FDA WARNING_LETTER - Shen Clinic, LLC.

The FDA issued a Warning Letter to Joel and Betty Schreck regarding labeling claims on their website, www.drshen.com, for products including "Acorus Tablets," "Blue Citrus," and "Dr. Shen's Cold Stop." The FDA determined that the marketing of these products violates the Federal Food, Drug, and Cosmetic Act.

The products are promoted for serious health conditions like cancer, epilepsy, hepatitis, and HIV, which require professional medical diagnosis and treatment. This promotion may lead consumers to delay necessary medical care, increasing risks of harm or death.

The FDA cited specific labeling claims that cause these products to be considered "drugs" under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)], as they are intended for disease diagnosis, cure, mitigation, treatment, or prevention, or to affect body structure/function. Furthermore, these products are "new drugs" under section 201(p) [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective. Introducing new drugs into interstate commerce without FDA approval violates sections 301(d) and 505(a) [21 U.S.C. §§ 331(d) and 355(a)].

Additionally, most products are misbranded under section 50