Daily Briefing (Insiders Only): The FDA Talks Finalized ‘Healthy’ Definition

Shauna Golden
FDA

Nutrition is a hot topic these days as the Make America Healthy Again crowd spreads its message across the country.

So it is important that, after years of discussion and controversy, the U.S. Food and Drug Association (FDA) is now talking through its finalized definition for the term “healthy.”

  • That final guidance was issued on Dec. 25 and developed in the pre-MAHA era under the Biden Administration.
  • The finalized rule for food and beverage packaging is set to go into effect on April 28.

The updated criteria aligns the term’s regulatory definition with current nutritional science and federal dietary guidance. The goal is to promote healthier dietary patterns to reduce chronic diseases. Here’s the skinny on what foods now qualify as “healthy”:

  1. Products must contain a “certain meaningful amount” of food from at least one nutrient-dense food group or subgroup (fruit, vegetables, grains, fat-free and low-fat dairy and protein) recommended by the Dietary Guidelines for Americans (DGA) AND
  2. Meet specific limits for added sugars, saturated fat and sodium based on the percent of the daily value (DV) recommended for each individual nutrient

Those parameters do overlap some with ongoing discussions around ultraprocessed foods (UPFs), which are also playing out at the federal and state level. Unlike “healthy” (whose definition was in discussion for over a decade), UPFs still lack their own spot in the FDA’s dictionary.

We can look at what has happened with “healthy” to possibly predict the path to regulatory guardrails around UPFs too. As research continues, it can be expected that any UPF parameters will also evolve. In the case of healthy, several changes have been made since the agency first proposed the rule back in 2022. Public feedback also plays a role.

For example: The FDA originally exempted raw whole fruits and vegetables. Those foods automatically qualify as “healthy” without having to meet food group equivalents (FGEs) and nutrient requirements. The final rule expands this exemption to single-ingredient foods (no additional ingredients other than water) across all food groups.

  • Examples include whole or sliced fruits, unsalted nuts, brown rice and frozen mixed vegetables.
  • Water (including carbonated water), tea and coffee with less than five calories per serving and no added caffeine can also bear the claim without having to meet the requirements.
  • The FDA also lowered dairy requirements so that more yogurt products can qualify as “healthy.”
  • The final, updated rule also provides flexibility on the amount of inherent and naturally occurring fats in seafood, nuts, seeds and soy products so that these items can qualify.

Manufacturers have three years to comply with the final rule and can begin using the updated criteria on April 28, 2025. What do you think, readers – did the FDA get this right? Send your thoughts to sgolden@bevnet.com.

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