FDA to Strengthen Dietary Supplements Regulation
On February 11, FDA Commissioner Scott Gottlieb, M.D. announced a new plan for modernizing and strengthening dietary supplement regulation and oversight. In making the announcement, Dr. Gottlieb pointed out that supplement use is increasing with three out of every four American consumers taking a dietary supplement on a regular basis. Also, since Congress passed the Dietary Supplement Health and Education Act (DSHEA) 25 years ago, the dietary supplement market has grown significantly—from a $4 billion industry to an industry worth more than $40 billion.
- “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,” Dr. Gottlieb explained, adding that the new plan has the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years. Under the plan, FDA will implement the five steps described below.
- Develop new ways to communicate more quickly when FDA is concerned that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements. This will involve a new rapid-response tool.
- Ensure that the regulatory framework for dietary supplements is flexible enough to adequately evaluate product safety while promoting innovation. The guidance that FDA is developing for preparing new dietary ingredient (NDI) notifications is part of this effort. “An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources,” Gottlieb explained. (See our blog on FDA’s NDI Draft Guidance for background information.)
- Undertake more collaborative research with industry, such as the recently created the Botanical Safety Consortium, a public-private partnership to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. This group will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing.
- Continue to take actions to protect public health and develop new enforcement strategies. (On February 11, FDA sent 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs.)
- Establish public dialog on whether additional steps are necessary to modernize DSHEA. These steps could include amending the statute to establish avenues for dietary supplement exclusivity and a mandatory listing requirement to improve transparency, possibly help facilitate efficient enforcement of the law, and establish new mechanisms to identify bad actors.
- In the coming months, FDA will provide addition details on steps it is taking to modernized dietary supplement regulation, Dr. Gottlieb added.