FDA Publishes GRAS Final Rule – Has Anything Really Changed?
Updated: Nov 22, 2018
Last Friday, FDA issued the Substances Generally Recognized as Safe (GRAS) Final Rule. Although GRAS foods are not subject to FDA pre-market approval, they must meet the same safety standards as approved food additives. Thus, the final rule details the criteria for concluding that a human or animal food ingredient is GRAS and formalizes the voluntary GRAS notification procedure.
For those of you who have been reading our newsletters for a while you will know that we have done a number of previous newsletters on the GRAS issue. At one point it looked as if there could be some major changes for GRAS foods. We now have a new final rule and it will be interesting to see where both industry and those pushing for much tighter GRAS requirements feel that this has landed.
The new rule stresses that, for an ingredient to be considered as GRAS, its safe use in human and animal food must be widely recognized by the appropriate qualified experts, so the rule addresses the types of scientific evidence and the role of publications by which safety can be demonstrated. As such, to be eligible for classification as GRAS:
The available data and information on the substance must satisfy the FD&C safety standard for a food additive under the conditions of the substance's intended use.
General recognition of safety requires common knowledge, throughout the expert scientific community knowledgeable about the safety of substances directly or indirectly added to food, that there is a reasonable certainty that the substance is not harmful under the conditions of its intended use.
“Common knowledge” can be based on either “scientific procedures” or on experience based on common use of a substance in food prior to January 1, 1958.
General recognition of safety through scientific procedures must be based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
In formalizing the voluntary GRAS notification procedure, which was originally established under an interim policy and pilot program for human food in 1997 and animal food in 2010, the rule defines key terms and general provisions; explains where and how to submit a GRAS notice; and details required information for a notice, including:
Signed statements and a certification.
The identity, method of manufacture, specifications, and physical or technical effect of the notified substance.
Self-limiting levels of use (if the amount of the substance that can be added to human food or animal food is limited because a higher amount would make the food unpalatable or technologically impractical).
The history of consumption of the substance for food use by a significant number of consumers/animals prior to January 1, 1958, if a conclusion of GRAS status is based on common use of the substance in food prior to 1958.
Explanation of the basis for conclusion of GRAS status, including why the scientific data, information, methods, and principles used provide the basis that qualified experts generally recognize the substance to be safe under the conditions of its intended use.
A list of the data and information used in the notice, specifying which are generally available, and which are not.
FDA's process upon receipt of a GRAS notification is:
The agency will conduct an initial evaluation of the submission to determine whether to file it as a GRAS notice for evaluation:
If it is filed, FDA will send the submitter a letter with the date of filing.
If it is not filed, a letter will be sent stating that fact and providing the reasons.
If an amendment is filed to update the notice or in response to an FDA question, FDA will consider the amendment, if feasible within the established timeframe, before it sends the evaluation response. If consideration of the amendment is deemed to not be feasible within the timeframe, a notice will be sent that the amendment is not being considered
A similar notice will be sent when FDA grants a submitter's request to cease the evaluation of a GRAS notice.
FDA will provide its evaluation within 180 days of filing, however it may extend the timeframe by 90 days if needed. If the timeframe is to be extended, FDA will notify the submitter of the extension as soon as practicable but no later than within 180 days of filing.
If circumstances warrant, FDA will send a subsequent letter about the notice.
It also is important for those who plan to file GRAS notifications to understand that the data and information in a GRAS notice are open to public disclosure on the date it is received by FDA. Additionally, FDA will make a list of filed GRAS notices and its responses readily accessible, with any letters sent by FDA in response to notifications or requests for cancellation also publicly disclosed. The fact that GRAS notifications are open to the public is not actually new but I suspect many were not aware of it.
Although the rule provides very specific requirements for GRAS notification filing, the notification continues to be voluntary. That said, FDA "strongly encourages companies to inform the agency of GRAS conclusions through the notification procedure," and notes that it can question the basis for an independent GRAS conclusion, whether notified or not, and can take action as appropriate. Additionally, FDA encourages notification because it "yields important information that aids the agency’s food safety monitoring efforts." So if it is not mandatory, has anything really changed? – Maybe not all that much.
The rule is effective on October 16 – 60 days after its August 17 publication in the Federal Register. Following this publication, FDA's next steps related to GRAS are to develop and implement regulatory and compliance strategies to improve premarket oversight and safety evaluation both additives and GRAS substances. Thus the FDA is saying we are going to be checking up more on the use of GRAS substances. That is probably a good thing for public health, but of course it raises the FDA resource question, especially in light of the increased inspection requirements for FSMA. So will anything really change with this new rule? Again, perhaps not that much.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com