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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...

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...

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...

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...

The U.S. Food and Drug Administration (FDA) issued draft guidance for industry on the registration and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on August 7, 2023. The draft guidance provides details on the submissions process, including the information required and who is responsible for the submission. FDA is accepting comments until September 7, 2023. In addition, FDA seeks applications from interested parties to...

In a move that some may not have seen coming, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. The MoCRA significantly strengthens the U.S. Food and Drug Administration (FDA) authority over cosmetic products. Key impacts are summarized below. Background On April 16, 2021, the Performance Enhancement Reform Act was introduced to the House of Representatives by Representative Gerald E. Connolly (D-VA)....

The U.S. Food and Drug Administration (FDA) issued a proposed rule on January 26, 2022, to amend procedures for determining when a food contact substance notification (FCN) is no longer effective. 87 Fed. Reg. 3949. FDA states that the proposed rule would allow industry and FDA more flexibility in responding to new information on the safety and use of food contact substances. The amendments aim to create administration mechanisms to improve the program’s overall efficiency. Comments...

On October 18, 2021, the Biden Administration announced a multi-agency plan to address per- and polyfluoroalkyl substances (PFAS) contamination nationwide. According to the White House, agencies, including the U.S. Environmental Protection Agency (EPA), the Department of Defense (DOD), the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Department of Homeland Security (DHS), and the Department of Health and Human Services (DHHS), will take actions to...

On July 26, 2021, Representative Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, introduced the Food Chemical Reassessment Act of 2021 (H.R. 4694), which would require the U.S. Food and Drug Administration (FDA) to study and reassess chemicals used in food. Representative Rosa DeLauro (D-CT) joined Schakowsky in introducing the legislation. According to Schakowsky’s July 26, 2021, press release, “thousands” of...

On June 2, 2020, the Senate Committee on Finance hosted a full Committee hearing entitled “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.” Witnesses represented the U.S. Food and Drug Administration (FDA), U.S. Government Accountability Office (GAO), and private sector companies. The hearing sought to examine the accountability of FDA’s vetting process, especially in regard to drugs necessitated by the COVID-19 pandemic. Lawmakers and witnesses...

The U.S. Food and Drug Administration (FDA) issued on April 18, 2020, an Emergency Use Authorization (EUA) for manufacturers and distributors of face masks in response to the ongoing efforts for prevention of the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As discussed below, in issuing this EUA, the FDA is effectively allowing manufacturers and distributors to address well-publicized concerns relating to national personal protective equipment (PPE)...

The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. According to FDA’s February 21, 2019, press...

Click here for a PDF brochure of the memorandum Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2019. In this richly detailed document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and provide our best informed judgment as to the shape of key developments we are likely to see in the New...

Available On-Demand – TSCA At 2: An Update On Implementation And Hot Topics: A recording of “TSCA at 2: An Update on Implementation and Hot Topics,” the third webinar in the 2018 Chemical Policy Summit Series, is now available. This webinar featured news and updates on Toxic Substances Control Act (TSCA) implementation from Nancy B. Beck, Ph.D., D.A.B.T.®, Deputy Assistant Administrator, U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution...

On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology.  The notice was published in the Federal Register on October 5, 2017.  82 Fed. Reg. 46500.  Guidance for Industry #236,...

On April 6, 2017, the U.S. Food and Drug Administration (FDA) published three waivers to the now final Sanitary Transportation rule mandated by the FDA Food Safety Modernization Act (FSMA) for businesses whose transportation operations are subject to separate state-federal controls in the Federal Register. 82 Fed. Reg. 16733. The waivers include: FDA reviewed comments on the waivers after they were included in the proposed rule and found that the waivers would not result in...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology.  The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the...

The second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products” will be held March 9, 2016, from 9:30 a.m. to 1:00 p.m. (CT) in Dallas, Texas. Registration is now open. To participate in person, registration should be completed by March 4, 2016. Registration is also required to view and participate in a live streaming of the public meeting. According to the U.S. Environmental Protection Agency...

What the implementation of new TSCA will look like, along with the general environmental program and emphasis of the new Trump Administration, is very unclear this early in the New Year (the new President will not arrive until January 20). What is more predictable is that the operating environment of OCSPP will change significantly, with uncertain impacts on both the U.S. Environmental Protection Agency’s (EPA) pesticide and toxic chemical regulatory programs. EPA institutionally may never...

On November 19, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved AquaBounty Technologies’ application for the genetically engineered (GE) salmon (AquAdvantage Salmon), the first time FDA has approved a GE animal. FDA regulates GE animals under the new animal drug requirements through the Center for Veterinary Medicine in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA states in the news release that it...

