FDA: Food Additive Reviews Stronger With Voluntary Notice

By Steven Gibb

Aug. 12 — After blocking partially hydrogenated oils and caffeinated alcoholic beverages, the Food and Drug Administration says its final rule allowing outside groups to evaluate food additive risks will streamline its “Generally Recognized as Safe” reviews.

The agency released its GRAS final rule (RIN:0910-AH15) Aug. 12 for its food additive program, switching reviews from a more formal but slower “petition-based” process to a voluntary “notification” process, which it says establishes “uniform criteria for describing the basis for a conclusion that a substance is GRAS under the conditions of its intended use.”

According to the FDA's review of its notification pilot program, “experience also has shown that streamlining our evaluation of conclusions of GRAS status will enable us to evaluate more, and higher priority, substances.”

But the change has prompted swift reaction from food safety advocates, who say industry should not be allowed to convene their own GRAS panels and then submit the results to the agency.


“FDA should not trade effective regulation for efficient regulation,” said Cristina Stella, an attorney with the nonprofit advocacy group the Center for Food Safety. “We're taking a close look at the final rule and evaluating our legal options,” she said.

The agency points to its treatment of partially hydrogenated oils and caffeinated alcoholic beverages as evidence the voluntary GRAS pilot notification program was, and will continue to be, effective.

The agency states that there “is no longer a consensus among qualified experts that PHOs are GRAS for any use in human food,” and that it “informed the companies who were marketing these caffeinated alcoholic beverages that caffeine, as used in the companies’ products, is an unsafe food additive, and therefore the products are adulterated.”

The FDA also states that since 1998, it has processed 638 GRAS notices, compared to the previous decade where the agency issued 25 GRAS affirmation petitions.

Under the former petition-based process the agency would publish an order in the Federal Register listing the substance as GRAS, and issue a corresponding regulation that prescribes the safe conditions of its use. If it determined that it was not GRAS, then the agency would notice that in the Federal Register.

Advocates Preferred Petition Process

Stella says advocates preferred the former process, saying at least “it required more on the part of FDA and industry” to ensure a safe food supply.

And Jessica Almy, deputy director of nutrition policy at the Center for Science in the Public Interest, says the final rule is “deeply disappointing in that they've had 19 years to address this and still haven't gotten to critical conflict of interest ground rules for industry's secret safety determinations.”

Agency spokesperson Lauren Sucher says “FDA can question the basis for an independent GRAS conclusion and take action as appropriate. The FDA has the authority to review and evaluate data on substances added to food in order to ensure safety.”

And the agency also asserts that its scientific criteria for quality data are more rigorous and transparent than under the previous program. “Unless both criteria, i.e., ‘generally available’ as well as ‘generally accepted’, are satisfied, there would be no basis for a conclusion of GRAS status.” It also eliminated the need for complete agreement among risk reviewers in the final rule, compared with the proposed rule. The final rule “uses the term ‘generally recognized' rather than the term ‘consensus,' ” according to the agency.

Calls to the Grocery Manufacturers Association for comment were not returned.

To contact the reporter on this story: Steve Gibb in Washington at sgibb@bna.com

To contact the editor responsible for this story: Larry Pearl at lpearl@bna.com

For More Information

The final rule is available at http://src.bna.com/hHD.

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