FDA WARNING_LETTER - Omega Tech Labs., LLC - February 11, 2008

An FDA inspection from January 31 to February 11, 2008, revealed significant violations by the firm regarding its "Fresh Protect Sanitizing Hand Foam," "Fresh Protect Sanitizing Hand Lotion," "Anti-Bacterial moisturizing lotion," "Stop," "Motion," and "Promise" products.

The Fresh Protect products and "Anti-Bacterial moisturizing lotion" were deemed unapproved new drugs and misbranded under Sections 505 and 502 of the Federal Food, Drug, and Cosmetic Act (the Act). They made unproven claims for antimicrobial, antiviral, skin protectant, skin cell rejuvenation, and lesion reduction uses, and did not comply with OTC drug monographs. Conflicting active ingredient information (benzethonium chloride vs. benzalkonium chloride), false "FDA APPROVED" claims, misleading effectiveness data due to formulation changes, and non-compliance with "Drug Facts" labeling further contributed to misbranding. One antibacterial lotion also misused a prescription drug's trade name and active ingredient, causing confusion and lacking proper manufacturer information, directions, and warnings.

"Stop," "Motion," and "Promise" products, marketed for smoking cessation, anti-emetic, and appetite control, respectively, were also classified as unapproved new drugs and misbranded. They lacked evidence of being Generally Recognized As Safe and Effective (GRASE) and did not conform to relevant monographs or have approved New Drug Applications (NDAs). They also failed to meet "