This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.
Continue Reading FDA Advertising and Promotion Enforcement Activities: Update
FDA and HHS Announce New Measures to Curb Direct-to-Consumer Prescription Drug Advertising
On September 9, 2025, the Department of Health and Human Services (“HHS”) and Food and Drug Administration (“FDA”) announced a series of measures to address “misleading” direct-to-consumer prescription drug (“DTC”) advertisements. The measures include (1) rulemaking to rescind the “adequate provision” requirement, which permits manufacturers to include a general statement
Continue Reading FDA and HHS Announce New Measures to Curb Direct-to-Consumer Prescription Drug AdvertisingFDA Advertising and Promotion Enforcement Activities: Update
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
Click here to read the full alert on cov.com.
Continue Reading FDA Advertising and Promotion Enforcement Activities: UpdateFDA Advertising and Promotion Enforcement Activities: Update
October 29, 2024, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
During the third quarter of 2024 FDA’s Office of Prescription Drug Promotion (OPDP) posted the following three untiled letters.
- Untitled Letter to AbbVie, Inc. re NDA 211765 UBRELVY (ubrogepant) tablets, for oral use (August 29, 2024) (Ubrelvy Untitled Letter)
- Untitled Letter to Mirati Therapeutics Inc. (a Bristol Myers Squibb Co.) re NDA 216340 KRAZATI™ (adagrasib) tablets, for oral use MA 166 (August 1, 2024) (Krazati Untitled Letter)
- Untitled Letter to Kaleo, Inc. re NDA 201739 AUVI-Q® (epinephrine injection, USP), for intramuscular or subcutaneous use MA 1021 (July 17, 2024) (Auvi-Q Untitled Letter)
The Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) and the Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) did not post any warning letters relating to the advertising and promotion of medical devices during this period. FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) has not posted any enforcement letters since 2018.
This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.Continue Reading FDA Advertising and Promotion Enforcement Activities: Update
FTC Issues New Guidance Regarding Health Products
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.Continue Reading FTC Issues New Guidance Regarding Health Products