Many supplements marketed for muscle growth, sexual enhancement, and weight loss contain unapproved or recalled pharmaceuticals that have "the potential to cause serious adverse health effects," according to a recent study in JAMA Network Open, the Washington Post reports.
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Details of the study
For the study, researchers from the California Department of Public Health and other state agencies reviewed FDA's Tainted Products Marketed as Dietary Supplements database, which contains supplements the agency has tested and found to be adulterated.
Between 2007 and 2016, FDA flagged 746 supplements that were pharmaceutically adulterated.
Around 80% of those supplements included one unapproved pharmaceutical, 20% contained at least two unapproved pharmaceuticals, and two of the supplements were contaminated by six unapproved pharmaceuticals. The most common unapproved pharmaceuticals were sildenafil, the active ingredient in Viagra, which was found in sexual enhancements supplements; sibutramine, the active ingredient in the weight loss drug Meridia, which was found in weight loss supplements; and synthetic steroids or steroid-like ingredients, which were found in muscle-building supplements.
The researchers said the unknown presence of these drugs in supplements "poses a serious public health risk," as the drugs could interact negatively with other medications or underlying health conditions.
The researchers also called into question FDA's ability to police the supplement industry, noting that the agency did not require any of the 146 companies that produced the tainted supplements to remove their products from the market. Of the 746 adulterated supplements flagged in the database, 360 were voluntarily recalled by manufacturers. In 342 cases, FDA placed a warning on its website about the supplements, and in seven cases, the agency sent a warning letter asking the manufacturer to remove the products.
The researchers called the findings "alarming, especially considering that the FDA is only able to test a portion of products available on the market."
Pieter Cohen—an internist with Cambridge Health Alliance in Boston and an associate professor at Harvard Medical School, who wrote an editorial accompanying the study—criticized FDA for failing "to recall more than half of the potentially hazardous supplements." He asked, "How could it be that our premier public health agency spends the time and money to detect these hidden ingredients and then doesn't take the next obvious step, which is to ensure that they are removed from the marketplace?"
However, Josh Sharfstein, former principal deputy commissioner of the FDA, noted under the 1994 Dietary Supplement Health and Education Act, FDA has the authority only to regulate supplements after they've reached the market. "Until the FDA has more authority to know what's on the market, there's no way they are ever going to get control of it," he said.
Both Cohen and Sharfstein agreed that current law should be changed to give FDA authority to ensure supplements are safe before they reach the market, such by requiring supplement manufacturers to register their products with the agency.
Daniel Fabricant, president of the Natural Products Association, a supplement industry trade group, said the products flagged in FDA's database should not be placed in the same category as dietary supplements. "We're completely on the FDA's side here," he said. "This is someone spiking the product. They're saying it's a supplement. It's not a supplement in any way, shape, or form."
In a statement, the FDA said it is "committed to doing everything within its resources and authorities to identify and remove unsafe products from the market" and "to help ensure that products marketed as dietary supplements are safe, well-manufactured, and accurately labeled" (Cohen, "Shots," NPR, 10/12; Bernstein, Washington Post, 10/12; Dreyfuss, Wired, 10/12).
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