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Department of Health and Human Services
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Food and Drug Administration
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February 24, 2015
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Daniel K. Goldfarb, President
10115 Greenwood Ave., N., #191
Seattle, Washington 98133-9197
Dear Mr. Goldfarb,
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.
Unapproved New Animal Drugs
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:
- FAQs about Canna-Pet™: “We find medical benefits, behavioral benefits, prolonged life, reduced stress, and improved quality of life with our pets.” (http://canna-pet.com/how-to-use/faqs/).
- Medical Benefits: “We Recommend Canna-Pet™ as a daily food additive for all pets, but especially for those with arthritis, allergies, anxiety or behavior issues, compromised immune systems, diabetes, digestive issues, nausea, chronic pain, cancer, seizures, and those receiving palliative care.” (http://canna-pet.com/how-it-works/the-basics/).
- Health Benefits of Cannabidiol (CBD) Canna-Pet: “Antitumor, Antiepileptic, Anticancer, Anti-inflammatory, Bone stimulant, Analgesic, Anti-depressant, Antibacterial, Antipsoriatic, Antidiabetic, . . . Anti-nausea, Anti-anxiety, . . . Antipsychotic, . . . Immunosuppressive.” (http://canna-pet.com/how-it-works/phytochemistry-active-compounds/).
Canna-Pet™ MaxCBD Capsules
- “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/).
The above referenced products are only intended to be a sampling of the violative products you are currently marketing. Similarly, the above referenced claims are only intended to be a sampling of statements that demonstrate the intended uses of your product.
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)].
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
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 firstname.lastname@example.org.
Mr. Eric Nelson
Director, Division of Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration