Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and Streptococcus thermophilus

Document 2025-16946 is a Final Rule published by the Food and Drug Administration in the Federal Register on September 4, 2025, with an effective date of September 4, 2025. The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>3</INF> as a nutrient supplement in yogurt and other cultured dairy products fermented with Lactobacillus delbrueckii, subspecies bulgaricus (L. delbrueckii, subsp. bulgaricus), and Streptococcus thermophilus (S. thermophilus) at a level higher than is currently permitted. We are taking this action in response to a food additive petition filed by General Mills, Inc. (General Mills or petitioner). We are also updating the reference for the vitamin D<INF>3</INF> specifications. View the original at https://www.federalregister.gov/documents/2025/09/04/2025-16946/food-additives-permitted-for-direct-addition-to-food-for-human-consumption-vitamin-d3-in-yogurt-and.

No. Document 2025-16946 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.