Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421217.htm
Timestamp: 2019-04-19 09:11:17+00:00

Document:
This letter concerns the marketing of the products Tumexal Capsules, Tumexal Liquid, and Tumexal Transdermal by your firm CanineCare.us, LLC. The U.S. Food and Drug Administration (FDA) reviewed your product labeling and your website at the internet address www.caninecare.us, 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 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, these productsare unapproved new animal drugs and your marketing of them violates the Act.
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 products.
Because your 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, as defined by 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-1]. Your products are not approved or listed by the FDA, and therefore the 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)].
Your written response should be sent to Ms. Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215)717-3076 or e-mail at robin.rivers@fda.hhs.gov.

References: § 321
 § 321
 § 321
 § 360
 § 351
 § 331