FDA WARNING_LETTER - Generic frontline plus

The FDA issued a Warning Letter to Mr. Umesh Pawar of Genericfrontlineplus.com for illegally marketing Lomac Equine and Omaktive Oral Paste on their website. An FDA review determined these products are intended to mitigate, treat, or prevent disease in animals, classifying them as drugs under section 201(g)(1)(B) of the FD&C Act. The products are further deemed new animal drugs under section 201(v) because they are not generally recognized as safe and effective by qualified experts. Since these products lack an approved new animal drug application, conditional approval, or index listing, they are considered unsafe under section 512(a)(1) and adulterated under section 501(a)(5) of the FD&C Act. The introduction of such adulterated drugs into interstate commerce is prohibited by section 301(a). The letter cites specific claims from the website, such as "For treatment and prevention of recurrence of gastric ulcers in horses and foals," as evidence of their intended drug uses. The FDA requires the firm to promptly correct these violations within fifteen working days, providing written notification and documentation of corrective actions. Failure to comply may result in enforcement actions, including product seizure and/or injunction.