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The U.S. Food and Drug Administration announced on May 12, 2026, “two decisive actions focused on food chemical safety.” First, FDA released two final documents for its new proactive food chemical safety post-market assessment program. Second, FDA launched reassessments of butylated hydroxytoluene (BHT) and azodicarbonamide (ADA), “chemical additives commonly used in a variety of food products.” As part of the reassessment, FDA issued two requests for information regarding the use and...

Concerns about microplastics and their effect on human and environmental health are no longer confined to academic literature or environmental advocacy. On April 6, 2026, the U.S. Environmental Protection Agency (EPA) and the U.S. Department of Health and Human Services (HHS) elevated the issue in a way that makes it harder for the regulated community to address the issue of microplastics as largely academic or purely speculative. EPA has proposed to add microplastics, for the first time, as a...

On May 6, 2026, the National Agricultural Law Center (NALC) and the National Association of State Departments of Agriculture (NASDA) Foundation will host a half-day program featuring the latest updates in agricultural and food law policy from experts across the country in Washington, D.C. The agenda includes: “Four Corners” Congressional Update: Ag Trade, E-15, MAHA, Farm Bill, and Related Issues: Fitzhugh Elder IV, Staff Director, Senate Committee on Agriculture, Nutrition, and Forestry;...

The U.S. Food and Drug Administration’s (FDA) Human Food Program (HFP) has prepared a list of priority research, data, and method needs that, if fulfilled, will help FDA better understand the underlying factors that may cause or contribute to health risks from HFP-regulated products. FDA states that it provided these research, data, and method needs for researchers interested in pursuing science that is useful to advancing the safety of the U.S. food supply. According to FDA, the list may also...

As required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), on December 29, 2025, the U.S. Food and Drug Administration (FDA) published a Report on the Use of PFAS in Cosmetic Products and Associated Risks. The scope of the report is limited to per- and polyfluoroalkyl substances (PFAS) intentionally added to cosmetic products as ingredients and does not include PFAS that may be present in the final product as contaminants. According to the report, “[c]ertain PFAS are...

Download a PDF of the Forecast 2026. 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 Forecast 2026. Our distinguished global team of chemical experts worked hard to summarize our collective best guess on what to expect in the New Year regarding global industrial, agricultural, and biocidal chemical regulatory and policy...

As 2025 draws to a close, one of the most consequential, but least publicly discussed, shifts in federal environmental governance has been the quiet expansion of artificial intelligence (AI) behind the scenes across multiple federal agencies. AI tools are not new in federal science programs, but 2025 marked a turning point: agencies began integrating machine-learning models into routine workflows in exposure modeling, surveillance, enforcement targeting, and environmental monitoring. The White...

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,...

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...

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...

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...

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...

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,...

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...

The U.S. Food and Drug Administration (FDA) issued a Constituent Update on March 4, 2024, that updates its “List of Select Chemicals in the Food Supply Under FDA Review.” FDA states that the intent of this update is “…to provide more insight on the status of the FDA’s post-market assessments of chemicals in the food supply.” The information posted today includes many chemicals that FDA has been actively engaged in reviewing for the past several years. The Update also explains the...

The U.S. Food and Drug Administration (FDA) has posted a February 2024 guidance entitled “Foods Derived from Plants Produced Using Genome Editing: Guidance for Industry.” According to FDA, one purpose of the guidance is to clarify how its 1992 policy statement “Statement of Policy: Foods Derived from New Plant Varieties” (NPV policy) (57 Fed. Reg. 22984) applies to foods derived from NPVs produced using genome editing. The NPV policy provides scientific and regulatory guidance on foods...

On November 13, 2023, the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) posted the following documents on the Unified Website for Biotechnology Regulation: Report on Stakeholder Outreach Related to Ambiguities, Gaps, Uncertainties in Regulation of Biotechnology Under the Coordinated Framework (Report on Stakeholder Outreach) (Mar. 11, 2023); and The Coordinated Framework for the Regulation of Biotechnology:...

