FDA Concludes That the Color Additive Use of Soy Leghemoglobin Is Safe

FDA Concludes That the Color Additive Use of Soy Leghemoglobin Is Safe

FDA: Objections do not raise genuine and substantial issues of fact or provide substantive evidence to justify a hearing or revocation of the regulatory amendment.

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December 18, 2019

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 (e.g., “veggie burgers”) is now lifted. This announcement follows the agency’s review of objections submitted by the Center for Food Safety (CFS), a public advocacy organization.

FDA has concluded that CFS’s objections do not raise genuine and substantial issues of fact and do 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 is denied and the final rule adding the regulation is effective.

“As new food ingredients come to market, companies have an obligation to ensure that these ingredients are safe, including through pre-market review or consultation with the FDA. In issuing the final rule, the FDA concluded that this color additive use of soy leghemoglobin is safe,” said CFSAN Director of the Office of Food Additive Safety Dennis Keefe. “After a thorough review of the objections submitted in response to the final rule, we have concluded that they do not provide any substantive evidence to cause us to change our determination of safety for the use of soy leghemoglobin as a color additive in ground beef analogue products. ”

The FDA regulatory amendment to provide for the safe use of soy leghemoglobin as a color additive in uncooked ground beef analogue products (e.g., vegetable burgers) was effective on Sept. 4, 2019. On July 31, 2019, FDA announced the final rule to amend its regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products. 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 FDA took final action on the objections.

FDA reviewed the objections and concluded that they do not raise genuine and substantial issues of fact and do not provide any substantive evidence that would justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. Therefore, the agency is denying the hearing request. The stay of the effective date of the final rule has been lifted and this color additive use of soy leghemoglobin is authorized.

FDA is affirming that the use of soy leghemoglobin as a color additive in ground beef analogue products such that the amount of soy leghemoglobin protein does not exceed 0.8 percent by weight of the uncooked ground beef analogue product is safe.