Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/canna-pet-llc-02242015
Timestamp: 2019-05-26 21:13:48
Document Index: 336840373

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

Canna Pet LLC - 02/24/2015 | FDA
Canna Pet LLC - 02/24/2015
Canna Pet LLC 24/02/2015
Canna Pet LLC
Daniel K. Goldfarb, President
10115 Greenwood Ave., N., #191
Seattle, Washington 98133-9197
This letter concerns the marketing of the products Canna-Pet™ for Cats, Canna-Pet™ for Dogs, Canna-Pet™ MaxCBD Capsules, and Canna-Biscuits for Dogs, by your firm Canna-Pet, LLC. The U.S. Food and Drug Administration (FDA) reviewed your product labeling and your website at the Internet address www.canna-pet.com, where you promote and sell the products.
We have determined that your products are drugs as defined by 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)], as the products are intended for use in the mitigation, treatment, or prevention of disease in animals. As discussed below, the products are unapproved new animal drugs and your marketing of them violates the FD&C Act.
Statements on your website and product labeling that establish these intended uses of your products include, but are not limited to, the following:
From the home page, www.canna-pet.com:
“For pets with extreme issues, who require larger doses of CBD. Most commonly these are pets suffering from seizures, although we often see pets with cancers and aggressive tumors, severe chronic pain, and in end-of-life care using our MaxCBD products.” (https://canna-pet.com/how-it-works/our-products/).
Because your product is intended to mitigate, treat, or prevent disease in animals, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. Further, 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.
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]. Your product is not approved or listed by the FDA, and therefore the product is considered unsafe under 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)].
Your written response should be sent to Mr. Dillard Woody, Supervisory Consumer Safety Officer, U.S. Food and Drug Administration, 7519 Standish Place, Rm 107, Rockville, MD 20855. If you have any questions about this letter, please contact Mr. Woody at 240-276-9237 or by e-mail at dillard.woody@fda.hhs.gov.