Healthy conversation: Where FDA’s “healthy” update stands—and what industry’s doing about it

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Government action has a reputation for unfolding at a pace only a glacier could rival. That being so, it may be too much to ask for anything even resembling a resolution to have emerged in the 10-odd months since FDA proposed changing the nutrition standards it requires of foods pursuing a “healthy” label claim.

But given the impact such change would have on companies operating within the food, and potentially supplement, industries, it’s decidedly not too much to ask folks in those industries—and the professionals counseling them—where the “healthy” discussion currently stands, when it might conclude, and what a new labeling environment might look like when it does.

Out with the Old

Or course, those who have turned their attention to other matters since FDA floated its proposal might appreciate a recap.

And in sum, the “healthy” rewrite, which FDA debuted last September at the White House Conference on Hunger, Nutrition, and Health, would replace a definition currently written in terms of minimum levels of desirable nutrients—vitamins, most minerals, protein, et al.—and upper limits on overrepresented ones like total fat, saturated fat, cholesterol, and sodium with what FDA touts as a “food group–based approach.”

So rather than focusing on individual nutrient totals, the new standards would emphasize “healthy dietary patterns” in accordance with the 2020-2025 Dietary Guidelines for Americans—a move many nutrition experts laud, as we eat whole foods, not individual nutrients.

Under the new regime, then, a product would need to contain a certain meaningful amount of food from at least one of the food groups or subgroups recommended in the Dietary Guidelines while also adhering to science-based limits on saturated fat, sodium, and—new to this healthy definition—added sugars to qualify for a “healthy” claim.

Just as important, the proposal aims to update existing rules that, after nearly 30 years, don’t comport with current nutritional knowledge—permitting, for example, “healthy” declarations on breakfast cereals now viewed as wildly high in added sugars while prohibiting the term’s use with respect to healthful foods like nuts, avocados, and salmon that experts once deemed too high in total and saturated fat.

So if a cereal, for example, delivered at least 0.75 oz of whole grains but had less than 1 g of saturated fat, 230 mg of sodium, and 2.5 g of added sugars, it would make the “healthy” cut.

Clarity at Last

Compared to the simplicity of the existing standards, the proposed “healthy” formula may seem a little nuanced, if not outright clunky. But if it brings clarity in the end, it may prove worth it.

After all, says Asa Waldstein, principal, Supplement Advisory Group (Boulder, CO), food brands can’t operate optimally without clarity.

“Companies making ‘healthy’ claims are subject to plaintiff attorney lawsuits because the current definition of healthy is unclear,” he points out. “This proposed rule would provide the requirements to make ‘healthy’ statements, just as FDA has done with other nutrient-content claims such as ‘high potency’ and ‘good source.’”

So as far as he’s concerned, “I support any rule that will help reduce the burden of plaintiff attorney lawsuits on the industry.”

First Principles

But that reduced burden and clarity will only pay off if a new rule finally sees light of day. And as of now, FDA continues reviewing comments and has yet to tease a final rule’s release date. “That said,” notes Katie Bond, partner, Keller and Heckman LLP (Washington, DC), “since the comment period closed, we have had a chance to review what commenters had to say.”

And like many of them, Bond continues to view the proposed standards with caution, largely out of concern for their First Amendment implications.

“Specifically,” she explains, “to suppress a truthful ‘healthy’ claim, FDA would have to show that, one, it has good reason to do so, and, two, the claim is so misleading that it can’t be cured by additional disclosure.”

In this case, she argues, “FDA hasn’t met either burden. It’s seeking to prohibit healthy except in narrow circumstances without first showing either a substantial public-health benefit or that ‘healthy’ claims with qualifiers would necessarily be deceptive.”

Compelling Points

Thus the trade associations SNAC International and the Consumer Brands Association, public-interest law firm Washington Legal Foundation, and several major food companies and organizations, including Ocean Spray and the California Walnut Commission, have all submitted comments making “compelling points” on the matter, Bond says.

Washington Legal Foundation, for example, “properly observed” that FDA’s purported justification for its rule—that “0% to 0.4% of people” would use the authorized “healthy” claim to make “meaningful, long-lasting food purchasing decisions”—would have an effect so de minimis as not to justify speech suppression.

Consumer Brands Association, meanwhile, compiled a list of foods for which the new “healthy” claim would be off limits and found it to include everything from 100%-whole-grain breads and tortillas to many high-fiber cereals; fat-free and low-fat cottage cheese; hummus; nearly all bagged salad kits with dressing packets; frozen or canned vegetables and vegetable soups with small amounts of added sugar or sodium; and frozen whole-grain and vegetable main dishes with small amounts of added sugars.

All these foods are, in fact, healthful per current USDA and Department of Health and Human Services Dietary Guidelines, Bond states, and Consumer Brands Association and several individual food brands were quick to note that many such products actually “provide healthier, affordable options for consumers lacking access to grocery stores or the time and resources to cook from scratch,” she says.

Finally, Bond says, Ocean Spray made a “formidable case” warning that the proposed rule would unfairly exclude most cranberry products from claiming the “healthy” mantle because, unlike many other fruits, cranberries require some added sugar to offset their natural tartness.

“Ocean Spray explained that where FDA is proposing a 0%-added-sugar requirement for fruit products, ‘comparable and competitive products with similar—or even higher—total sugar content’ could use healthy simply because those products contain naturally occurring sugar,” she contends, despite FDA’s stated acknowledgement that the body processes added sugar no differently than it does “natural.”

In any case, Ocean Spray is “closely watching the implications this proposal has on its First Amendment rights and is prepared to defend its ability to communicate truthful and non-misleading information about its cranberry products,” Bond says, speculating that the “caution” Ocean Spray voiced, along with other parties’ comments, “might resonate where FDA hasn’t had the greatest success against the First Amendment commercial doctrine.”

To wit, FDA has racked up three significant losses since 2020, she says: two on off-label drug advertising and one that created the qualified-health-claims regime in the food and supplement space. “In each case,” she says, “the courts found FDA failed to carry its burden to justify suppressing truthful health information.”

As for what effect that those precedents might have on the current proposal’s fate, only time—glacial though it may be—will tell. But this is certain: Advocates for the food and supplement industries will be watching.