Six Dietary Supplement Manufacturers Cited by FDA for Promoting Unproven Claims, CGMP Violations

Posted 03 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) fired off numerous warning letters to dietary supplement manufacturers this week. While its actions against ten manufacturers of dimethylamylamine (DMAA) garnered significant attention, FDA also sent warning letters to six other dietary supplement manufacturers for allegedly violating numerous regulations under the Federal Food, Drug and Cosmetic Act (FDCA).

Manufacturer Vitality Distributing, Inc., received an FDA warning letter after it promoted its aviate caffeinated water for the treatment of cancer, depression, Alzheimer's disease and Parkinson's disease. Under the FDCA, any product that makes claims regarding the "cure, mitigation, treatment or prevention of disease" is classified as a drug product, and must be approved by FDA.

FDA specifically called our Vitality for expressing these claims on its social media platforms including Twitter and Facebook in addition to its website.

Similar claims were leveled against From Fatigued to Fantastic (FtF), LLC of Maryland, which was cited by FDA for promoting a litany of products for numerous unproven therapeutic claims. FtF, like Vitality, claimed its products could treat Alzheimer's disease, Parkinson's disease, cancer, depression, as well as Hepatitis, Cirrhosis, diabetes, nerve injury, influenza, heart disease and arthritis.

FtF was cited for its use of social media to promote unproven claims in violation of federal regulations.

Nature's Pearl Corporation, Healing With Essiac Tea, and High Performance Formulas, L.L.C also received warnings from FDA for promoting products with unproven therapeutic claims. These warning letters were similar in form to those sent to Vitality Distributing and FtF.

One supplement manufacturer, SEI Pharmaceuticals, Inc,, was cited for deficiencies identified in its current Good Manufacturing Practices (cGMPs).

FDA's inspection of SEI's facilities identified what it termed "significant violations" of cGMPs, which "cause the dietary supplements manufactured in [SEI's] facility to be adulterated within the meaning of Section 402(g)(1) of the FDCA," wrote FDA.

FDA identified nine cGMP-related deficiencies in SEI's manufacturing facility, including failure to establish written procedures for staff responsibilities, failure to test finished batches, failure to ensure conformity of batches to specifications and failure to maintain sanity conditions.

SEI responded to FDA's warning letter, but the agency noted it failed to establish specific procedures for taking corrective actions and its response was "inadequate."

Read more:

Regulatory Focus - FDA Sends out Warning Letters to Supplement Manufacturers

FDA Warning Letter | Vitality Distributing, Inc. 4/24/12

FDA Warning letter | From Fatigued to Fantastic, LLC 4/18/12

FDA Warning letter | High Performance Formulas, L.L.C. (HPF, L.L.C.)

FDA Warning Letter | Healing With Essiac Tea 4/12/12

FDA Warning letter | Nature's Pearl Corporation 4/19/12

FDA Warning Letter | SEI Pharmaceuticals, Inc. 3/26/12

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