GRAS UPDATE
Delay
The FDA has delayed its anticipated publication of a proposed rule to require notification of certain (GRAS) substances used in human and animal food to December, according to an update from the federal Unified Agenda.
Currently, the GRAS program allows manufacturers to achieve self-affirmed GRAS status. Notification to the FDA isn’t required. If a manufacturer submits a voluntary notice with their ‘research’ to the FDA, the manufacturer could receive a “no questions” letter from the agency on the GRAS status. That is as approved as it gets.
According to the FDA:
“This proposed rule would revise the procedures by which a person introducing a human or animal food substance into interstate commerce notifies FDA of a conclusion that the use of such substance is generally recognized as safe (GRAS). Specifically, the proposed rule would require the submission of GRAS notices to FDA for certain uses of food substances. A substance that is GRAS under the conditions of its intended use is not subject to FDA premarket review and approval as a food additive for that particular use (see sections 201(s) and 409 of the FD&C Act). Under our current regulations, a person who concludes that the use of a substance is GRAS under the conditions of its intended use may, but is not required to, notify FDA of this conclusion. The submission of a GRAS notice is therefore currently voluntary. If the proposed rule is finalized, GRAS notices will be required for certain uses of substances in human and animal food. Uses of food substances that are subject to the mandatory notification requirement will be presumed by FDA not to be GRAS unless the notification requirement has been met regarding the use of the substance.”
The FDA’s focus on food has been characterized as putting the F back in FDA. I think they are leaving out a few letters. At this rate, the loophole that took 19 years to finalize won’t close for years to come.
