In January, the United States Court of Appeals for the Tenth Circuit issued a published opinion in Serna v. Denver Police Department, No. 21-1446 (10th Cir. Jan. 24, 2023), upholding the dismissal of a hemp farmer’s lawsuit...more
With the approval of the modified mifepristone Risk Evaluation and Mitigation Strategy (REMS), it has been a momentous few weeks in the reproductive health legal space.
Modification to the REMS for Mifepristone...more
On December 20, 2022, the US Senate unveiled the long-awaited federal omnibus spending bill. The US House of Representatives passed—and President Biden signed—the bill three days later, which will keep the federal government...more
The Medical Marijuana and Cannabidiol Research Expansion Act (MMCREA) became law last Friday. The bipartisan legislation will roll back federal restrictions on medical marijuana research and the cultivation of research-grade...more
12/8/2022
/ Cannabidiol (CBD) oil ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Federal Register ,
Food and Drug Administration (FDA) ,
Marijuana ,
Marijuana Cultivation ,
Medical Marijuana ,
National Institute of Health (NIH) ,
SAFE Act
On November 18, 2022, a collection of organizations and providers that oppose abortion filed suit against the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS), seeking — among...more
On September 27, 2021, a substantive amendment was approved by the Department of Cannabis Control (DCC) in an emergency rulemaking action. In addition to clarifying ambiguities in the preexisting regulations and other...more
On March 31, 2021, New York Governor Andrew Cuomo signed the Marijuana Regulation and Taxation Act (MRTA) into law, legalizing adult-use cannabis in the state and establishing a regulatory framework to govern what likely will...more
On March 31, 2021, New York Governor Andrew Cuomo signed the Marijuana Regulation and Taxation Act (MRTA) into law, legalizing adult-use cannabis in the state and establishing a regulatory framework to govern what likely will...more
6/11/2021
/ Cannabis-Related Businesses (CRBs) ,
Criminal Justice Reform ,
Decriminalization of Marijuana ,
Dispensaries ,
Distributors ,
Fees ,
Licenses ,
Marijuana Cultivation ,
Marijuana Regulation & Taxation Act (MRTA) ,
Medical Marijuana ,
New York ,
Recreational Use
In this installment of Arent Fox’s Cannabis Counsel Cast, Partners Emily M. Leongini and Lynn R. Fiorentino discuss a recent proposal to require new Prop 65 warnings for cannabis products that expose consumers to THC and/or...more
As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in...more
Advertising cannabis products along California’s interstate highways, briefly lived, is now significantly restricted.
On January 21, 2021, the California Bureau of Cannabis Control (BCC) released a notice explaining that,...more
In our first Cannabis Counsel Cast episode, Partners Emily Leongini and Lynn Fiorentino discuss the potential impact of California’s Prop. 65 on manufacturers, distributors, and sellers of cannabis products, particularly in...more
1/4/2021
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Distributors ,
Hemp ,
Hemp Related Businesses ,
Manufacturers ,
Marijuana ,
Product Labels ,
Proposition 65 ,
Retailers ,
Sellers ,
Warning Labels
Cannabis and cannabis resin, formerly classified on the most restrictive schedule under the 1961 Single Convention on Narcotic Drugs (Single Convention) were moved to the least restrictive schedule following a historic vote...more
Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a...more
On August 21, 2020, the Drug Enforcement Administration (DEA) published an interim final rule (IFR) to implement hemp-related amendments to the Federal Controlled Substances Act (CSA) that were made by the Agriculture...more
The United States Trademark Trial and Appeal Board (TTAB) recently affirmed a refusal to register a trademark for “hemp oil extracts” when used as an ingredient in dietary supplements, finding that the applicant could not...more
For years, regulators, industry, and lawmakers alike have sought to modernize the regulatory framework under which most over-the-counter (OTC) drugs are marketed in the US. With the enactment of the Coronavirus Aid, Relief,...more
On March 23, 2020, the US Drug Enforcement Administration (DEA) issued a proposed rule that, if finalized, would establish processes by which individuals and entities could apply to DEA to lawfully grow marijuana. The...more
The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US. In response, the US Food and Drug Administration (FDA) and the US Treasury Department’s...more
As we reported earlier this week, in an effort to increase the domestic supply of hand sanitizer, the US Food and Drug Administration (FDA) recently announced policies that temporarily relax certain requirements for the...more
California’s Safe Drinking Water and Toxic Enforcement Act of 1986, more frequently referred to as Prop 65, requires businesses whose products reach California consumers to notify consumers about the presence of certain...more
3/10/2020
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Disclosure Requirements ,
Manufacturers ,
Marijuana ,
OEHHA ,
Product Labels ,
Proposition 65 ,
Safe Drinking Water Act ,
Safe Harbors ,
Toxic Chemicals ,
Warning Labels
This new action by EPA follows its Federal Register notice in August 2019, announcing receipt of 10 applications seeking to expand the permitted use of previously-registered pesticides to include hemp. Although not required...more
If enacted, the law would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to require cosmetic products labeled as “natural” to contain at least 70 percent natural substances, (excluding water and salt) and be made...more
On October 31, 2019, the US Department of Agriculture (USDA) published its eagerly anticipated interim final rule governing the domestic production of hemp, pursuant to the Agriculture Improvement Act of 2018 (commonly...more
11/6/2019
/ Agricultural Sector ,
Cannabis Products ,
Comment Period ,
Controlled Substances Act ,
DEA ,
Farm Bill ,
Hemp ,
Interim Rule ,
Laboratories ,
Licensing Rules ,
Regulatory Requirements ,
Reporting Requirements ,
Testing Requirements ,
Tribal Governments ,
USDA
With the news media covering the link between marijuana vaping, deaths, and lung conditions, California’s push to add THC to the Proposition 65 harmful chemicals list could mean financial, legal, and reputational challenges...more