Supplements Involved in Half of Drug Recalls

Supplements Involved in Half of Drug Recalls

April 16th, 2013 // 1:16 pm @

Dietary supplements that contain unapproved ingredients accounted for just over half of all major drug recalls in the U.S., researchers found.

Analysis of FDA data showed 51% of Class I recalls over a 9-year period involved adulterated dietary supplements instead of a pharmaceutical product, Ziv Harel, MD, of St. Michael’s Hospital in Toronto, and colleagues reported in a Research Letter published online in JAMA Internal Medicine.

Most of those supplements were either sexual-enhancement, body-building, or weight-loss aids, they reported.

Harel and colleagues called for increased efforts “to regulate this industry through more stringent enforcement and a standard of regulation similar to that for pharmaceuticals.”

“Keeping the status quo may taint the dietary supplement industry as a whole,” they added.

Americans spend more than $20 billion annually on dietary supplements — a market for which there is little oversight, as federal law doesn’t require supplements to go through the FDA approval process before they are marketed.

Supplement manufacturers are expected to adhere to current good manufacturing practices (CGMP) to ensure quality, but supplements adulterated with pharmaceutical compounds have continued to enter the market.

To describe the frequency and characteristics of dietary supplement recalls in the U.S., Harel and colleagues looked at FDA enforcement reports for Class I recalls from Jan. 1, 2004 to Dec. 19, 2012.

During that time, 465 drugs were subject to a Class I recall; 237 of the recalls were for dietary supplements.

Nine out of 10 (89%) supplement recalls occurred after 2008, and unapproved drug ingredients were involved in all of the supplement recalls, they reported.

Sexual-enhancement aids were the most commonly recalled product (40%), followed by body-building (31%) and weight-loss products (27%).

About a quarter (24%) of the recalled supplements were manufactured outside the U.S., a concern given that manufacturing practices in foreign countries may not be held to the same standard, the researchers wrote. They noted, however, that the FDA has found CGMP violations in at least half of the domestic dietary supplement firms it has inspected.

No adverse events related to these recalled products were noted in the FDA database, but the researchers noted that the 1994 Dietary Supplement Health and Education Act (DSHEA) has “permitted the introduction of numerous supplement products, often containing unapproved active pharmaceutical ingredients, into the marketplace, which has led to harm.”

The study was limited because it focuses only on Class I recalls, and was unable to associate the use of many adulterated supplements with adverse events.

It is also unclear if the increase in recalls of dietary supplements is due to the improvement in detection by the FDA, improved enforcement by the FDA, or an increase in the number of adulterated supplements on the market.

In an editor’s note, Mitchell Katz, MD, said it’s likely that the number of recalls “grossly underestimates the number of products on sale with unapproved ingredients.”

“Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health,” Katz wrote.

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