Weekly Compliance Digest – FDA Rule on Substances Generally Recognized as Safe
Substances Generally Recognized as Safe (GRAS)
What is it?
In August 2016, the U.S. Food and Drug Administration (FDA) issued a final rule that amends and clarifies the criteria in its regulations for when the use of a substance in food for humans or animals is not subject to the pre-market approval requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act), because the substance is generally recognized as safe (GRAS) under the conditions of its intended use.
Although the FDA has pre-market review authority over food additives, a food manufacturer can intentionally add a substance to human food or animal food without FDA’s pre-market review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use. Since the 1970s, there have been regulations clarifying the statutory provision for eligibility for classification as GRAS. There have also been regulations governing a procedure for any person or company to voluntarily submit a petition asking FDA to affirm the GRAS status of a substance under the conditions of its intended use, and for FDA to engage in an intensive rule-making process in response to that petition. FDA says that its regulations need more clarification to help stakeholders understand when a substance is eligible for classification as GRAS in human food or animal food under the conditions of its intended use.
The final rule amends and clarifies the criteria for when a substance is GRAS under the conditions of its intended use in human food or animal food, and replaces the voluntary administrative procedure for petitioning FDA to affirm the GRAS status of a use of a substance in human food or animal food with a voluntary administrative procedure for notifying about a conclusion that a substance is GRAS under the conditions of its intended use in human food or animal food.
What are the requirements?
The final rule outlines a voluntary notification procedure under which any person or company may notify FDA of a conclusion that a substance is GRAS under the conditions of its intended use. Any person or company that would like to submit a GRAS notice must provide the following specific information:
- Signed statements and a certification.
- The identity, method of manufacture, specifications, and physical or technical effect of the notified substance.
- Dietary exposure.
- Self-limiting levels of use, in circumstances where the amount of the notified substance that can be added to human food or animal food is limited because the food containing levels of the notified substance above a particular level would become unpalatable or technologically impractical.
- The history of consumption of the substance for food use by a significant number of consumers (or animals in the case of animal food) prior to January 1, 1958, if a conclusion of GRAS status is based on common use of the substance in food prior to 1958.
- A narrative that provides the basis for the conclusion of GRAS status, including why the scientific data, information, methods, and principles described in the notice provide a basis for the conclusion that the notified substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use.
- A list of the data and information that is discussed in the narrative of the GRAS notice, specifying which of these data and information are generally available, and which of these data and information are not generally available.
The FDA commits to respond within 180 days of the filing of a GRAS notice, with a potential to extend the response timeframe by another 90 days.
What is next?
The final rule was issued on August 17, 2016, and will be effective as of October 17, 2016.
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