FDA Prescription Drug Guidance Signals Cross-Agency Focus On Disclosure of Risk Information in Health Product Advertising, Regardless of Rx Status

On November 21, the U.S. Food and Drug Administration (FDA) issued a final rule titled “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format.” This final rule specifies standards for ensuring direct-to-consumer (DTC) TV and radio advertisements for prescription drugs present information relating to side effects and contraindications in a clear, conspicuous, and “neutral” manner. As explained in more detail in our client Advisory, the rule establishes five standards for conveying risk information in a clear, conspicuous, and neutral manner:

• Information must be presented in consumer-friendly language and terminology that is readily understandable.
• Audio information in the risk statement must be at least as understandable as the audio information presented in the rest of the ad.
• The ad must not include audio or visual elements during the presentation of the risks that are likely to interfere with comprehension.
• For ads in TV format:
  • The information presented in the audio portion of the risk information must also be presented concurrently in text for a sufficient duration to allow it to be read easily.
  • The information in text must be formatted such that the information can be read easily.

While FDA’s final rule is limited to prescription drug advertising, it is important to note that it is largely consistent with the Federal Trade Commission’s (FTC) latest guidance for disclosing risks in all health product advertising, highlighting the importance of this issue for marketers of all health products. Notably, the FTC applies its health product advertising guidance to all health benefit claims, including those made for products positioned as over-the-counter drugs, dietary supplements, food, and cosmetics, and, like FDA, the FTC is emphasizing the importance of disclosing material risk and side effect information in a manner that is clear and conspicuous.

For example, though not legally binding, the FTC’s Health Products Compliance Guidance — which applies to all health products and all mediums of advertising (including social media) — echoes FDA’s position that advertisers should disclose information regarding side effects or contraindications, stating specifically that such disclosures should be made where (1) a product can result in “potentially serious risk,” such as an increase in blood pressure, (2) the product is contraindicated with commonly used drug products in related categories, or (3) the product is advertised as having fewer side effects than another product. According to the FTC, “advertising that makes either an express or implied safety representation should include information about any significant safety risks,” and “[e]ven absent affirmative safety representations, advertisers may need to inform consumers of significant safety concerns related to the customary use of a product.” As illustrative examples, FTC includes the following:

Example 10: An energy drink contains an ingredient that, when consumed daily over an extended period, can result in a significant increase in blood pressure. Even absent any representation about the product’s safety, the marketer should disclose this potentially serious risk.

Example 11: A botanical supplement is marketed as an all-natural sleep aid for “when life’s stresses get you down or you are just too anxious to fall asleep.” Although the botanical supplement doesn’t present any safety risk when used alone, the active compounds in the product use the same metabolic pathway as common prescription medications for anxiety and depression, interfering with the efficacy of those medications. This potential interaction should be disclosed.

The FTC’s interpretation of “clear and conspicuous” disclosure likewise aligns with the standards set forth in FDA’s final rule. Like FDA, the FTC emphasizes that disclosures should be difficult to miss and easily understandable by ordinary consumers. The agency also takes the position that a disclosure should appear the same way as the related advertising claim (e.g., both visually and audibly) and, if written, should stand out and be easily noticed, read, and understood. Further, while not using the “neutral manner” language, the FTC (and related bodies such as the National Advertising Division of BBB National Programs) have applied a similar framework for determining whether disclosures are clear and conspicuous. For example, according to the FTC, if audible, the disclosure should be delivered in a volume, speed, and cadence that can be easily heard and understood. Similarly, the National Advertising Division, which gives great deference to FTC guidance, has particularly noted in assessing whether disclosures are clearly and conspicuously presented, “the size of the font, the duration that the [disclosure] appears on screen, the extent to which it contrasts with the background, as well as surrounding visuals and sounds that may distract a viewer’s attention away from the [disclosure]” as key factors in its determination.

FDA’s recent rulemaking reinforces regulatory bodies’ focus on health product advertising and is a good reminder to all companies marketing health products — not just prescription drugs — that regulators are paying close attention to how they communicate risk information in their advertising. In light of the growing regulatory focus on these issues, it is advisable for all companies engaged in health product advertising to reevaluate how they are addressing and disclosing risk information regarding their products to assess whether their current marketing strategies are in alignment with the current agency priorities and the desired risk threshold for their companies.

© Arnold & Porter Kaye Scholer LLP 2023 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.