Future of Dietary Supplements Discussed at CHPA’s RSQ

Issues including DSHEA Modernization, CBD, and product quality among hot topics at 2021 virtual conference.
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The Consumer Healthcare Products Association’s (CHPA) 2021 Regulatory, Scientific, and Quality (RSQ) Conference, held virtually last week, included a dietary supplement track with panels on emerging trends and issues for the category. The conference featured record participation from the U.S. Food and Drug Administration (FDA), including Acting Commissioner Janet Woodcock, MD, and Acting Director for the Office of Dietary Supplement Programs (ODSP) in the Center for Food Safety and Applied Nutrition (CFSAN), Cara Welch, Ph.D.

Acting Commissioner Woodcock highlighted the need for modernizing the Dietary Supplement Health and Education Act of 1994 (DSHEA), which established a regulatory framework for dietary supplements. “The industry is not in the same place as it was 27 years ago when DSHEA was passed. We all know that. We have people all across the United States who take multiple dietary supplements, and our job is to make sure they’re not harmed by those. That those unsafe or unlawful products do not get into the market and holding companies accountable should they not comply with the requirements of the law. However, our tools to do that are fairly limited.”

Dr. Woodcock also stressed the importance of industry collaboration with the Administration to strengthen the framework to prioritize public health. “I think we need to evaluate mutually and collaboratively with the industry, the current regulatory framework to make sure that FDA has the tools to keep bad actors out of the marketplace, to keep reputational issues for the industry good and strong, and also protect patients and consumers.”

Dr. Woodcock concluded her remarks by discussing FDA’s cross agency work on regulatory policy for cannabidiol (CBD), “We continue to underscore the need for scientific evidence to support the safety profile of CBD, especially in consideration of both the known and unknowns about the science, safety and quality of products that contain CBD. To this end, we remain steadfast in our effort to obtain research, data and other safety and public health input to inform our approach and to address consumer access in a way that protects public health and maintains incentives for cannabis drug development through established regulatory pathways.”

Dr. Cara Welch provided an update on ODSP staffing and top priorities, including targeted modernization of DSHEA. Dr. Welch expressed the crucial role mandatory product listing can play in allowing FDA to manage its resources more effectively and better inform retailers and consumers about marketed products. “The patient-healthcare provider conversation can really be informed by having a product listing. If someone can literally pull up a listing and tell their physician ‘this is the product I’m taking,’ they’ll be able to see it. What are the levels of these ingredients? How might this product affect what else my patient is taking?”

The topic of DSHEA modernization was also the subject of a panel of experts from the public health, industry, and legislative sectors. During the panel,

Liz Richardson, Director of Health Care Products Project at Pew Charitable Trusts, and Diane McEnroe, J.D., Partner, Sidley Austin, LLP laid out DSHEA modernization priorities for Pew and CHPA, with both signaling consensus that policies, such as mandatory product listing, can support FDA and result in more effective regulation. Liz Richardson also noted the overwhelming bipartisan support for product listing, with 97 percent of Democrats and 93 percent of Republicans supporting the policy.

Also joining the panel was Angela Wiles, Health Policy Director for U.S. Senator Richard Burr (R-NC), who provided perspective from Capitol Hill, and shared that Congress must understand the “demonstrated safety need” for legislation to be introduced and adopted. While Congress grapples with COVID-19 and other urgent healthcare priorities, industry must be prepared to communicate to Congress “what is the very specific problem we are trying to solve, and how does that benefit both patients and encourage innovation in the space?”

Other dietary supplement highlights from the conference include:

  • Discussion on standards underlying New Dietary Ingredient Notification and the Generally Recognized as Safe (GRAS) pathways
  • Insights into the regulatory, scientific, and legislative landscape of CBD
  • Discussion on retailer support for harmonizing quality programs to protect consumers when purchasing products
  • Overview on the growing use and future of probiotics

While the live conference is over, registration to watch sessions and all on-demand content will remain open until October 10. Registration for media is complimentary. Click here to explore the full RSQ program and register today.

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.