/>i- On June 30, 2025, FDA’s Human Foods Program published its proposed 2025 guidance agenda, including the Agency’s priority topics for new or revised guidance documents, as we previously blogged. As a recent article discusses, the agenda’s publication comes amid heightened scrutiny on food ingredients, particularly petroleum-based synthetic dyes and transparency concerns. Regardless, the agenda is “a strong signal to industry stakeholders of the FDA’s strategy.” Overall, the topics presented in the agenda reflect public and political pressure for FDA to modernize food and beverage industry oversight.
- Industry response to the agenda, as well as other recent FDA regulatory proposals, has been mixed. Some stakeholders welcome the Agency’s “proactive stance on chemical safety,” especially in light of years of concern about processes for substances that are generally recognized as safe (GRAS). Meanwhile, others are concerned that “the weight of focus given to synthetic dyes and post-market chemical assessments . . . could divert resources from more urgent issues like food insecurity and nutrition labeling.” Following FDA’s recent effort to phase out certain food colors, some companies have moved to reformulate their products, while others are “questioning the science behind the decision.”
- Congress is also increasing pressure on FDA to tighten food chemical oversight. Two recent bills aim to reform the GRAS process:
- The Ensuring Safe and Toxic-Free Foods Act, introduced by Sens. Edward Markey and Cory Booker, would require FDA review and public comment on all GRAS determinations, as well as require FDA to reassess the safety of at least 10 substances or substance classes every three years.
- In addition, the Food Chemical Reassessment Act, introduced by Reps. Jan Schakowsky and Rosa DeLauro, would also require reassessment of at least 10 substances every three years, starting with Tert-butylhydroquinone, titanium dioxide, red dye 40, yellow dye 5, blue dyes 1 and 2, green dye 3, perchlorate, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), trichloroethylene, methylene chloride, benzene, ethylene chloride, propyl gallate, sodium nitrite, and sodium benzoate.
FDA Publishes 2025 Guidance Agenda
Thursday, August 7, 2025
Current Public Notices
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