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
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
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 March 18, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced the launch of Operation Stork Speed “to enhance [FDA’s] efforts to ensure the ongoing quality, safety,...more
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 April 10, 2025, the Food and Drug Administration (FDA) released a pre-recorded webinar outlining the updated "healthy" nutrient content claim rule. As we previously discussed, the rule will go into effect on April 28,...more
4/21/2025
/ Compliance Dates ,
Consumer Protection Laws ,
Dietary Supplements ,
False Advertising ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Government Investigations ,
New Rules ,
Regulatory Requirements ,
State Attorneys General ,
Webinars
As we previewed, West Virginia is the latest state to regulate food dyes. On Monday, Governor Patrick Morrisey signed HB2354, deeming the following food additives unsafe and prohibiting their use, with some limited...more
On February 25, the Food and Drug Administration (FDA) announced a delay in the effective date for its final rule updating the criteria to use the "healthy" nutrient content claim on food labeling....more
On January 15, 2025, the Food and Drug Administration (FDA or Agency) issued an order to revoke the authorization for the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs in response to a 2022 color additive...more
On January 8, 2025, a bill prohibiting the sale of certain dietary supplements for weight loss and muscle building and other products to minors was formally introduced to the Virginia House of Delegates (House Bill No. 1585...more
On December 19, 2024, the Food and Drug Administration (FDA) announced a final rule updating the definition of the term "healthy" as used in food labeling. Under the rule, manufacturers may use the term "healthy" and similar...more
On October 22, Novo Nordisk (Novo) nominated semaglutide products, which include its popular drugs marketed as Ozempic for type 2 diabetes and Wegovy for chronic weight management, for inclusion on FDA's Demonstrable...more
We previously covered California's landmark Food Safety Act, the legislative proposals inspired by it, and the FDA's final rule revoking the authorization of brominated vegetable oil (BVO) in food products. Since then, there...more
State legislatures are actively pursuing bans on food and color additives. California’s landmark Food Safety Act (Act), effective January 2027, bans the manufacture and sale of products containing brominated vegetable oil...more
Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more
7/11/2024
/ Administrative Procedure Act ,
Biologics Price Competition and Innovation Act of 2009 ,
Chevron Deference ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Jurisdiction ,
Loper Bright Enterprises v Raimondo ,
Prescription Drugs ,
Public Health Service Act ,
Rulemaking Process ,
SCOTUS ,
Statutory Interpretation
We want to inform you of a new law in Maryland, effective January 1, 2025, that mandates baby food manufacturers to test for toxic heavy metals, excluding infant formula. Known as Rudy’s Law, this legislation was inspired by...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more
On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more
As promised last month, we are happy to announce that on April 3, FDA issued the New Dietary Ingredient Notification Master Files for Dietary Supplements draft guidance. In a related constituent update, FDA explained that the...more
On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification...more
The Food and Drug Administration (FDA) regulates the marketing of dietary supplements, over-the-counter (OTC) drugs, cosmetics, medical devices, foods, infant formula, pet foods/supplements, and even e-cigarettes. However,...more