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 world changed in 2020. Many of the activities formerly conducted in person now occur remotely and will likely occur remotely for the foreseeable future. This includes depositions, interviews, and other forms of testimony....more
DOJ Attorney’s House Testimony: Industry “Unpopular” With Attorney General Barr -
The federal government does not generally enforce the Controlled Substances Act (CSA) in states that have legalized cannabis, unless...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
California’s Office of Environmental Health Hazard Assessment (OEHHA) added ?9-tetrahydrocannabinol, better known as “THC,” to the list of chemicals requiring specific labeling for retail sale in California. Proposition 65,...more
2/15/2020
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Disclosure Requirements ,
Manufacturers ,
Marijuana ,
OEHHA ,
Product Labels ,
Proposition 65 ,
Safe Drinking Water Act ,
Safe Harbors ,
Toxic Chemicals ,
Warning Labels
The Department of Justice (DOJ) recovered more than $3 billion in settlements and judgments from civil cases involving the False Claims Act (FCA) in the fiscal year ending September 30, 2019, according to statistics released...more
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
Late last month, the U.S. House of Representatives passed H.R. 595, the Secure and Fair Enforcement Banking Act of 2019 (the “SAFE Banking Act”). The stated purpose of the SAFE Banking Act is to “increase public safety by...more
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
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
From 2010 to 2015, the Antitrust Division of the U.S. Department of Justice filed criminal charges against more than 120 corporations and more than 350 individuals, and collected fines and penalties of more than $8 billion....more
3/26/2019
/ Antitrust Division ,
Antitrust Violations ,
Cartels ,
Corporate Counsel ,
Corporate Misconduct ,
Criminal Investigations ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FBI ,
Search Warrant ,
White Collar Crimes
The legal Canadian cannabis industry is booming, and U.S. companies can benefit from the prospering cross-border industry by partnering with Canadian companies. However, U.S. Customs and Border Protection (CBP) cannabis law...more
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
In recent guidance, we wrote about what companies should do to minimize the risk of federal criminal penalties when doing business with or investing in cannabis industry companies. One principle we stressed is the need to...more
6/13/2018
/ Decriminalization of Marijuana ,
Department of Justice (DOJ) ,
Due Diligence ,
Federal Land ,
Federal v State Law Application ,
Law Enforcement ,
Legislative Riders ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Medical Marijuana
For many companies, protecting intellectual property is a significant concern made more difficult in recent years by the persistent efforts of foreign agents to steal valuable trade secrets. Analysis of public sources...more
The International Consortium of Investigative Journalists (ICIJ), collaborating with German newspaper Süddeutsche Zeitung, in spring 2016 began leaking approximately 11 million internal documents obtained without permission...more
8/11/2016
/ Banking Sector ,
FBAR ,
Financial Institutions ,
Foreign Trusts ,
Money Laundering ,
Mossack Fonseca ,
Offshore Funds ,
Panama Papers ,
Penalties ,
Popular ,
Shell Corporations ,
Tax Haven
Recently, John C. Cruden, DOJ’s Assistant Attorney General in charge of the Environmental and Natural Resources Division (ENRD), which oversees DOJ’s environmental litigation, voiced a heightened commitment to enforcing...more
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