- USDA-regulated food products will be able to carry the "healthy" label claim if their fat profile contains predominantly mono and polyunsaturated fats or a serving has at least 10% of the government-set daily value of potassium or vitamin D, according to a notice set to be published in the Federal Register later this week.
- These guidelines mirror recommendations for the label claim that were set out by the FDA in 2016, the notice says.
- The Federal Register states this regulation is being published to clarify confusion among manufacturers about the "healthy" label claim. USDA's Food Safety and Inspection Service's labeling program and delivery staff review proposed labels referencing FDA’s “healthy” guidelines, and the notice states most have errors and need to be corrected. Going forward, if a USDA-regulated company wants to use a “healthy” claim using FDA's recommendations, it needs to submit at least one label sketch to the USDA labeling team for approval.
The question of what "healthy" means has been unanswered for years, and this Federal Register entry may start to set some parameters.
However, the parameters aren't too large and not necessarily too binding. This definition only applies to USDA-regulated food products, meaning only about 23% of what consumers eat. USDA regulates items that are mostly meat, poultry and eggs.
The rest of the food regulatory world is under FDA's jurisdiction. And while this regulation says it mirrors what the FDA uses to say an item is "healthy," that agency has yet to redefine the term. Manufacturers hoping to use the "healthy" label claim can reference a 2016 guidance document, which is made up of nonbinding recommendations. And while this guidance is helpful, an actual new definition of the term has not yet come out.
Four years ago, FDA opened a docket asking manufacturers, dietitians and the general public what they thought the term "healthy" should mean on food and beverage labels. The term had been initially defined in 1994, but the last 25 years has seen more research and deeper understanding of nutrition and its effects on the body. To accompany the opening of the docket, the FDA put out the guidance document, which it states reflected agency thinking at the time. It was not codified, allowing for public and industry input into the definition.
A public hearing to discuss "healthy" was held in 2017, and more than 1,100 comments about the definition have been posted on the FDA's docket. Since then, the regulatory agencies have been relatively quiet. Last March, former FDA Commissioner Scott Gottlieb said at an event that the definition would come in the summer. However, Gottlieb had tendered his resignation weeks earlier, and the department has still not yet added an actual definition to the Federal Register.
While it appears this regulation was necessitated by confusion among manufacturers, it doesn't seem that there is as much of a disconnect for USDA-regulated products as those regulated by the FDA. While the 1994 "healthy" definition emphasized that healthy food was low in fat, this guideline mandates that products' fat profiles contain more of the "good" naturally occurring fats.
Meat products generally have more saturated fat — which is one of the "bad" fats that cannot be called "healthy." Egg label claims follow FDA guidance, even though the eggs themselves fall under USDA regulation, the Federal Register says. The guidance is mostly for meal products regulated by USDA, which include anything with between 2% and 3% meat or poultry.
Even though this regulation brings food labeling into some semblance of harmony between USDA and FDA, there still is no binding definition for a label claim that is vital to consumers. A study last year from the International Food Information Council Foundation and the American Heart Association found 95% of Americans look for healthy options when food shopping, but more than a quarter say that information is hard to find.
Although nutritional information is much clearer on the revamped Nutrition Facts label, a regulated claim for "healthy" that manufacturers could use would make communicating that information much easier.
USDA and the Department of Health and Human Services, which oversees FDA, are currently doing research to develop the latest set of the Dietary Guidelines for Americans, which are revamped every five years. Perhaps the committee's work will wrap into what FDA started four years ago, and a true definition of "healthy" will be published then.