Can you call it “milk” if it didn’t come from a mammalian breast?
That’s a question the Food and Drug Administration plans to take up soon, according to statements from Commissioner Scott Gottlieb at a Politico Pro Summit on Tuesday. But depending on who you ask, the agency has already answered it-either with a “no,” according to the National Milk Producers Federation, or with a “maybe,” according to the Plant Based Foods Association.
The FDA “will soon begin enforcing regulations that define milk as an animal product, not a plant-based food,” the NMPF said in a statement Tuesday.
That’s not what the PBFA heard. “We’re looking forward to providing the agency with data that we have to make our case,” said executive director Michele Simon. She called the Commissioner’s statement an “opportunity,” adding “we feel like this is part of an ongoing conversation.”
Gottlieb’s comments, similar to those made in April at a Senate appropriations meeting, are ambiguous enough that both sides of this argument see a win. As milk sales continue a multi-decade decline, plant-based alternatives are seeing multi-year growth. Dairy farmers regularly complain about labels like “almond milk” since they’re not, technically, milk. “This has been a little bit of a bugaboo to the dairy industry,” as Gottlieb described it.
As the dairy group highlights, the commissioner said the agency has a standard of identity for milk, referring to the regulation that defines it as the “lacteal secretion. of one or more healthy cows.” More importantly, they say, Gottlieb clearly announced his intent to enforce that standard.
But since the standard has not been enforced before, Gottlieb said, the FDA needs to go through a process before it begins any crackdown. “We’re going to open a docket very soon, solicit public comment with the hope of, you know, developing a guidance document that would enforce a standard of identity differently,” he said.
Or, as Simon heard it, “The agency isn’t just putting out a fiat.”
An FDA spokesperson said the agency wouldn’t be commenting further.
Even the experts aren’t sure what to make of the situation.
“If I were in the almond or soy milk business I wouldn’t be terribly encouraged by this,” says Cary Coglianese, director of the University of Pennsylvania Law School’s Penn Program on Regulation. But he notes, “The silver lining is that the agency isn’t going to start enforcing the standard of identity as its been written.”
The agency has the authority to enforce the existing standard, even if Gottlieb implies it does not, argues Brent Johnson, a litigation attorney with a focus on food at Holland & Hart.
“There is a regulation that is clear,” he says, describing the comment period as “an extra step, but not one required by law.” Gottlieb seems to be taking public comments out of a sense of caution. He mentioned that the agency was likely to get sued during the process.
The agency probably recognizes it wouldn’t be easy to start mailing out Warning Letters tomorrow. “The FDA doesn’t have a slam dunk case in my assessment,” Coglianese says.
He cites two reasons: First, echoing Gottlieb, the agency’s failure to enforce the rule as written for so long means that “it’s essentially like they abandoned the rule.” But the stronger reason, Coglianese says, is more fundamental: The current regulation is defining the word “milk,” not any product that uses the word, like “almond milk,” or other plant-based dairy alternatives. Plus, because the regulation requires the milk to come from cows specifically, even goat milk is technically in violation.
The most likely outcome, Johnson says, is no outcome. He points to the lack of resolution around the word “natural,” which the agency has repeatedly sought comments on and repeatedly left undefined.
Simon says she isn’t overly concerned with the outcome: “The consumer is already making their choice so we don’t even care about this stupid fight over labeling.”