21 CFR 184.1950
Vitamin D
21 CFR 184.1950 is the regulation titled “Vitamin D” in 21 CFR Part 184, Direct Food Substances Affirmed as Generally Recognized as Safe. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 101.3, in 1 letter
- Closed out
- 100% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 12022
- 02023
- 02024
- 02025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 184.1950 most often, as written in the letters.
- 1 letterYour use of vitamin D2 and vitamin D3 in beverages such as your Hydro Brew Unsweetened Green Tea and Silver Bullet Green Tea with Zinc is not authorized under either FDA’s GRAS regulations or FDA’s food additive…
The regulation
Read the text of 21 CFR 184.1950 (eCFR, as of Sep 1, 2026)
(a) Vitamin D is added to food as the following food ingredients:
(1) Crystalline vitamin D2 (C28H44O, CAS Reg. No. 50-14-6), also known as ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. The ingredient is produced by ultraviolet irradiation of ergosterol isolated from yeast and related fungi and is purified by crystallization.
(2) Crystalline vitamin D3 (C27H44O, CAS Reg. No. 67-97-0), also known as cholecalciferol, is the chemical 9,10-seco(5Z,7E,)-5,7,10(19)-cholestatrien-3-ol. Vitamin D3 occurs in, and is isolated from, fish liver oils. It is also manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced from cholesterol. It is purified by crystallization. Vitamin D3 is the vitamin D form that is produced endogenously in humans through sunlight activation of 7-dehydrocholesterol in the skin.
(3) Vitamin D2 resin and vitamin D3 resin are the concentrated forms of irradiated ergosterol (D2) and irradiated 7-dehydrocholesterol (D3) that are separated from the reacting materials in paragraphs (a)(1) and (2) of this section. The resulting products are sold as food sources of vitamin D without further purification.
(b) Vitamin D2 and vitamin D3 as crystals meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 344 and 345, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Vitamin D2 resin and vitamin D3 resin must be of a purity suitable for their intended use.
(c)(1) In accordance with § 184.1(b)(2), the ingredients are used in food as the sole source of added vitamin D only within the following specific limitations:
(2) Vitamin D may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act.
(3) Vitamin D may be used in margarine in accordance with § 166.110 of this chapter.
(d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived.
[50 FR 30152, July 24, 1985, as amended at 73 FR 8608, Feb. 14, 2008]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 184.1950.
- 21 CFR 101.3Identity labeling of food in packaged form1 letter cites both
- 21 CFR 101.4Food; designation of ingredients1 letter cites both
- 21 CFR 101.5Food; name and place of business of manufacturer, packer, or distributor1 letter cites both
- 21 CFR 101.54Nutrient content claims for “good source,” “high,” “more,” and “high potency.”1 letter cites both
- 21 CFR 101.9Nutrition labeling of food1 letter cites both
- 21 CFR 165.110Bottled water1 letter cites both
- 21 CFR 172.345Folic acid (folacin)1 letter cites both
- 21 CFR 172.379Vitamin D1 letter cites both
Latest letters citing it
The letter citing 21 CFR 184.1950 that FDA posted most recently.
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