Politics

FDA proposes mandatory reporting for self-certified food additives

The proposed rule would require companies to notify the agency of new ingredients but does not require pre-market approval.

Updated Aug 31, 2026 · 19:26 UTC1 reports

The short version

The FDA proposed making its voluntary notification program mandatory for companies introducing food ingredients under the "generally recognized as safe" (GRAS) exemption.
The rule would force companies to share their safety bases for new substances, but it does not require them to wait for FDA approval before selling products.
Health experts note that the proposal lacks a pre-market approval requirement or robust enforcement mechanisms, leaving questions about the FDA's ability to evaluate all filings.

Under a new federal proposal, food and beverage companies would be required to notify the FDA when introducing new ingredients self-certified under the GRAS exemption.[PBS NewsHour]
The proposed rule does not require companies to delay marketing products until the FDA conducts a safety review or makes a formal safety determination.[PBS NewsHour]
The policy change is part of Health and Human Services Secretary Robert F. Kennedy Jr.'s "Make America Healthy Again" agenda.[PBS NewsHour]
If the rule takes effect, companies would have one year to submit streamlined notices for previously self-affirmed GRAS substances without submitting underlying safety data.[PBS NewsHour]
The public comment period for the proposed rule remains open through early December.[PBS NewsHour]

It is unclear what specific penalties or legal consequences companies would face if they fail to comply with the proposed notification requirement.[PBS NewsHour]
Experts questioned whether the FDA possesses the statutory authority or staffing resources necessary to independently review all incoming submission notifications.[PBS NewsHour]