[Brief Introduction of Seminar]
The US Food and Drug Administration (FDA) regulates products marketed for physiological benefits under the Federal Food, Drug, and Cosmetic Act. These products are categorized based on their composition and intended use, rather than a distinct “functional food” category. Any novel component must meet one of two foundational premarket safety frameworks before entering interstate commerce.
For conventional food matrices, added substances are legally considered unapproved food additives unless they achieve Generally Recognized as Safe (GRAS) status. A GRAS conclusion requires expert scientific consensus on safety under specific conditions of use, primarily relying on publicly available, peer-reviewed literature. Manufacturers can fulfill this requirement through an independent expert panel for a “Self-Affirmed GRAS” determination (that actively facing elimination and being replaced by mandatory notification) or voluntarily submit a formal dossier to the agency for official administrative closure.
On the other hand, novel components engineered for dietary supplements rely on the New Dietary Ingredient (NDI) mechanism. This mechanism applies to any dietary ingredient not marketed in a supplement in the United States prior to October 15, 1994. If a substance lacks this historical market baseline, the manufacturer must file an electronic New Dietary Ingredient Notification (NDIN) to the FDA. This statutory mechanism mandates a strict 75-day premarket hold while the agency conducts its scientific safety evaluation. During this period, commercial distribution is legally blocked. Unlike the public data requirements of the GRAS pathway, an NDIN safety dossier can utilize confidential, proprietary toxicology data to demonstrate that the ingredient is reasonably expected to be safe under its proposed conditions of use.
[Brief Introduction of Speaker]
Ph.D. and MPH, Biologist/Regulatory Toxicologist from US FDA from 1998 to 2026