Tec Laboratories Inc – FDA Warning Letter, Apr 18, 2011

The FDA issued a Warning Letter to Tec Laboratories, Inc. regarding their Staphaseptic First Aid Antiseptic/Pain Relieving Gel, citing violations of the Federal Food, Drug, and Cosmetic Act. The product is deemed an unapproved new drug under section 505(a) of the Act [21 U.S.C. § 355(a)] because there is insufficient evidence it is generally recognized as safe and effective (GRASE) for its claimed uses, particularly preventing infections from MRSA, Staphylococcus, or Streptococcus. Additionally, the product is misbranded under sections 502(e) and 502(a) [21 U.S.C §§ 352(e) and 352(a)] due to inconsistencies between its website and package labeling regarding active ingredients, with the website listing tea tree oil, white thyme oil, and essential oils not present on the package. The product's formulation and claims do not align with any existing Tentative Final Monographs for OTC topical antimicrobials or external analgesics, nor are they under review. The firm's previous response to a Form FDA 483 was found invalid. Tec Laboratories must promptly correct these violations and submit a written response to the FDA within fifteen working days, detailing corrective actions and timelines. Failure to comply may lead to legal actions, including seizure and injunction, and could affect federal contract awards.