Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast

What it does

• •Amends food additive regulations to allow vitamin D2 inactive bakers yeast (produced by exposing bakers yeast to ultraviolet light and then heat-inactivating it) as a food additive source of vitamin D2.
• •Permits use of vitamin D2 inactive bakers yeast in the same food categories and at the same use levels, on a D2 basis, as currently authorized for vitamin D2 mushroom powder under 21 CFR 172.382.
• •Establishes this as a final rule effective September 25, 2026, in response to a food additive petition filed by Lallemand Inc.

Why it matters

• •Vitamin D is essential for human health; deficiency can cause rickets in children or osteomalacia in adults, making safe fortification sources important.
• •The FDA determined vitamin D2 inactive bakers yeast is safe for the intended uses based on safety data and toxicological evaluation, allowing it as an alternative source to existing approved vitamin D2 additives.

Who is affected

• •Food manufacturers and producers who wish to fortify foods with vitamin D2 using inactive bakers yeast as an ingredient source.
• •Consumers who purchase vitamin D2-fortified food products in the approved categories (including plant-based beverages, breakfast cereals, grain products, certain juices, and other foods where vitamin D2 mushroom powder is currently allowed).

What happens next

Objections and requests for a hearing must be submitted electronically or in writing by October 26, 2026, to be considered in the docket FDA-2021-F-1157.