On September 29, FDA released a long-awaited revision to the definition for “healthy” claims. Hot off the press, we took a deep dive into the proposed rule so we could summarize it for you here. Here are the key points of the revised definition:

• Criteria are based on encouraging nutrient dense foods and healthy dietary patterns (as outlined in the Dietary Guidelines for Americans), rather than individual nutrient levels in foods
• Requires certain amounts of foods (the “food group equivalent”) from each food group, rather than requiring minimum amounts of recommended nutrients
• Includes upper limits for saturated fat, sodium, and added sugars content

Under the proposed rule, eligible products for the “healthy” claim include:

• All raw, whole fruits and vegetables
• Individual foods from food groups recommended in the Dietary Guidelines: vegetables, fruits, whole grains, low-fat dairy, protein foods, plus oils
• Combination foods 
  • Mixed products containing at least ½ a food group equivalent from 2 or more food groups
    Example: granola bar with ½ whole grains and ½ nuts
  • Main dish products containing at least 1 food group equivalent from 2 or more food groups
    Example: vegetable lasagna made with whole wheat pasta
  • Meal products containing at least 1 food group equivalent from 3 or more food groups
    Example: salmon fillet with brown rice and green beans
• Plain water and plain, carbonated water

The revised definition for “healthy” also includes nutrients to limit: saturated fat, sodium, and added sugars. The proposed rule defines upper limits specific to each food group, recognizing that some foods containing higher levels of these three nutrients may be nutrient dense and still support a healthy diet. Food groups that don’t inherently contain saturated fat, sodium, or added sugars are assigned lower limits to discourage manufacturers from unnecessarily adding these nutrients to their foods. For example, the saturated fat limit for low-fat dairy is higher than the limit for fruits and vegetables.

The limits apply to both individual and combination foods and are adjusted based on combined food group scenarios. For example, a mixed granola bar product with whole grains and nuts would use the average limits for grains plus nuts, while a main dish cheese quesadilla would use the combined limits for dairy and grains.

The proposed rule also adds recordkeeping requirements for “healthy” claims. Recordkeeping will be required when it’s not apparent if a food meets the criteria for food group equivalents simply by reading the label. For example, a multigrain bread containing both whole wheat and refined flours would require recordkeeping, whereas a 100% whole wheat bread would not require recordkeeping. Manufacturers can choose the type of records they maintain, which may include recipe formulations, database analysis results, or other verification documents.

The proposed rule is now open for a 90-day comment period. Once the comment period concludes, FDA will review the comments and may open a second comment period or publish the final requirements. At this time, no immediate action is required for existing products labeled as “healthy.” Manufacturers looking to make healthy claims based on the new criteria should wait until the rule is finalized, as the requirements are likely to change (at least somewhat) between now and then. As always, we’ll be sure to keep you updated as the rulemaking process continues.

September was a full and exciting month for Food Label Insiders! We welcomed new members to the community and hosted two Office Hours sessions. The first was a “sneak peek” session for prospective members, followed by our monthly session with current members. Within our community, we've been busy discussing the proposed changes to “healthy” claims and addressing other questions that arise in our day-to-day work as food labelers.

We're looking forward to our next Office Hours session with special guest Pooja Nair, Food and Beverage Attorney and Partner at Ervin Cohen & Jessup LLP. 

As we get to know our newest members, enrollment for our membership community is currently closed. If you’re interested in joining in the future, we invite you to sign up for our waitlist.