On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The submission portal and paper forms are part of FDA’s implementation of the new registration and listing requirements mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA has provided screenshots of the draft electronic system, draft Form FDA...

On September 19, 2023, the Congressional Research Service (CRS) published a report providing an overview of cell-cultivated meat. The report provides an overview of the science of cell-cultivated meat, the industry, the regulatory framework for cell-cultivated meat products, congressional interests, and potential policy considerations. CRS states that cell-cultivated meat is developed in a lab, grown from a sample of animal cells that does not require the slaughter of animals. Developing...

The U.S. Food and Drug Administration (FDA) will hold a virtual 2023 NanoDay symposium on October 11, 2023, on the continuous manufacturing of nanomaterials. In the symposium, FDA will provide an overview of Center for Drug Evaluation and Research (CDER) experience with approving several solid oral drug products that benefited from the continuous manufacturing technologies. FDA states that it will also provide case studies of intramural and extramural research in the areas of nanomaterials and...

The Congressional Research Service (CRS) published an updated report on August 4, 2023, on the U.S. Department of Agriculture’s (USDA) Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. The revisions note that USDA’s Animal and Plant Health Inspection Service’s (APHIS) five-year Strategic Plan for fiscal years (FY) 2023-2027 states that “one of its objectives is to ensure the safe development of agricultural biotechnology products using a...

The National Nanotechnology Initiative (NNI) will hold two public webinars providing an overview of the key activities of U.S. government agencies in tackling the challenge of plastic waste in the environment. NNI states that the plastic waste issue includes more than just solid waste accumulation. According to NNI, the breakdown of bulk plastics to micro- and nanoscale particles in the environment “has further challenged efforts to understand the potential human and environmental impacts of...

The U.S. Food and Drug Administration (FDA) announced on May 3, 2023, that it has filed a color additive petition (CAP 3C0325), submitted by the Environmental Defense Fund (EDF), the Center for Environmental Health (CEH), the Center for Food Safety (CFS), the Center for Science in the Public Interest (CSPI), and the Environmental Working Group (EWG). 88 Fed. Reg. 27818. The petition proposes that FDA repeal the color additive regulation for titanium dioxide in 21 C.F.R. Section 73.575,...

By Lynn L. Bergeson and Carla N. Hutton   On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to: Protect agriculture from plant and animal...

On February 22, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced that it will co-host a virtual public meeting with the U.S. Food and Drug Administration’s (FDA) Center of Veterinary Medicine (CVM) on March 22, 2023. As stated in our February 17, 2023, blog, EPA and FDA are considering how best to update their respective oversight responsibilities for specific products in an efficient and...

On February 15, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) and the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced plans to seek public input on the best approaches for updating their respective oversight responsibilities for specific products. EPA states the goal is to determine responsibilities in an efficient and transparent manner and in alignment with each agency’s...

October 26, 202212:00 p.m. - 1:00 p.m. (EDT) The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to outbreaks to...

The U.S. Food and Drug Administration (FDA) will hold the “FDA NanoDay Symposium 2022” on October 11, 2022. The symposium will address the following topics: An overview and discussion of the recent “Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterials.” More information on the guidance is available in our April 24, 2022, blog item; A contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products; A...

On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration...

On July 20, 2022, the Food and Drug Administration (FDA) published a request for information (RFI) to obtain data and information on the use of fluorinated polyethylene for food contact applications. 87 Fed. Reg. 43274. FDA states that it is seeking scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and the safety of certain per- and polyfluoroalkyl substances (PFAS) that may migrate from...

The National Nanotechnology Initiative (NNI) will hold a webinar on “What We Know about NanoEHS: Building International Bridges” on March 1, 2022. NNI states that it has supported the emergence of an international community of collaborative researchers on the environmental, health, and safety aspects of nanomaterials (nanoEHS). According to NNI, “[b]y advancing tools, methods, and standards for robust health and safety evaluation, these cooperative efforts have furthered the safe and...

