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Posted April 23, 2013

Seller of Digestion, Thyroid and Vitamin D Supplements Warned For Drug Claims

On November 5, 2012, the FDA issued a warning letter to The Women's Health Institute at Texas following a review of the company's various websites which found statements made about Digest + SEB, Iodine Plus 2, and D5000 Vitamin D dietary supplements to be drug claims.

Digest + SEB contains digestive enzymes amylase, proteases, lipase, cellulase, maltase, invertase, bromelain, papain and alpha galactosidase. It was promoted for the treatment of irritable bowel syndrome and diseases of the immune system.

Statements on the company's websites and described Digest + SEB as the "First line treatment for Irritable Bowel Syndrome," and "New front-line recommendation for auto-immune diseases."

Iodine Plus 2 contains selenium, vitamin B-2, vitamin B-3, and iodine. It was promoted on the company's website,, for the treatment of hypothyroidism with statements such as "Iodine-Plus 2 is effective as a stand-alone in many thyroid-deficient conditions" and "Iodine-Plus alone may enable your thyroid gland to function normally without having to resort to prescription thyroid hormones." D5000 is a vitamin D supplement that was promoted on the company's website,, for the treatment of various conditions ranging from inflammation and the flu to heart disease and cancer. Statements found on the website included "the less Vitamin D in the body, the more cancer is likely to develop," and "Influenza epidemics are inversely correlated with Vitamin D deficiency."

The FDA also cited metatags that the company used to direct search engines to the sites, including "treatment fibromyalgia" and "hypothyroidism" as evidence of drug claims.

In addition, Digest + SEB, Iodine Plus 2, and D5000 were found to be misbranded because their labels lacked adequate directions for use.

See's Reviews of Vitamin D Supplements and Digestive Enzyme Supplements for tests of related products.