Data / Federal rules / 2025-16946

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

The Food and Drug Administration published this final rule in the Federal Register on September 4, 2025. It took effect on September 4, 2025.

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What the agency says

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.

Key facts

Document number: 2025-16946
Type: Final rule
Action: Final amendment; order
Agency: Health and Human Services Department; Food and Drug Administration
Published: September 4, 2025
Takes effect: September 4, 2025
Dates: This order is effective September 4, 2025. The incorporation by reference of certain material listed in the order is approved by the Director of the Federal Register as of September 4, 2025. Submit either electronic or written objections and requests for a hearing by 11:59 p.m. Eastern Time on October 6, 2025. See section VIII for further information on the filing of objections.
Docket: Docket No. FDA-2021-F-0366
Code of Federal Regulations: 21 CFR 172
Topics: Food additives; Incorporation by reference; Reporting and recordkeeping requirements
Pages: 6

The document on federalregister.gov PDF

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Everything from the Food and Drug Administration · Rules on food additives · Rules on incorporation by reference · Rules on reporting and recordkeeping requirements · Published in September 2025

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.