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 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
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
This week, the Natural Products Association (NPA) filed a lawsuit against New York State challenging the constitutionality of a new state law prohibiting the sale of over-the-counter diet pills and dietary supplements for...more
Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more
7/21/2023
/ Adverse Events ,
Best Practices ,
Cosmetics ,
Disclosure Requirements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Filing Deadlines ,
Food and Drug Administration (FDA) ,
Interstate Commerce ,
Manufacturers ,
Manufacturing Facilities ,
New Legislation ,
Personal Care Products ,
Product Labels ,
Recordkeeping Requirements ,
Registration Requirement