Heads-up: Front-of-Pack labels, GRAS changes, and supplement definition update

FDA has signaled three significant rulemakings in the Unified Agenda that could affect food and dietary supplement companies. These are not official final rules—but they’re far enough along that your regulatory, R&D, and labeling teams may want to prepare.

1) Front-of-Package (FOP) Nutrition Labeling

FDA is advancing a framework that would require certain nutrition information on the front of food labels to help consumers make quick, informed choices. Timetable notes reflect the project moving toward a final rule stage following the January 16, 2025 NPRM (Notice of Proposed Rule Making). Implementation timing and specifics will determine label redesign scope, claim alignment, and artwork changeover.

What to do now:

• Map SKUs by label families to estimate changeover burden.
• Flag claims/attributes that could be affected by revised nutrient content criteria.
• Pre-plan artwork cycles and packaging inventory run-down.

Learn more: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&RIN=0910-AI80

2) Substances Generally Recognized as Safe (GRAS)

FDA is proposing to require mandatory submission of GRAS notices for human and animal food substances purported to be GRAS (with exemptions for substances already listed/affirmed by regulation or with prior “no questions” letters). The rule would clarify FDA’s public GRAS notice inventory and the process to determine when a substance is not GRAS. This is listed as Economically Significant with a target NPRM (Notice of Proposed Rule Making) in October 2025.

What to do now:

• Inventory all GRAS-positioned ingredients; confirm existing regulatory bases.
• Document safety dossiers and intended use conditions to streamline submissions.
• Identify suppliers that may need to coordinate on notice content.

Learn more: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&RIN=0910-AJ02

3) Dietary Supplement Definition—Ingredient Not Excluded

FDA indicates intent to issue a rulemaking that a specific ingredient is not excluded from the dietary supplement definition, allowing products containing that ingredient to be lawfully marketed as dietary supplements (if all other conditions are met). Target stage shows Proposed Rule, with an NPRM (Notice of Proposed Rule Making) targeted for January 2026.

What to do now:

• If you market supplements, evaluate portfolio scenarios contingent on this determination.
• Prepare parallel assessments for section 301(ll) considerations and labeling impacts.
• Coordinate with QA/RA on documentation in case of rapid pathway opening.

Learn more: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&RIN=0910-AI91

Important note: These items appear in the Unified Agenda and timelines can change. No official final actions have been issued yet.

If you’d like help assessing portfolio impact, label changeover planning, or GRAS notice strategies, contact EAS Consulting Group. We can run a tailored gap assessment and a phased implementation plan so you’re ready when specifics land.