Food and Drug Administration Commissioner Scott Gottlieb announced last month a new working group to improve oversight of the dietary supplement industry. The move could mean increased safety for consumers, but also increased scrutiny of dietary supplement merchants and the payment facilitators that onboard them.
An Unwieldy Industry
In a speech at the Food and Drug Law Institute's Enforcement, Litigation, and Compliance Conference, Gottlieb stressed the need for more oversight of an industry that has grown increasingly complex and profitable. Part of the problem, Gottlieb said, is the exponential growth of new products and manufacturers since the Dietary Supplement Health and Education Act of 1994.
"The dietary supplement industry has grown significantly from where it was 25 years ago," Gottlieb said. "What was once a $4 billion industry of about 400 products is now an industry of over $40 billion and more than 50,000 products. And while much of this industry is responsible to consumers and the public health, there are also too many bad actors who are not."
Gottlieb said the problems in the supplement world are manifold, and that the industry has gotten bigger and riskier faster than the FDA's policies and its capacity to manage the risk.
"Some products marketed as dietary supplements contain dangerous and illegal ingredients, often without identifying them to consumers," he said. "Some contain lawful ingredients, but their manufacturing processes fall far short of GMPs that are needed to assure a quality product. And others make illegal and unproven claims about their ability to treat serious diseases. We take seriously our obligation to protect consumers from all of these dangerous products."
Although Gottlieb said the FDA has specific, new policy measures it plans to pursue to modernize the administration's overall approach to dietary supplements, he didn't specify what those would be. Whatever measures result from the Dietary Supplement Working Group, they'll almost certainly have a wide-reaching impact on dietary supplement merchants and payment facilitators that process payments for them. It's conceivable that policies could include tighter regulation of dietary supplement ingredients and stronger action against merchants that make problematic claims.
Despite these problems, the dietary supplement industry is increasingly lucrative and shows no signs of slowing down. According to Kantar Media's 2018 MARS Consumer Health Study, 61 percent of Americans believe vitamins and supplements make a difference in long-term health, up 9 percent from 2015. Although new FDA regulations might hamper noncompliant businesses, stricter standards may have the potential to be a boon for merchants and ISOs with strong compliance measures in place.
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