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WARNING LETTER

Catnip Cocktail MARCS-CMS 577026 —

Product:
Animal & Veterinary
Drugs

Recipient:
Recipient Name
Mr. David Bunata
Catnip Cocktail

United States

Issuing Office:

United States


WARNING LETTER

 

VIA SIGNATURE CONFIRMED DELIVERY

 

March 27, 2019

 

Mr. David Bunata                       

Catnip Cocktail

(b)(6), (b)(7)(C) 

 

Dear Mr. Bunata,

This letter concerns your marketing of the veterinary product “Catnip Cocktail” for use in dogs and cats. The U.S. Food and Drug Administration (FDA) reviewed your websites, www.buycatnipcocktail.com and www.catnipcocktail.com where you promote and sell this product. You market your product for the following intended uses: “The ultimate mood enhancer”; “Helpful pain relieving properties”; “… anxiety relief...”. We also reviewed the label affixed to your product stating: “This product is intended solely for the treatment of anxiety in cats and dogs.” Based on our review, we determined that your product is intended for use in the mitigation, treatment, or prevention of diseases in animals and to affect the structure or function of the body of animals, which makes it a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)]. Moreover, this product 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. It is 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], respectively. Therefore, the product is 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)]. The introduction or delivery for introduction into interstate commerce of this product therefore violates section 301(a) of the FDCA. 

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 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. 

Your written response should refer to the Warning Letter number above (CMS 577026). Please address your reply to:

 

CDR Steven E. Porter, Jr.

Director, Division of Pharmaceutical Quality Operations IV

United States Food and Drug Administration

19701 Fairchild Road

Irvine, CA 92612

 

If you have any questions about the content of this letter, please contact CAPT Matthew R. Dionne, Compliance Officer, at 303-236-3064 and reference unique identifier CMS 577026 on all correspondence.

 

Sincerely,

/S/ 

CDR Steven E. Porter, Jr.

Director, Division of Pharmaceutical Quality Operations IV 

 

 

Cc: Mr. David Bunata

(b)(6), (b)(7)(C)