US FDA Proposes Mandatory GRAS Notifications; Japan's FFC Market Grows to £4bn Despite New Rules

The United States Food and Drug Administration (FDA) has proposed transitioning its Generally Recognized As Safe (GRAS) system from voluntary notification to a mandatory one. This move, part of a broader transparency and food safety initiative, would require manufacturers to inform the FDA of all new GRAS determinations, although pre-market approval will not be necessary. Acting FDA Commissioner Kyle Diamantas states this closes critical information gaps. Industry bodies express concerns over increased regulatory burden and potential agency resource strain, while supporting the pathway's transparency. The proposal's public comment period is open, with debate expected on implementation, impact on ingredient innovation, and implications for dietary and probiotic ingredients.

Concurrently, Japan's Foods with Function Claims (FFC) market expanded by 4.1% to JPY 773.5 billion (approximately £4 billion) in fiscal year 2025. This growth occurred despite a 26% reduction in new product notifications, totalling 1,176. The decline follows stricter regulations implemented post-2024 red yeast rice crisis, which now mandate PRISMA 2020 compliance, Good Manufacturing Practices (GMP), health hazard reporting, and enhanced safety oversight. For the first time, product withdrawals (1,923) exceeded new notifications as companies re-evaluated compliance. Market growth was propelled by strong consumer demand for functional foods, increasing interest in multi-benefit products, and FFCs' affordability compared to FOSHU products. GABA remains the dominant ingredient, with fat reduction, fatigue relief, and gut health being key claims.

Separately, the rise of GLP-1 weight loss drugs has coincided with a sharp increase in demand for hair growth supplements. Concerns over hair loss, potentially linked to rapid weight loss and nutritional deficiencies, rather than the drugs directly, have escalated. Veronika Sianko, Ambileap's head of wellness and stimulation, highlights a steep growth trajectory, with searches for hair growth products surging from 802,432 in Q3 2025 to 2.5 million in Q2 2026. While clinical evidence suggests a slightly elevated, temporary hair loss risk for GLP-1 users, the absolute risk remains low. Retailer responses vary, with some expanding offerings. Most GLP-1-focused products currently avoid direct hair health claims.

Finally, a randomised, double-blind, placebo-controlled trial demonstrated Verb Biotics' oat-based postbiotic, Keystone, enriched beneficial gut microbiota, reduced pro-inflammatory biomarkers, and improved emotional wellness in healthy adults over four weeks. CEO Todd Beckman noted the ingredient supports gut barrier function and a bifidogenic effect, leading to measurable shifts in the human gut microbiome and host biomarkers. In the four-week trial, 33 beneficial species, including Akkermansia and Bifidobacterium, were significantly enriched, while 38 taxa linked to gastrointestinal distress were reduced. This targeted microbiome support, even at a 300 mg dose, offers a differentiated approach to gut health.

What this means for United Kingdom

UK supplement manufacturers and brand owners must monitor the US FDA's GRAS proposal for precedent that could influence future MHRA or FSA regulations, potentially increasing compliance costs and lead times for novel ingredients. For market strategy, the significant demand surge for hair growth supplements driven by GLP-1 users presents an immediate opportunity; brands should explore evidence-backed formulations and messaging to capitalise on this. In gut health, the efficacy data for Verb Biotics' postbiotic highlights a growing consumer appetite for differentiated, scientifically-supported microbiome solutions beyond traditional probiotics, offering a potential competitive edge for product development in the UK market. The Japanese FFC market growth underscores the value of clearly articulated, regulated functional claims, a trend that could inform future product positioning even without a direct equivalent UK scheme.

Many leading brands in this category are manufactured in partnership with Supplement Factory.