FDA WARNING_LETTER - Anastasia Marie Laboratories, Inc.

The FDA issued a Warning Letter to Anastasia Marie Laboratories, Inc. regarding their product, Anastasia Diapedic Foot & Leg Treatment, marketed and distributed as an OTC drug. The product's labeling, obtained during an inspection of the manufacturer, was found to contain unapproved and misbranded drug claims.

The product is cited as an unapproved new drug under Section 505(a) of the FD&C Act because its labeling makes claims for uses not covered by any OTC monograph, specifically targeting diabetic patients for conditions like diabetic neuropathy, stimulating circulation, and acting as an antifungal. These claims include "Temporarily relieves pain of: diabetic neuropathy," "High performance treatment penetrates to cellular level to soothe the effects of diabetic neuropathy and alleviate pain," and "Natural anti-fungal formula fights infections, athlete's foot and nail fungus." Furthermore, the product is misbranded under Section 502(a) for falsely stating "FDA Approved," as it lacks an approved application.

The FDA requires the company to take prompt action to correct these violations within fifteen working days, including investigating causes, preventing recurrence, and reviewing all labeling and promotional materials. Failure to comply may result in legal action, including seizure and injunction, and may impact future federal contracts or drug application approvals.