MENU

Cannabis

CBD AND DELTA-8 THC – UPDATE ON FDA ENFORCEMENT

FDA, Cannabis /

As part of its ongoing enforcement against unlawful cannabis-containing foods and dietary supplements, the U.S. Food and Drug Administration (FDA) has recently posted two new Warning Letters against cannabis marketers: Both Warning Letters cite the marketers for promoting and distributing human and animal foods and dietary supplements containing (or that purport to contain) the cannabinoids […]

CBD AND DELTA-8 THC – UPDATE ON FDA ENFORCEMENT Read More »

Comment Period on First Congressional Bipartisan and Bicameral Request for Information on Cannabidiol Closes

Cannabis /

On August 18, 2023, comments were due to Congress on the bipartisan and bicameral request for information (RFI), which sought written stakeholder comments and analysis to “asses[s] the potential for a regulatory pathway for hemp-derived [cannabidiol (CBD)] products that prioritizes consumer safety and provides certainty to the U.S. market.”   By way of background on

Comment Period on First Congressional Bipartisan and Bicameral Request for Information on Cannabidiol Closes Read More »

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

Agriculture & Agribusiness, Cannabis, FDA, Government Relations /

On Friday, U.S. Food and Drug Administration (FDA) released its first draft guidance on the conduct of clinical trials for psychedelic drugs. The Draft Guidance for Industry, Psychedelic Drugs: Considerations for Clinical Investigations, if finalized, will guide researchers investigating psychedelics as potential treatments for medical conditions.  There has been significant media, marketing, and legislative interest

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs Read More »

Hemp Now Included in Agricultural Technical Advisory Committee (ATAC)

Agriculture & Agribusiness, Cannabis, Government Relations, USDA, USTR /

The United States Department of Agriculture (USDA) will include ‘Hemp’ in the title of one of the six Agricultural Technical Advisory Committees (ATACs) – noting a significant evolution in both agriculture and cannabis policy. Specifically, ‘Hemp’ has now earned a place within the ATAC titled ‘Tobacco, Cotton, Peanuts, and Hemp.’ The ATACs were established under

Hemp Now Included in Agricultural Technical Advisory Committee (ATAC) Read More »

Cannabis Regulatory Update: CBD, The Farm Bill, and The Punt from FDA to Congress

Cannabis, FDA /

Earlier this year, the U.S. Food and Drug Administration (FDA) concluded that existing regulatory frameworks for food and supplements are not appropriate for cannabidiol” (CBD) and the agency will “work with Congress on a new way forward.” Since this announcement, speculation on how FDA and Congress will work to handle the ever-evolving over $9.1 billion

Cannabis Regulatory Update: CBD, The Farm Bill, and The Punt from FDA to Congress Read More »

January Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, Cannabis, FDA /

OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from January that should be highlighted. If you have any questions or would like more information, please do

January Food and Agriculture Regulatory Recap Read More »

The FDA Concludes “Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate” for CBD

FDA, Cannabis /

Today, the United States Food and Drug Administration (FDA) announced their conclusion “that existing regulatory frameworks for food and supplements are not appropriate for cannabidiol,” and the agency will “work with Congress on a new way forward.” This position was announced in a Statement by Dr. Janet Woodcock, Principal Deputy Commissioner, who chairs FDA’s cannabis

The FDA Concludes “Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate” for CBD Read More »

Federal Cannabis Research Bill Signed into Law

Cannabis, Public Policy /

Today, December 2, 2022, President Biden signed into law H. R. 8454 to expand research on cannabidiol and marijuana, and for other purposes which will create cannabis research opportunities for medical cannabis and will protect doctors who advise their patients about medical cannabis. The bill was passed unanimously in both the House and the Senate

Federal Cannabis Research Bill Signed into Law Read More »

FDA’s Woodcock Holds Meeting on Regulatory Pathways for Hemp and CBD

FDA, Agriculture & Agribusiness, Cannabis, Government Relations /

On November 1, 2022, the Principal Deputy Commissioner of the U.S. Food and Drug Administration (FDA) Janet Woodcock had a virtual meeting on “Regulatory Pathways for Hemp Products, including Cannabidiol (CBD)” with representatives of the U.S. Health and Human Services Office of the Secretary and the Executive Office of the President. This meeting was announced

