FDA proposes expanding safety exemptions for direct food additives

The U.S. Food and Drug Administration (FDA) is proposing a regulatory expansion of its ‘threshold of regulation’ exemption. This change could allow certain substances to be added directly to food without undergoing the standard, formal safety review process.

Currently, this exemption primarily applies to substances in food packaging or those resulting from processing, provided they do not exceed a 0.5 ppb limit and are not classified as carcinogens. The new proposal would extend this framework to include ingredients added directly to food, such as flavors, preservatives, emulsifiers, enzymes, and processing aids.

Public health experts and consumer advocates have expressed significant concerns regarding the proposal. Critics argue that focusing primarily on cancer risk and extremely low exposure levels may overlook other biological impacts, such as hormonal disruption, neurological development issues, and thyroid function interference. Specific substances of concern mentioned include perchlorate, PFAS, and phthalates.