FDA WARNING_LETTER - Calroy Health Sciences, LLC - November 17, 2022

The FDA issued a Warning Letter to Mr. Chen and Mr. Hoyt regarding their Arterosil product, sold on www.arterosil.com. An October 2022 website review determined that claims establish Arterosil 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)], intended for disease cure, mitigation, treatment, or prevention.

Specifically, the claim "What you need to remember is that LDL can only cause problems if it lodges in the artery wall. A healthy glycocalyx can slow or stop that from happening" on the Arterosil product page indicates drug intent. Arterosil 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 these 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, Arterosil is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(