The FDA has proposed a new definition of healthy and related terms for the purpose of food labeling. The current definition became effective in 1994 and focuses on limited levels of total fat, saturated fat, cholesterol, and sodium to establish a food as “healthy”. Under this rule unprocessed nuts, seeds, and avocados did not qualify as healthy. In March 2015 Kind, LLC received a warning letter from FDA regarding various nutrient content claims on their nut bar labels, including healthy claims. In May of the same year, Kind submitted a Citizen Petition to FDA requesting an update to the definition of healthy that would consider the Dietary Guidelines for Americans , which recommended then and continue to recommend consumption of whole foods, including nuts, major components of Kind products. In May of 2016, FDA announced a policy of enforcement discretion for “healthy” claims. In 2017 FDA held a hearing on use of the term healthy in food labeling.
Now, in 2022, FDA has issued a proposed rule to redefine healthy “to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans.” As noted previously, the current definition of healthy from 1994 only considers the level of specific nutrients; total fat, saturated fat, cholesterol, and sodium in the evaluation of healthy claim eligibility. The newly-proposed rule still considers levels of saturated fat and sodium for processed food products. Added sugars levels are new to the list of nutrients to consider before a “healthy” claim can be made. There are also two entirely new provisions regarding use of a healthy claim:
- Use of the term ‘healthy’ is permitted on all unprocessed fruits, vegetables, nuts and seeds.
- Plain water and plain carbonated water may also be labeled as “healthy”.
Interestingly, FDA has included “plant-based milk alternatives and plant-based yogurt alternatives” in the dairy group and will allow those products to be evaluated against the dairy criteria for the purposes of the ‘‘healthy’’ nutrient content claim. Plant based milk and yogurt alternatives could be eligible to bear a “healthy” claim if their ‘overall nutritional content is similar to dairy (e.g., provide similar amounts of protein, calcium, potassium, magnesium, vitamin D, and vitamin A). Unfortunately, whole milk and other full fat dairy products still are not eligible for healthy claims.
Criteria for claim evaluation:
The proposed rule includes several tables defining products that are eligible to be labeled as ‘healthy’. Of particular note are the following:
TABLE 1—FOOD GROUP EQUIVALENTS
| Food group and/or subgroup | Food group equivalent |
|---|---|
| Vegetables
Fruit |
|
| Grains | |
| Dairy | |
| Protein Food | Game Meats 1.5 oz equivalent
Seafood 1 oz equivalent Egg 1 oz equivalent Beans, peas, and soy products 1 oz equivalent Nuts and Seeds 1 oz equivalent |
Adapted from page 16 of the proposed rule
TABLE 2—ELIGIBLE PRODUCTS FOR ‘‘HEALTHY’’ NUTRIENT CONTENT CLAIM
| Product | Criteria for bearing ”healthy” claim |
|---|---|
| Raw, whole fruits and vegetables | No additional criteria; all raw, whole fruits and vegetables may bear the claim |
| Individual food products | At least 1 food group equivalent per RACC from 1 food group & Nutrients to limit* |
| Mixed Products | At least 1⁄2 food group equivalent each from at least 2 food groups, and Nutrients to limit* |
| Main dish per 21 CFR 101.13(m) | At least 1 food group equivalent each from at least 2 food groups, and Nutrients to limit* |
| Meal per 21 CFR 101.13(l) | At least 1 food group equivalent each from at least 3 food groups, and Nutrients to limit* |
| Water | Plain water and plain, carbonated water may bear the claim. |
| *Nutrients to limit: | Sodium, saturated fat, added sugars |
Adapted from page 17 of the proposed rule
Under the proposed rule some products that currently bear “healthy” claims will no longer be able to do so. Examples include several breakfast cereals that either do not include sufficient whole grains or that have disqualifying levels of added sugars. Many other products would become eligible for the claim if the proposed rule is enacted. Determination of eligibility for the claim will involve analysis of the levels of the food groups and the product nutrient breakdown. The proposed rule includes record-keeping requirements to support the claim and a two-year retention period for those records.
The proposed rule is subject to public comment as part of the rule making process. Comments submitted to FDA by December 28, 2022 will be considered when FDA drafts the final rule. FDA intends that any resulting final rule would become effective 60 days after the date of the final rule’s publication in the Federal Register with a compliance date 3 years after the effective date. Food companies should consider looking into the eligibility of their products for “healthy” claims and consider whether they can make logical arguments if they wish to object to portions of the proposed rule. We encourage food companies to review the provisions and make comments. Contact us with questions or for help with your comments.
