Publication of ‘healthy’ definition and draft guidance on plant-based milk imminent

The FDA – which had previously announced its intention to release draft guidance on plant-based milk labeling by the end of June, told us: “The FDA intends to release a draft guidance expected to be entitled ‘Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Draft Guidance for Industry’ in the near future. The draft guidance is currently under review by OMB​ [which has a standard review time of 90 days].”

Asked when the FDA would define ‘healthy,’ the agency said: “FDA has drafted a proposed rule and the rule is being reviewed by OMB.​” Separately, two studies – outlined here –​ into a symbol that firms may use on products that meet the ‘healthy’ definition will be conducted “in the near future​,” added the agency.

Plant-based milk labeling


In some markets, Oatly is described on pack as an Oat Drink. In others, such as the US, it is described as Oat Milk. Image credits: Oatly

While terms such as ‘soymilk’ and ‘oatmilk’ are prohibited in the EU (where Oatly is an Oat Drink), they are widely used in the US (where Oatly is Oat Milk). And the FDA – say critics – has fluctuated unhelpfully on the issue of whether such terms mislead shoppers or violate federal standards of identity,which limit the term ‘milk’ to the “milk secretions“of cows.

For example, the FDA queried the term ‘soy milk’ in warning letters to a couple of manufacturers in 2008 and 2012, but thereafter maintained radio silence on the topic until then-FDA commissioner Dr Scott Gottlieb reignited the debate in mid-2018telling delegates at a conference in Washington that, “We have a standard of identity for milk ​​and I intend to enforce that… an almond doesn’t lactate.”


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