On May 22, 2025, the U.S. Department of Health and Human Services (HHS) announced the release of a new federal report, Making Our Children Healthy Again (MAHA Assessment) issued by the Make America Healthy Again (MAHA) Commission. The MAHA Commission was established by Executive Order (EO) 14212 to: (a) study the scope of the childhood chronic disease crisis and any potential contributing causes, including the American diet, absorption of toxic material, medical treatments, lifestyle,...
Archives
June 2, 2025
Chemical Policy Crossroads: MAHA Report’s Assessment Calls for Reform Amid Deregulatory Trends
In response to President Trump’s February 13, 2025, Executive Order (EO) 14212, “Establishing The President’s Make America Healthy Again Commission,” the White House issued part of what is being called “The MAHA Report” (with MAHA an acronym for Make America Healthy Again), entitled “Make Our Children Healthy Again: Assessment” (the Assessment) on May 22, 2025. Section One of the Assessment, “The Shift to Ultra-Processed Foods,” includes the Commission’s thoughts on the...
May 21, 2025
Congress and the Feds — the Impact of Nonperformance
Ponder the following existential question: Who does their job less effectively? Members of Congress, or employees of federal agencies? Let’s examine the U.S. Environmental Protection Agency (EPA) employees versus those responsible for legislating environmental laws. Congress has not been able to reauthorize environmental statutes for years, with some (most) needing significant attention. EPA relies on 1990 Clean Air Act amendments to sort out air pollution issues and address climate change...
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...
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...
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...
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)...
On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The Coordinated Framework for the Regulation of Biotechnology: Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology (the Plan) provides a roadmap for actions the agencies will take,...
April 9, 2024
FDA Reports That No Asbestos Was Detected in Its 2023 Testing of Talc-Containing Cosmetic Products
The U.S. Food and Drug Administration (FDA) announced on April 5, 2024, the results of its 2023 sampling assignment, testing talc-containing cosmetic products for the presence of asbestos. The testing was conducted using Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM). FDA states that “[a]sbestos was not detected in any of the 50 samples tested in 2023.” FDA states that it selected and purchased cosmetic products, and then it blinded and transferred the samples to...