FDA WARNING_LETTER - PruTect Rx - August 29, 2013
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On August 27, 2012, the FDA issued a Warning Letter to PruTect Rx, specifically addressing Chad Prusmack, M.D., after reviewing the company's website, www.prutectrx.com, in August 2012. The FDA determined that PruTect Rx's products—NeuroPruTect, Omega3PruTect, VitaminD3PruTect, and OsteoPruTect—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 website, such as "lowering cholesterol," "reducing cognitive decline, including Alzheimer's," "prevent nerve damage and post-concussion syndrome," "prevent cancer," "reduce mood disorders, depression, and memory loss," "optimize surgical recovery," "reduces back pain, joint pain, arthritis, and allergies," and "lowers the risk of colon, breast and prostate cancer—even multiple sclerosis (MS)," establish that these products are intended for the cure, mitigation, treatment, or prevention of disease.
These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 32
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