Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
Federal and state health authorities are investigating a recent infant botulism outbreak linked to certain infant formula products. In response, FDA expanded its initial advisory into a nationwide recall of multiple lots...more
11/24/2025
/ Baby Products ,
Contamination ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Food Recalls ,
Food Safety ,
Manufacturers ,
Product Recalls ,
Public Health ,
Regulatory Oversight ,
Supply Chain
On October 11, 2023, the United States Environmental Protection Agency (EPA) promulgated a final rule pursuant to section 8(a)(7) of the Toxic Substances Control Act (TSCA) imposing a one-time reporting obligation on entities...more
11/21/2025
/ Chemicals ,
Comment Period ,
Environmental Protection Agency (EPA) ,
Exemptions ,
Final Rules ,
Manufacturers ,
PFAS ,
Proposed Rules ,
Reporting Requirements ,
Rulemaking Process ,
Toxic Chemicals ,
Toxic Substances Control Act (TSCA)
On November 12, 2025, Michigan joined the growing list of states that have introduced legislation prohibiting the sale of over-the-counter products and dietary supplements for weight loss or muscle building to consumers under...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders. ...more
As of October of this year, seven states have passed EPR laws (i.e., California, Colorado, Maine, Maryland, Minnesota, Oregon, and Washington), and more have bills pending in their legislatures. These laws are intended to...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
10/28/2025
/ Appropriations Bill ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Food Safety ,
Government Shutdown ,
New Guidance ,
Orphan Drugs ,
Public Health ,
Public Meetings
California’s law governing heavy metals in baby food requires manufacturers to test products, disclose results, and meet specific labeling requirements. The testing provisions have been effective since January 2024, and the...more
Last month the Food and Drug Administration (FDA or the Agency) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. This interactive dashboard provides access to...more
On October 8, California Governor Newsom signed AB 1264 into law. The law will begin phasing out ultra-processed foods (UPFs) of concern from California schools by July 1, 2029. By July 1, 2032, vendors will be prohibited...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
On Monday, the U.S. Food and Drug Administration (FDA or the Agency) responded to a citizen petition about beta nicotinamide mononucleotide (NMN), signaling a shift in its regulatory approach that brings both opportunities...more
Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions. ...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
9/17/2025
/ Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Imports ,
Medical Devices ,
OIRA ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda
On August 15, Illinois amended the Illinois Food, Drug and Cosmetic Act to impose certain labeling and testing requirements on baby food manufacturers. The law is similar to a California baby food law that became fully...more
9/15/2025
/ Amended Legislation ,
Baby Products ,
Consumer Protection Laws ,
Disclosure Requirements ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Labeling ,
Product Labels ,
Regulatory Requirements ,
State and Local Government ,
Testing Requirements ,
Toxic Chemicals
Last week, the Office of Information and Regulatory Affairs released the spring 2025 edition of the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). This semiannual publication outlines the...more
9/10/2025
/ Administrative Procedure Act ,
Deregulation ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GRAS ,
Notice of Proposed Rulemaking (NOPR) ,
OIRA ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Authority ,
Rulemaking Process ,
Statutory Interpretation
Earlier this month, the Office of Information and Regulatory Affairs (OIRA) updated its list of rules pending review under Executive Order 12866 to include FDA's request to rescind its controversial Laboratory Develop Test...more
8/29/2025
/ Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Layoffs ,
Medical Devices ,
OIRA ,
Pharmaceutical Industry ,
Public Health ,
Reduction of Force ,
Regulatory Agenda ,
Regulatory Reform
In our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or the Agency) that may affect the Agency′s structure and stakeholder interactions. ...more
Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more
Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions....more
8/4/2025
/ Artificial Intelligence ,
Center for Drug Evaluation and Research (CDER) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Hiring & Firing ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
SCOTUS ,
Voluntary Reduction in Force
On July 23, 2025, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) announced a joint Request for Information (RFI) to gather information and data to help establish a federally recognized...more
Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more
7/18/2025
/ Consumer Protection Laws ,
Cosmetics ,
Deregulation ,
Dietary Supplements ,
Enforcement Priorities ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
Health and Safety ,
Imports ,
Manufacturers ,
Public Health ,
Regulatory Requirements
By June 1, all entities that supply, manufacture, produce, or distribute aerosol products that contain fluorinated greenhouse gases with a GWP20 greater than 10 (regulated substances), for sale or use in New York, must...more
On May 14, as part of Operation Stork Speed (the Operation), the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) to begin its review of infant formula nutrition requirements. FDA’s last...more