Does this rule allow me to use vitamin D2 inactive baker's yeast in my supplement?

The rule does not mention dietary supplements. It amends 21 CFR Part 172, which covers food additives for conventional foods. The text does not state the additive is permitted in supplements, nor does it prohibit that use—it is simply silent on the question.

Will this change Amazon's supplement documentation requirements?

The rule does not discuss Amazon, testing documentation, Certificates of Analysis, or supplement verification. It covers food additive authorizations for specific conventional food categories. A supplement brand's Amazon obligations remain governed by Amazon's own policies.

What are the maximum vitamin D2 levels in the new rule?

Table 1 in Sec. 172.383(e) lists 18 food categories with maximum levels on a vitamin D2 basis. Examples: breakfast cereals at 350 IU/100 g, plant-based milk alternatives at 84 IU/100 g, yeast-leavened baked goods at 400 IU/100 g, and meal replacement beverages at 500 IU/240 mL with a 1,000 IU daily limit.

Is this additive the same as vitamin D2 mushroom powder?

FDA says the petitioned uses and maximum levels mirror those already authorized for vitamin D2 mushroom powder under Sec. 172.382. The cumulative dietary exposure estimate does not change because the new additive is considered substitutional on a vitamin D2 basis.

When does the rule take effect?

The order is effective September 25, 2026. Written or electronic objections and requests for a hearing must be submitted by October 26, 2026. The text does not mention any phase-in periods or separate compliance dates.

Does this rule create new labeling requirements for my products?

The rule requires that the label of the additive container give directions to achieve final product compliance with the maximum levels. It does not impose new labeling obligations on finished food products and says nothing about supplement labeling.

Regulatory updateWatchFederal Register

What FDA's new vitamin D2 inactive bakers yeast rule covers—and what it doesn't

By Jake, founder · Published 2026-09-25 · Source dated 2026-09-25

FDA added vitamin D2 inactive baker's yeast as an approved food additive in 21 CFR Part 172. The rule lists 18 food categories and maximum vitamin D2 levels, mirroring those for vitamin D2 mushroom powder. The text does not address dietary supplements, supplement labeling, or Amazon document requirements.

What did FDA publish on September 25, 2026?

The Food and Drug Administration published a final amendment to its food additive regulations in the Federal Register (Docket No. FDA-2021-F-1157). The amendment creates a new section, 21 CFR 172.383, permitting vitamin D2 inactive baker's yeast as a source of vitamin D2 in specific foods.

This action responds to a food additive petition from Lallemand Inc. The new regulation defines the additive, sets specifications, and lists the food categories where it may be used, along with maximum vitamin D2 levels for each.

What is vitamin D2 inactive baker's yeast, exactly?

Under the new Sec. 172.383, vitamin D2 inactive baker's yeast is produced by exposing baker's yeast (Saccharomyces cerevisiae) to ultraviolet light. The UV light causes a photochemical conversion of endogenous ergosterol into vitamin D2 (ergocalciferol). The yeast is then inactivated using heat.

The additive can be used alone or in combination with conventional baker's yeast. It must meet specifications for moisture (less than 7 percent), microbial limits (negative for Salmonella, Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa; coliforms less than 10 CFU/g; total plate count less than 3,000 CFU/g; yeasts and molds less than 300 CFU/g), and heavy metals (lead not more than 0.5 mg/kg, arsenic not more than 0.3 mg/kg, cadmium not more than 0.5 mg/kg, mercury not more than 0.1 mg/kg).

Which food categories does the new rule list?

Table 1 in Sec. 172.383(e) lists 18 food categories with maximum vitamin D2 levels. The categories include breakfast cereals at 350 IU/100 g, edible plant-based beverages marketed as milk alternatives at 84 IU/100 g, edible plant-based products marketed as yogurt alternatives at 89 IU/100 g, and yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods at a maximum of 400 IU/100 g.

Additional categories: extruded vegetable snacks (80 IU/28 g), fruit smoothies (100 IU/240 mL), 100% fruit juices fortified with at least 330 mg calcium per 240 mL (100 IU/240 mL), fruit juice drinks fortified with at least 100 mg calcium per 240 mL (100 IU/240 mL), grain products and pastas (90 IU/100 g), meal replacement bars for special dietary use in reducing or maintaining body weight (100 IU/40 g), meal replacement beverages not intended for special dietary use (500 IU/240 mL, with total daily vitamin D from the product not exceeding 1,000 IU), plant protein products (80 IU/85 g), soups and soup mixes excluding USDA-regulated products (100 IU/245 mL), soy-based spreads marketed as butter alternatives (330 IU/100 g), soy-based products marketed as cheese and cheese-product alternatives (270 IU/100 g), soy beverage products (89 IU/100 g), soy-protein based meal replacement beverages for special dietary use (140 IU/240 mL), and vegetable juices (100 IU/240 mL).

