• 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.