FDA WARNING_LETTER - Biorica International Corp. - November 07, 2023

The FDA issued a Warning Letter to Jacqueline Baxas regarding the product Plaquex® Oral Dietary Supplement, sold via websites https://www.plaquex.com/, https://biorica.biz/en/, and Facebook pages. A May 2023 review of these websites found claims establishing the product as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] due to its intended use in the cure, mitigation, treatment, or prevention of disease.

Specific claims on the websites indicate drug intent. Plaquex® Oral Dietary Supplement is deemed a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)] because it is not generally recognized as safe and effective for its claimed uses. Introducing or delivering a new drug into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].

Furthermore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] as it lacks adequate directions