FDA Issues Small Entity Compliance Guidance for Yogurt Standard of Identity

The U.S. Food and Drug Administration (FDA) announced the availability of a Small Entity Compliance Guide (SECG) to help manufacturers comply with the FDA's final rule modernizing the standard of identity (SOI) for yogurt. This guidance arrived just in the nick of time, as the compliance deadline is January 1, 2024.

The Final Rule did two major things: first, it revoked the SOIs for lowfat yogurt and nonfat yogurt; and second, it significantly modernized the SOI for yogurt, allowing for new ingredients and manufacturing methods. Now, lowfat yogurt and nonfat yogurt must comply with the general definition and SOI in 21 C.F.R. 130.10 for foods deviating from standardized foods due to compliance with a nutrient content claim.

As detailed in the SECG, the new SOI for yogurt has several key provisions, including:

• Setting a minimum dairy requirement. Yogurt must contain not less than 3.25 percent milk fat and not less than 8.25 percent milk solids, not fat.

• Yogurt with 2.44% to 3.25% milk fat must be labeled with the following, which must appear together in the statement of identity: (1) The word "yogurt" in type of the same size and style for each letter, and (2) The statement "__ percent milk fat" with the blank containing the actual milk fat content of the product rounded to the nearest half percent.

• The minimum dairy requirement must come from cream, milk, partially skimmed milk, skim milk, or reconstituted versions of these ingredients. These may be homogenized, but must be pasteurized before adding the required bacterial cultures.

• Optional dairy ingredients can be used to increase the milk solids, not fat content of the food above the required minimum of 8.25 percent (with certain requirements).
• Yogurt must use bacterial cultures that contain specific lactic acid-producing bacteria, but companies can use other cultures as well so long as they are safe and suitable.
• Allowing for other optional ingredients, including flavoring ingredients, color additives, stabilizers, emulsifiers, preservatives, Vitamin A, and Vitamin D. In addition, in a big win for the industry, the rule allows for the use of all safe and suitable sweeteners as ingredients in yogurt, including non-nutritive sweeteners. Note that if Vitamins A or D are added, they must be included at a minimum of 10% of the Daily Value.
• Setting a required pH of 4.6 or lower measured on the finished product within 24 hours after filling. According to the International Dairy Foods Association, this is important because it allows for "cup-set" yogurts "to continue being made and sold, while ensuring the safety of yogurt." These are the very popular "fruit-on-the-bottom" yogurts.
• Allowing an optional label statement that the product "contains live and active cultures" or similar language, but only if (1) the yogurt contains at least 10⁷ Colony Forming Units per gram (CFU/g) of live and active cultures at the time the yogurt is manufactured; and (2) there is a reasonable expectation that the yogurt will maintain 10⁶ CFU/g through the shelf life assigned to the product by the manufacturer.
• For yogurt that is treated to inactivate live microbials, the labeling must now state: "does not contain live and active cultures."
• Allowing the use of fat-containing flavors in lower fat milk. For example, nonfat yogurt containing the flavoring agent coconut flakes, can make a nutrient content claim corresponding to the yogurt's milk fat content (e.g., "lowfat"). The label must contain a descriptor of the fat-containing flavoring ingredient. For example, a product with 1.5% milk fat and coconut flakes as a flavoring ingredient would be labeled "lowfat yogurt with coconut flakes."

The SECG also discusses some tricky labeling elements, like how to label nutrient content claims or added vitamins. But be sure to discuss any label changes with your regulatory attorney, as even small changes to a label can have regulatory implications. Contact Alli Condra (allisoncondra@dwt.com) or Kim Bousquet (kimbousquet@dwt.com) to discuss this significant change and how it might impact you or your business.