Developments in Precision fermentation, GRAS regulation, and other FDA initiatives

In 2025, several animal-derived proteins produced via precision fermentation received FDA “no questions” letters, while discussions on GRAS oversight emerged.

Precision fermentation GRAS notifications

The FDA issued multiple “no questions” letters for animal proteins produced via precision fermentation, including: Vivici, Verley, and Shanghai Changing Biotechnology (bovine β-lactoglobulin); Turtle Tree (bovine lactoferrin); Geltor (chicken collagen); and Onego Bio (chicken ovalbumin). These notifications are a promising step toward market entry for alternative proteins and indicate the FDA has no further questions about the safety of the proteins for their intended uses.

GRAS reform initiatives

In parallel, the FDA advanced a proposed rule to tighten GRAS oversight. The rule, sent to the White House for final review, would make FDA notification mandatory for all GRAS substances, and clarify how FDA would determine a substance is not GRAS. The proposal effectively ends the self-affirmed GRAS pathway. Separately, the Better Food Disclosure Act of 2025, introduced in the Senate, would also mandate notification and public listing of all GRAS substances, and require companies to report existing GRAS substances within two years.

Other regulatory developments

·         In 2025, the FDA advanced tools and guidance to strengthen chemical and contaminant safety assessments. The Expanded Decision Tree screening tool provides a structured approach to evaluate potential food chemical toxicity, while the Chemical Contaminants Transparency Tool consolidates contaminant data across foods in a searchable format.

·         For color additives, the FDA authorized three new natural substances derived from minerals, algae, and flower petals, and removed the petroleum-based Orange B dye, reflecting an ongoing shift toward natural alternatives in the food supply.

·         Regulatory attention on ultra-processed foods (UPFs) intensified in 2025. A comprehensive Lancet study linked UPF consumption to damage across multiple organ systems, highlighting public health risks. California enacted AB 1264, defining UPFs in law and mandating phased reductions of high-risk products in schools by 2029. The FDA and USDA issued a joint Request for Information to develop a uniform federal UPF definition, and a bipartisan bill was introduced to require health warning labels on UPFs.

·         In the UK, the Food Standards Agency (FSA) launched a Precision Fermentation Business Support Service to guide companies in developing and submitting novel food applications, backed by £1.4 million in funding for innovation hubs.