FDA WARNING_LETTER - savvy holistic health - April 02, 2020

On April 7, 2020, the FDA and FTC issued a Warning Letter to Holistic Animal Remedies, citing violations observed on their website, holistichealthypet.com, on March 25 and April 2, 2020. The company was found to be selling "China Oral Nosode" (also "China Corona Nosode") and the "CV Respiratory Kit" under the description "AN330 – CORONA VIRAL IMMUNE SUPPORT AND/OR ACTIVE RESPIRATORY INFECTION FOR ALL AGES," claiming to mitigate, prevent, treat, cure, or diagnose COVID-19 in both people and animals.

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and are also considered unsafe and adulterated for animal use under sections 512(a) and 501(a)(5) of the FD&C Act, 21 U.S.C. §§ 360b(a) and 351(a)(5), respectively, as they lack approved new animal drug applications or index listings. Furthermore, the products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction of these products into interstate commerce