Federal Register #FDA-2021-F-1157

FDA Approves Vitamin D2 Inactive Bakers Yeast as Food Additive

This regulatory action from the Food and Drug Administration (FDA) amends food additive regulations to permit vitamin D2 inactive bakers yeast as a nutrient supplement in specific food categories. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Office of Pre-market Additive Safety, Human Foods Program - OEMs and Vendors: - Lallemand Inc. (petitioner and manufacturer of vitamin D2 inactive bakers yeast) - Products/Services Requested: - Vitamin D2 inactive bakers yeast (Saccharomyces cerevisiae exposed to UV light and heat inactivation) - Part number: 172.383 - Used as a source of vitamin D2 in foods such as breakfast cereals, plant-based beverages, fruit smoothies, grain products, soups, soy-based products, and yeast-leavened baked goods - Maximum vitamin D2 levels specified per food category - Unique/Notable Requirements: - Safety specifications for the additive - Approval based on scientific studies and safety data - Regulatory approval, not a procurement or purchase - No specific purchase quantities or contract terms - OEM Highlight: - Lallemand Inc. is the primary manufacturer and petitioner for this food additive

Description

The Food and Drug Administration (FDA) is amending the food additive regulations to allow the safe use of vitamin D2 inactive bakers yeast as a source of vitamin D2 in specific food categories. This action responds to a food additive petition filed by Lallemand Inc. The amendment permits the use of vitamin D2 inactive bakers yeast produced by exposing bakers yeast to ultraviolet light and then heat inactivation. The FDA concluded that the proposed uses are safe and do not increase overall dietary exposure to vitamin D. The final order is effective September 25, 2026, with objections due by October 26, 2026.

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