According to the U.S. Food and Drug Administration (FDA), approximately 70 percent of Americans are now obese or overweight. Not surprisingly, FDA, industry, consumer groups, and various other stakeholders are all trying to do something about that dismal statistic. I’ve convinced my children that apples are eaten as dessert around the world, so there is hope for us all.
In 2018, FDA announced its Nutrition Innovation Strategy to consider “what can be done to reduce preventable death and disease related to poor nutrition.” As part of that initiative, FDA has updated the Nutrition Facts Label that makes the calories disclosure front and center and implemented a menu labeling rule, for example. (Note: FDA recently notified industry that it does not intend to take enforcement actions on the new nutrition labeling requirements for the first six months of 2020.)
What else can we expect near term? Apologies if your business is already weary from making formulation, supply chain, marketing, or branding updates, but “healthy” changes are on the horizon. You might even like some of them.
Don’t we already have a definition for “healthy” claims? Yes, “healthy” is an implied nutrient content claim that characterizes a food as having “healthy” levels of total fat, saturated fat, cholesterol, and sodium, as defined in the FDA regulation authorizing use of that claim, 21 C.F.R. 101.65(d). But it was last defined in 1993, when fat was largely blamed for our myriad ills.
For years, a food could only make a “healthy” claim per the regulation if it had 1 gram or less of saturated fat per serving and no more than 15 percent of its calories from saturated fat, for example. In 2015, FDA sent a warning letter to KIND, challenging its use of the claim “healthy” on some of its bars, even though at least some of the products’ saturated fats came from nuts and coconuts. In response, KIND pointed out that its bars, like avocados, salmon, and eggs, are “generally considered to be good for you” but do not meet the standard for healthy. Much debate ensued.
Fast forward to 2016, when FDA announced it was considering how to redefine the term “healthy” as a nutrient content claim. As part of its rationale, FDA noted that “Public health recommendations for various nutrients have evolved…healthy dietary patterns now focus on food groups, the type of fat rather than the total amount of fat consumed and now address added sugars in the diet.” During the comment period on use of the term “healthy,” FDA received around 1,200 comments during rulemaking, which is modest compared to the over 7,600 comments FDA received regarding “natural” and the over 14,000 comments that the U.S. Department of Agriculture (USDA) received regarding the National Bioengineered Food Disclosure Standard.
While in the midst of its rulemaking process in 2016, FDA issued guidance to industry advising of the agency’s intent to exercise enforcement discretion for foods labeled “healthy” that (1) are not low in fat, but that have a fat profile of predominantly mono- and polyunsaturated fats; and (2) contain at least 10 percent of daily value per reference amount customarily consumed of vitamin D. The FDA has also explored a “healthy” labeling icon or symbol.
FDA is expected to propose its new definition for “healthy” labeling any day now. On September 27, 2019, Dr. Susan Mayne, director of the Center for Food Safety and Applied Nutrition at FDA, said the agency is “close” to proposing its new definition. FDA already sent a proposed rule to the Office of Management and Budget for final clearance.
Some commenters requested that the revamped “healthy” definition address processed foods, pesticides, and food additives. But it is more likely “healthy” will focus on FDA’s current dietary guidance, such as types of fat, rather than total amount (consistent with FDA’s 2016 guidance), and added sugars, vitamin D, and potassium, rather than anything too far afield from positions it has already taken.
Modernizing Standards of Identity
FDA is also exploring modernizing standards of identity, which are federally mandated requirements for what can be in various foods to legally use the name of the food, including bread, chocolate, and cheese. There are about 350 of these FDA and USDA standards. Most lay people are familiar with these standards due to former FDA Commissioner Gottlieb’s comment that “an almond doesn’t lactate” when discussing the current definition of milk (a “lacteal secretion”). FDA has received 13,000 comments on the use of dairy names in labeling plant-based products alone.
FDA held public meetings on standards of identity in July 2018 and September 2019. The more recent meeting discussed “horizontal approaches” to modernizing standards of identity. What could this actually look like in practice? The example FDA gave is salt substitutes. FDA may allow salt substitutes for part of the sodium chloride in products across the board to promote sodium reduction. FDA will likely need to partner with USDA to address standards that also cut across meat and poultry.
And FDA wants your input, stating it plans to reopen the comment period on the 2005 proposed rule on general principles and food standards modernization. FDA plans to issue a new standard of identity for yogurt soon and also remove some other obsolete standards.
Why Does This Matter?
Manufacturers will likely want to take advantage of the regulatory change and adopt the “healthy” labeling claim, if possible. Similarly, manufacturers that were once precluded from calling themselves by a common name may one day want a branding overhaul. There may be reformulation and supply changes for products at the end of compliance. Food safety managers will play a critical role in shepherding food products through this process.
FDA estimates relabeling costs at $3,000 per UPC and reformulating costs at $900,000 per reformulation, although these costs vary widely depending on internal resources and other factors. Businesses should allocate time and budget to consider formulas and labeling claims to address these changes and consult their counsel, when necessary.
Also recall that USDA’s National Bioengineered Food Disclosure Standard requires compliance by January 1, 2022. One costly labeling refresh is better than two.
Rachel Lowe, Esq., is a counsel in Alston & Bird’s Agribusiness, Food, Beverage & Cosmetics Team who regularly practices in state and federal courts defending food manufacturers in false advertising class actions stemming from product labeling.