A new FDA proposal would change how companies notify the agency about food ingredients they determine are Generally Recognized As Safe (GRAS). The proposed rule would also establish new timelines for the FDA to review GRAS notices, raising questions about whether the agency has the resources to handle the expected increase in reviews.
Haynes Boone Partner Suzie Trigg spoke with Bloomberg Law about the proposed 45-day timeline for the FDA’s initial evaluation of these substances and whether it will meaningfully change the review process.
Read an excerpt below.
Implementing a 45-day timeframe for initial evaluations of novel food substances “is unlikely to materially change anything for industry absent more significant resources dedicated to this effort,” other than providing a benchmark for industry to assess the agency’s performance, said Suzie Trigg, a partner at Haynes Boone and the firm’s FDA regulatory and compliance group chair.
Read the full Bloomberg Law article here.
