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  1. FDA In Brief

FDA In Brief: FDA approval of soy leghemoglobin as a color additive is now effective

December 17, 2019

Media Inquiries

  Peter Cassell
  240-402-6537

The following quote is attributed to Director of the Office of Food Additive Safety Dennis Keefe, Ph.D., in the FDA’s Center for Food Safety and Applied Nutrition:

“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.

“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. ”

Related information

  • The U.S. Food and Drug Administration color additive regulation 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, the 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 the FDA took final action on the objections.
  • The 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.
  • The 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.