Avcor Health Care Products, Inc – FDA Warning Letter

The FDA issued a Warning Letter to Hi-Tech Pharmacal Co., Inc. regarding its over-the-counter (OTC) products: ZOSTRIX Diabetic Foot Pain Relief Cream, ZOSTRIX Diabetic Joint & Arthritis Pain Relief Cream, and Diabeti-Derm Antifungal Cream. All three are deemed unapproved new drugs, violating Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], which prohibits their introduction into interstate commerce under § 301(d).

The ZOSTRIX products are considered unapproved new drugs under Section 201(p) because their labeling claims target diabetic patients for conditions like diabetic foot pain and circulation stimulation. These uses are not covered by the OTC External Analgesics Tentative Final Monograph and lack general recognition of safety and effectiveness.

Diabeti-Derm Antifungal Cream is also an unapproved new drug under Section 201(p). Its claims for treating nail fungus and stimulating blood flow for diabetics are inconsistent with the Topical Antifungal OTC Drug Products monograph (21 CFR Part 333, Subpart C) and prohibited for OTC antifungals without an NDA (21 CFR § 310.545(a)(22)(iii)). Additionally, Diabeti-Derm is misbranded under Section 502(a) [21 U.S.C. § 352(a)] as its labeling misleadingly promotes L-Arginine, a listed inactive ingredient, as having an active role [21 CFR § 201.10(c)(4)].

Hi-Tech Pharmacal must promptly correct these violations, investigate causes, and prevent recurrence. A written response detailing corrective actions and timelines is required within fifteen working days. Non-compliance may lead to legal action, including seizure and injunction, impact federal contracts, and hinder approval of export certificates or drug applications. The firm must ensure all products comply with federal law.