FDA commissioner: ‘An almond doesn’t lactate… we have a standard of identity for milk and I intend to enforce that’

Speaking at a Politico​ Pro Summit​​ in Washington on Tuesday, Dr Gottlieb said federal standards of identity limit the use of the term ‘milk’ to the lacteal secretions of cows: “You see the proliferation of products like soymilk and almondmilk calling themselves 'milk' and if you look at the standard of identity there is a reference to a lactating animal… and an almond doesn’t lactate…”​

But he added: “The question becomes, have we been enforcing our own standard of identity? The answer is probably not… But if I want to change our regulatory posture with respect to how we’re enforcing the existing standard of identity, I can’t just do it unilaterally…​

“I’d need to at the very least issue a guidance document suggesting we’re going to enforce our existing standard of identity differently. That’s what we intend to do… We’ll open a docket soon and solicit public comment … ​We do have a standard of identity and I do intend to enforce that."​

But he added: “We’ll probably get sued.”​

NMPF: The FDA is listening to milk producers​

The National Milk Producers Federation (NMPF) - which claims the FDA has been turning a “blind eye”​ to alleged violations of its own standards of identity – welcomed Dr Gottlieb’s comments, which echoed a statement made to lawmakers in April​.​

“This is an indication that the NMPF’s requests for action by the agency are being heard,” ​said president and CEO Jim Mulhern.

“Once FDA acts to provide guidance to industry on enforcement of existing standards of identity, manufacturers currently playing fast and loose by using standardized dairy terms on products containing no dairy will know the jig is up. Their products have every right to be in the marketplace, but they will have to be properly identified to comply with FDA standards.”​

GFI: ‘Optimistic the FDA will make the right call’​

Bruce Friedrich, executive director at the Good Food Institute (GFI) – which promotes plant-based and cell-cultured foods – said he looked forward to having a public debate on labeling conventions for plant-based foods and beverages.

He added: “We are in complete support of Commissioner Gottlieb’s desire to ensure that consumers are informed, to foster competition on behalf of more nutritious foods, and to modernize the standards of identity​. All three of these goals point toward explicitly allowing terms like milk or butter or yogurt modified by clear words like ‘soy’ and ‘almond.​’​

“Once FDA has considered all of their options, we believe they will grant our rulemaking petition​ ​[filed in March 2017] which simply asks FDA to clarify that commonsense modifiers are allowed when naming new foods."  ​

Given Dr Gottlieb's “laudable record of combining an understanding of scientific nuance with common sense practicality​,” said Friedrich, “We are optimistic the FDA will make the right call, allowing plant-based producers to continue to clearly label their products as what they are.​”​

According to the GFI’s petition, “the government is only allowed to restrict commercial speech if there is a substantial risk of consumer harm and its solution is narrowly tailored to solve the harm,” ​he claimed. “As we discussed in our rulemaking petition, there is no way that the act of censoring plant-based milk makers would be able to clear this clear constitutional bar.”  ​

“Notably, multiple courts have considered the issue of consumer confusion; all of them have essentially laughed the concept out of the courtroom. GFI’s goal is to ensure that the FDA’s labeling rules do what they are intended to do: protect and inform consumers, not privilege specific industries.”​

What do the courts say about terms such as 'almondmilk?'​

Courts handling false advertising cases over plant ‘milks’ have  argued that​​​ the federal standard of identity for ‘milk’​​​ - which limits it to lacteal secretions from cows - does not categorically preclude a company from giving food products names that include ​​the word ‘milk.’

For example, in a case vs Trader Joe’s​​,​​ judge Vince Chhabria noted that the word ‘soy’ before ‘milk’ cleared up any confusion as to the contents of the package in question: “Trader Joe's has not, by calling its products ‘soymilk,’ attempted to pass off those products as the food that the FDA has standardized (that is, milk).”​​

As for nutritional equivalency, Stephen Wilson, the judge handling a false advertising case vs Blue Diamond Growers (Almond Breeze) in California, did not buy the argument​​​ that the word ‘milk’ came with a certain set of nutritional expectations, adding: “If the consumer is concerned about the nutritious qualities of the product, they can read the nutrition label…”​​

PBFA welcomes ‘open and constructive’ conversation with the FDA  ​

Michele Simon, executive director at the Plant Based Foods Association (PBFA), told FoodNavigator-USA that she too welcomed an “open and constructive​” conversation with the FDA, noting that the PBFA would be issuing a public statement on standards of identity at a July 26 meeting on the FDA’s nutrition innovation strategy.

Click HERE​​ to read the PBFA’s voluntary standards for plant-based milks, which suggest that the percentage of solids derived from the characterizing ingredient or ingredients (eg. nuts, legumes, grains etc) should be at least 2% of the end product's final weight or volume.

Plant-based milks should also feature the term ‘dairy-free’ or ‘nondairy’ prominently on the principal display panel, added the PBFA, while the statement of identity should include the characterizing ingredient(s) coupled with the word ‘milk,’ either as a single word (‘almondmilk') or two words (‘almond milk’). The term 'plant-based milk’ is also OK as long as the characterizing ingredients are also stated on the principal display and information panels, suggests the PBFA.

The FDA and federal standards of identity​

The FDA, say critics, has fluctuated unhelpfully on the issue of whether terms such as 'almondmilk' or 'vegan cheese' violate federal standards of identity or mislead shoppers.

For example, it queried the term ‘soy milk’ in warning letters to manufacturers Lifesoy​​​​ in 2008 and Fong Kee Tofu​​​ in 2012, but thereafter maintained radio silence on the topic, which some plant-based brands say leaves them vulnerable to lawsuits, and dairy milk producers (who believe plant ‘milk’ brands are openly flouting the law​​​​), find infuriating.

The agency also raised eyebrows in 2016 by telling Hampton Creek (now called JUST) it could keep its ‘Just Mayo’ brand​​ name​​​ for its egg-free spread (which does not comply with the standard of identity for mayonnaise​​​), albeit with minor tweaks to the label, just weeks after accusing it of violating said standard.

It has not formerly weighed in since (although FDA commissioner Dr Scott Gottlieb indicated he would look again at this issue​​ during a recent Senate Appropriations Committee hearing), but has signaled its intent to “modernize certain standards of identity”​ in its 2018 strategic roadmap​​​.