MDR Fitness Corp. of Sunrise, FL Subject of FDA Warning By Tod Aronovitz | 02/12/13 | 0 Comment

Nutritional supplement company MDR Fitness, also known as Medical Doctors Research, recently received a Warning Letter from the U.S. Food & Drug Administration (FDA).  MDR “failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements,” according to the FDA.

The MDR product line features capsules, lotions, and other offerings marketed under the names Artery Factors, Cardio Tone, Cranberry Concentrate, Fitness Tabs for Men and Longevit-E.

The FDA claims that MDR products are promoted for conditions which cause the products to be viewed as new drugs. Sales of a new drug require prior FDA approval before they can be sold to consumers. MDR has not received FDA approval, making sales of the products under review illegal.

MDR is based out of a 70,000 square foot building on NW 4th Street in Sunrise, according to the MDR website. Bottling and labeling of nutritional supplements takes place at the MDR headquarters, which also includes an order processing division, R&D laboratory, a shipping facility, as well as marketing and customer service departments.

“Even if your products did not contain disease claims in their labeling that cause them to be drugs, they would still be adulterated dietary supplements within the meaning of Section 402(g)(1) of the Act because they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements,” warns the FDA letter.

FDA inspection of MDR’s Sunrise facilities dates back to July, 2012. The agency and MDR have been engaged in correspondence regarding the firm’s compliance status since August of last year.

Click on the link to read the FDA’s warning letter to M.D.R. Fitness Corp.

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