The U.S. Food and Drug Administration (FDA) announced “Exploring the Scope of Dietary Supplement Ingredients,” a public meeting that will discuss the evolving landscape of dietary supplement ingredients and how recent scientific and technological advances are shaping the industry. The goal: to help inform FDA’s next steps regarding the meaning of the dietary ingredient categories defined in the Dietary Supplement Health and Education Act of 1994 (DSHEA).

FDA’s Office of Dietary Supplement Programs (ODSP) is inviting stakeholders to participate in the March 27th meeting, with registration required to attend in person (in College Park, MD) or virtually. Virtually, the meeting can be viewed here.

There will be the opportunity to provide oral comment for FDA’s consideration. Comments must be submitted on or before April 27. (Learn how to submit electronic or written comments.) And while it won’t be possible for all industry members to participate, it is important to be represented. Leading trade organizations are preparing to participate on behalf of industry, showing the importance of joining a trade group that aligns with your beliefs and will advocate on your behalf. Leading groups to know include AHPA, CRN, NPA, Organic & Natural Health, and UNPA.

About the dietary supplement meeting

The event will feature presentations that provide background on:

• The scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” as used in DSHEA;
• New methodologies to produce existing dietary ingredients;
• Specific ingredient types, including proteins, enzymes, and microbials.

Currently, the FD&C Act defines “dietary supplement,” in part, as a product that contains one or more dietary ingredients, including “a dietary substance for use by man to supplement the diet by increasing the total dietary intake” (Section 201(ff)(1)(E) of the FD&C Act). The meeting will collect stakeholder input regarding that meaning.

FDA explained: “Scientific and technological advancements have led to an increase in development of novel ingredients. For example, new technologies and approaches are being applied to the science of dietary supplements, including precision fermentation, cell culture technology, and recombinant production, which has led to the development of bioactive compounds derived from foods, plants, and other sources. Accordingly, it would be helpful to better understand how these scientific and technical advancements intersect with dietary ingredient production to inform our assessment.”

The meeting also will explore “questions related to determining the identity of notable supplement ingredients like proteins, enzymes, and microorganisms, which are not specifically listed in section 201(ff)(1) of the FD&C Act. ODSP is interested in learning about the different attributes that are important for assessing identity.”