September 28, 2021

Volume XI, Number 271

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September 27, 2021

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FDA Revokes & Revises SOIs for Yogurt Products

  • On June 11, 2021, the FDA will issue its final rule to revoke the standards of identity (SOIs) for lowfat and nonfat yogurt, and amend the SOI for yogurt. The final rule regulates lowfat and nonfat yogurts under the general SOI for yogurt at 21 CFR § 131.200 and 21 CFR § 130.10 (“Requirements for foods named by use of a nutrient content claim and a standardized term”).  This action is in response to a citizen petition filed by the National Yogurt Association (NYA) in 2000 and is part of FDA’s Nutrition Innovation Strategy.  FDA states that the final rule modernizes the yogurt standard “by allowing for greater flexibilities and technological advances in yogurt production.”

  • The final rule permits the use of any optional safe and suitable milk-derived ingredient to increase “milk solids not fat content,” as well as safe and suitable emulsifiers, flavors, color additives, preservatives, cultures, stabilizers, and nutritive carbohydrate sweeteners.  FDA decided to retain reference to “nutritive carbohydrate sweeteners” instead of referring to “sweeteners” to exclude nonnutritive sweeteners.  FDA explained that, to comply with FDA’s regulatory framework under the Nutrition Labeling and Education Act (NLEA), nonnutritive sweeteners may only be added to yogurt under § 130.10 with a corresponding nutrient content claim (e.g., “reduced calorie yogurt”).  The final rule also optionally permits fortification with vitamins A (at a minimum of 10% of the daily value per serving) and vitamin D (at a minimum of 25% of the daily value per serving) and within the limits of current good manufacturing practices.

  • The final rule establishes minimum amounts of live and active cultures for yogurt products to bear the optional labeling statement, “contains live and active cultures.” To bear the label, yogurt must contain at least 107 CFU/g of live and active cultures at the time of manufacture and a reasonable expectation of 106 CFU/g throughout the product’s assigned shelf life.  If dairy ingredients are treated after culturing to inactivate viable microorganisms, the final rule requires a statement of “does not contain live and active cultures” on the label (§ 131.200(f)(1)(ii)). The statement must appear in letters not less than one-half of the height of the letters used in the product name.

  • The final rule is effective on July 11, 2021 and has a compliance date of January 1, 2024.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 161
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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