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
12/9/2025
/ Animal Testing ,
Center for Drug Evaluation and Research (CDER) ,
Clinical Trials ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Government Agencies ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Oversight
On December 1, the U.S. Food and Drug Administration (FDA) sent its proposed Generally Recognized as Safe (GRAS) rule, which is expected to mandate submission of GRAS notices for human and animal food substances, to the...more
12/8/2025
/ Administrative Procedure Act ,
Comment Period ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
GRAS ,
Notice Requirements ,
OIRA ,
Proposed Rules ,
Rulemaking Process ,
Statutory Authority
On December 2, 2025, the FDA, with the Department of Justice and U.S. Marshals Service, seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products from three Missouri firms. ...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 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)
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
The President signed into law the government funding package that includes a sweeping amendment redefining “hemp” and imposing a 0.4 mg total THC limit per finished product. ...more
11/17/2025
/ Agricultural Sector ,
Appropriations Bill ,
Cannabis Products ,
Compliance Dates ,
Controlled Substances ,
Department of Health and Human Services (HHS) ,
Federal Bans ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Hemp ,
Hemp Related Businesses ,
New Legislation ,
New Regulations ,
THC
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
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
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
The U.S. District Court for the Southern District of New York recently upheld New York City's prohibition on steeped kava beverages, concluding that steeping kava root in water constitutes the creation of an unapproved "food...more
8/27/2025
/ Beverage Manufacturers ,
Dietary Supplements ,
DSHEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Municipalities ,
Preemption ,
Regulatory Authority ,
State and Local Government ,
State Bans ,
Statutory Interpretation
On July 29, 2025, during a joint press conference, the U.S. Food and Drug Administration (FDA or the Agency) recommended to the Drug Enforcement Administration (DEA) to classify 7-hydroxymitragynine (7-OH) as a Schedule I...more
8/13/2025
/ Administrative Procedure Act ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Due Process ,
Food and Drug Administration (FDA) ,
Joint Statements ,
Judicial Review ,
Opioid ,
Public Comment ,
Public Health ,
Rulemaking Process ,
Schedule I Drugs
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
Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more
4/30/2025
/ Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Medical Devices ,
Prescription Drugs ,
Presidential Appointments ,
Presidential Nominations ,
Proposed Rules ,
Regulatory Agencies ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Termination ,
Trump Administration
On April 22, 2025, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration announced a series of new measures to quickly phase out all petroleum-based synthetic dyes from the nation’s food...more
On April 21, 2025, it was reported that the U.S. Department of Health and Human Services (HHS) has released a media advisory describing the Food and Drug Administration’s (FDA) intention to remove petroleum-based synthetic...more
On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS Secretary Robert F. Kennedy has directed the Food and Drug Administration (FDA or Agency) “to take steps to explore potential...more