August 19, 2018

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FDA to Issue a Guidance Document Limiting Use of Milk in Plant-Based Beverages

  • In the 2018 POLITICO Pro Summit, FDA Commissioner Scott Gottlieb signaled that FDA will begin collecting comments regarding enforcement of standard of identity for “milk”.  As noted in our June 27 blog, FDA is holding a public meeting on July 26, 2018 to discuss its Nutrition Innovation Strategy, including standards of identity.  FDA indicated in April that it might solicit comments, Commissioner Gottlieb’s comments at the POLITICO Pro Summit appear to echo this sentiment.
  • Industry and certain lawmakers have taken issue with the use of the term “milk” by manufacturers of plant-based products, such as soy milk and almond milk, taking the position that it is a violation of the standard of identity.  Milk is defined as the “lacteal secretion . . . obtained by the complete milking of one or more healthy cows”, though FDA regulations also contemplate milk from other animals.  In his POLITICO Pro Summit speech, Dr. Gottlieb said “an almond doesn’t lactate,” implying that almond milk and other plant-based beverages, do not meet the standard of identity for milk.
  • Commissioner Gottlieb acknowledged that FDA has not been enforcing the standard of identity for milk as it pertains to plant-based beverages and that he cannot change FDA’s enforcement posture unilaterally.  He did commit, however, to developing a guidance document in about a year announcing FDA’s intent to enforce the standard of identity.
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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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