The Food and Drug Administration (FDA) published a Federal Register notice on October 13, 2021, announcing the withdrawal of three guidance documents: “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”; “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”; and “Temporary Policy for Manufacture of Alcohol for Incorporation Into...

By Lynn L. Bergeson  On September 20, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of its revised final guidance for industry on biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Titled “Questions and Answers on Biosimilar Development and the BPCI Act,” the revised guidance aims to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable...

The January 29, 2021, issue of the U.S. Food and Drug Administration’s (FDA) NCTR Research Highlights includes an item highlighting the National Center for Toxicological Research’s (NCTR) nanotechnology-related activities in 2020.  The activities include: Nanotechnology Standards:  Two work items developed by the NCTR Nanotechnology Core Facility (Nanocore) staff became standards in February 2019 and January 2020 (Standard Practice for Performing...

The Society of Toxicology (SOT) in conjunction with the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide a colloquia series on Emerging Toxicological Science:  Challenges in Food and Ingredient Safety.  The colloquia will present scientific information that is high-quality, cutting-edge, future-oriented toxicological science and is intended to provide a well-grounded foundation to inform the work of FDA...

Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021.  Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff.  According to the...

On November 10, 2020, the Senate Committee on Appropriations released 12 fiscal year (FY) 2021 appropriations bills and explanatory statements.  The bill for the Department of the Interior, environment, and related agencies includes funding for the U.S. Environmental Protection Agency (EPA).  The explanatory statement for the bill includes language regarding nanomaterials research at EPA and states: The Committee notes the increased capabilities that the Food and...

By Lynn L. Bergeson On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Under BsUFA, FDA collects user fees to support its process for the review of biosimilar and biological products and the current legislative authority is set to expire in September 2022. At the aforementioned time, new legislation will be required for FDA to...

The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in nanotechnology at FDA.  The agenda lists the following presentations: A Decade of Progress and Innovation in Nanotechnology at U.S. FDA; Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Regulatory Science Research in...

The U.S. Food and Drug Administration (FDA) published a report entitled Nanotechnology — Over a Decade of Progress and Innovation that highlights FDA’s advancements in the field of nanotechnology since it released its last report in 2007.  The report also reviews FDA’s role in advancing the public health through its regulation of products within its jurisdiction that involve the application of nanotechnology.  According to the report, FDA “will rely on a combination...

By Lynn L. Bergeson  On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through...

By Lynn L. Bergeson On June 30, 2020, from 9:00 a.m. to 5:30 p.m. (EDT),the U.S. Food and Drug Administration (FDA) will host a free regulatory training for industry on bioanalysis requirements and expectations. Focused on how FDA’s Center for Drug Evaluation and Research (CDER) approaches various issues in bioanalysis, the workshop aims to provide participants with a better understanding of how FDA performs bioanalysis. Topics to be covered, among others, include: Bioanalytical method...

By Lynn L. Bergeson On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature allowing users to download reports. Historical reports now include highlighted...

On April 29, 2020, the U.S. District Court for the District of Utah issued a temporary restraining order (TRO) to halt the sale of a fraudulent coronavirus (COVID-19) treatment.  The U.S. Department of Justice (DOJ) announced the court’s decision in an effort to halt the sale of silver products fraudulently claimed to prevent and cure COVID-19. DOJ filed a civil complaint on April 27, 2020, against defendants Gordon Pedersen of Cedar Hills, Utah and his companies, My Doctor...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. Titled “Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations,” the analysis of the methodology was reviewed by an...

On March 10, 2020, the Federal Trade Commission (FTC) and U.S. Food and Drug Administration (FDA) announced that warning letters were sent to seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19).  The warning letters are the first issued by the Agencies alleging unapproved and/or unsupported claims that products can treat or prevent...