Nutrition Business Journal
Adulterated supplements account for half of FDA drug recalls

Adulterated supplements account for half of FDA drug recalls

Dietary supplements account for half of FDA class-one recalls in the U.S., according to a new report. Most of these recalls occurred after 2008 and are due to unapproved ingredients or drugs. The most common recalled supplements were sexual-enhancement aids, body-building and weight-loss products.

A new report from the Journal of the American Medical Association found that dietary supplements account for half of all class-one drug recalls in the United States.

The research, supported by the Canadian Institutes of Health Research, showed that over a nine-year period (20042012), 51 percent of the U.S. Food & Drug Administration's (FDA) recalls involved dietary supplements containing unapproved ingredients or drugs. During this period, 465 products were recalled, of which 237 were dietary supplements.

The majority of these supplement recalls occurred after 2008, all of which involved unapproved drug ingredients. It’s unclear if the increase in recalls of supplements is due to an increased number of adulterated supplements, an improvement in detection by the FDA or improved enforcement by the FDA.

Major offenders

According to MedPage Today, the most commonly recalled products were:

  • Sexual-enhancement aids, at 40 percent
  • 31 percent were body-building products
  • 27 percent were weight-loss products

Need for more oversight?

Drugs can't be incorporated into dietary supplements—that's a pretty standard no-no. However, it’s clearly not stopping adulterated supplements from entering the market. The report also states that the number of recalls likely does not represent the number of products in the market with unapproved ingredients. Another cause for concern is that foreign manufacturers are not held to the same standard and those in the United States. Almost a quarter of the recalled supplements were manufactured in foreign countries.

To prevent adulterated dietary supplements in the future, the report called for increasing efforts “to regulate this industry through more stringent enforcement and a standard of regulation similar to that for pharmaceuticals.”

Duffy MacKay, vice president of scientific and regulatory affairs at the Council for Responsible Nutrition, begs to differ, arguing that adulteration is the work of criminals, not industry. "It's not the supplement industry," he says. "It's this fraudulent outlier group that preys on our space. To penalize the supplement industry is just misguided."

He argues that increased enforcement and prosecution of fraudulent actors should be a higher priority than tightening the reins on supplements. "Let's say that we do get pre-market approval for dietary supplements," he says. "This problem could just shift into the food category. Is the solution then pre-market approval for food?"

The proliferation of internet sales has compounded the problem, offering offenders quick access to market—and an even quicker exit for when the Feds come calling. But MacKay reiterates that this problem is not peculiar to the dietary supplement market. "As long as there are police, there will be criminals."

A little common sense on the part of consumers would go a long way too, MacKay says. "We can really reduce this problem by giving consumers the tools to make informed decisions." The absurd promises and label claims—specifically in the sexual health category—made by such recently recalled products as Mojo Nights, ROCK-It MAN, Ninja Mojo, AFFIRM XL and Love Rider should be the first warning that a supplement is adulterated.

"I would go so far as to say that I've read the existing literature and there is no natural product that works in an hour and sustains an erection for more than 24 hours," MacKay says. "These are just little red flags that should pop into consumers' minds so they don't become victims of these fraudulent attempts."

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