FDA Revamps Rules for Food Ingredients Recognized as Safe

By Casey Wooten

Aug. 12 — The Food and Drug Administration issued final rules today updating how the agency determines a substance used in food to be “generally recognized as safe,” known by the shorthand GRAS.

The 329-page final rules clarify criteria for GRAS classification and formalizes a voluntary GRAS notification procedure.

“The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the [Federal Food, Drug and Cosmetic Act], and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status,” the agency said in the rules.

Unlike food additives, substances determined to be GRAS are not subject to pre-market approval by regulators, thought they must meet the same safety standards as additives.

Some pesticides, dietary supplement ingredients and color additives are classified as GRAS.

More Clarification Needed

The FDA has had statutory provisions in place since the 1970s for determining GRAS eligibility, but the agency said that stakeholders needed additional information.

“Experience has shown that our 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,” FDA said.

The final rules clarify that:

  •  A substance cannot be classified as GRAS if available data doesn't satisfy the safety standard for a food additive under the Federal Food, Drug and Cosmetic Act.
  •  GRAS classification requires “common knowledge” throughout the scientific community that the substance is not harmful.
  •  Scientific recognition that a substance is safe must be concluded using generally accepted scientific data, information and methods.

The final rules also include various clarifications about required documents for the GRAS application process and its time line.

The rules will come into effect 60 days after it is published in the Federal Register, which is expected to happen Aug. 17.

The FDA said the rules are the most recent step in an effort to strengthen oversight of substances added to human and animal food. The agency said it will next develop and implement new compliance strategies aimed at improving oversight of pre-market evaluation of food additives.

To contact the reporter on this story: Casey Wooten in Washington at cwooten@bna.com

To contact the editor responsible for this story: Heather Rothman at hrothman@bna.com

For More Information

Text of the final rules are available at http://src.bna.com/hG0.

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