Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Rockville, MD 20855|
October 29, 2014
Mr. Umesh Pawar
Westside Trading FZE UAE
United Arab Emirates
Dear Mr. Pawar:
This letter concerns your marketing of the products Lomac Equine and Omaktive Oral Paste on your website at the internet address genericfrontlineplus.com. The U.S. Food and Drug Administration (FDA) reviewed your website, where you promote and sell these products.
We have determined that the above referenced products are intended for use in the mitigation, treatment, or prevention of disease in animals, which makes them drugs under section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Under the FD&C Act, drugs intended for use in animals require an approved new animal drug application unless they are generally recognized as safe and effective. As discussed below, we have determined that these drugs are not generally recognized as safe and effective, and are therefore unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], because you are marketing them without approved new animal drug applications.
Statements on your website and product labeling that show these products are intended for use in the mitigation, treatment or prevention of disease in animals include, but are not limited to, the following:
• "For treatment and prevention of recunence of gastric ulcers in horses and foals 4 weeks of age and older."
• "It is an effective medicine that is used to treat ulcer in all breeds of horse."
Omaktive Oral Paste
• "For the treatment and prevention ofrecunence of gastric ulcers in horses and foals 4 weeks of age and older."
• " ... helps to cure equine ulcers and gastric horses so that they live disease-free and for longer."
The above referenced products are only a sampling of the violative products you are currently marketing. Similarly, the above referenced claims are only a sampling of statements that demonstrate the intended uses of your products.
Because the above referenced products are intended to mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321 (g)(1)(B)]. Further, these products are new animal drugs, as defined by section 201(v) of the FD&C Act [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. The above referenced products are not approved or index listed by the FDA, and therefore the products are considered unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
This letter is not intended to be an all-inclusive review of your products and their promotion. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Please direct your response to Dillard H. Woody Jr., Supervisor, Post Market Compliance Team at the U.S. Food and Drug Administration with the Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855-2773. If you have any questions about this letter, please contact Dillard Woody at 240-276-9237.
Eric Nelson, Director
Division of Compliance (HFV-230)
Office of Surveillance & Compliance
Center for Veterinary Medicine