From Fatigued to Fantastic, LLC – FDA Warning Letter, Feb 29, 2012
On April 18, 2012, the FDA issued a Warning Letter to Jacob Teitelbaum, M.D., of From Fatigued to Fantastic, LLC, following a February 2012 review of their website, http://www.endfatigue.com. The FDA determined that products including "Corvalen (D-Ribose)," "Coenzyme Q10," and "Eskimo 3 Fish Oil" were promoted with therapeutic claims that classify them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).
The website's "Cures A-Z" section listed numerous medical conditions with recommended products for treatment, cure, mitigation, or prevention. Examples include "Eskimo 3 Fish Oil" for Alzheimer's and depression, "Coenzyme Q10" and "Black Cohosh" for breast cancer, "Alpha Lipoic acid" and "Acetyl-L-Carnitine" for diabetes, "Thymic Protein" for infections, "Chol-less" for high cholesterol, "Coenzyme Q10" for hypertension, and various products for Parkinson's Disease and Heart Disease. "Healthy Knees and Joints" was promoted for arthritis.
These products are considered "new drugs" under section 201(p)(1) of the Act because they are not generally recognized
ID · 5d80f1e1-18a3-433e-aab7-374e08f52f63
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