High-Protein Yogurt; Request for Information

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-N-5716]</DEPDOC> <SUBJECT>High-Protein Yogurt; Request for Information</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice; request for information. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is requesting information and data about the manufacturing processes and ingredients used to make certain dairy products referred to as high-protein yogurt, Greek yogurt, or Greek-style yogurt in this document. We are taking this action, in part, because the yogurt standard of identity may not align with certain manufacturing processes and ingredients used to concentrate protein to manufacture these products. We intend to use the information and data to help determine what type(s) of actions, if any, should be taken. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Either electronic or written comments on the notice must be submitted by April 15, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments and information as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 15, 2025. Comments 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 comments in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment 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 comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment 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 comments submitted to the Dockets Management Staff, FDA will post your comment, 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-2024-N-5716 for “High-Protein Yogurt; Request for Information.” Received comments, 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 a comment with confidential information that you do not wish to be made publicly available, submit your comments 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, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Yan Peng, Office of Nutrition and Food Labeling, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371, or Holli Kubicki, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to establish definitions and standards of identity (SOIs) for foods whenever such action would promote honesty and fair dealing in the interest of consumers (see section 401 of the FD&C Act (21 U.S.C. 341)). SOIs specify the ingredients, both mandatory and optional, of a standardized food, and sometimes describe the amount or proportion of each ingredient. Many SOIs also prescribe a method of production. The yogurt SOI is stated at 21 CFR 131.200. There is not a separate SOI for high-protein yogurt, Greek yogurt, or Greek-style yogurt. For purposes of this document, high-protein yogurt, Greek yogurt, or Greek-style yogurt (collectively referred to in this document as “high-protein yogurt”) generally refers to a dairy product cultured with, at minimum, <E T="03">Lactobacillus delbrueckii,</E> subspecies <E T="03">bulgaricus,</E> and <E T="03">Streptococcus thermophilus,</E> which has undergone a manufacturing method to increase the protein level. In recent years, the yogurt industry has raised concerns that the existing, single yogurt SOI does not accommodate the current practices or technologies to manufacture high-protein yogurt. Specifically, FDA received comments from the yogurt industry during the FDA 2019 Public Meeting on Horizontal Approaches to Food Standards of Identity Modernization (84 FR 45497, August 29, 2019 (Docket No. FDA-2018-N-2381)), and after the reopening of comments on the FDA 2005 proposed rule titled Food Standards; General Principles and Food Standards Modernization (85 FR 10107, February 21, 2020 (Docket No. FDA-1995-N-0062)), advocating for an additional SOI for strained, high-protein yogurt (which some comments referred to as Greek yogurt). The comments stated that a new SOI for strained, high-protein yogurt should include language that describes the authentic straining process, the characteristics of the product, and the distinguishing compositional nutritional elements of the product. We understand that since high-protein yogurt was introduced to the U.S. market, this category continues to expand substantially in product availability and variety, along with innovations in formulations and manufacturing processes. We also understand that there are different methods used by industry to increase the protein level of yogurt, some of which may not be consistent with the yogurt SOI. One method is to concentrate yogurt after culturing to remove liquid whey by a straining process (Refs. 1 and 2). The straining process can be done in a traditional way using cheesecloth, but is more commonly done commercially using a centrifugal separator (Refs. 1 and 2). Many yogurt manufacturers that use the straining process to make high-protein yogurt add cream after culturing and straining to achieve the desired fat content specified for the product. These manufacturers state that cream must be added after culturing and straining due to a variety of challenges that occur if cream is added before culturing, including reduced production efficiency due to clogging of centrifugal separators by fat, loss of fat in acid whey, and reduced ability to recycle acid whey with high fat content. Another method is the addition of milk-protein ingredients to milk prior to culturing (Refs. 1 and 2). This method is also known as the protein-fortified method, which allows for the production of high-protein yogurt on the same processing equipment used for yogurt not fortified with milk-protein ingredients, without the need for liquid whey removal after culturing (Refs. 1 and 2). Yet another method is to concentrate protein in milk before or after culturing ( <E T="03">e.g.,</E> membrane ultrafiltration (Refs. 1 and 2)). (We note that FDA granted a temporary permit to Chobani to market test certain yogurt products deviating from the yogurt SOI by using ultrafilt ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 17k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━