Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
February 24, 2015
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Canna Companion, LLC
Sarah Brandon, DVM
Greg Copas, DVM
928 Merea Lane
Sultan, WA 98294
Dear Drs. Brandon and Copas,
This letter concerns the marketing of the product Canna Companion by your firm Canna Companion, LLC. The U.S. Food and Drug Administration (FDA) reviewed your product labeling and your website at the Internet address www.cannaforpets.com, where you promote and sell the product.
We have determined that your product is a drug 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 product is intended for use in the mitigation, treatment, or prevention of disease in animals. As discussed below, this product is an unapproved new animal drug and your marketing of it violates the FD&C Act.
Unapproved New Animal Drug
Statements on your website and product labeling that establish these intended uses of your product include, but are not limited to, the following:
From the home page, www.cannaforpets.com:
- Under the heading “Here’s how Canna Companion may help your dog or cat:”
o “Reduce cancer-associated symptoms”
o “Aid in decreasing severity of dementia”
o “Reduce bronchial spasms in asthmatics”
- “CBD Antibacterial . . . Inhibits cancer cell growth . . . Reduces blood sugar levels … Reduces inflammation, Reduces risk of artery blockage, . . . Slows bacterial growth, . . . Treats psoriasis”
- Under the heading “Scientific”:
o “CBD . . . Antidiabetic, . . . Antimicrobial, Antineoplastic, Anti-proliferative, Antipsoriatic, Antipsychotic. . . .” (http://www.cannaforpets.com/scientific).
Further, claims made on your Facebook page, https://www.facebook.com/pages/Canna-Companion-LLC/277998209043875, which also has a link to your website at http://www.cannaforpets.com/ where products can be purchased directly, provide additional evidence that your product is intended for use as a drug:
Posts by your company on your Facebook page include the following:
- On November 21, 2014: “Good news about our Texas friend, Cyndi … She’s a 14 yr lab who has spinal arthritis & a type of cancer called adenocarcinoma. Miss Cyndi is responding well to her Canna C. . . .”
- On November 19, 2014: “Morgaine, one of our lymphoma patients is responding very positively to the ‘extra strength’ capsules.”
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)].
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