The U.S. Food and Drug Administration (FDA) is providing notice that the stay of the effective date for the final rule amending the color additive regulations to allow for the safe use of soy leghemoglobin as a color additive in ground beef analogue products is now lifted. The final rule was published in the Federal Register on Aug. 1, 2019, with an effective date of Sept. 4, 2019. The agency received multiple comments before the deadline of Sept. 3, 2019, including one submission containing objections to the final rule and request for a hearing. Under the law, the effective date of the final rule was stayed until the FDA took final action on the objections.

The FDA reviewed the objections by the Center for Food Safety (CFS), a public advocacy organization, and concluded that they did not raise genuine and substantial issues of fact and did not provide any substantive evidence that would justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. Therefore, the request for the hearing was denied and the final rule adding the regulation is now effective.

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