an expert should not be referred to as a doctor in an advertisement if the expert is not licensed and does not practice in a field relevant to the product and claim.  The updated guidance emphasizes that there is no exception to the substantiation standard for traditional use/homeopathic products—while claims can be made about traditional use, these products also must be substantiated with competent and reliable scientific evidence.

The updated guidance is intended to serve only as business guidance and does not have the force or effect of law.

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Photo of Libbie Canter Libbie Canter

Libbie Canter represents a wide variety of multinational companies on privacy, cyber security, and technology transaction issues, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with global privacy laws. She routinely supports…

Libbie Canter represents a wide variety of multinational companies on privacy, cyber security, and technology transaction issues, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with global privacy laws. She routinely supports clients on their efforts to launch new products and services involving emerging technologies, and she has assisted dozens of clients with their efforts to prepare for and comply with federal and state privacy laws, including the California Consumer Privacy Act and California Privacy Rights Act.

Libbie represents clients across industries, but she also has deep expertise in advising clients in highly-regulated sectors, including financial services and digital health companies. She counsels these companies — and their technology and advertising partners — on how to address legacy regulatory issues and the cutting edge issues that have emerged with industry innovations and data collaborations.

Photo of Laura Kim Laura Kim

Laura Kim draws upon her experience in senior positions at the Federal Trade Commission to advise clients across industries on complex advertising, privacy, and data security matters. She provides practical compliance advice and represents clients in FTC and State AG investigations. Ms. Kim…

Laura Kim draws upon her experience in senior positions at the Federal Trade Commission to advise clients across industries on complex advertising, privacy, and data security matters. She provides practical compliance advice and represents clients in FTC and State AG investigations. Ms. Kim advises on a wide range of consumer protection issues, including green claims, influencers, native advertising, claim substantiation, Made in USA claims, children’s privacy, subscription auto-renewal marketing, and other digital advertising matters. In addition, Ms. Kim actively practices before the NAD, including recent successful resolution of matters for both challengers and advertisers. She co-chairs Covington’s Advertising and Consumer Protection Practice Group and participates in the firm’s Internet of Things Initiative.

Ms. Kim re-joined Covington after a twelve-year tenure at the FTC, where she served as Assistant Director in two divisions of the Bureau of Consumer Protection, as well as Chief of Staff in the Bureau of Consumer Protection and Attorney Advisor to former Chairman William E. Kovacic. She worked on key FTC Rules and Guides such as the Green Guides, Jewelry Guides, and the Telemarketing Sales Rule. She supervised these and other rule making proceedings and oversaw dozens of the Commission’s investigations and enforcement actions involving compliance with these rules. Ms. Kim also supervised compliance monitoring for companies under federal court or Commission order.

Ms. Kim also served as Deputy Chief Enforcement Officer at the U.S. Department of Education, where she helped establish a new Enforcement Office within Federal Student Aid. In this role, she managed investigations of higher education institutions and oversaw issuance of fines and adverse actions for institutions in violation of federal student aid regulations. Ms. Kim also supervised the borrower defense to repayment division and the Clery campus safety and security division.

Photo of Stefanie Doebler Stefanie Doebler

Stefanie Doebler is co-chair of the firm’s Health Care Practice Group, and a member of the Food, Drug, and Device Practice Group. Her practice focuses on health care compliance matters for pharmaceutical, biotech, and medical device clients. She provides advice related to advertising…

Stefanie Doebler is co-chair of the firm’s Health Care Practice Group, and a member of the Food, Drug, and Device Practice Group. Her practice focuses on health care compliance matters for pharmaceutical, biotech, and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, transparency requirements, state law compliance and reporting regulations, interactions with health care professionals, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Stefanie also advises on the development and implementation of health care compliance programs.

Photo of Lindsey Tonsager Lindsey Tonsager

Lindsey Tonsager helps national and multinational clients in a broad range of industries anticipate and effectively evaluate legal and reputational risks under federal and state data privacy and communications laws.

In addition to assisting clients engage strategically with the Federal Trade Commission, the…

Lindsey Tonsager helps national and multinational clients in a broad range of industries anticipate and effectively evaluate legal and reputational risks under federal and state data privacy and communications laws.

In addition to assisting clients engage strategically with the Federal Trade Commission, the U.S. Congress, and other federal and state regulators on a proactive basis, she has experience helping clients respond to informal investigations and enforcement actions, including by self-regulatory bodies such as the Digital Advertising Alliance and Children’s Advertising Review Unit.

Ms. Tonsager’s practice focuses on helping clients launch new products and services that implicate the laws governing the use of endorsements and testimonials in advertising and social media, the collection of personal information from children and students online, behavioral advertising, e-mail marketing, artificial intelligence the processing of “big data” in the Internet of Things, spectrum policy, online accessibility, compulsory copyright licensing, telecommunications and new technologies.

Ms. Tonsager also conducts privacy and data security diligence in complex corporate transactions and negotiates agreements with third-party service providers to ensure that robust protections are in place to avoid unauthorized access, use, or disclosure of customer data and other types of confidential information. She regularly assists clients in developing clear privacy disclosures and policies―including website and mobile app disclosures, terms of use, and internal social media and privacy-by-design programs.

Elizabeth Brim

Elizabeth Brim is an associate in the firm’s Washington, DC office. She is a member of the firm’s Health Care and Data Privacy and Cybersecurity Practice Groups, advising clients on a broad range of regulatory and compliance issues. In addition, Elizabeth maintains an…

Elizabeth Brim is an associate in the firm’s Washington, DC office. She is a member of the firm’s Health Care and Data Privacy and Cybersecurity Practice Groups, advising clients on a broad range of regulatory and compliance issues. In addition, Elizabeth maintains an active pro bono practice.