On November 16, 2022, the Food and Drug Administration (FDA) issued five new warning letters to various companies making edible products containing cannabidiol (CBD) and/or Delta-8-tetrahydrocannabinol (THC)...more
11/29/2022
/ Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Enforcement Actions ,
Farm Bill ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Marijuana ,
Regulatory Agenda ,
THC
On the heels of the U.S. Food and Drug Administration’s (FDA) recent declarations regarding the safety of products containing cannabidiol (CBD), several companies have been hit with class action lawsuits alleging that that...more
On November 25, 2019, the U.S. Federal Drug Administration (FDA) took several significant actions regarding sellers of products containing cannabidiol (CBD). The FDA announced that it cannot conclude that CBD is “generally...more
11/27/2019
/ Cannabidiol (CBD) oil ,
Dietary Supplements ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GRAS ,
Health and Safety ,
Health Claims ,
Hemp ,
Marijuana ,
Marijuana Related Businesses ,
Marketing ,
Product Labels
Following the recent public hearing held by the Food and Drug Administration (FDA) regarding the safety and efficacy of cannabidiol (CBD), many in the food and beverage industry asked how long it will take for the agency to...more
8/5/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Corporate Counsel ,
Dietary Supplements ,
Expedited Approval Process ,
Expedited FDA Approval ,
FDA Approval ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Hemp ,
Marijuana-Infused Edibles ,
Rulemaking Process
The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more
9/23/2015
/ Amarin ,
Commercial Speech ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs