On September 4, 2025, the U.S. Food and Drug Administration (FDA) published its Unified Regulatory Agenda, a key planning document that outlines the Agency’s top priorities over the coming year. Among the many proposed and final rules, three initiatives stand out for their potential to significantly impact food and dietary supplement regulation: a proposed rule to mandate GRAS (Generally Recognized As Safe) notifications, a final front-of-package (FOP) nutrition labelling rule, and a reclassification proposal for a dietary supplement ingredient that was previously excluded from lawful marketing.
Although these initiatives are U.S.-specific, they also have important implications for Canadian companies that manufacture, export, or distribute products into the United States. Together, the published plans reflect a clear shift toward greater regulatory oversight, increased transparency, and stronger alignment with principles already familiar to Canadian stakeholders. However, the implementation details and compliance expectations differ significantly between the two countries.
Below is an overview of what each regulatory initiative entails, where the U.S. currently stands, and how these efforts compare to Canada’s existing frameworks.
FDA Targets the End of Self-Affirmed GRAS Status
Under the current U.S. regulatory framework, firms may independently conclude that a substance is Generally Recognized As Safe (GRAS) based on either a history of safe use in food prior to 1958 or consensus among qualified scientific experts. While the U.S. Food and Drug Administration (FDA) maintains a voluntary GRAS notification program, there is presently no legal requirement for firms to submit self-affirmed GRAS determinations for FDA review or concurrence. This approach has been criticized by public health stakeholders and legislators for lacking regulatory oversight, transparency, and a formal mechanism for Agency evaluation.
According to the FDA’s Unified Regulatory Agenda, the Agency intends to issue a proposed rule in October 2025 to amend 21 CFR Parts 170 and 570. The proposed amendments would remove the self-affirmation pathway for new GRAS determinations and mandate the submission of GRAS notices for FDA review and response prior to market entry. Substances that are the subject of an existing GRAS regulation or that have previously received a “no questions” letter from the FDA would be exempt from this requirement. The proposed rule would also establish a publicly accessible GRAS notice inventory and formalize procedures for the Agency to determine when a substance does not meet GRAS criteria.
The proposed rule follows earlier direction from Congress, which asked the FDA to revise the GRAS framework and related guidance to eliminate the self-affirmed route. If implemented, this change would increase the level of regulatory oversight and create a more structured, enforceable process for ingredient approval.
In contrast, Canada does not have a GRAS system but follows a comparable approach. Any new or novel ingredients that were not widely consumed before May 1997 must undergo a mandatory pre-market safety assessment under Health Canada’s Novel Foods program. Unlike the GRAS framework, all novel substances in Canada must be evaluated and authorized before entering the market to confirm they have a history of safe use in their intended form, preparation, and applicable limits. This assessment process is fully formalized, with no option for voluntary notification or self-affirmation, which makes Canada’s system more rigorous and precautionary.
For Canadian companies exporting to the United States, the proposed U.S. shift toward mandatory GRAS notifications may introduce additional regulatory steps. However, it would also help align the two systems more closely. Businesses already meeting Canada’s mandatory assessment requirements may be better positioned to adapt quickly to the FDA’s forthcoming expectations once the rule is finalized.
Front-of-Package Nutrition Labelling Nears Finalization
Another major priority in the Unified Agenda is the FDA’s proposed front-of-package (FOP) nutrition labelling rule. First published in January 2025, this rule would require a standardized Nutrition Info box on the principal display panel of most packaged foods. The box would display interpretive indicators showing whether the levels of saturated fat, sodium, and added sugars are low, medium, or high, alongside their corresponding percent Daily Value.
This initiative forms part of the FDA’s broader efforts to help consumers make healthier dietary choices. By moving key nutrition information to the front of packages, the rule is intended to improve visibility and support informed decision-making at the point of purchase. It would serve as supplementary guidance to help consumers better understand the nutritional value of foods and alert them when a product is high in any of the three targeted nutrients.
After an extended public comment period that closed in July 2025, the FDA reported receiving more than 13,000 submissions. The Agency currently expects to publish the final rule in May 2026, although this timeline could shift depending on internal review processes.
Canada is already ahead in this area. In July 2022, Health Canada finalized regulations requiring a front-of-package nutrition symbol on prepackaged foods high in saturated fat, sodium, or sugars. The symbol must appear when a product exceeds the established thresholds for any of these nutrients and takes the form of a standardized bilingual magnifying glass icon. The transition period ends on December 31, 2025, and enforcement will begin on January 1, 2026.
Although both the U.S. and Canadian frameworks target the same nutrients, their design and implementation differ. Canada uses a binary visual cue that appears only when a product is “high in” one of the nutrients. The U.S. proposal adopts a tiered interpretive system that shows relative levels of each nutrient. Canadian companies selling products in both markets will need to account for these differences and prepare for two separate compliance pathways, even if their nutritional formulations remain unchanged.
