FDA draft guidance for “healthy” ingredients on food labels triggers concerns over limitations on innovation, consumer autonomy

By Deniz Ataman

- Last updated on GMT

Source: iStock / Getty Images Plus
Source: iStock / Getty Images Plus

Related tags Fda healthy diet food labeling Food labeling regulations Food and drug administration Cpg companies Dietary guidelines Ingredients

Products making dietary guidance statements should contain a meaningful amount of the featured ingredient or food category and not exceed certain amounts of saturated fat, sodium and added sugar, according to FDA’s draft guidance for industry on questions and answers about Dietary Guidance Statements in food labeling published March 27 in the Federal Register.

According to the agency, the intended update is in accordance with current nutrition science and research, federal dietary practices (i.e. The Dietary Guidelines for Americans, 2022-2025) and the updated Nutrition Facts label. Rather than focusing on how food and beverage choices influence the entirety of the diet, the guidance proposes using “more nutrition-related labeling statements that focus on foods and food groups in relation to nutritious eating patterns.” 

This week’s draft guidance​ stems from a public meeting hosted by FDA in July 2018​ to discuss its Nutrition Innovation Strategy. At that meeting, stakeholders also indicated interest in labeling claims, statements, symbols and vignettes to assist consumers in determining how foods can impact nutritious dietary patterns. 

October 2022 proposal defines “healthy,” outlines specific nutrient criteria

Under the proposed definition of 'healthy' released in October 2022​, CPGs must meet specific nutrient criteria. This means a food product must contain a specific quantity of food from a minimum of one of the food groups or subgroups. These groups include fruit, vegetables, grains, dairy and protein foods—all of which are recommended by the Dietary Guidelines for Americans, 2022-2025.

Raw whole fruits and vegetables automatically qualify, limits on sugars, salt and fat

While raw whole fruits and vegetables automatically qualify to be considered “healthy,” the proposal places specific limits for added sugars, saturated fat and sodium. These ingredients would be limited based on a percentage of the daily value for nutrient content.

Adding to the existing definitions of total fat, saturated fat, cholesterol and sodium limits, the proposal states that “foods must also provide at least 10% of the daily value for one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein and fiber.”

Consumer Brands Association raises concerns over “healthy” definition

The Consumer Brands Association (CBA), which is comprised of CPG manufacturers like Kellogg’s, General Mills and Campbell Soup Company, raises concern over the proposal, citing its significant restrictions on innovation and exclusion of existing nutrient-rich food categories.

“As it stands, the proposed rule would eliminate an inordinate number of packaged products from being considered ‘healthy,’” Roberta Wagner, vice president, regulatory and technical Affairs, CBA, wrote on the organization’s website ​last month. Nutrient-dense products like whole grain breads, breakfast bars, yogurts, cereals, canned fruits/vegetables and salad kits would not be labeled as such, Wagner added.

While there is no debate between the FDA and CPG manufacturers' intentions to provide consumers with healthy options, Wagner explains that the FDA’s proposal “contradicts the current Dietary Guidelines, causing confusion among consumers and potentially inviting legal challenges for the agency.”

CBA proposes a flexible alternative leveraging CPG innovation and consumer autonomy

CBA proposed a more flexible alternative​ that allows for consumers to decide which products to purchase and simultaneously gives CPG manufacturers the opportunity to meet consumer tastes and preferences through reformulations and repackaging. Further, the organization cites that CPG innovations are intended to help strengthen access to healthier options, along with convenience and affordability for shoppers.

Despite FDA and CPG manufacturers' goals to promote health equity on food labels, the question lies in how CPG innovation and consumer autonomy will be addressed pending government requirements.

Stakeholders can comment on the proposed draft guidance​ through June 26.

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