On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term “natural” in the labeling of human food products. The notice states that it is establishing “a docket to receive information and comments on the use of the term ‘natural’ in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering.” FDA states that this...

FDA Announces GUDID Public Website: On May 4, 2015, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that the data submitted to the Global Unique Device Identification Database (GUDID) are now publicly available. The website, in partnership with the National Library of Medicine, is part of the phase-in for the Unique Device Identification compliance timeline and offers anyone access to search or download information submitted for...

Click here for a PDF version of the memorandum. 2015 will be a very interesting year. There are two overarching considerations that will make the year more difficult to predict than merely assuming most of this year’s issues will simply be extensions of past issues, with a few new initiatives sprinkled in. First, the new Republican majority in the Senate will change the dynamic between the Executive and Legislative branches. Second, the Obama Administration will...

On June 26, 2014, the U.S. Food and Drug Administration (FDA) held a public meeting to discuss the proposed changes to the nutrition label and serving sizes. The meeting was attended by interested parties both in Washington, D.C. and via webcast. The Acting U.S. Surgeon General, Rear Admiral Boris D. Lushniak, M.D., M.P.H., gave the opening remarks stating the importance of these changes in relation to the Surgeon General’s national prevention strategy started in June...

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.” One final guidance addresses FDA’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals,...

This is the first in a series of updates concerning compliance initiatives underway by the U.S. Food and Drug Administration (FDA) that affect various segments of the regulated industry. This issue focuses on court actions, Warning Letters, recalls, and other matters pertaining to dietary supplements. We will periodically outline actions and issues affecting prescription and over-the-counter (OTC) drugs, medical device and diagnostic products, food, cosmetics, animal drugs, and biologics....

On April 20, 2012, the U.S. Food and Drug Administration (FDA) issued two new draft guidance documents on the use of nanotechnology in food and cosmetic products — “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, including Food Ingredients that are Color Additives,” which is available online, and “Guidance...

The Acta Group, L.L.C.’s (Acta) thoughts are below on what may be headed our way in 2012 from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). The 2012 Presidential Election cycle will influence any activity by either party or the Administration over the next year. We also offer a few thoughts on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), the Food and Drug Administration (FDA), and Asian...

On June 14, 2011, the U.S. Food and Drug Administration (FDA) took long-awaited action to update regulations for testing and labeling over-the-counter (OTC) sunscreen products. The Agency emphasized that the primary intent of its initiative was to establish a consistent standard for testing and labeling sunscreen products to reduce consumer confusion and encourage proper use of these products to enhance their protective function. The most significant elements of FDA’s action include...

On June 9, 2011, the Food and Drug Administration (FDA or the Agency) posted on its home page a Draft Guidance on Considering Whether an FDA-Regulated Product Involves Application of Nanotechnology. The Agency states that this document is the first step in providing regulatory clarity about the use of nanomaterials in FDA-regulated products and other more product-specific guidance documents are likely to follow. Specifically, the Draft Guidance is “intended to help industry and others...

Two of the trade associations named as negotiators by the U.S. Food and Drug Administration (FDA) regarding its proposal for the imposition of generic drug user fees have filed comments regarding the proposal that may frame their negotiating posture with the Agency going forward. The Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Pharmaceutical Task Force and the European Chemical Industry Council’s (CEFIC) Fine Chemicals Group urged FDA to impose a registration fee...

On March 30 and 31, 2011, the Center for Food Safety and Applied Nutrition (CFSAN) of the U.S. Food and Drug Administration (FDA) will hold a Food Advisory Committee meeting on the possible link between synthetic dyes in food products and behavioral issues in children, such as attention deficit hyperactivity disorder (ADHD). Members of the Food Advisory Committee have been charged to “consider available relevant data on the possible association between consumption of certified color...

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) published on January 19, 2011, a “plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.” See FDA News Release, “FDA to improve most common review path for medical devices” (Jan. 19, 2011), available online. That path is the Premarket Notification, or 510(k) process, used for the bulk of...

On September 21, 2010, the U.S. Food and Drug Administration (FDA) held a public hearing on the issue of labeling food made from the genetically engineered (GE) fish AquAdvantage Salmon, an Atlantic salmon produced by AquaBounty Technologies, Inc. The purpose of this hearing was to present the relevant legal principles for food naming and labeling, and describe information made available prior to the hearing about characteristics of AquAdvantage Salmon (e.g., the chemical composition and...

On March 5, 2010, the U.S. Government Accountability Office (GAO) released a report entitled Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS). The Federal Food, Drug, and Cosmetic Act (FFDCA) exempts generally recognized as safe (GRAS) substances, which include spices, artificial flavors, emulsifiers and binders, vitamins and minerals, and preservatives, from the general requirement that companies obtain Food and Drug...

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