As announced earlier this month, the longstanding Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA or Agency) and the Association of American Feed Controls Officials (AAFCO) will expire on...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
In a monumental opinion issued today, the U.S. Supreme Court in Loper Bright Enterprises v. Raimondo overruled Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., holding (6-3) that deference to an agency's...more
7/1/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Constitutional Challenges ,
Government Agencies ,
Judicial Authority ,
Loper Bright Enterprises v Raimondo ,
National Marine Fisheries Service ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Stare Decisis ,
Statutory Interpretation ,
Unconstitutional Condition
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
It’s that time of year again—Ad Law Symposium is back!
Please join us in DC for this highly anticipated event focused on providing you with the information you need to promote your brand with confidence. Combining the...more
2/22/2024
/ Advertising ,
Advertising Substantiation ,
Artificial Intelligence ,
Automatic Renewals ,
Best Practices ,
Defense Strategies ,
Enforcement Actions ,
Events ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Green Marketing ,
Lanham Act ,
Legal Ethics ,
Marketing ,
Pricing ,
Regulatory Requirements ,
Social Media ,
State Privacy Laws ,
Telemarketing ,
Text Messages
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
Listen to Episode 2 of our new podcast, the Ad Law Tool Kit Show. In this episode, partner Todd Harrison talks to host Shahin Rothermel about marketing FDA-regulated products. Check out the episode....more
The U.S. Supreme Court on Monday agreed to review Loper Bright Enterprises v. Raimondo, a direct challenge to Chevron deference. A decision in the case could either overrule Chevron altogether, or alternatively narrow the...more
Join us on December 14 for a webinar providing a 2022 FDA year-in-review, with a crystal ball look into 2023. Venable Partners Claudia Lewis and Todd Harrison will discuss myriad topics, including a recap of major issues...more
Recent trends indicate that consumers and the U.S. government are paying more attention to where products are sourced from.
The Biden administration, for example, has made efforts to raise federal procurement standards for...more