Warning Letter

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On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product qualifies as an unregulated wellness product[1] and alleging, instead, that the product qualifies as a “device”[2] under the Food, Drug, and Cosmetics Act (“FDCA”) (i.e., is intended for use in the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition).[3] FDA concludes, therefore, that the product is misbranded and adulterated, as WHOOP is currently marketing the product with a cleared 510(k) notification or approved premarket application (“PMA”). Continue Reading What to Watch: WHOOP Warning Letter

Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”)[1] for allegedly promoting its diagnostic product (which was labeled for research use only “RUO” and therefore, not cleared or approved by FDA) for clinical purposes in violation of the U.S. Food, Drug, and Cosmetics Act (the “FDCA”).[2] The Agena Warning Letter – the first issued to an RUO product manufacturer in over five years – left the industry wondering whether FDA intended to ramp up enforcement against manufacturers who improperly utilize the regulatory carve-out for RUO diagnostic devices.[3] However, after the issuance of that Agena Warning Letter last April, all had been quiet on the enforcement front in the RUO space and, given the priorities of the new administration, we expected it to remain that way. But surprisingly, last month, FDA posted yet another warning letter to DRG Instruments GmbH (“DRG”) alleging failure to qualify for the RUO carve-out (the “Warning Letter”), potentially signaling the Agency’s intention to increase, or at least maintain, oversight for RUO-labeled products.[4]Continue Reading What to Watch: Potential Increase in Enforcement of “RUO” Diagnostics

This week, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) posted a warning letter (the “Letter”)[1], issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. (“Sprout”) and its CEO, Cindy Eckert (“Eckert”), regarding a social media post promoting ADDYI® (flibanserin) (“Addyi”). According to FDA, the now-flagged Instagram post, shared by Eckert, touted Addyi’s benefits but left out crucial safety information and important details on for the indicated population. There is a lot to unpack with this Letter and FDA’s manner of issuance, but as previewed in our prior blog posts this year, we believe this to be yet another example of FDA’s enhanced focus on drug advertising and promotion. Expect to see more warning letters—especially via social media advertising and promotion, actions directed at executives or personal social media accounts, and other creative ways the agency can push its mandate—in lieu of written regulation—to police the pharmaceutical industry.Continue Reading FDA Ratchets Enforcement on Social Media Promotion in New Warning Letter

On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations following a back-and-forth between FDA and Akan. The Form FDA-483 highlights a number of observations about 585 vials of an Akan product, but the warning letter spends considerable time beforehand covering reasons why Akan’s product does not meet the requirements of 21 C.F.R. § 1271.10(a), which qualify certain human cells, tissues, or cellular or tissue-based products (HCT/Ps) for exemptions from key FDCA requirements, including premarket review. Akan’s product is an adipose derived, stromal vascular fraction (SVF) cellular product for allogenic use with the brand name Ayama™.Continue Reading FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company

On August 4, 2023, the Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning Letter to AstraZeneca which stated that the company made misleading claims in a promotional sales aid about the effectiveness of BREZTRI AEROSPHERE™ (“Breztri”). Given that it has been almost a year and half since OPDP issued a Warning Letter (the last Warning Letter was issued in February 2022), the takeaways here are significant for industry and provide insight into how FDA will examine efficacy claims that are so-called “consistent with label” and require compliance with FDA’s June 2018 guidance (the “CFL Guidance”).[1],[2] Going forward, we expect the agency’s focus to remain on product communications to the public—to either a general consumer or professional audience—and whether those communications include essential contextual information to avoid the potential that such claims could be viewed as misleading.Continue Reading Context is Key: FDA Sends a Strong Message About Efficacy Claims

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication response and patient receptivity to drugs (among other things). FDA identified three genetic tests, including one called “MediMap Plus,” which was designed to provide insight into how a patient would respond to drugs used for anesthesia, cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety, and diabetes. FDA deemed the tests to be adulterated and misbranded because Inova had not sought premarket clearance.
Continue Reading FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests