FDA WARNING_LETTER - Union Springs Pharmaceuticals, LLC - May 23, 2011

The FDA issued a Warning Letter to Union Springs Pharmaceuticals, LLC regarding its MyClyns Personal Protection Spray, citing that the product is an unapproved new drug and is misbranded. The company markets MyClyns under a 510(k) clearance for Dermacyn Wound Care, a device intended for mechanical wound cleansing. However, MyClyns' labeling and promotional materials make extensive antimicrobial claims, including 99.99% pathogen reduction and protection against MRSA, HIV, and Hepatitis C after exposure to bodily fluids. These claims establish the product as a drug intended to prevent disease and affect body function, not a device. The FDA found no sufficient evidence that MyClyns is generally recognized as safe and effective (GRAS/GRAE) for its claimed topical antimicrobial uses, especially for preventing infection from serious pathogens or for use on wounds and mucous membranes. The product also does not qualify for evaluation under the OTC Drug Review. Therefore, its introduction into interstate commerce without an approved new drug application violates sections 301(d) and 505(a) of the Act. Additionally, the product is misbranded under section 502(c) of the Act because its labeling lacks a required "Drug Facts" panel, as per 21 C.F.R. § 201.66. Union Springs Pharmaceuticals must take prompt corrective action and notify the FDA within fifteen working days, detailing steps to correct violations and prevent recurrence, or face potential legal action including seizure and injunction.