FDA WARNING_LETTER - Dixie Health Inc - July 31, 2013

The FDA reviewed www.dixiehealth.net and www.tidesoflife.com in July 2013, identifying that products marketed as dietary supplements (Rx Erect, Vaso-Prophin Rx, Dermal K, High-Q 501) and topical products (Beta Yam 900, Dermal E, Dermal K, Vasoderm, Dermal DHEA, Dermal-XL, Miracle Thigh Cream, Estrogyn Gel, Breastique) are promoted for conditions that classify them as unapproved new drugs under section 201(g)(1)(B) and/or (C) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims on the websites and promotional materials, such as "Relief from varicose veins" for Dermal-K Pills, "treatment of Erectile Dysfunction" for Vaso-Prophin Rx, and "PMS & Menopause Relief & Osteoporosis Protection" for Beta Yam-900, establish their intended use in the cure, mitigation, treatment, or prevention of disease, or to affect the body's structure/function.

These products are not generally recognized as safe and effective for their claimed uses, making them "new drugs" under section 201(p) of the Act, requiring prior FDA approval per section 505(a). Furthermore, these products are misbranded under section 502(f