FDA WARNING_LETTER - Dr Foster'S Essentials

The FDA issued a Warning Letter to Ms. Cynthia Foster regarding products promoted on www.drfosteressentials.com. The FDA determined that products such as "Adrenal Support," "Blood Detox Formula," and "Candida-G" are promoted for conditions that classify them as 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)].

The website's "Search by Health Concern" feature, "List of Health Concerns" webpage, and "Ailment Reference Guide" link products to the cure, mitigation, treatment, or prevention of numerous diseases, including Attention Deficit, Crohn's, Cancer, Diabetes Type I, Hepatitis, Colon Cancer, and Epilepsy. Specific therapeutic claims and personal testimonials on the website further establish these products as drugs.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their promoted uses and lack prior FDA approval. Marketing them without approval violates section 505(a) of the Act [21 U.S.C. § 355(a)].

Furthermore, the products are misbranded under section 502(f)(1)