FDA WARNING_LETTER - JD Nelson and Associates, LLC

The FDA issued a Warning Letter to JD Nelson and Associates, LLC, concerning the marketing of their Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant. The FDA determined that both products are unapproved new drugs, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act.

Safe4Hours Hand Sanitizing Lotion, with active ingredient triclosan 1%, is marketed with claims such as "KILLS 99% OF GERMS," effectiveness against MRSA, E. Coli, Staphylococcus aureus, and H1N1, and prevention of "Occupational Hand Disease." The FDA states there is insufficient evidence for these claims, making it a "new drug" requiring an approved application. Furthermore, its "leave on" directions without rinsing are inconsistent with the Tentative Final Monograph (TFM) for OTC topical antimicrobials, which evaluates triclosan for uses followed by rinsing.

Safe4Hours First Aid Antiseptic Skin Protectant, containing allantoin 1% and triclosan 1%, is marketed as a combination skin protectant and first aid antiseptic, with claims of effectiveness against MRSA and long-lasting protection. The FDA found it non-compliant with the OTC Final Monograph for Skin Protectant Drug Products (21 C.F.R. Part 347) and lacking sufficient evidence for its claimed efficacy, thus classifying it as a "new