FDA Updates General Food Labeling Requirements Compliance Program – What it Means for Label Compliance
FDA Updates General Food Labeling Requirements Compliance Program – What it Means for Label Compliance
The U.S. Food and Drug Administration (FDA) announced on June 24, 2025, that it has updated Compliance Program 7321.005, now titled General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import. This update replaces the previous 2010 version of the program and reflects current labeling regulations, operational guidance, and enforcement priorities.
Read the full Food and Drug Administration Compliance Program Manual for Compliance Program 7321.005 here.
What the FDA has Announced / Finalized
1. Updated Definition of “Healthy” Nutrient Content Claim
On December 19, 2024, the FDA issued a final rule changing what foods may bear the label “healthy” (and related terms like “healthful,” “healthier,” etc.). The update was driven by newer nutrition science and is aligned with the Dietary Guidelines for Americans. Two main criteria are now required for a food to make the “healthy” claim: It must include a certain amount of food (or food group equivalent, like fruits, vegetables, dairy, protein foods, whole grains) from at least one of the recommended food groups. And it must meet specific limits for added sugars, saturated fat, and sodium. Some foods that previously didn’t qualify will now be able to use “healthy” (e.g. nuts, seeds, higher‑fat fish like salmon, some oils, water), assuming they meet the other requirements. In contrast, some foods that currently use “healthy” but are high in added sugars or outside the revised criteria (e.g. certain sweetened yogurts, cereals, fortified white bread, fruit snacks with lots of added sugar) may no longer qualify beginning in February 2028.
2. Uniform Compliance Date
For all final food‑labeling regulations published between January 1, 2025, and December 31, 2026, there will be a uniform compliance date of January 1, 2028. This helps companies by giving more lead time and letting them plan, use up old label inventory, etc.
3. Front‑of‑Package (FOP) Nutrition Label Proposed
The FDA has proposed a rule to require a “Nutrition Info Box” on the front of most packaged foods. This label would show amounts of saturated fat, sodium, and added sugars – nutrients that are linked to chronic disease risk. The goal is to make it easier for consumers to see at a glance how “healthy” or not a packaged food is. There is a comment period and study data backing this up: for example, in an FDA experimental study of nearly 10,000 U.S. adults, a black‑and‑white scheme with percent Daily Value performed best for helping consumers judge healthfulness. If the rule becomes final, the compliance timeline is:
- For businesses with ≥ $10 million annual food sales: three years after the final effective date.
- For smaller businesses (< $10 million): four years after that same date.
4. Synthetic (Petroleum‑based) Food Dyes Phase‑Out
In April 2025, the FDA announced its intention to phase out certain synthetic food dyes (like Red No. 40, Yellow No. 5, etc.) by end of 2026. The plan is to encourage voluntary cooperation from food manufacturers to replace these dyes with natural alternatives. The agency will also initiate the process of revoking authorization for some dyes that are not widely used (Citrus Red No. 2, Orange B).
Key Impacts & Timelines
- By February 25, 2028, manufacturers must comply with the new “healthy” claim definitions.
- By January 1, 2028, compliance for other final labeling requirements (those rules published in 2025‑2026) is expected.
- The FOP nutrition label is not yet final; there’s a rulemaking process (public comments, etc.).
What’s the goal?
These updates are intended to:
- Reflect current nutrition science and dietary guidance, which emphasize added sugars, saturated fat, sodium, dietary patterns, and food groups rather than just isolated nutrients.
- Make labeling clearer and more helpful to consumers, enabling quicker, better informed decisions at the point of purchase.
- Encourage the food industry to reformulate products (to lower added sugars, sodium etc.) so more products qualify under “healthy” or have better front‑of‑package labeling.
Now is the time to review your product labels, assess compliance risks, and plan for updates. Start preparing today to ensure your labels meet tomorrow’s standards. Contact us for your labeling needs.
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