Alternative Proteins

Keller and Heckman’s food attorneys counsel companies across the world on alternative proteins, including those that are plant-derived, fermentation-derived, and cell-cultured. We are well-versed in laws and regulations pertaining to regulatory approval and compliance issues for these alternative protein products and advise food manufacturers on the regulatory pathway to enter global markets as well as the labeling complexities involved with marketing these products. Our in-house scientists help clients review and identify the technical issues surrounding alternative protein products, including ensuring successful product approvals by providing practical technical solutions for the preparation of food applications, as well as responding to authorities’ questions. 

Keller and Heckman attorneys advise clients on product composition and the use of genetically modified microorganisms and enzymes, as well as on various labeling matters, including nutrition, allergen, claims, and statements. We conduct regulatory risk assessments and provide advice on import and export procedures, food safety, and other food regulatory matters to help companies minimize or eliminate the legal risks and achieve business success.

Representative Matters

• Submitted GRAS Notices to the U.S. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) for plant-derived and fermentation-derived proteins 
• Reviewed labels for clients to ensure that a defensible product identity statement is used and that the product is adequately described to avoid allegations that consumers are misled 
• Developed self-determined GRAS opinions for various alternative protein ingredients
• Helped clients determine if there is sufficient information in the published literature to reach a GRAS position or advised on what additional safety data needs to be generated and then published to support a GRAS position 
• Counseled clients on the regulatory paths of entering the markets in Asia Pacific for alternative protein products
• Advised on the development of regulatory strategies for genetically modified alternative protein products entering the Asian market 
• Prepared and submitted novel food applications for alternative protein manufacturers to obtain product approvals 
• Reviewed alternative protein product labeling and advertising statements in China and other markets in Asia 
• Advised on the legal status in the EU of a product made through microbial fermentation
• Counseled clients on labeling requirements in the EU for plant-based meat alternative products, particularly green claims, health claims, natural ingredient claims, legal product names, etc.
• Provided guidance to companies on EU approval processes for novel foods, food enzymes, and GMOs, while also providing strategic advice taking into account costs, timelines, and scientific data needed to build technical dossiers
• Helped in the safety assessment of a microalgae product by reviewing toxicological data, also taking into account the qualified presumption of safety (QPS) list by EFSA