Category: FDA

July 18, 2025

FDA Extends Comment Period on Method for Ranking Chemicals in Food for Post-Market Assessments

The U.S. Food and Drug Administration (FDA) announced on July 14, 2025, that it is extending the public comment period on its proposed method for ranking chemicals in the food supply by 30 days, to August 18, 2025. As reported in our July 8, 2025, blog item, FDA proposes to use Multi-Criteria Decision Analysis (MCDA) to determine a score for each chemical based on evaluating the information about a chemical against a pre-determined set of criteria. FDA notes that this method is similar in...
July 15, 2025

Recent Federal Developments for July 2025

Register Now For “Regulation Without Borders: The EUDR and the New Era of Global Due Diligence,” August 5, 2025, 10:00 a.m. – 11:15 a.m. (EDT): Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®); EPPA; and Preferred by Nature (PBN) are pleased to present “Regulation Without Borders: The EUDR and the New Era of Global Due Diligence,” a complimentary webinar providing a detailed exploration of the European Union Deforestation Regulation (EUDR) and how it applies to...
July 8, 2025

FDA Begins Public Comment Period on Method for Ranking Chemicals in Food for Post-Market Assessments 

The U.S. Food and Drug Administration (FDA) announced on June 18, 2025, the release of its proposed method for ranking chemicals in the food supply. According to the document, the systematic post-market assessment of food chemicals consists of the following steps: signal detection, triage, prioritization, scoping, scientific assessment (safety, risk, and/or hazard), risk management review, and risk management action. FDA states that it will publish a full description of the process later in 2025...
June 16, 2025

Recent Federal Developments for June 2025

Register Now For “TSCA Reform – Nine Years Later” Virtual Conference, 8:30 a.m. – 4:30 p.m. (EDT), June 25, 2025: Complimentary registration is now open for this dynamic virtual conference providing updates and insights regarding the current state of Toxic Substances Control Act (TSCA) implementation, ongoing and emerging issues, and related developments. As with our previous TSCA anniversary events, a stellar faculty of speakers from government, non-governmental organizations, industry,...
May 21, 2025

FDA Advances Post-Market Chemical Review Program

On May 15, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of “a stronger, more systematic review process for food chemicals already on the market -- especially those that concern consumers most.” Over the coming months, FDA will roll out the following key actions: A modernized, evidence-based prioritization scheme for reviewing existing chemicals. According to FDA, it will soon release a draft for public comment; A final, systematic post-market review process shaped...
April 15, 2025

Recent Federal Developments for April 15, 2025

Register Now For “PFAS Updates: What’s Happening in the U.S. and EU,” May 13, 2024, 11:00 a.m. – 12:00 p.m. (EDT), Via Webinar: Register now to join Bergeson & Campbell, P.C. (B&C®) affiliate The Acta Group (Acta®) and EPPA for “PFAS Updates: What’s Happening in the U.S. and EU,” a complimentary webinar offering expert updates on per- and polyfluoroalkyl substances (PFAS) regulatory developments. During this webinar, Meglena Mihova, Managing Partner, EPPA, and Richard E....
February 14, 2025

Recent Federal Developments for February 14, 2025

ABA And B&C Announce Release Of Chemical Product Law and Supply Chain Stewardship Book: Chemical Product Law and Supply Chain Stewardship, edited by Lynn L. Bergeson and published by the American Bar Association (ABA), provides a road map to navigate efficiently the transformational changes in chemical product law, identifies the practical business and product stewardship implications of the new normal in product regulation, and explains the urgent need for supply chain awareness so that the...
January 15, 2025

Recent Federal Developments for January 2025

2025 Forecast For U.S. Federal And International Chemical Regulatory Policy: On January 6, 2025, Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) published the “Forecast for U.S. Federal and International Chemical Regulatory Policy 2025.” This carefully curated document represents our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the New...
January 6, 2025

2025 Forecast for U.S. Federal and International Chemical Regulatory Policy

Bergeson & Campbell, P.C. (B&C®), its global consulting affiliate The Acta Group (Acta®), and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to share with you our 2025 Forecast. For all the reasons you might imagine, our seasoned team was especially challenged this year in speculating on what to expect in 2025 regarding global industrial, agricultural, and biocidal chemical regulatory and policy initiatives. Given the European Parliamentary...
December 13, 2024

OPPT Deputy Director Mark Hartman Will Become Director of FDA’s Office of Food Chemical Safety, Dietary Supplements, and Innovation

Mark Hartman, the highly respected Deputy Director for Programs in the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), will become Director of the U.S. Food and Drug Administration’s (FDA) Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI) in its newly formed Human Foods Program (HFP). According to FDA’s website, OFCSDSI “uses a risk-based approach to food chemical safety and dietary supplement policy and...
November 15, 2024

Recent Federal Developments for November, 2024

TSCA/FIFRA/TRI EPA Proposes To Add 16 PFAS And 15 PFAS Categories To The TRI List Of Chemicals: The U.S. Environmental Protection Agency (EPA) proposed on October 8, 2024, to add 16 individual per- and polyfluoroalkyl substances (PFAS) and 15 PFAS categories representing more than 100 individual PFAS to the Toxics Release Inventory (TRI) list of toxic chemicals subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA) to...
October 31, 2024

