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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations
107 CFU/g of live and active cultures at the time of manufacture with a reasonable expectation of 106 CFU/g throughout the manufacturers assigned shelf life of the product 131.200f2.
We also do not agree that the provisions of fermentation, minimum titratable acidity, and maximum pH can replace the requirement of the levels of live and active cultures in the finished product. Although the culturing of yogurt is achieved by milk fermentation by the characterizing culture as described in 131.200a and other cultures as described in 131.200d1
see response 6, the optional labeling statement contains live and active cultures or another appropriate descriptor refers specifically to the presence of live and active cultures in the finished product. The minimum level of live and active cultures at the time of manufacturing and a reasonably expected level throughout the assigned shelf life provide a uniform production standard. Therefore, the final rule, at 131.200f1ii, requires that, if the yogurt product is labeled with the phrase contains live and active cultures or another appropriate descriptor, the yogurt product must contain a minimum of 107 CFU/g of live and active cultures at the time of manufacture with a reasonable expectation of 106 CFU/g throughout the manufacturers assigned shelf life of the product.
On our own initiative, for added clarity, we relocated the provisions in proposed 131.200a regarding the minimum number of live and active microorganisms yogurt may contain, to 131.200f, Nomenclature, describing the number of live and active microorganisms necessary for the product to be labeled with the phrase contains live and active cultures.
Comment 9 One comment opposed heat treatment after culturing and said that, if we permit such practice in the final rule, we should require all nonheat-treated yogurt to contain the proposed minimum levels of live and active cultures regardless of whether any live and active cultures label claims are made for the product. The comment reasoned that, under the proposed rule, there were at least three classes of yogurt products: 1 Heattreated yogurt after culturing; 2 yogurt with live and active cultures and labeled with the voluntary live and active cultures claim; and 3 yogurt with live and active cultures but without any live and active cultures claim. The comment said that these different classes of yogurt can create consumer confusion and that, if we allow heat treatment of yogurt, we
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should require all non-heat-treated yogurt to contain the minimum levels of live and active cultures to reduce consumer confusion.
Response 9 We disagree that these categories of products will cause consumer confusion. As discussed in responses 7 and 8, it is not evident that consumers always expect yogurt to contain live and active cultures. As such, labeling appears to be a better approach to informing consumers about the absence or presence of live and active cultures. The labeling provisions in 131.200f1ii and 2 of the final rule will allow consumers to identify products that do not contain live and active cultures which is a consequence of treatment after culturing and products that contain a meaningful amount of live and active cultures. The disclosure statements specified in the provisions are required to accompany the name on the principal display panel of the product label and therefore readily inform consumers about the absence or presence of live and active cultures.
Comment 10 One comment asked us to clarify that nonstandardized products that use yogurt as an ingredient are not required to meet the minimum level of 107 CFU/g live and active cultures. The comment gave examples of nonstandardized products, such as frozen yogurt, yogurt-coated cereal, and dried yogurt powder. The comment also asked us to clarify whether foods that do not meet the standard of identity for yogurt can continue to use the descriptive term yogurt as part of the foods name on the label.
Response 10 Any food that purports to be or is represented as yogurt, must conform to the definition standard of identity for yogurt and its label must bear the name yogurt see 21 U.S.C.
343g. Foods that do not purport to be or are not represented as yogurt, are not subject to these requirements. In our experience, products such as frozen yogurt, yogurt-coated cereal, and dried yogurt powder are not represented as and do not purport to be yogurt. Instead, they are nonstandardized foods, and their labels must bear their common or usual names in accordance with section 403i1 of the FD&C Act. Common or usual names are generally established by common usage, though in some cases, common or usual names for nonstandardized foods have been established by regulation see 21 CFR
part 102, subpart B. Because no such regulation for these nonstandardized foods exists, they should be labeled with their common usage names e.g., frozen yogurt, provided that the
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names do not mislead consumers see 21 U.S.C. 343a1.
When yogurt is used as part of the name of products such as frozen yogurt, yogurt-coated cereal, and dried yogurt powder, we generally expect that yogurt, or a substance derived from yogurt i.e., yogurt powder is used as an ingredient in their manufacture. The ingredient must be or be derived from yogurt that complies with 131.200. For example, we expect that an ingredient used in a yogurt drink is yogurt made in accordance with 131.200, which is then combined with other ingredients to produce a drink product. The ingredient must be declared by its common or usual name in the ingredient statement on the product label in accordance with section 403i2 of the FD&C Act, and 101.4a and b.
D. Section 131.200bBasic Dairy Ingredients The proposed rule, at 131.200b, would state that cream, milk, partially skimmed milk, skim milk, and the reconstituted versions of these ingredients may be used alone or in combination as the basic dairy ingredients in yogurt manufacture. The portion of 131.200b that excluded the use of reconstituted versions of the basic ingredients in yogurt was stayed in 1982, so we could not take compliance action against the use of these ingredients until the stay was formally resolved. Although requested by the NYA petition, we did not propose to permit the use of whey protein concentrate as a basic dairy ingredient in yogurt manufacture see 74 FR 2443
at 2453.
Comment 11 Some comments opposed the use of reconstituted forms of basic dairy ingredients but did not provide data to support their assertions of any potential safety or technical concerns. Other comments supported the use of reconstituted forms of basic dairy ingredients and stated that these ingredients are already permitted in the manufacture of other standardized dairy foods, have been routinely used by the yogurt industry due to the stay of 131.200c, and do not adversely impact the safety or characteristics of yogurt. One comment would allow the use of all types of safe and suitable milk-derived ingredients to meet the minimum required 8.25 percent milk solids not fat.
Response 11 The comments opposed to reconstituted forms of dairy ingredients did not provide any data nor do we have any information to indicate any technical or safety concern or that use of these ingredients affects the basic nature and essential characteristics of
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