FDA Updates Food Labeling Compliance Program: What Manufacturers Need to Know
The U.S. Food and Drug Administration (FDA) has released major revisions to its Compliance Program 7321.005, now titled “General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import.”
This update, issued on June 24 2025, replaces the previous 2010 version and marks a significant shift in how the FDA monitors, enforces, and interprets food labeling compliance for both U.S.-made and imported products.
At Cosmereg, we help food, supplement, and beverage companies stay compliant with every new regulatory requirement — from label reviews to FDA facility and importer registration. Here’s what these latest changes mean for your business.
1. Updated Definition of the “Healthy” Nutrient Content Claim
The FDA finalized a new definition for the “healthy” claim on December 19 2024, modernizing how brands can market the nutritional value of their foods.
Under the new rule, a food may only bear the “healthy” or related claims (“healthier,” “healthful”) if it:
- Contains a qualifying amount of one or more food groups recommended in the Dietary Guidelines for Americans (such as fruits, vegetables, whole grains, dairy, or protein foods); and
- Meets strict limits for added sugars, saturated fat, and sodium.
This update aligns FDA policy with current nutrition science and consumer expectations. Foods like nuts, seeds, olive oil, and salmon — once excluded — may now qualify as “healthy,” while others high in added sugars (e.g., sweetened yogurts or cereals) may lose eligibility.
Compliance deadline: February 25 2028.
Companies should begin label and formulation reviews now to meet the new nutrient thresholds.
2. Uniform FDA Food Labeling Compliance Date for New Labeling Rules
To streamline industry planning, the FDA has set a uniform compliance date of January 1 2028 for all final food-labeling regulations published between January 1 2025 and December 31 2026.
This gives manufacturers additional time to:
- Update labeling systems and artwork;
- Use up existing packaging inventory; and
- Implement consistent changes across product lines.
Key takeaway: Align all upcoming label updates — including the new “healthy” claim — to the January 2028 deadline wherever possible.
3. Front-of-Package (FOP) Nutrition Info Box – Proposed Rule
To improve transparency, the FDA has proposed a Front-of-Package (FOP) Nutrition Information Box highlighting critical nutrients such as saturated fat, sodium, and added sugars.
The proposed design, supported by consumer studies involving nearly 10,000 U.S. adults, uses a black-and-white format showing Percent Daily Values (%DV) — proven most effective for helping shoppers assess product healthfulness at a glance.
If adopted, the implementation timeline will be:
- Large manufacturers (≥ $10 million in annual food sales): 3 years after the final rule’s effective date;
- Small businesses (< $10 million): 4 years after the same date.
Status: Proposed rule under review — not yet mandatory.
4. Phasing Out Synthetic (Petroleum-Based) Food Dyes
In April 2025, the FDA announced a plan to phase out certain petroleum-based synthetic dyes (such as Red No. 40, Yellow No. 5, and Blue No. 1) by the end of 2026.
The agency is encouraging a voluntary transition toward natural coloring alternatives and will begin revoking authorization for lesser-used dyes (e.g., Citrus Red No. 2, Orange B).
Implication for manufacturers: Begin identifying natural or compliant color substitutes now to avoid reformulation delays.
5. Compliance Timeline Overview
| Regulatory Area | Requirement | Deadline |
|---|---|---|
| “Healthy” nutrient content claim | New definition applies | Feb 25 2028 |
| Uniform labeling compliance | For all FDA food-labeling rules (2025-2026) | Jan 1 2028 |
| Synthetic dye phase-out | Voluntary transition encouraged | End of 2026 |
| Front-of-Package label | Proposed – pending final rule | TBD (3–4 years post-final) |
6. What Food Companies Should Do Now about FDA Food Labeling Compliance
To ensure smooth transition and compliance readiness:
- Review all labeling content — especially nutrient content claims and ingredient statements.
- Reformulate where necessary to reduce added sugars, sodium, and saturated fat.
- Monitor FDA rulemaking on the Front-of-Package proposal and dye authorization updates.
- Document compliance plans for the January 2028 deadlines to demonstrate due diligence during inspections.
At Cosmereg, our regulatory experts can help your team:
- Perform full FDA labeling reviews and nutrient content claim assessments;
- Update labels and Nutrition Facts Panels according to the new “healthy” definition;
- Assist importers and manufacturers with registration and facility compliance under FDA oversight.
Conclusion
The FDA’s 2025 updates mark the most comprehensive food labeling reform in over a decade.
By aligning with Compliance Program 7321.005 and preparing for upcoming enforcement deadlines, food manufacturers and importers can strengthen brand credibility, minimize regulatory risk, and ensure continued market access in the United States.
Stay compliant with confidence — contact Cosmereg today for expert guidance on FDA food labeling compliance and upcoming 2028 deadlines.
