March 31, 2020
With COVID-19 dominating headlines and food manufacturers struggling to ensure that grocery store shelves remain stocked during this pandemic, manufacturers may have missed an important update from the U.S. Department of Agriculture (USDA) on use of “healthy” on food labels. While USDA’s announcement will not cause immediate changes for manufacturers, it provides more concrete guidance for the use of “heathy” on USDA-regulated foods.
Although many foods claim to be “healthy,” not all foods meet USDA’s and the Food and Drug Administration’s (FDA’s) definition for use of the descriptor. Use of the term “healthy” has a complex regulatory history and the most recent guidance comes from FDA’s 2016 “Guidance for Industry: Use of the Term ‘Healthy’ in the Labeling of Human Food Products.” In that guidance, FDA came to terms with the fact that not all foods that are “healthy” would meet the complex criteria laid out in 21 C.F.R. 101.65(d) for saturated fat, cholesterol and vitamins. In reconciling this conundrum, FDA stated that it would exercise enforcement discretion for foods that are either: (1) not low in fat, but have predominantly only mono- and polyunsaturated fats; or (2) contain at least 10 percent of the daily value per reference amount customarily consumed (RACC) of potassium or vitamin D. At that time, USDA decided it would simply “adopt” FDA’s definitions of “healthy” from the 2016 guidance.
On March 19, USDA published guidance in the Federal Register reiterating its position allowing for implied nutrient content claims of “healthy” on foods that “have a fat profile of predominantly mono and polyunsaturated fats” (i.e., the sum of monounsaturated fats and polyunsaturated fats is greater than the total saturated fat content of food), but do not meet the regulatory definition of ‘‘low fat.” This is applicable only if food meets the sodium and cholesterol requirements outlined in 9 C.F.R. 317.363. Food with a high fat profile of mono- and polyunsaturated fats will continue to be allowed to use the claim. USDA’s guidance made it clear that very few of the products the Food Labeling Program delivery staff (LPDS) at the Food Safety and Inspection Service (FSIS) review are “healthy.” The guidance also requested that a company submitting a label for approval provide at least one sketch of the product to LPDS and in the format of the new FDA nutrition panel. It also noted that USDA, like FDA, will continue evaluating the term “healthy” and that new regulations are forthcoming.
For industry this means two key takeaways: (1) Continue to expect USDA will harmonize with FDA on food labeling and definitions, where possible; and (2) the current state of enforcement discretion for use of the term “healthy” on specific high-fat foods will remain in place. Manufacturers should check their labels, fat content, sodium content and cholesterol content on their food to make sure that, despite having mono- and polyunsaturated fats, the products also meet the regulatory requirements for cholesterol and sodium prescribed by USDA.