Joanne Hawana

Mintz

+ Follow Contact

Readers' Choice Awards

Life Sciences

Latest Posts › Enforcement

Share:

FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more

7/22/2025 / Advertising , Enforcement , Food and Drug Administration (FDA) , Labeling , Marketing , Medical Devices , Product Labels , Regulatory Authority , Warning Letters , Wellness Programs

FDA Warns “Natural” Birth Control Company: Three Takeaways from the NOV Letter

A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this...more

8/2/2023 / Birth Control , Dobbs v. Jackson Women’s Health Organization , Enforcement , Food and Drug Administration (FDA) , Labeling , Notice of Violation , Over The Counter Drugs (OTC) , Reproductive Healthcare Issues

Recent FDA Warning Letter to Amazon.com Suggests the Agency Is Getting Tired of the Whack-a-Mole Game

Receiving a warning letter from the U.S. Food and Drug Administration (FDA) means that the agency has identified what it calls “violations of regulatory significance” and that you (as the recipient) need to take corrective...more

8/23/2022 / Amazon , Enforcement , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA)

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

1/3/2018 / Advertising , Draft Guidance , Enforcement , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Homeopathic Remedies , Labeling , Marketing , Pharmaceutical Industry , Public Comment

FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade...more

11/15/2016 / Enforcement , False Advertising , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Homeopathic Remedies , Over-the-Counter Sales

5 Results

View per page

Page: of 1