Publication of ‘healthy’ definition and draft guidance on plant-based milk imminent

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preliminary guidance on the labeling of plant-based milk by the end of June, told us: “The FDA intends to publish draft guidance that is expected to be titled ‘Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Declarations: Draft Guidance for Industry’ in the near future. The draft guidance is currently under review by OMB​ [which has a standard review time of 90 days].”

When asked when the FDA would define ‘healthy,’ the agency said: “The FDA has drafted a proposed rule and the rule is under review by the OMB.​” Separately, two studies – outlined here​ in a symbol that companies can use on products that meet the definition of ‘healthy’ will be held “in the near future”, added the agency.

Plant-based milk labeling

In some markets, Oatly is described on the package as an oat drink. In others, such as the US, it is described as oat milk. Image credits: Oatly

While terms like ‘soy milk’ and ‘oat milk’ are banned in the EU (where Oatly is an oat drink), they are widely used in the US (where Oatly is oat milk). And the FDA, critics say, has vacillated uselessly on whether such terms mislead buyers or violate federal Identity Standards,​​that limit the term ‘milk’ to the “milk secretions“of cows.

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

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