Biotechnology Guidance Documents & Regulatory Information

Guidance documents contain nonbinding recommendations.

For additional information, see the Food from New Plant Varieties section.

Guidance for Industry

• Guidance for Industry: Foods Derived from Plants Produced Using Genome Editing
• Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
• Guidance on Consultation Procedures under FDA's 1992 Statement of Policy - Foods Derived from New Plant Varieties
• Providing Regulatory Submissions to OFAS: Centralized Online Submission Module (COSM)​
• Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon
• Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants

Regulatory Information

• Premarket Notice Concerning Bioengineered Foods
• New Plant Variety Regulatory Information
• Statement of Policy on Foods Derived from New Plant Varieties
• Letter to Industry on the Food Safety Risks of Transferring Genes for Proteins that are Food Allergens to New Plant Varieties Used for Food (April 2023)