As 2022 drew to a close, the Wall Street Journal reported that the FDA is finally considering releasing potential guidance regarding cannabidiol (“CBD”) in the coming year. While the exact timeline and scope of the FDA’s...more
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
More than 20 state attorneys general (AGs) authored an open letter to congressional leaders calling for legislation that would regulate tetrahydrocannabinol (THC) edibles that mimic the packaging and names of popular...more
On May 26, the FDA issued warning letters to four companies alleging that the companies sold unapproved animal drugs containing cannabidiol (CBD). Specifically, these products were intended for use in food-producing...more
On May 19, 2022, the U.S. Circuit Court of Appeals for the Ninth Circuit issued an opinion holding that Delta-8 THC products are legal at the federal level and eligible for intellectual property protection...more
5/20/2022
/ Appeals ,
Controlled Substances ,
Farm Bill ,
Federal Trademark Register ,
Food and Drug Administration (FDA) ,
Hemp ,
Legalization ,
New Legislation ,
New Regulations ,
Regulatory Oversight ,
State and Local Government ,
THC ,
Warning Letters
On May 13, the FDA issued a public warning regarding reports of accidental ingestion of food products containing tetrahydrocannabinol (THC) by children. The FDA warned that edible products containing THC “can be easily...more
Earlier today, May 4, 2022, the FDA issued warning letters to five companies selling products that contain delta-8 tetrahydrocannabinol (Delta-8 THC). Several of the companies also manufactured products containing...more
5/4/2022
/ Advertising ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Dietary Supplements ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Health Claims ,
Marijuana Related Businesses ,
Product Labels ,
Warning Letters
The U.S. Food and Drug Administration (FDA) submitted a report to Congress on July 8, 2020, providing an analysis of the cannabidiol (CBD) marketplace. The submission was in response to the Further Consolidated Appropriations...more
The federal Food and Drug Administration (FDA) just released a report to Congress regarding the agency’s progress toward comprehensive regulation of hemp-derived cannabidiol (CBD). The report echoes the hard-line approach to...more
3/9/2020
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Health Claims ,
Marijuana ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Standards ,
Rulemaking Process
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
Since late February 2019, the U.S. Department of Agriculture (USDA) has been promising to publish guidelines regarding hemp production. Aside from the obvious importance of these guidelines to hemp farmers, the guidelines are...more
11/4/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Interim Final Rules (IFR) ,
Interstate Commerce ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Public Comment ,
Tribal Governments ,
USDA
The U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent a joint warning letter on Tuesday, October 22, 2019, to Rooted Apothecary, LLC, alleging that the Florida-based company has been making...more
10/28/2019
/ Advertising ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
FDA Warning Letters ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Claims ,
Hemp ,
Marijuana Related Businesses ,
Marketing ,
Risk Mitigation
On May 31, 2019, the Food and Drug Administration (FDA) held its first public hearing concerning products containing cannabis or cannabis-derived compounds (in particular, cannabidiol (CBD), a popular additive to food,...more
6/3/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Hemp ,
Labeling ,
Marijuana ,
Marijuana Related Businesses ,
Marijuana-Infused Edibles ,
Public Comment ,
Public Hearing
President Trump signed the Agriculture Improvement Act of 2018 (popularly known as the 2018 Farm Bill) into law on December 20, 2018. Among the 2018 Farm Bill’s broad-ranging provisions, it legalizes the cultivation and sale...more
1/2/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Controlled Substances Act ,
DEA ,
Enforcement Actions ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Interstate Commerce ,
Marijuana Related Businesses ,
New Legislation ,
Regulatory Oversight
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