Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and Streptococcus thermophilus

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 172</CFR> <DEPDOC>[Docket No. FDA-2021-F-0366]</DEPDOC> <SUBJECT> Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D <E T="0735">3</E> in Yogurt and Other Cultured Dairy Products Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and Streptococcus thermophilus </SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final amendment; order. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D <E T="52">3</E> as a nutrient supplement in yogurt and other cultured dairy products fermented with <E T="03">Lactobacillus delbrueckii,</E> subspecies <E T="03">bulgaricus</E> ( <E T="03">L. delbrueckii,</E> subsp. <E T="03">bulgaricus</E> ), and <E T="03">Streptococcus thermophilus</E> ( <E T="03">S. thermophilus</E> ) at a level higher than is currently permitted. We are taking this action in response to a food additive petition filed by General Mills, Inc. (General Mills or petitioner). We are also updating the reference for the vitamin D <E T="52">3</E> specifications. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This order is effective September 4, 2025. The incorporation by reference of certain material listed in the order is approved by the Director of the Federal Register as of September 4, 2025. Submit either electronic or written objections and requests for a hearing by 11:59 p.m. Eastern Time on October 6, 2025. See section VIII for further information on the filing of objections. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept objections until 11:59 p.m. Eastern Time at the end of October 6, 2025. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic objections in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2021-F-0366 for “Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D <E T="52">3</E> in Yogurt and Other Cultured Dairy Products Fermented with <E T="03">Lactobacillus delbrueckii,</E> subspecies <E T="03">bulgaricus,</E> and <E T="03">Streptococcus thermophilus.”</E> Received objections, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852; phone: 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Marissa Santos, Office of Pre-market Additive Safety, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835; phone: 240-402-8160; or Alexandra Beliveau, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740; phone: 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> In the <E T="04">Federal Register</E> of April 23, 2021 (86 FR 21675), we announced that we filed a food additive petition (FAP 1A4827) submitted on behalf of General Mills by Exponent, 1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. The petition proposed that FDA amend the food additive regulations in 21 CFR 172.380 to provide for the safe use of vitamin D <E T="52">3</E> as a nutrient supplement at levels up to 178 international units (IU) vitamin D <E T="52">3</E> per 100 grams (g) in “standardized yogurt and non-standardized milk-based yogurt products.” We consider the foods subject to this order to be yogurt and other cultured dairy products fermented with <E T="03">L. delbrueckii,</E> subsp. <E T="03">bulgaricus,</E> and <E T="03">S. thermophilus.</E> While the petition refers to “standardized yogurt and non-standardized milk-based yogurt products,” all yogurt is standardized. Yogurt is standardized under 21 CFR 131.200 and lower fat yogurt ( <E T="03">i.e.,</E> reduced fat yogurt, low fat yogurt, and nonfat yogurt) is standardized under 21 CFR 130.10. Accordingly, we understand the petitioned uses to be yogurt and other cultured dairy products fermented with <E T="03">L. delbrueckii,</E> subsp. <E T="03">bulgaricus,</E> and <E T="03">S. thermophilus.</E> We note that, after the petition was submitted, FDA amended the standard of identity for yogurt several times (see 88 FR 22907, April 14, 2023; 87 FR 76559, December 15, 2022; 87 FR 16394, March 23, 2022; and 86 FR 31117, June 11, 2021). Of most relevance, in December 2022, FDA reduced the minimum level of vitamin D fortification that, if added, would be required for yogurt and lower fat yogurt from 25 percent Daily Value (DV) to 10 percent DV, explaining that a minimum of 25 percent DV (equal to 5 micrograms (µg) per reference amount customarily consumed (RACC)) conflicts with the level authorized by our generally recognized as safe (GRAS) regulation for vitamin D, which sets the limit for vitamin D in milk products at 89 IU/100 g of food (21 CFR 184.1950(c)(1)), equivalent to 3.8 µg per RACC (see 87 FR 76559 at 76562). In reducing the minimum level of vitamin D fortification to 10 percent DV, we reduced the vitamin D per RACC to 2 µg. Consequently, until the issuance of this order, optional vitamin D fortification in yogurt and lower fat yogurt has been permitted in the range of 2 µg to 3.8 µg per RACC. This order revises the upper limit. The limit of 178 IU/100 g proposed in the petition is equivalent to 7.6 µg per RACC. (One IU of vitamin D is equivalent to 0.025 µg of vitamin D.) FDA is also updating the reference for specifications for vitamin D <E T="52">3</E> established in § 172.380(b) by incorporating by reference the most recent monograph for vitamin D <E T="52">3</E> in the 14th edition of the Food Chemica ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 40k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━