FDA Proposes Mandatory GRAS Notifications; Japan FFC Market Grows Despite Product Decline

The US Food and Drug Administration (FDA) has proposed a significant shift in its Generally Recognized as Safe (GRAS) system, moving from a voluntary notification process to a mandatory one. This change, part of a broader transparency and food safety initiative, will require manufacturers to formally notify the FDA of new GRAS determinations. While not a pre-market approval system, it aims to close critical information gaps, providing the FDA with greater visibility into substances entering the food supply chain. Industry groups have voiced concerns regarding increased regulatory burden, potential strain on agency resources, and the legal basis for such a mandate. However, proponents argue it enhances transparency while preserving the core self-affirmed GRAS pathway. The proposal is currently open for public comment, indicating an upcoming period of intense debate and potential revisions impacting ingredient innovation, particularly for dietary and probiotic ingredients.

Concurrently, Japan's Foods with Function Claims (FFC) market experienced robust growth, expanding by 4.1% to JPY773.5bn (US$4.9bn) in FY2025. This expansion occurred despite a notable 26% decline in new product notifications, totalling 1,176. The reduction in new launches follows stricter regulations implemented after the 2024 red yeast rice crisis, which mandated PRISMA 2020 compliance, Good Manufacturing Practices (GMP), and enhanced safety reporting. For the first time, product withdrawals (1,923) exceeded new notifications, as companies recalibrated their portfolios to meet stricter compliance standards. Growth was primarily driven by sustained consumer demand for functional foods, a rising interest in multi-benefit products, and the affordability of FFCs compared to more traditional Foods for Specified Health Uses (FOSHU) products. GABA remained the dominant ingredient, with fat reduction, fatigue relief, and gut health leading claim categories.

A notable market trend is the surging demand for hair growth supplements, correlated with the increased popularity of GLP-1 weight loss drugs. Data indicates a steep rise in online searches for hair growth products, escalating from 802,432 in Q3 2025 to 2.5 million in Q2 2026. This surge is attributed to concerns over hair loss, potentially linked to rapid weight loss and associated nutritional deficiencies rather than direct drug effects. While clinical evidence suggests a slightly elevated, temporary risk, the absolute risk remains low. Retailers are beginning to respond, with some expanding their hair growth product offerings, although most GLP-1-focused products currently lack specific hair health claims.

Separately, Verb Biotics announced positive results from a clinical trial on its oat-based postbiotic, Keystone. The randomised, double-blind, placebo-controlled study demonstrated that daily supplementation over four weeks enriched beneficial gut microbiota, reduced pro-inflammatory biomarkers, and improved emotional wellness in healthy adults. Mechanistic studies showed the postbiotic enhances gut barrier function and modulates immunity. This ingredient is positioned for precise, differentiated gut health support by strengthening keystone species rather than introducing new organisms, with 33 beneficial species, including Akkermansia and Bifidobacterium, enriched within four weeks.

What this means for United Kingdom

UK ingredient suppliers targeting the US market must prepare for heightened due diligence and potential regulatory delays under mandatory GRAS notifications, necessitating robust data packages and legal counsel. For brand owners, reformulating existing products or developing new FFCs could leverage Japan's robust market growth, focusing on proven claims like gut health or fatigue relief, aligning with FSA guidance on functional claims. The explosive demand for hair growth supplements, potentially linked to GLP-1 drug usage, presents a significant product development opportunity, requiring careful substantiation and market positioning for new SKUs. Manufacturers should assess MOQs and lead times for key ingredients, anticipating increased demand in these high-growth segments to maintain competitive advantage.

Brand owners increasingly rely on contract-manufacturing partners such as Supplement Factory to navigate these requirements.