FDA’s Chemistry Guidance Update Not Expected in 2025

The U.S. Food and Drug Administration’s (FDA) Human Foods Program Guidance Agenda for 2025 does not include an updated version of the Agency’s Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations) (Chemistry Guidance). The Chemistry Guidance, which has not been substantially updated since 2007, was first added to FDA’s Guidance Agenda in 2022 (more information on the 2022 list can be found here). It also appeared on FDA’s 2023 and 2024 Program Guidance Agendas.

The revised Chemistry Guidance is anticipated to include several significant updates, including new recommended packaging factors used to estimate exposure to food contact substances (FCSs), such as consumption factors (CFs) and food type distribution factors (fTs). During a June 8, 2022, presentation before the PLASTICS Industry Association, Dr. Allan Bailey, then Chief of FDA’s Chemistry Review Branch in the Division of Food Contact Substances (DFCS), said that the revised packaging factors, when completed, would be incorporated into FDA’s Chemistry Guidance. (More information on that presentation can be found here.)

Because the update to FDA’s Chemistry Guidance appears to have been temporarily shelved, the 2007 edition of the Chemistry Guidance will remain effective for the foreseeable future.