USA FDA takes action against PET CBD salesSeveral other companies have jumped in ahead of True Leaf in attempted sales of Pet foods/Treats containing CBD cannabis components in the USA. They are now facing legal actions from the FDA.. For now I would say True Leaf’s marketing plans for the USA are dead in the pet water dish, unless they register their products as drugs.
One major USA player Curaleaf, Inc. was issued an official warning letter July 22 by the US Food and Drug Administration (FDA) reprimanding the company
for selling three versions of edible pet tinctures containing cannabidiol (CBD), , deeming the products as “unapproved new drugs.”Donald D. Ashley, director of the FDA’s Office of Compliance for its Center for Drug Evaluation and Research, and Eric Nelson, Office of Compliance director for the agency’s Center for Veterinary Medicine (CVM), stated in the letter that the CBD-infused products were “in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act.”The use of products sold on Curaleaf’s website, “Bido CBD for Pets” in three flavors (pure, bacon and salmon), have been determined by the FDA to be used as a form of treatment or prevention of certain diseases, which constitutes them as drugs under section 201(g)(1)(B) of the FD&C Act, according to the agency.The FDA stated this conclusion was reached after observing claims on Curaleaf’s website, including the treats’ effectiveness in aiding symptoms of anxiety, compulsive behavior, inflammation, seizures and neurological problems and other issues. The website also claims that the treats can be used in the place of veterinarian-prescribed anxiety medicine, “whereas CBD oil is natural and offers similar results without the use of chemicals.”The agency stated the pet tinctures 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.”Curaleaf was instructed to begin an investigation of its products, including those for humans, to correct the violations cited in the letter and avoid legal action.Because the products are intended to mitigate, treat, or prevent disease 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). Further, these products are “new animal drugs” under 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.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-l. These products are not approved or index listed by the FDA, and therefore these products are 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).