Reopening the Door for Previously Excluded Dietary Ingredients
The final initiative involves a forthcoming proposed rule that would reclassify a currently excluded substance as a dietary ingredient, thereby permitting its lawful marketing as a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA), provided all other statutory and regulatory requirements are met. Although the U.S. Food and Drug Administration (FDA) has not specified the ingredient, industry stakeholders have noted that the initiative is likely intended to address nicotinamide mononucleotide (NMN), a substance commonly used in products marketed for anti-ageing and energy support.
In 2022, the FDA determined that NMN was excluded from the dietary supplement definition pursuant to section 201(ff)(3)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), on the basis that it had been the subject of an Investigational New Drug (IND) application prior to being marketed as a dietary supplement. This determination resulted in warning letters to firms marketing NMN-containing supplements and prompted multiple citizen petitions requesting that the Agency reverse its position and clarify the regulatory status of NMN.
The FDA’s Unified Agenda suggests that a proposed rule will be published in January 2026, which would clarify that the ingredient is not excluded from the dietary supplement definition. This change would allow it to be legally marketed as a supplement, provided it meets all other regulatory requirements, such as proper labelling, adherence to good manufacturing practices, and submission of a New Dietary Ingredient (NDI) notification where applicable.
In Canada, NMN and similar compounds fall under the Natural Health Products (NHP) framework. To be sold legally, the product must undergo a premarket review by the Natural and Non-prescription Health Products Directorate (NNHPD). This includes submitting safety and efficacy evidence and receiving a product licence number (NPN). Unlike the U.S., Canada does not automatically exclude ingredients based on their drug status, unless they are listed on the Prescription Drug List or Schedule F.
While the FDA’s approach may allow for faster market re-entry of NMN and other contested compounds, Canada’s licensing system offers a more standardized pathway for approval. Companies working in both countries must remain aware of these procedural differences to ensure regulatory compliance in each market.
Final Remarks
The U.S. Food and Drug Administration (FDA)’s Fall 2025 Unified Regulatory Agenda reflects a shift toward stronger oversight and transparency in the regulation of food ingredients and dietary supplements. The move to mandate GRAS notifications, introduce front-of-package (FOP) nutrition labelling, and potentially reclassify previously excluded dietary ingredients indicates the Agency’s intent to tighten pre-market controls and create clearer, more enforceable regulatory pathways.
For Canadian companies exporting to the U.S., these changes may introduce new compliance requirements but also offer alignment with the structured pre-market frameworks already in place under Health Canada. Companies should begin assessing their ingredient documentation, labelling strategies, and product portfolios to prepare for upcoming U.S. requirements and minimize potential disruptions once these rules are finalized.
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FAQ
What is self-affirmed GRAS and how would the FDA’s proposal change it?
Self-affirmed GRAS is a process in the United States where companies determine on their own, based on expert consensus, that an ingredient is Generally Recognized As Safe without submitting documentation to the FDA. The FDA’s proposed rule, expected in October 2025, would require mandatory submission of GRAS notices for new substances, exempting only those that already have a GRAS regulation or a “no questions” letter, and would establish a public GRAS inventory.
How would the proposed GRAS changes affect Canadian companies exporting to the U.S.?
Canadian companies exporting to the U.S. may need to submit GRAS notices for ingredients previously marketed under the self-affirmed route if the proposal is finalized. Companies that already conduct Health Canada Novel Food assessments may have data that could support these submissions, but additional documentation or safety evidence could be required depending on FDA criteria.
What would the proposed U.S. FOP rule require, and how does it differ from Canada’s?
The proposed U.S. FOP rule would require a standardized Nutrition Info box on the front of most packaged foods showing whether levels of saturated fat, sodium, and added sugars are low, medium, or high, along with their percent Daily Value. Canada’s finalized FOP regulations, which will be enforced starting January 1, 2026, use a bilingual magnifying glass symbol to indicate when a product is “high in” any of these nutrients, rather than providing tiered levels.
What is the dietary ingredient reclassification proposal, and why is NMN relevant?
The FDA plans to publish a proposed rule in January 2026 to clarify that a specific ingredient is not excluded from the dietary supplement definition, which could allow it to be marketed as a dietary supplement if all other requirements are met. Industry stakeholders have noted that this may involve nicotinamide mononucleotide (NMN), which is currently excluded in the U.S. but would require premarket licensing as a Natural Health Product (NHP) in Canada.
What are the main uncertainties associated with these proposed changes?
Uncertainties include the final timelines for publication and enforcement, the scope of substances that will be affected, the data requirements for GRAS submissions, and whether transitional provisions will apply to previously self-affirmed GRAS ingredients. The FDA has not yet released the draft rule text, so the specific implementation details remain unknown.
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