Merit Pet Products, LLC FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

This letter concerns your firm's marketing of numerous products intended for use in animals including: Petshield-KI, Tear-Stain Away, Re-Lief, Flow-Eez and Re-Flex. The U.S. Food and Drug Administration (FDA) reviewed product labeling and your website at the internet address http://www.meritpet.com, where you promote and sell these products. We have determined that these products are intended for use in the mitigation, treatment, or prevention of disease in animals, and/or to affect the structure or function of the body of animals, which makes them drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)]. Further, as discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act.

“FLOW-EEZ, fortified with powerful Anti-Oxidants and Vitamin C, will strengthen your pet’s immune system and also prevent bacteria from adhering to the walls of your pet’s bladder and urethra.”

Because your products are intended to prevent, mitigate or treat diseases 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)]. Moreover, 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. They are not the subject of 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

Potential Health Risks

“RE-FLEX JOINT HEALTH FORMULA is the most complete, all natural, dietary supplement that helps maintain and repair your pet's cartilage and joint structures.”

Regulatory Context

“…the only dietary supplement specifically made for pets that provides protection from cancers caused by exposure to radioactive iodine most commonly associated with a nuclear event.”

In addition, your tear stain remover product containing tylosin tartrate is a new animal drug, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because it is 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. You are using tylosin tartrate as an ingredient in the formulation of your product. Although tylosin tartrate is an approved drug, your use of Tylosin tartrate in your product is not a use covered by its approved application, and your products are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index lis

This letter is not intended to be an all-inclusive review of your products. It is your responsibility to ensure that all of your products are in compliance with the FD&C 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.