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Supplements Subject of More than Half of FDA’s Class I Drug Recalls, for Nearly Decade

Filed April 19th, 2013 Laurie

Dietary supplements such as DMAA accounted for more than half of the U.S. Food and Drug Administration (FDA)’s Class I drug recalls from 2004 to 2012, according to a new study published online at JAMA Internal Medicine.

The FDA recalled 465 drugs under the Class I heading between January 2004 and December 2012, and 237 of them were dietary supplements. Sexual enhancement supplements were the most recalled, followed by bodybuilding and weight loss supplements. The supplement industry does not have to gain the FDA’s approval before it starts selling a product. There are at least 65,000 dietary supplements on the market in the U.S. today, according to

Because of the lack of regulatory oversight, overseas supplements find their way onto U.S. shelves, and there is no guarantee that they are manufactured under safe conditions or with safe ingredients. Dr. Ziv Harel, the study’s lead author and a nephrologist, says the FDA is required to trace the source of an adulterated dietary supplement by contacting the manufacturer to initiate a recall, but the agency does not have the accurate contact information for about 20 percent of supplement manufacturers.

“Despite these initiatives, products subject to Class I recalls continue to be readily available for sale, which may be due to an increasingly complex distribution network associated with these products, as well as ineffective communication by the FDA to consumers,” Harel told

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