Regulatory Oversight, Enforcement Actions, FDA Warning Letters

Will FDA’s Warning Letter to WHOOP Put a Chill on Wearables?

Orrick, Herrington & Sutcliffe LLP on 8/6/2025

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more

FDA signals uptick in enforcement with market sweep on depression claims

Hogan Lovells on 2/25/2021

On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more

FDA Releases Report to Congress Regarding CBD

Perkins Coie on 3/9/2020

The federal Food and Drug Administration (FDA) just released a report to Congress regarding the agency’s progress toward comprehensive regulation of hemp-derived cannabidiol (CBD). The report echoes the hard-line approach to...more

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on 12/4/2019

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

FDA Stresses CBD Safety Concerns in 15 Warning Letters and Revised Consumer Update

Seyfarth Shaw LLP on 12/4/2019

In its largest mass enforcement action involving cannabidiol (CBD) yet, the U.S. Food & Drug Administration (FDA) announced on November 25 the issuance of 15 warning letters to various companies for illegally selling products...more

Senate Majority Leader Intensifies Pressure on FDA to Expedite Cannabis Guidance

Wilson Sonsini Goodrich & Rosati on 9/20/2019

In the latest sign that congressional pressure on the Food and Drug Administration (FDA) to expedite regulations on cannabidiol (CBD) products continues to intensify, Senate Majority Leader Mitch McConnell (R-KY) this week...more

Telemedicine Platform Recalled Over Failure to Obtain Pre-Market Clearance or Approval from FDA

Mintz - Health Care Viewpoints on 8/30/2019

On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more

Regulatory Oversight › Enforcement Actions › FDA Warning Letters