FDA’s Woodcock Holds Meeting on Regulatory Pathways for Hemp and CBD Read More »

SEC Stock Promotion Scheme Charges Against the Cannabis Industry

Cannabis, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing /

In October, the United States Securities and Exchange Commission (SEC) announced that it would be charging two (2) cannabis companies, Emerald Health and HighTimes, and six (6) associated individuals who worked with the companies, for their involvement in “stock promotion schemes.”   Stock promotion schemes are “fraudulent schemes to promote the securities of issuers that were

SEC Stock Promotion Scheme Charges Against the Cannabis Industry Read More »

Federal Cannabis Updates: New Cannabis Policy Expert at FDA and Executive Announcement on Marijuana Reform 

Cannabis, FDA, Government Relations /

At the end of September, the United States Food and Drug Administration (FDA) hired cannabis policy expert Norman Birenbaum as a Senior Public Health Advisor at FDA’s Center for Regulatory Programs. Mr. Birenbaum comes to FDA with a deep background in regulation in several state cannabis departments.  Most recently, in New York State he served

Federal Cannabis Updates: New Cannabis Policy Expert at FDA and Executive Announcement on Marijuana Reform  Read More »

Summary of Senate’s Hearing “Decriminalizing Cannabis at the Federal Level: Necessary Steps to Address Past Harms”

FDA, Cannabis, Food Manufacturing, Processing, and Marketing, Government Relations, Miscellaneous, Public Policy /

On July 26, 2022, the Senate Judiciary Committee’s Subcommittee on Criminal Justice and Terrorism held a hearing on “Decriminalizing Cannabis at the Federal Level: Necessary Steps to Address Past Harms.” The hearing largely addressed the recently introduced S. 4591, “Cannabis Administration and Opportunity Act” (the “CAOA”). The witnesses included: Malik Burnett, Medical Director, Maryland Department

Summary of Senate’s Hearing “Decriminalizing Cannabis at the Federal Level: Necessary Steps to Address Past Harms” Read More »

CAOA Filed in the Senate

Miscellaneous, Cannabis, FDA, Food Manufacturing, Processing, and Marketing, Public Policy /

On Thursday, July 21, 2022, Senators Chuck Schumer (D-NY) Cory Booker (D-NJ), and more officially filed the Cannabis Administration and Opportunity Act (CAOA) (S.4591) to legalize cannabis nationwide. OFW has prepared material on this bill and will be monitoring supplementary announcements and hearings for more information. Please note that OFW has provided other posts on key areas of interest in

CAOA Filed in the Senate Read More »

FDA Issues First Set of Warning Letters to Companies Selling Delta-8 THC

FDA, Cannabis /

On May 4, 2022, the United States Food and Drug Administration (FDA) issued for the first time Warning Letters to companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC). While the FDA has sent warnings to companies utilizing hemp-derived cannabidiol (CBD) before, this is the first set of Warning Letters to those selling delta-8 THC products for

FDA Issues First Set of Warning Letters to Companies Selling Delta-8 THC Read More »

Federal Cannabis Legalization & Regulation: A Timely Discussion of The Mace States Reform Act

FDA, Cannabis, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing /

Background By the end of 2021, ninety-one percent of Americans reported favoring some form of marijuana legalization. To date, eighteen (18) states and Washington, DC, have legalized adult recreational use of marijuana, and thirty-seven (37) states and four (4) territories have medical use programs. More states will likely be expanding access to marijuana with ballot

Federal Cannabis Legalization & Regulation: A Timely Discussion of The Mace States Reform Act Read More »

OFW logo white

We provide legal, regulatory, and advocacy services for clients regulated by FDA, USDA, and CBP.

FIRM
INDUSTRIES
Food & Agriculture
Customs and Trade
Consumer and Commercial Litigation
Cannabis

NEWSLETTER

Subscribe to our newsletter and stay up to date:
Facebook-f Linkedin-in Twitter
Copyright 2020. All rights reserved. Sitemap.
Built and powered by Direction.com​

Industries

Food & Agriculture
Medical Products
Customs and Trade
Consumer and Commercial Litigation
Cannabis

Our Firm

Home
People
About
Contact

Insights

News & Insights
Facebook Twitter Linkedin