Regulatory Oversight, Enforcement Actions, Manufacturers

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

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz on 7/9/2025

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

Retailers at Risk: FDA Issues Advisory on Recreational Nitrous Oxide Products

McGuireWoods LLP on 6/17/2025

On June 4, 2025, the U.S. Food and Drug Administration issued a public advisory urging consumers not to inhale nitrous oxide (N2O) from commercial dispensers, including canisters, tanks and portable chargers. The advisory...more

FDA Accuses Third Party Testing Labs of Falsifying Data

Knobbe Martens on 5/30/2025

The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...more

Staying Prepared Amid FDA Changes

Gardner Law on 5/30/2025

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Stay ADvised: 2025, Issue 6

Davis Wright Tremaine LLP on 3/27/2025

Reckitt Benckiser Tastes Sweet Success as Mucinex Honey False Ad Dismissed - Plaintiffs alleging that Reckitt Benckiser falsely advertised certain Mucinex products as containing honey failed to sufficiently allege that the...more

Wisconsin AG Resolves Investigation Into Alleged Violation of State Air Laws With $85K Settlement

Troutman Pepper Locke on 7/31/2024

Wisconsin Attorney General (AG) Josh Kaul has announced an $85,000 settlement with the global food supply company Kerry, Inc. in relation to the company’s operation of a liquid smoke manufacturing facility....more

Tennessee AG Sues More Than 20 PFAS Manufacturers

Troutman Pepper Locke on 7/21/2023

Tennessee AG Jonathan Skrmetti is suing more than 20 per- and polyfluoroalkyl substance (PFAS) manufacturers, including 3M and DuPont, seeking injunctive and monetary relief under the state’s public nuisance and uniform...more

New Intended Use Rule Finalized

Foley Hoag LLP on 8/6/2021

On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...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

The Environmental Black Swan: What Manufacturers Don’t Know They Don’t Know

Vedder Price on 5/16/2019

Regardless of what side of the political fence you reside on and regardless of whether under this current administration you believe environmental enforcement has taken a holiday, the fact remains that most manufacturers...more

Solid and Hazardous Waste Judicial/Regulatory Developments (2018-2019): Arkansas Environmental Federation Presentation...

Mitchell, Williams, Selig, Gates & Woodyard,... on 4/23/2019

I undertook a presentation on April 17th at the Arkansas Environmental Federation Regulated Waste Seminar titled: Solid and Hazardous Waste Judicial/Regulatory Developments: 2018 – 2019 - The discussion addressed...more

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