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Study Says More Efforts Needed to Regulate Dietary Supplements

FDA marketing approval isn’t required (Apr. 18)

According to a report from St. Michael’s Hospital in Toronto, Canada, dietary supplements accounted for more than half of the Class 1 drugs recalled by the FDA from 2004 to 2012, meaning that they contained substances that could cause serious health problems or even death.

Most of the recalled supplements were bodybuilding, weight loss, or sexual-enhancement products that contained unapproved medicinal ingredients, including steroids, said the study’s lead author, Dr. Ziv Harel. Almost one-quarter of the substances were manufactured outside the U.S.

The new study was published online in JAMA Internal Medicine.

Unlike pharmaceutical products, dietary supplements do not require FDA approval before they can be sold. The FDA defines a dietary supplement as a product taken by mouth that contains a “dietary ingredient,” such as vitamins, minerals, herbs or other botanicals, amino acids, or other substances, such as metabolites. Dietary supplements are consumed by more than 150 million Americans.

Of the 465 drugs subject to a Class 1 recall in the U.S. between January 1, 2004, and December 19, 2012, a total of 237 (51%) were dietary supplements. Most of the recalls occurred after 2008 for unknown reasons, the researchers said.

Supplements marketed as sexual-enhancement products had the highest recall rate (95 products [40%]).

Harel, a nephrologist, said that when the FDA learns of an adulterated dietary supplement, it is required to contact the manufacturer to trace the source of the product and to initiate a recall. However, a recent investigation by the Office of the Inspector General determined that the FDA does not possess accurate contact information for 20% of supplement manufacturers.

The FDA has recently introduced a number of initiatives aimed at mitigating the effect of the most common adulterated supplements, including the creation of multinational enforcement groups and widespread media campaigns focusing on improving awareness.

“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 said.

“We also found a number of recalled products to be manufactured outside of the U.S., where manufacturing practices may not be subject to the same oversight and regulation required of domestic companies.”

Harel said increased efforts are needed to regulate this industry. “Keeping the status quo may taint the dietary supplement industry as a whole,” he said.

Source: St. Michael’s Hospital; April 18, 2013.

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