A Conversation with Deputy Commissioner Jim Jones

Download transcript. This week I had the pleasure of speaking with U.S. Food and Drug Administration (FDA) Deputy Commissioner for Human Foods, Jim Jones, about all the amazing initiatives Jim is overseeing as the first FDA Deputy Commissioner for Human Foods. Many of us in the chemical community know Jim and his extraordinary career at the U.S. Environmental Protection Agency (EPA) leading both the EPA pesticides and toxics program offices, culminating his EPA career as Assistant Administrator...
October 15, 2024

Recent Federal Developments for October 2024

TSCA/FIFRA/TRI White House OSTP Releases PFAS Federal R&D Strategic Plan:The White House Office of Science and Technology Policy (OSTP) announced on September 3, 2024, the release of its Per- and Polyfluoroalkyl Substances (PFAS) Federal Research and Development Strategic Plan (Strategic Plan). Prepared by the Joint Subcommittee on Environment, Innovation, and Public Health PFAS Strategy Team (PFAS ST) of the National Science and Technology Council, the Strategic Plan provides a federal...
September 16, 2024

Recent Federal Developments for September 2024

TSCA/FIFRA/TRI EPA Updates Safer Choice And DfE Standard: The U.S. Environmental Protection Agency (EPA) announced on August 8, 2024, the availability of the final updated Safer Choice and Design for the Environment (DfE) Standard (the Standard). 89 Fed. Reg. 64915. According to EPA, the update includes a name change to the title of the Standard, a revision to the packaging criteria, a new certification for cleaning service providers, a new provision allowing for preterm partnership termination...
September 6, 2024

House Subcommittee Will Hold Legislative Hearing on Evaluating FDA Human Foods and Tobacco Programs

On September 10, 2024, the House Energy and Commerce Subcommittee on Health will hold a legislative hearing on “Evaluating FDA Human Foods and Tobacco Programs.” According to the Committee’s September 3, 2024, hearing announcement, the hearing will give members a chance to hear from the head of the Human Foods Program, as well as the head of the Tobacco Center, to learn how the U.S. Food and Drug Administration (FDA) is “helping adult smokers quit, keeping illegal products away from...
August 27, 2024

PCRM NURA Program Will Hold Webinar Series on Human-Based Methods in FDA Submissions

The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program will hold a series of webinars on human-based methods in U.S. Food and Drug Administration (FDA) submissions. PCRM notes that traditionally, submissions have included data from animal studies, but industry has started submitting NAMs. According to PCRM, the use of NAMs in FDA submissions is expected to grow, as many toxicologists seek to use human-based...
August 22, 2024

FDA Posts Discussion Paper on Development of an Enhanced Systematic Process for Its Post-Market Assessment of Chemicals in Food; Comments Due December 6, 2024

As reported in our August 7, 2024, blog item, the U.S. Food and Drug Administration (FDA) announced on August 1, 2024, that it will hold a public meeting on September 25, 2024, on the development of an enhanced systematic process for its post-market assessment of chemicals in food. 89 Fed. Reg. 65633. FDA has posted a Discussion Paper Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food (Discussion Paper). The Discussion Paper “broadly...
August 15, 2024

Recent Federal Developments for August 2024

TSCA/FIFRA/TRI EPA Releases Draft Risk Evaluation For 1,1-Dichloroethane And Draft Hazard Assessment Of 1,2-Dichloroethane For Public Comment And Peer Review: On July 2, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of the draft risk evaluation for 1,1-dichloroethane (1,1-DCE) and the draft human health hazard assessment supporting the draft risk evaluation for 1,2-dichloroethane (1,2-DCE, also known as ethylene dichloride) prepared under the Toxic Substances Control...
August 7, 2024

FDA Will Hold Meeting in September 2024 on Development of Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food, Announces Executive Career Opportunities Related to Human Foods Program

The U.S. Food and Drug Administration (FDA) announced on August 1, 2024, that it will hold a public meeting on September 25, 2024, on the development of an enhanced systematic process for its post-market assessment of chemicals in food. FDA states that this includes ingredients considered generally recognized as safe (GRAS), food additives, color additives, food contact substances, and contaminants. According to FDA, this is intended to guide its post-market assessment work going forward and...
July 16, 2024

Lynn L. Bergeson, “Chemicals in Food: FDA Steps Up Post-Market Review,” Chemical Processing, July 16, 2024.

The U.S. Food and Drug Administration (FDA), the primary federal agency committed to safe exposure to chemicals in the food supply, has recently stepped up efforts to ensure food safety, especially in the post-market assessment area. Stakeholders in commercial chemical operations and product lines involving chemicals used for or found in the food supply should be prepared for increased inspections and enforcement in this area. Chemicals in Food The Federal Food, Drug, and Cosmetic Act (FFDCA)...