FDA stated the petitioned uses and maximum levels mirror those authorized for vitamin D2 mushroom powder under existing Sec. 172.382. The agency concluded the new additive is substitutional on a vitamin D2 basis for the currently approved mushroom powder uses.

Does this rule change anything for dietary supplements?

The text of the final rule does not mention dietary supplements. The amendment is placed in 21 CFR Part 172, which governs food additives permitted for direct addition to food for human consumption. It does not amend any section specific to dietary supplements.

The preamble discusses FDA's safety evaluation solely in terms of conventional food categories and cumulative dietary exposure from food sources. The agency did not state that the additive is excluded from supplements or that supplement-specific authorizations exist. The rule is silent on dietary supplement formulations, ingredient listings, and labeling.

What does the rule say about cumulative vitamin D exposure?

The petitioner argued the proposed uses would not increase cumulative dietary exposure because they are substitutional for vitamin D2 mushroom powder uses. FDA noted that the exposure estimate the petitioner referenced did not include contributions from two later authorizations: vitamin D3 in breakfast cereals and grain-based bars (January 2023), and vitamin D3 in yogurt and cultured dairy products (September 2025).

FDA stated its current cumulative eaters-only dietary exposure estimate, discussed in the September 2025 yogurt order, includes those contributions. At the 90th percentile for the overall U.S. population 1 year and older, the estimated cumulative dietary exposure from all food sources is 3,170 IU per person per day. The estimated exposures for each population group remain below the Institute of Medicine's Tolerable Upper Intake Levels. FDA concluded the petitioned uses are safe because the dietary exposure does not change from the level previously estimated.

What should a supplement brand owner do in response to this rule?

A brand that sells only dietary supplements and does not manufacture conventional foods will find nothing in this rule that requires action. The amendment does not modify 21 CFR Part 111 (current good manufacturing practices for supplements), does not impose new labeling obligations, and does not reference Amazon's supplement documentation requirements.

A brand that also formulates conventional foods within the listed categories may consider whether vitamin D2 inactive baker's yeast offers an alternative ingredient source. The rule requires that the label or labeling of the additive container bear adequate directions for use to produce a final product that complies with the maximum levels in Table 1. A brand's contract manufacturer would need to ensure any ingredient sourced meets the specifications in Sec. 172.383(c).

We suggest reviewing your product portfolio against the 18 food categories if your brand operates across both supplements and conventional foods. For supplements, the source text provides no new regulatory obligations.

What the rule does NOT cover

The source text is silent on several areas a brand owner might ask about. The rule does not address—neither permitting nor prohibiting—the use of vitamin D2 inactive baker's yeast in dietary supplements. It does not mention FDA's supplement labeling rules under 21 CFR Part 101, nor does it discuss Supplement Facts panels, structure/function claims, or new dietary ingredient notifications.

The rule does not reference third-party certification bodies, Amazon's testing requirements, Certificates of Analysis for finished supplement products, or heavy metals limits beyond the specifications listed for the additive itself. No compliance deadlines or phase-in periods appear in the text; the order is effective September 25, 2026. The rule also does not state whether food containing this additive could implicate section 301(ll) of the FD&C Act—FDA explicitly noted it did not consider that question during its review.

Frequently asked questions

Does this rule allow me to use vitamin D2 inactive baker's yeast in my supplement?: The rule does not mention dietary supplements. It amends 21 CFR Part 172, which covers food additives for conventional foods. The text does not state the additive is permitted in supplements, nor does it prohibit that use—it is simply silent on the question.
Will this change Amazon's supplement documentation requirements?: The rule does not discuss Amazon, testing documentation, Certificates of Analysis, or supplement verification. It covers food additive authorizations for specific conventional food categories. A supplement brand's Amazon obligations remain governed by Amazon's own policies.
What are the maximum vitamin D2 levels in the new rule?: Table 1 in Sec. 172.383(e) lists 18 food categories with maximum levels on a vitamin D2 basis. Examples: breakfast cereals at 350 IU/100 g, plant-based milk alternatives at 84 IU/100 g, yeast-leavened baked goods at 400 IU/100 g, and meal replacement beverages at 500 IU/240 mL with a 1,000 IU daily limit.
Is this additive the same as vitamin D2 mushroom powder?: FDA says the petitioned uses and maximum levels mirror those already authorized for vitamin D2 mushroom powder under Sec. 172.382. The cumulative dietary exposure estimate does not change because the new additive is considered substitutional on a vitamin D2 basis.
When does the rule take effect?: The order is effective September 25, 2026. Written or electronic objections and requests for a hearing must be submitted by October 26, 2026. The text does not mention any phase-in periods or separate compliance dates.
Does this rule create new labeling requirements for my products?: The rule requires that the label of the additive container give directions to achieve final product compliance with the maximum levels. It does not impose new labeling obligations on finished food products and says nothing about supplement labeling.

Sources

Federal Register — Federal Register :: Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast accessed 2026-09-25

Written from the source text above and checked against it before publishing: every date, figure and section cited appears in the source. Information, not legal advice.