Company News, Regulations

FDA Sends Walmart Warning Letter for Molluscum Treatment Kit

The agency says the product being sold on walmart.com is an unapproved new drug, according to the Federal Food, Drug & Cosmetic Act.

Author Image

By: Christine Esposito

Editor-in-Chief

Walmart was sent a warning letter from the US FDA related to a molluscum treatment kit that it was distributing through its online store. The kit, according to FDA, is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act. The Aug. 18, 2023 letter sent to Doug McMillon, president and CEO of Walmart, Inc., FDA stated: “molluscum contagiosum is not a condition amenable to self-diagnosis and treatment, and there are no legally marketed over-the-counter (OTC) dru...

Continue reading this story and get 24/7 access to Happi for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Happi Newsletters