The use of dietary supplements has become a routine part of the lives of many consumers. Three-quarters of the U.S. population take dietary supplements on a regular basis. In the 25-years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed FDA’s authority to regulate dietary supplements, the market has greatly expanded from ~4,000 in 1994 to more than 80,000 products present day. DSHEA imposes a number of requirements around the manufacturing and labeling of dietary supplements, and while most players in this industry act responsibly there are opportunities for exploitation of current regulations to market unsafe products to consumers. As the popularity of dietary supplements continues to expand, the number of misleading claims and dangerous products has also risen. Many have criticized current regulations as “outdated” and/or “insufficient” to fully protect consumers of these “bad actors.” The unforeseen rise of the internet and ecommerce have greatly expanded access to information and products. Leading trade associations have developed various successful self-regulatory programs and voluntary labeling initiatives to better protect and inform consumers. Recent scientific advancements have led to new opportunities for consumers to improve their health, but at the same time opened the door to many new potential dangers. For this reason, the FDA created the Office of Dietary Supplement Programs (ODSP) in 2016. In the coming months, the Agency will be undertaking various efforts to advance its policy goals outlined by a recent statement from FDA Commissioner, Scott Gottlieb. These goals include:
1. New ways to communicate more quickly when the Agency has concerns over an ingredient that is unlawful and potentially dangerous.
2. Update the compliance policy regarding new dietary ingredients (NDIs).
3. Creation of a Botanical Safety Consortium, a public-private partnership that will gather leading scientific minds from industry, academia and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures.
4. Take actions to protect public health.
5. Convene a public dialogue around whether additional steps to modernize DHSEA are necessary, while preserving the balance struck by DSHEA between access to supplements and consumer protection.
The American Society for Nutrition (ASN) and Journal of Dietary Supplements (JDS) are recognized as two leading voices of the scientific community in regard to the composition, safety and efficacy of dietary supplements. Thus, we propose to convene a sponsored Science and Policy Forum discussion at the ASN Nutrition19 annual meeting. Panelists represent scientists and regulatory experts from industry, academia and government (if permitted) that will engage on various topics related to regulatory and policy reform reflected in the Commissioner’s recent statements.
Questions to be addressed by the panel include:
1. What has the FDA proposed to modernize its approach to regulating dietary supplements? How will these assure the safety, efficacy and composition of dietary supplements?
2. What additional steps might the agency take within its authority to modernize its approach?
3. What statutory changes might Congress consider modernizing DSHEA while preserving the balance between consumer access and protection?
Breakfast will be served.