FDA Under Trump Should Continue Streamlining Regulations for New Plant Varieties

The FDA plays a critical role in regulating genetically engineered crops through premarket review of New Plant Varieties (NPVs), ensuring food safety while supporting agricultural innovation. In 2024, FDA introduced Premarket Meetings, a faster review pathway for some gene-edited NPVs compared to the existing Premarket Consultation process. The six products that have utilized the Premarket Meeting pathway so far indicate that the new process is enabling a wider range of crop species from smaller developers to reach the market more efficiently. However, most NPVs still undergo lengthy and unpredictable reviews, often exceeding a year. This continues to particularly disadvantage smaller developers with limited resources.

Genetically engineered crops have historically contributed significantly to yield growth and farm income, while reducing pesticide use and environmental impact. To continue enabling these benefits, FDA’s regulatory process must be predictable and proportionate to risk. The agency could improve efficiency by clarifying submission requirements, making NPV reviews through the Premarket Consultation pathway a two-step process, limiting the NPV characteristics that trigger Premarket Consultations to only those associated with unreasonable risk, and ensuring the Human Foods program has adequate resources to conduct NPV reviews. Only more risk-based factors like the presence of toxins or allergens should guide FDA’s decisions rather than the type of genetic change.

FDA initiated Premarket Meetings under the Biden administration and the new process for review has remained in place since the start of the second Trump administration in 2025. By building on this progress to further optimize its review framework, FDA can accelerate the availability of beneficial products, ensure that small and large developers alike are able to contribute to advances in biotechnology, and keep American innovation onshore.