FDA WARNING_LETTER - Women's Health Institute of Texas - November 06, 2013

The FDA issued a Warning Letter to Andrew Jones, MD, of The Women's Health Institute at Texas, on November 5, 2012, following a September 2012 review of his websites (www.1-ibs-irritablebowelsyndrome.com, www.1-fibromyalgia.com, www.1-thyroid.com, www.1-vitamind.com). The FDA determined that the products Digest + SEB, Iodine Plus 2, and D5000 (Vitamin D) 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 claims on the websites, including "First line treatment for Irritable Bowel Syndrome" for Digest + SEB, "We Can Now Treat, Reverse…Even eliminate your most troubling Fibromyalgia symptoms" for Protease + NK & Digest-SEB, and dosage recommendations for "Mild hypothyroidism" to "Severe hypothyroidism" for Iodine Plus 2, establish the products' drug intent. Claims for D5000 (Vitamin D) included treating "Cancers," "Body Inflammation," "Heart Disease," and "Pain Issues." These claims, along with metatags like "treatment fibromyalgia" and "Irritable bowel syndrome