FDA Update: The New "Healthy" Nutrient Content Claim
FDA REGULATION UPDATE: Use of the term “Healthy”
Author, Daniel Gastelu
On December 19, 2024 the U.S. Food and Drug Administration issued a final rule to update the “healthy” nutrient content claim. The term "healthy" is meant to guide consumers in identifying foods that serve as a foundation for a diet aligned with the Dietary Guidelines, supporting healthy eating patterns.
Food product companies can begin using the updated "healthy" claim criteria starting February 25, 2025, the effective date. Food companies have three years from this date (2/25/2025) to comply with the new requirements and adjust their labeling if necessary. Companies may adopt the new "healthy" labeling rules as early as the effective date.
The updated FDA rule for using “healthy” nutrient content claim on food labeling does apply to certain foods and beverages, and also dietary supplement products that meet all the requirements of the regulation. Some overview information is provided herein, with links to the final rule and FDA's website for details.
FDA’s Response to Comments Related to the Effective and Compliance Dates
(Response 134) The comments suggest there may be some confusion regarding the meaning of the effective date. The effective date is the date on which the Office of the Federal Register amends the Code of Federal Regulations in § 101.65(d) to reflect the new requirements for the “healthy” implied nutrient content claim as promulgated by this final rule. The effective date for this final rule is 60 days after the date of the final rule’s publication in the Federal Register. The compliance date, meaning the date on which we would begin enforcing the rule, is 3 years after the effective date.
As explained in the proposed rule, a compliance date that is 3 years after the effective date is intended to provide industry time to revise labeling to come into compliance with the new labeling requirements while balancing the need for consumers to have the information in a timely manner. However, although companies are not required to be in compliance with the new requirements for the “healthy” implied nutrient content claim until the date that is 3 years after the effective date, a company is free to choose to relabel in accordance with the new requirements sooner, as discussed further in section V.K (“Legal Comments”).
Regarding the comments requesting that we recognize the compliance date as applying to the date a product is labeled rather than the date it is introduced into interstate commerce, we agree. Compliance with the updated definition of “healthy” in § 101.65(d) will be assessed for products that are labeled, (i.e., when the label is placed on the product), with the “healthy” implied nutrient content claim on or after the compliance date (3 years after the effective date). We will not begin to enforce the updated final rule requirements before the compliance date. We evaluate the date the food product was labeled for purposes of determining whether the product must meet the updated requirements.
Further, as discussed in response to comment 161, manufacturers would not be required to comply with requirements of the final rule until the compliance date. Thus, once any new requirements for the definition of the nutrient content claim “healthy” are in effect, manufacturers could either comply with the new requirements or continue to use the original definition of “healthy” until the compliance date.
While the updated rule is just a few pages in length, the preamble of the prepublication version is over 300 pages in length, and includes background, insights and responses to 166 comments from the public and industry; required reading for food label experts and useful reading for others involved in food product communications.
Other recommended reading includes the previous rule and guidance document, and the preceding proposed rule of this final rule, along with FDA’s related web pages, infographics and fact sheets, provided at the end of this article.
For readers new to this topic, the “healthy” nutrient content claim is unique in comparison to other nutrient content claims in that it implies a positive health outcome, while in comparison, other nutrient content claims are related to the composition of food products and nutrient levels. For example, Free or Low or Reduced/Less related to calories, Total Fat, Saturated Fat, Cholesterol, Sodium, and Sugars; also High, Rich In, Excellent Source of, or High Potency to mention a few.
Here are some examples published by the FDA of what qualifies to use the “healthy” claim under the updated definition:
Nuts and seeds, olive oils, higher-fat fish, like salmon, and eggs would qualify as healthy because of their nutrient profile. Noting they didn’t qualify under the previous definition.
Water. While water isn’t part of a food group, it is considered an optimal beverage by the Dietary Guidelines.
Dietary supplements are not included in the examples where “healthy” is utilized.
Here are some examples published by the FDA of what no longer qualifies to use the “healthy” claim under the updated definition:
Fortified white bread, highly sweetened yogurt, highly sweetened cereal.
What Is Involved?
When reading the updated rule, including reference tables, determining the legal use of “healthy” in food labeling is a bit complicated when compared to other food label rules.
Some points include:
Some foods / beverages and dietary supplements permitted to use the healthy nutrient content claim only if they qualify by meeting the criteria detailed in the rule / regulation.
Food Group Equivalents (FGE).
Use of permitted derivative terms (see box about healthy).
Individual foods or mixed food products comprised of one or more of the permitted foods considered to be the foundation of a healthy dietary pattern, with no other added ingredients except for water.
Meeting the reference amount customarily consumed (RACC) requirement.
Written records to verify the food meets the food group equivalent requirements.
Record keeping for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce. Records must be available to FDA inspectors during inspections.
Not for use on food products used by children under 2 years of age.
