FDA's New Year, New Rules: Labeling for Healthier Choices
Highlights
- As part of the Biden Administration's concluding acts, the U.S. Food and Drug Administration (FDA) has released a final rule to update the definition of "healthy" when used as an implied nutrient content claim in food labeling. The compliance date for the final rule is Feb. 25, 2028.
- The FDA also proposed a rule that mandates front-of-package nutrition labeling, for which stakeholders have until May 16, 2025, to submit comments.
- There also is an order revoking the authorized uses of FD&C Red No. 3 in food and ingested drugs. Manufacturers who use the ingredient in food and ingested drugs have until Jan. 15, 2027, or Jan. 18, 2028, respectively, to reformulate their products.
The U.S. Food and Drug Administration (FDA) is taking a stronger approach toward supporting health goals in 2025 and beyond by setting the tone and releasing a number of regulatory actions aimed at enhancing consumer health awareness and food safety, along with empowering consumers to make informed decisions.
Final Rule on Nutrient Content Claims and Definition of Term "Healthy"
On Dec. 27, 2024, the FDA published its long-awaited revisions to the "healthy" rule. This concluded a 30-year effort to update the standards for a "healthy" claim, which were first set in 1994. The final rule aligns the definition with current nutrition science and federal dietary guidelines, particularly the Dietary Guidelines for Americans, 2020-2025. It shifts focus from individual nutrients to food groups and nutrient density, emphasizing the importance of a consumer's overall dietary patterns. It also aims to help consumers identify foods that can serve as the foundation of a nutritious diet.
Under the new rule, foods must meet specific criteria for food group equivalents (FGEs) and nutrients to limit (NTL) to qualify as "healthy." Therefore, to qualify as a "healthy" claim, food products must contain a certain amount of fruits, vegetables, protein, dairy and grains. There are also new limitations to saturated fat, sodium and added sugars. Certain nutrient-dense foods, such as raw fruits and vegetables, automatically qualify for the claim without needing to meet all specified criteria, provided they contain no added ingredients except water.
The rule introduces significant changes in food classification compared to previous requirements. Some foods that were previously considered healthy, particularly in the dairy category or certain packaged foods high in added sugars, sodium or saturated fats, may no longer qualify under the final rule. Conversely, some foods that may not have qualified before, such as certain whole-grain products and plant-based foods, may now be eligible for the claim if they meet the updated FGE and NTL criteria.
Manufacturers have until Feb. 25, 2028, to comply with the new requirements. This three-year period offers industry time to assess current product lines to determine which items may need reformulation or relabeling.
The "healthy" rule reflects a broader understanding of nutrition science, focusing on dietary patterns and nutrient density rather than isolated nutrient content. The incoming Trump Administration, particularly U.S. Department of Health and Human Services (HHS) Secretary nominee Robert F. Kennedy Jr., has placed an emphasis on combating chronic disease through nutrition initiatives. It remains to be seen how the rule will be implemented and enforced.
Proposed Rule on Front-of-Package Labeling
On the heels of the "healthy" final rule, FDA has proposed a new rule that would require most packaged foods to display a standardized "Nutrition Info" box on the front of packaging. This concept, which was recently implemented in Canada, is also intended to highlight health risks associated with eating foods high in saturated fat, sodium and added sugars. This proposal is based on research showing that interpretive front-of-package nutrition labeling can help consumers, including those with lower nutrition literacy, more easily compare products and make healthier choices.
In addition to the new front-of-package labeling requirements, the proposed rule would update certain nutrient content claim regulations to align with current nutrition science.
The FDA is proposing a staggered compliance timeline for implementing the new labeling requirements. Larger businesses with $10 million or more in annual food sales would have three years after the final rule's effective date to comply. Smaller businesses with less than $10 million in annual food sales would have four years to comply.
The FDA is currently seeking public comment on this proposed rule through May 16, 2025.
Revocation of Red Dye No. 3
Lastly, and perhaps the "cherry on top," is the FDA's order to revoke the color additive listing for Red Dye No. 3 in food and ingested drugs and amending its color additive regulations. This order was prompted by the agency's decision to grant a color additive petition submitted in 2022 by the Center for Science in the Public Interest and other organizations. The petition argued that Red Dye No. 3 should be deemed unsafe due to its carcinogenic potential, as demonstrated in studies showing it induces cancer in male rats. Of note, the Delaney Clause, incorporated into the Federal Food, Drug, and Cosmetic Act by the Food Additives Amendment of 1958, requires the FDA to ban food additives that are found to cause or induce cancer in humans or animals as indicated by testing.
The order will take effect on Jan. 15, 2027. This date marks the point at which the FDA will no longer provide certificates for Red Dye No. 3, and any existing certificates for batches of the color additive will cease to be effective for use in food. For ingested drugs, the removal of the color additive listing will become effective on Jan. 18, 2028. Therefore, food and ingested drugs should not contain Red Dye No. 3 after the effective dates, and companies should consider reformulation to avoid market disruption. Upon the effective dates, any use of Red Dye No. 3 in food or ingested drugs will render such products "adulterated." The FDA has provided a process for filing objections to this order, which must be submitted no later than Feb. 18, 2025.
This action marks another area of alignment with the incoming Trump Administration's "Make America Healthy Again" approach. Kennedy has previously indicated that additives are an area he plans to target, and these regulatory updates could mark the beginning of a growing momentum at the agency.
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