Silver Spring, MD—The U.S. Food and Drug Administration (FDA) has shared its latest efforts as part of a government-wide effort to combat the nation’s chronic disease crisis. The goals of the White House National Strategy on Hunger, Nutrition and Health is to reduce diet-related diseases by 2030. FDA's efforts include:
- The recently updated “healthy” claim (read more below).
- FDA’s work to develop a “healthy” symbol.
- Proposed requirement for front-of-package (FOP) nutrition label for most packaged foods.
- The draft Phase II voluntary sodium reduction targets.
FDA said these efforts can help consumers more easily identify foods recommended by the Dietary Guidelines for Americans and may assist them in reducing their consumption of certain nutrients found in ultra-processed foods.
Front-of-package (FOP) nutrition label
Regarding FDA's proposal to require a front-of-package (FOP) nutrition label for most packaged foods, the Agency said this would give consumers visible information about a food’s saturated fat, sodium, and added sugars content, all of which are directly linked with chronic diseases when consumed in excess. On the proposed label, which FDA also referred to as the “Nutrition Info box,” information on saturated fat, sodium, and added sugars will be displayed in a simple format showing whether the food has “Low,” “Med” or “High” levels of each. FDA said the label complements the Nutrition Facts label.
"Chronic diseases, including heart disease, cancer and diabetes, are the leading cause of disability and death in the U.S.," FDA reported. "With 60% of Americans having at least one chronic disease, such diseases are also the leading drivers of the nation’s $4.5 trillion in annual health care costs." The Agency added that there is a proliferation of foods in the food supply that are considered ultra processed foods (UPFs), which often contain high levels of saturated fat, sodium, and added sugars.
“The science on saturated fat, sodium and added sugars is clear,” said FDA Commissioner Robert M. Califf, M.D., in the announcement. “Nearly everyone knows or cares for someone with a chronic disease that is due, in part, to the food we eat. It is time we make it easier for consumers to glance, grab and go. Adding front-of-package nutrition labeling to most packaged foods would do that. We are fully committed to pulling all the levers available to the FDA to make nutrition information readily accessible as part of our efforts to promote public health.”
FDA Deputy Commissioner for Human Foods Jim Jones added, “Food should be a vehicle for wellness, not a contributor of chronic disease. In addition to our goal of providing information to consumers, it’s possible we’ll see manufacturers reformulate products to be healthier in response to front-of-package nutrition labeling. Together, we hope the FDA’s efforts, alongside those of our federal partners, will start stemming the tide of the chronic disease crisis in our country.”
To determine the best approach to help consumers make healthier choices, FDA conducted an experimental study of nearly 10,000 U.S. adults to explore consumer responses to three types of FOP labels. The finding: The black and white Nutrition Info scheme with the percent Daily Value performed best in helping consumers identify healthier food options.
If finalized, the rule would require food manufacturers to add a Nutrition Info box to most packaged food products three years after the final rule’s effective date for businesses with $10 million or more in annual food sales and four years after the final rule’s effective date for businesses with less than $10 million in annual food sales. FDA called for comments on the proposed rule can be submitted electronically to http://www.regulations.gov by May 16, 2025.
Updated “healthy” claim
The "healthy" claim has been updated to help consumers find foods that are the foundation of a healthy dietary pattern, FDA said, adding that it could also result in the development of healthier foods. Manufacturers can voluntarily use the “healthy” claim on a food package if a product meets the updated definition. The rule is effective February 25, 2025. The compliance date of this final rule is February 25, 2028.
“It’s critical for the future of our country that food be a vehicle for wellness. Improving access to nutrition information is an important public health effort the FDA can undertake to help people build healthy eating patterns,” said Dr. Califf. “It is vital that we focus on the key drivers to combat chronic disease, like healthy eating. Now, people will be able to look for the ‘healthy’ claim to help them find foundational, nutritious foods for themselves and their families.”
Jones added, “Food labeling can be a powerful tool for change. Food labeling, like ‘healthy,’ may help foster a healthier food supply if manufacturers choose to reformulate their products to meet the new definition. There’s an opportunity here for industry and others to join us in making ‘healthy’ a ubiquitous, quick signal to help people more easily build nutritious diets.”
To qualify as “healthy” under the updated definition:
- Food products must contain a certain amount of a food from at least one of the food groups or subgroups outlined by the Dietary Guidelines for Americans including fruits, vegetables, protein foods, dairy, and grains.
- Foods that qualify for the “healthy” claim must meet certain limits on saturated fat, sodium, and added sugars.
To help industry navigate, Venable LLP’s Claudia Lewis wrote a new client alert. Lewis explains: "To determine whether a product contains the right amount of food, the rule creates what FDA calls food group equivalents (FGEs). These are a reference measure for how much of a certain food group must be present in a food product for its manufacturer to be permitted to use a 'healthy' claim. The rule sets differing FGE and sodium, added sugar, and saturated fat nutrient limits for individual food products, mixed products (contain more than one food group), and main dish and meal products." Read more from Venable here, and stay tuned for the company's in-depth analysis.
The American Herbal Products Association (AHPA) said several elements of the final rule on the labeling of foods with the word “healthy” as an implied nutrient content claim responded to comments from AHPA, including (as outlined by AHPA):
- FDA declined to exempt dietary supplements from the nutrient content and food group equivalency requirements established for conventional foods.
- In response to comments from AHPA and others, FDA modified the rule such that coffees and teas (of Camellia sinensis specifically) may bear “healthy” nutrient content claims, so long as they do not contain added caffeine and contain fewer than 5 calories per labeled serving and reference amount customarily consumed.
- In response to comments from AHPA, FDA clarified that the term “healthy” may continue to be used in valid structure function claims.
- Products lawfully bearing “healthy” claims in compliance with the prior rule will not be in violation so long as they were labeled in advance of the compliance date.
- FDA stated that herbs or spices may qualify as vegetables for the purpose of calculating food group equivalence for the use of “healthy” claims, but declined to permit them to automatically qualify as “healthy.”
- In response to comments from AHPA and others, the agency agreed that dried or other powdered fruits and vegetables can be considered in food group equivalency calculations provided that the powders are essentially the dried and ground forms of the original whole food.
Additional information on the rule is available here.
Regarding the “healthy” symbol that manufacturers could use to indicate their food meets the criteria of “healthy,” FDA said this is another way to convey to consumers that a food meets the “healthy” claim criteria.
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