FDA WARNING_LETTER - Strictly Health Corp - March 31, 2015

On May 7, 2015, the FDA and FTC issued a Warning Letter to Strictly Health Corporation, Anna McLean, regarding products sold on www.fenvir.com, www.herpescuresinvestigated.com, and www.strictlyhealth.com, and promoted on social media. The FDA determined that FENVIR, Prosta Pep, and Tonalin brand CLA are unapproved new drugs 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 therapeutic claims for conditions like herpes, cancer, and diabetes. These products are not generally recognized as safe and effective, lacking FDA approval, violating sections 505(a) and 301(d) of the Act.

Furthermore, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because they are intended for conditions not amenable to self-diagnosis, thus lacking adequate directions for layperson use. The FENVIR product label is also misbranded under section 403(y) for failing to include a domestic address or phone number for adverse event reporting, and under section 403(s)(2)(C) for not identifying the