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FDA Issues Rule That Details Criteria For Concluding That Food Substance Is GRAS
Consumer Groups Say Final Rule Is Flawed
The US Food and Drug Administration (FDA) last Friday issued a final rule detailing the criteria for concluding that the use of a substance in food is generally recognized as safe (GRAS).
FDA is also amending its regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify the agency of a conclusion that a substance is GRAS under the conditions of its intended use.
Although FDA has premarket review authority over food additives, a food manufacturer can intentionally add a substance to human food or animal food without the agency’s premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use (GRAS).
Since the 1970s, FDA has had regulations clarifying the statutory provision for eligibility for classification as GRAS. The agency has also had regulations governing a procedure for any person to voluntarily submit a petition asking it to affirm the GRAS status of a substance under the conditions of its intended use, and for the agency to engage in an intensive rulemaking process in response to that petition.
FDA said experience has shown that its regulations need further 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. Experience also has shown that streamlining its evaluation of conclusions of GRAS status will enable FDA to evaluate more, and higher priority, substances.
The final rule, which is effective October 17, 2016, clarifies the criteria for the use of a substance to be eligible for classification as GRAS and establishes a new administrative procedure for any person to notify FDA of the basis for a conclusion that a
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