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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations
not been required to conform to them.
Consequently, yogurt, lowfat yogurt, and nonfat yogurt have varied with respect to the type of milk-derived ingredients used to increase the milk solids not fat content, the use of reconstituted dairy ingredients as basic ingredients, addition of preservatives, level of acidity, and application of the minimum milkfat level. These products have, however, been required to conform to the non-stayed provisions in 131.200, 131.203, and 131.206.
In 1990, the Nutrition Labeling and Education Act NLEA Pub. L. 101535
amended the FD&C Act and established the circumstances in which claims that describe the nutrient content of food could be made. In response to the NLEA, we published a final rule on January 6, 1993, entitled Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definitions of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food that established definitions for specific nutrient content claims in part 101 21 CFR part 101 together with principles for their use 58 FR 2302 the 1993 final rule. At the same time, we published a final rule entitled Food Standards: Requirements for Foods Named by Use of a Nutrient Content Claim and a Standardized Term 58 FR
2431 that established the general definition and standard of identity in 130.10 for foods that substitute for a standardized food but deviate from the standard of identity due to compliance with an expressed nutrient content claim defined by FDA regulation, including the expressed nutrient content claims no fat and low fat see 101.62b and light or reduced calorie see 101.60b.
We noted in the 1993 final rule 58 FR
2302 at 2314 that the common or usual names of certain foods with existing standards of identity include nutrient content claims. Lowfat yogurt and nonfat yogurt are among these foods. We further noted that these foods are exempt under section 403r5C of the FD&C Act from compliance with nutrient content claim definitions established by regulation, provided that the foods were subject to a standard of identity on November 8, 1990. As such, nonfat yogurt and lowfat yogurt are subject to the fat content requirements specified in their respective standards of identity rather than the requirements in 101.62b1 for no fat and 101.62b2 for low fat. In 1995, we proposed to revoke the standards of identity for lowfat yogurt and nonfat yogurt, along with the standards of identity for other dairy foods, so that the
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foods would be covered under 130.10
and subject to the nutrient content claim definitions in part 101 60 FR 56541.
This action was intended to provide for consistency in the nomenclature and labeling of food products.
We deferred action on our proposal to revoke the standards of identity for lowfat yogurt and nonfat yogurt 61 FR
58991, November 20, 1996, citing economic considerations and technical difficulties for the yogurt industry if required to fortify lowfat yogurt and nonfat yogurt in accordance with the nutritional equivalence requirement in 130.10b 61 FR 58991 at 58999. We later withdrew the proposed rule on November 26, 2004 69 FR 68831.
C. Description of the Proposed Rule In the Federal Register of January 15, 2009 74 FR 2443, we published a proposed rule to revoke the standards of identity for lowfat yogurt 131.203
and nonfat yogurt 131.206 and amend the standard of identity for yogurt 131.200. The proposal was, in part, in response to a citizen petition submitted by the NYA on February 18, 2000, and our ANPRM 68 FR 39873;
July 3, 2003 in which we asked for comments and information concerning the NYA petition Docket No. FDA
2000P0126, formerly Docket No.
2000P0685.
We proposed to revoke the standards of identity for lowfat yogurt 131.203
and nonfat yogurt 131.206 so that yogurt under proposed 130.200 could be modified according to the low fat and no fat nutrient content claim definitions in 101.62b, thereby bringing lowfat yogurt and nonfat yogurt within the coverage of 130.10.
Consequently, lowfat yogurt and nonfat yogurt would be standardized foods under the general definition and standard of identity, rather than standardized foods under 131.203
and 131.206.
We also proposed numerous changes to the standard of identity for yogurt in 131.200. In brief, we proposed to modify the description of the standardized food yogurt; define basic dairy, optional dairy, and other optional ingredients used in the manufacture of yogurt; revoke the provisions for optional addition of vitamins A and D
and the associated labeling requirements; update or provide the methods of analysis for milk solids not fat, titratable acidity, pH, and live and active cultures; and modify nomenclature, including required and recommended descriptors based on the manufacture of the product.
We further discussed our disagreement with some of the requests
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in the NYA citizen petition, including the requests to require that yogurt contain a specified amount of live and active cultures; permit the addition of optional milk-derived ingredients after culturing; permit the use of whey protein concentrate as a basic dairy ingredient; require a minimum amount of dairy ingredients; and permit a broad category of safe and suitable ingredients for nutritional or functional purposes see 74 FR 2443 at 2449 through 2453.
IV. Comments on the Proposed Rule, FDA Responses, and Description of the Final Rule A. Introduction We requested comments on the proposed rule by March 31, 2009. We later extended the comment period to April 29, 2009 Ref. 1. We received over 6,200 comments including more than 6,000 form letters from consumers, industry, trade associations, a scientific organization, and academia.
Some comments supported one or more of the proposed requirements.
Other comments opposed certain proposed requirements, suggested changes to the proposed requirements, or asked us to clarify the proposed requirements. Comments from several trade associations representing food manufacturers and ingredient suppliers supported the need to modernize the yogurt standard to allow for recent technological advances in food processing and to incorporate flexibility in yogurt manufacturing while preserving the basic nature and essential characteristics of yogurt. However, other comments urged us not to revoke or change the standards of identity for yogurt, expressing concerns that the proposal would reduce the requirements for yogurt, including those provisions regarding nutrition, quality, safety, and labeling.
In this section, we discuss the issues raised in the comments on the proposed rule and our responses, and we describe the final rule. For ease of reading, we preface each comment discussion with a numbered Comment, and each response with a corresponding numbered Response. We have numbered each comment to help distinguish among different topics. The number assigned to each comment is for organizational purposes and does not signify the comments importance or the order in which it was received.
We did not respond to comments outside the scope of this rulemaking, such as comments related to the safety of domestic versus imported ingredients, or country of origin labeling. The final rule is limited to
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