Inspections, Compliance, Enforcement, and Criminal Investigations

Merit Pet Products, LLC 5/12/17

 

  

Black HHS-Blue FDA Logo

 

 

 
New England District Office (NWE-DO)
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500 

UNITED PARCEL SERVICE
OVERNIGHT DELIVERY

WARNING LETTER

CMS 524285

May 12, 2017

Jon Sowa
aka, Joseph Jonathan Sowa
Merit Pet Products, LLC
6 Holly Lane
Cumberland, RI 02864

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.

Statements on your website and product labeling that show these intended uses of your products include, but are not limited to, the following:

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

“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

“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.”

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]. 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)].

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)].

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.

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 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
 

Sincerely,
/S/

Joseph Matrisciano, Jr.
District Director
New England District Office

Page Last Updated: 05/18/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English