FDA GRAS Rule About to be Finalized - Clarifications, but No Surprises
06 Sep 2016
After 19 years as a proposed rule, the United States (U.S.) Food and Drug Administration (FDA) will finalize the criteria by which food ingredients can be concluded to be "Generally Recognized as Safe" (GRAS)
Since the 1970's, food ingredient manufacturers have had the option of either: a) submitting a food additive petition to the U.S. FDA to obtain an official approval (i.e., written into law) for their new ingredient or; b) to independently determine (via a panel of qualified experts) that the use of a particular food ingredient is GRAS, with the option to submit the determination to the FDA for confirmation. Both approaches require the same quality and quantity of evidence to support the safety of the ingredient.
The specific rule being finalized now is based on the 1997 proposed rule change from the voluntary GRAS "petition process", which required the FDA to affirm a GRAS conclusion (very resource-intensive and resulted in backlogs), to a voluntary GRAS notification process (wherein a company informs the FDA of a determination, that the use of a substance was GRAS, and the FDA issues a "no questions" response, if the agency considered the conclusion acceptable based on the presented information).
Although the proposed rule was never finalized, it was readily adopted by industry over the past 19 years as an effective approach in balancing food innovation with regulatory obligations.
After reviewing the draft final rule, we do not see any substantial changes that would significantly impact industry in their use of this process. The key highlights consist of the following clarifications:
- various definitions (e.g., "GRAS", "qualified expert", "scientific procedures"),
- specific statements (e.g., "GRAS determination" is now "GRAS conclusion" or "conclusion of GRAS status") ,
- certain requirements (e.g., the types of technical evidence of safety that could form the basis for classification as GRAS and the role of corroborative evidence; the specific data to be included in the notification),
- the inclusion of a description of the physical or technical effect the substance is intended to produce when necessary to demonstrate safety.
The Federal Register document also includes FDA's responses to comments on the proposed rule, based on its 2010 request for public comments – this section provides additional insights into the FDA's thinking on various topics related to food safety and ingredient regulation in the U.S..
Following the current comment period on the proposed final rule, it is set to be adopted into law on October 17th, 2016. The FDA also plans to issue guidance on Expert Panels used to conclude on the GRAS status of the use of food ingredients.
Do you have any questions about the GRAS rule or the process in general?
Intertek Scientific & Regulatory Consultancy experts have been involved in the GRAS process for several decades and are able to assist your company in obtaining efficient market access for your food/supplement ingredients in the U.S.