Editor's Note
FDA is amending the food additive regulations to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories. This action is in response to a petition filed by Oakshire Naturals, LP. Based the safety data the agency reviewed, it was concluded that there is a reasonable certainty that no harm will result from the uses of vitamin D 2  mushroom powder
  1. Foods to which vitamin D2, vitamin D3, and vitamin D2 bakers yeast are allowed under §§ 184.1950, 172.379, 172.380, and 172.381 (excluding cheese and cheese products, foods represented for use as a sole source of nutrition for enteral feeding, infant formula, milk and milk products, and margarine);
  2. fruit smoothies;
  3. vegetable juices;
  4. extruded vegetable snacks;
  5. soups and soup mixes (except for those containing meat or poultry that are subject to regulation by the U.S. Department of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act); and
  6. plant protein products as defined in 21 CFR 170.3(n)(33).
Summary

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D2mushroom powder as a nutrient supplement in specific food categories. This action is in response to a petition filed by Oakshire Naturals, LP.

Dates

This rule is effective July 13, 2020. See section VII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by August 12, 2020.

Background

In the Federal Register of September 18, 2018 ( 83 FR 47118 ), we announced that we filed a food additive petition (FAP 8A4821) submitted by Oakshire Naturals LP (Oakshire), 295 Thompson Road, P.O. Box 388, Kennett Square, PA 19348. The petition proposes that we amend our food additive regulations in part 172 ( 21 CFR part 172 ) Food Additives Permitted for Direct Addition to Food for Human Consumption to provide for the safe use of vitamin D 2  mushroom powder, produced by exposing homogenized edible mushrooms to ultraviolet (UV) light, as a nutrient supplement in: (1) Foods to which vitamin D 2,  vitamin D 3 , and vitamin D 2  bakers yeast are currently allowed to be added under §§ 184.1950, 172.379, 172.380, and 172.381 ( 21 CFR 184.1950 , 172.379, 172.380, and 172.381) (excluding cheese and cheese products, foods represented for use as a sole source of nutrition for enteral feeding, infant formula, milk and milk products, and margarine); (2) fruit smoothies; (3) vegetable juices; (4) extruded vegetable snacks; (5) soups and soup mixes (except for those containing meat or poultry that are subject to regulation by the U.S. Department of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act); and (6) plant protein products as defined in  21 CFR 170.3 (n)(33).

Vitamin D is essential for human health. The major function of vitamin D is the maintenance of blood serum concentrations of calcium and phosphorus by enhancing the absorption of these minerals in the small intestine. Vitamin D deficiency can lead to abnormalities in calcium and bone metabolism, such as rickets in children or osteomalacia in adults. Excessive intake of vitamin D elevates blood plasma calcium levels by increased intestinal absorption or mobilization from the bone that can lead to vascular and tissue calcification, with subsequent damage to the heart, blood vessels, and kidneys (Ref. 1).

To ensure that vitamin D is not added to the U.S. food supply at levels that could raise safety concerns, we affirmed vitamin D as generally recognized as safe (GRAS) with specific limitations as listed in § 184.1950. Under § 184.1(b)(2), an ingredient affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food, functional use, and level of use. Any addition of vitamin D to food beyond those limitations requires a food additive regulation. ...

To support their petition, Oakshire submitted dietary exposure estimates of vitamin D from the proposed uses of vitamin D 2  mushroom powder, as well as from naturally occurring dietary sources of vitamin D, uses in accordance with our approved food additive regulations (§§ 172.379, 172.380, and 172.381) and our GRAS affirmation regulation (§ 184.1950), and from dietary supplements. Oakshire compared their dietary exposure estimates to the Tolerable Upper Intake Level (UL) for vitamin D established by the Institute of Medicine (IOM) of the National Academies. Oakshire also submitted a number of publications pertaining to human clinical studies on vitamin D. Oakshire included analyses to determine the presence of lumisterol, tachysterol, and vitamin D 4  that are formed as a result of the UV treatment of the mushroom homogenate. Based on this information, Oakshire concluded that the proposed uses of vitamin D 2  mushroom powder are safe.

Evaluation of Safety

To establish with reasonable certainty that a food additive is not harmful under its intended conditions of use, we consider the projected human dietary intake of the additive, the additive's toxicological data, and other relevant information (such as published literature) available to us. We compare an individual's estimated daily intake (EDI) of the additive from all food sources, including dietary supplements, to an acceptable intake level established by toxicological data. The EDI is determined by projections based on the amount of the additive proposed for use in particular foods and on data regarding the amount consumed from all food sources of the additive. We use the EDI for the 90th percentile consumer of a food additive as a measure of high chronic dietary intake.

Conclusion

Based on all data relevant to vitamin D 2  mushroom powder we reviewed, we conclude that there is a reasonable certainty that no harm will result from the uses of vitamin D 2  mushroom powder, produced using UV light treatment, as a source of vitamin D 2  in: (1) Foods to which vitamin D 2 , vitamin D 3 , and vitamin D 2  bakers yeast are allowed under §§ 184.1950, 172.379, 172.380, and 172.381 (excluding cheese and cheese products, foods represented for use as a sole source of nutrition for enteral feeding, infant formula, milk and milk products, and margarine); (2) fruit smoothies; (3) vegetable juices; (4) extruded vegetable snacks; (5) soups and soup mixes (except for those containing meat or poultry that are subject to regulation by the U.S. Department of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act); and (6) plant protein products as defined in  21 CFR 170.3 (n)(33). Thus, we are amending our food additive regulations as set forth in this document.

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