21 CFR Part 172, Subpart H - Other Specific Usage Additives

The Food and Drug Administration (FDA or we) is correcting a notice that appeared in the Federal Register of Wednesday, July 26, 2017 (82 FR 34615). The document announced that we have filed a petition, submitted by the Juice Products Association, proposing that the food additive regulations be amended to replace the current Recommended Daily Intake (RDI) percentage values of calcium in fruit juices and fruit juice drinks in the regulation for vitamin D 3 with absolute values and to update the specifications for vitamin D 3. The document was published with incorrect information on the absolute level of added calcium for fruit juice drinks that are fortified with calcium. This document corrects that error.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Juice Products Association, proposing that the food additive regulations be amended to replace the current Recommended Daily Intake (RDI) percentage values of calcium in fruit juices and fruit juice drinks in the regulation for vitamin D 3 with absolute values and to update the specifications for vitamin D 3 .

The Food and Drug Administration (FDA or we) is amending the food additive regulations to expand the safe uses of vitamin D 2 as a nutrient supplement in edible plant-based beverages intended for use as milk alternatives and in edible plant-based yogurt alternatives and vitamin D 3 as a nutrient supplement in milk at levels higher than those currently permitted. We are taking this action in response to a food additive petition filed by Dean Foods Company and WhiteWave Foods Company.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Styrene Information and Research Center (SIRC), requesting that we amend our food additive regulations to no longer provide for the use of styrene as a synthetic flavoring substance and adjuvant in food because these uses of styrene have been abandoned.

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of folic acid in corn masa flour. We are taking this action in response to a food additive petition filed jointly by Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice of filing that appeared in the Federal Register of January 4, 2016. In the notice, FDA requested comments on a filed food additive petition (FAP 5A4810), submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or we) is amending certain regulations to update the location of references cited in our food regulations. We are taking this action to reflect the transfer of those references from our facility in College Park, MD, to our library at our main campus in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Grocery Manufacturers Association, proposing that the food additive regulations be amended to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in various food applications.

The Food and Drug Administration (FDA or we) is amending the food additive regulations by removing the upper bound of the melting point range in the regulation for the antioxidant tertiary butylhydroquinone (TBHQ) and adding a purity acceptance criterion. This action is in response to a petition submitted by Eastman Chemical Company.

The Food and Drug Administration (FDA or we) is responding to objections we received on the final rule that amended the food additive regulations to provide for the safe use of advantame as a non-nutritive sweetener and flavor enhancer in foods generally, except in meat and poultry. After reviewing the objections to the final rule, we have concluded that they do not provide a basis for modifying or revoking the regulation. We are also confirming the effective date of May 21, 2014, for the final rule.

The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 3A4798) proposing that the food additive regulations be amended to prohibit the use of carrageenan and salts of carrageenan in infant formula. In addition, FDA is also announcing the withdrawal of a citizen petition requesting that the generally recognized as safe (GRAS) regulations be amended to prohibit the use of Chondrus extract (carrageenin) in infant formula.

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D 3 as a nutrient supplement in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and for use in foods that are sole sources of nutrition for enteral feedings. We are taking this action in response to a petition filed by Abbott Laboratories (Abbott).

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of advantame as a non-nutritive sweetener and flavor enhancer in foods generally, except meat and poultry. This action is in response to a petition filed by Ajinomoto Co., Inc.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Eastman Chemical Company, proposing that the food additive regulations be amended to remove the upper bound of the melting point range in the regulation for the antioxidant TBHQ (tertiary butylhydroquinone) and add a purity acceptance criterion.

The Food and Drug Administration (FDA or we) is responding to objections that we have received on the final rule that amended the food additive regulations authorizing the use of vitamin D 2 bakers yeast as a source of vitamin D 2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D 2 per 100 grams (g) in the finished food. After reviewing the objections to the final rule, FDA has concluded that they do not provide a basis for amending or revoking the regulation.

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the expanded safe use of acacia (gum arabic) in foods. This action is in response to a petition filed by Nexira.

The Food and Drug Administration (FDA or we) is amending select food additive regulations that incorporate by reference food-grade specifications from prior editions of the Food Chemicals Codex (FCC) to incorporate by reference food-grade specifications from the FCC 7th Edition (FCC 7). We are taking this action in response to a petition filed by the United States Pharmacopeial Convention (U.S.P. or petitioner).

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition submitted by the Dean Foods Company and the WhiteWave Foods Company proposing that the food additive regulations be amended to provide for the expanded safe uses of vitamin D 2 and vitamin D 3 as nutrient supplements in food.

The Food and Drug Administration (FDA or we) is announcing that Richard C. Theuer, Ph.D., has filed a petition proposing that the food additive regulations be amended to prohibit the use of carrageenan and salts of carrageenan in infant formula. In addition, the petitioner has submitted a citizen petition, under FDA regulations, requesting that we amend the generally recognized as safe (GRAS) regulations to prohibit the use of Chondrus extract (carrageenin) in infant formula.

The Food and Drug Administration (FDA) is amending certain regulations regarding food and color additives to correct minor errors (such as misspelled chemical names) and to update office names and addresses. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by Ajinomoto Co., Inc., to indicate that the petitioned additive, N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl-α-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (proposed additive name Advantame, CAS Reg. No. 714229-20-6), is for use as a non-nutritive sweetener and flavor enhancer in foods generally, except meat and poultry. The previous filing notice indicated that the proposed additive was for use as a non-nutritive sweetener in tabletop applications and powdered beverage mixes.

The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by Nexira proposing that the food additive regulations be amended to provide for the expanded safe use of acacia gum (gum arabic) in foods.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D 2 bakers yeast as a source of vitamin D 2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D 2 per 100 grams (g) in the finished food. This action is in response to a petition filed by Lallemand, Inc. (Lallemand).

The Food and drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 13, 2012 (77 FR 35317). The document announced that Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza had jointly filed a petition proposing that the food additive regulations be amended to provide for the safe use of folic acid in corn masa flour. The document was published with an error in the title of the document signer's signature. This document corrects that error.

The Food and Drug Administration (FDA) is announcing that Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza have jointly filed a petition proposing that the food additive regulations be amended to provide for the safe use of folic acid in corn masa flour.

The Food and Drug Administration (FDA) is announcing that Abbott Laboratories has filed a petition proposing that the food additive regulations be amended to provide for the expanded safe use of vitamin D 3 as a nutrient supplement in food.