New Efforts Mulled to Modernize Dietary Supplement Regulation
FDA has released a new plan to modernize dietary supplement regulation and oversight. It has been more than 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), and the regulated industry has exploded from 4,000 unique products to potentially more than 80,000 different products available to consumers, FDA says.
While DSHEA imposed many requirements for making and labeling of dietary supplements, the growth of the industry has allowed “opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk,” the agency says. “As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.”
FDA commissioner Scott Gottlieb says FDA is taking new steps to communicate to the public as soon as possible when there is a concern about a dietary supplement on the market. FDA is also evaluating its regulatory framework to make sure it is “flexible enough to adequately evaluate product safety while also promoting innovation,” and “developing new enforcement strategies,” he says. To illustrate FDA’s new enforcement posture against certain supplement marketers, he cites 12 Warning Letters and five online advisory letters recently sent to companies whose products are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s and other diseases.
Gottlieb also says he recently directed the establishment of a Dietary Supplement Working Group. “I’ve tasked this group with taking a close look at our organizational structures, processes, procedures and practices in order to identify opportunities to modernize our oversight of dietary supplements,” he says. “Additionally, when the FDA created the Office of Dietary Supplement Programs (ODSP) three years ago, the agency recognized that keeping up with the evolving marketplace meant giving dietary supplement regulation more attention and making it a higher priority.”
In the coming months, Gottlieb says the agency will provide additional details on the steps it will take to modernize the agency’s dietary supplements program. FDA is also planning a public meeting this spring on “responsible innovation in the dietary supplement industry.” he says. “We’ll look to address other challenges that may act as barriers to dietary supplement innovation and safety including issues such as what the right incentives might be for establishing dietary supplement exclusivity, and the scope of permitted dietary ingredients. We invite all our stakeholders to share their views on how the FDA should strengthen the dietary supplement program for the future.”