Term “Healthy” and Derivative Terms from The Final FDA Rule
“(3) You may use the term “healthy” or derivative terms “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if the food meets the criteria of one or more of the following paragraphs (d)(3)(i) through (vi) of this section as follows: …”
Dietary Supplement Focus
Owing to dietary supplement products being a major category of nutraceuticals, it is interesting to include an excerpt from the final rule, Comment 48, concerning dietary supplements and FDA’s response. So here we go:
“(Comment 48) Some comments note that the Dietary Guidelines, 2020-2025 recognizes that dietary supplements are useful for individuals who cannot otherwise adequately obtain their nutrient needs or have different nutritional needs. The comments ask that FDA exempt dietary supplements from the “healthy” nutrient content claim requirements.
One commenter asserted that dietary supplements are outside the scope of the “healthy” implied nutrient content claim rule because, according to the comment, dietary supplements are, by definition, intended to supplement the diet and are not represented as conventional foods. The comment requests that if dietary supplements are not exempted from the “healthy” implied nutrient content claim criteria, then FDA either exercise enforcement discretion related to dietary supplements or establish parameters that would permit dietary supplements to bear the “healthy” claim. Another comment seeks clarification as to whether a dietary supplement that does not meet the “healthy” claim criteria may still bear the word “healthy” as part of a claim related to a products’ ability to maintain a healthy structure or function or an otherwise lawful dietary supplement claim.
(Response 48) The proposed rule did not exclude dietary supplements from our definition (87 FR 59168 at 59176). However, as explained in the proposed rule, current nutrition science reflects the view that “good nutrition does not come from intake of individual nutrients (as dietary supplements often provide) but rather from foods with their mix of various nutrients working together in combination” (id.). Consistent with this scientific understanding, the “healthy” claim is intended to highlight those foods that are particularly useful in constructing healthy dietary patterns, which includes food choices from across the different food groups, and we have included FGE requirements to update the claim definition to focus on such foods.
Because this is the intent of the claim, we decline to exempt dietary supplements from the “healthy” criteria. However, dietary supplements may bear nutrient content claims, including “healthy,” if they meet applicable criteria. Under some circumstances, a dietary supplement product may use the term “healthy” as part of a structure/function claim, without being subject to the requirements of the “healthy” nutrient content claim (see Response 123).”
To provide additional information regarding potential to use the Healthy nutrient content claim on dietary supplement labeling, the FDA was contacted and the following response was provided from a FDA spokesperson / official: "Dietary supplements are regulated by the FDA as food. The composition of dietary supplement products varies. Some are in pill form, while others have characteristics of conventional foods. As noted in Response 48 of the final rule, dietary supplements are not exempt from the "healthy" criteria (i.e., they have to meet the applicable criteria to bear the claim). Dietary supplement products could bear the "healthy" nutrient content claim if they meet all of the requirements of the regulation (e.g., meet the food group equivalent and nutrient limits criteria). Further, as explained in the final rule, some dietary supplements could use the term "healthy" as part of a structure/function claim that does not suggest that a food, because of its nutrient content, contributes to a healthy dietary pattern."
In Summary
It is clear that health benefits for customers and business benefits for food companies can be experienced when using the “healthy” nutrient contain claim. To assist with this unique food labelling option, the FDA is in the process of developing a “healthy” symbol to use on food labeling, coming soon. An FDA article notes that: “Having a standardized graphic to show that a food meets the criteria for the “healthy” claim would further support the FDA’s goal of helping consumers to identify food products that can be the foundation of healthy eating patterns.” FDA is also developing an updated guidance document and education materials for food companies and for consumers, with some already published, refer to the infographics and fact sheets herein.
Useful Links:
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
DATES: This rule is effective February 25, 2025. The compliance date of this final rule is February 25, 2028.
FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” Final Rule
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” Proposed Rule
Use of the Term Healthy on Food Labeling FDA Article
FDA Published Infographics and Fact Sheets
ABOUT THE AUTHOR
Daniel Gastelu, Founder and president, Health Products Business Success LLC & SUPPLEMENTFACTS International LLC
Daniel Gastelu, MS, MFS, ISSA Certified Specialist in performance, sports, fitness and weight loss nutrition, is founder and president of Health Products Business Success LLC. Health Products Business Success is a multi-service consulting company focused on product development, scientific affairs, regulatory compliance, claims substantiation, business development, sustainability and marketing. He also is founder and president of SUPPLEMENTFACTS International LLC, specializing in research and writing about the science and business of nutraceuticals, other health products and health and fitness topics. As a health product industry expert since the 1980s he has been involved in making and marketing thousands of nutrition products / nutraceuticals and other regulated health products. Additionally, Daniel has served as an International Sports Sciences Association (ISSA) Professor and Director of Nutritional Sciences (Emeritus).
He can be contacted at contact@hpbsllc.com or (973) 729-2240
