Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558405.htm
Timestamp: 2019-01-18 18:01:56
Document Index: 554239137

Matched Legal Cases: ['§ 321', '§ 321', '§ 360', '§ 360', '§ 351', '§ 331']

CMS 524285
Jon Sowa
aka, Joseph Jonathan Sowa
Dear Mr. Sowa:
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.
PETSHIELD-KI
“…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.”
TEAR-STAIN AWAY
“Tear stains can also cause skin irritation, discomfort for your pet, and a pungent odor.”
“Extra Strength Tear Stain Formula is a safe and effective product for the elimination of tear stain on cats and dogs.”
“Re-Lief Joint Pain Formula is a natural anti-inflammatory and pain reducing supplement that is a safe and effective alternative to Aspirin & Rimadyl.”
“Re-Lief Joint Pain Formula for Dogs is an outstanding dietary assist for dogs suffering from painful joints and pain associated with aging, hip dysplasia, luxating patella, and osteo-arthritis.”
FLOW-EEZ
“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.”
“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.”
“Your pet will gain increased mobility with reduced pain.”
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 listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, the products are unsafe within the meaning of section 512(a) 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)].
Please send your reply to the Food and Drug Administration, Attention: Compliance Officer Maya Davis, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Maya Davis at 860-240-4289 X25 or at maya.davis@fda.hhs.gov