Recalls & Warnings
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Posted April 23, 2013
Seller of Digestion, Thyroid and Vitamin D Supplements Warned For 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 www.1-ibs-irritablebowelsyndrome.com and www.1-fibromyalgia.com 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, www.1-thyroid.com, 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, www.1-vitamind.com, 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.
To read the FDA's warning letter, use the link below.