News & Analysis as of

Food and Drug Administration (FDA) Federal Food Drug and Cosmetic Act (FFDCA) Farm Bill

Foley Hoag LLP - Cannabis and the Law

Senate Wades Into the Muddy Waters of Intoxicating Hemp

With the persisting uncertainty surrounding the next iteration of the Farm Bill and its treatment of hemp-derived consumable products, perhaps it should come as no surprise that legislators on Capitol Hill have proposed...more

Akin Gump Strauss Hauer & Feld LLP

High Stakes: HHS Shakes Things Up on Marijuana Scheduling and DEA Abides

On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more

Mintz

Rescheduling Madness: Key Takeaways from the Proposed Rule to Reschedule Marijuana under the CSA

Mintz on

Moving marijuana under the Controlled Substances Act (“CSA”) from Schedule I to Schedule III will bring celebrated changes to the beleaguered state-sanctioned cannabis industries currently operating in 37 states, but will...more

Mintz - Health Care Viewpoints

2023: Another Year Chock Full of Challenges for FDA

At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more

Mintz - Health Care Viewpoints

Those Aren’t Doritos: FTC and FDA Send Warning Letters to Companies Marketing Delta-8 Infused Munchies

The Federal Trade Commission’s (FTC) recent press release marks a continuation in government action against manufacturers of products infused with delta-8 tetrahydrocannabinol (delta-8).  In May 2022, the U.S. Food and Drug...more

Lippes Mathias LLP

FDA Regulation of CBD is TBD

Lippes Mathias LLP on

After rounding out 2022 with a series of warning letters to companies selling products containing cannabidiol (“CBD”) the U.S. Food and Drug Administration (“FDA”) began 2023 by issuing a press release announcing its...more

Latham & Watkins LLP

FDA Finalizes Quality Recommendations for Cannabis in Clinical Investigations

Latham & Watkins LLP on

FDA provides recommendations on sources of cannabis in clinical research, resources for information on quality, and control status considerations under the Controlled Substances Act. Key Points: ..The Food and Drug...more

Eversheds Sutherland (US) LLP

FDA says “no” to CBD: Now what?

The FDA’s recent decision not to regulate CBD like a food or dietary supplement leaves a multi-billion-dollar industry in a lurch. What’s next, and what should companies do now?...more

Butler Snow LLP

Half-Baked: An Overview of Current Cannabinoid Laws & Regulations

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Over 50 years ago President Nixon declared a “War on Drugs,” leaving housewives over the country proclaiming marijuana to be the devil’s lettuce and urging sweet Billy to steer clear of the gateway drug...more

Perkins Coie

FDA Issues New Warning Letters to Companies Making CBD and Delta-8 THC Edibles

Perkins Coie on

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

Ward and Smith, P.A.

Delta-8 THC: More Risk than Reward

Ward and Smith, P.A. on

Hemp product producers and sellers must consider a large number of legal and regulatory compliance risks each day.  Are their inputs and plant material coming from legally compliant sources?  Are their products,...more

King & Spalding

FDA Rejects Bids To Market CBD-Based Dietary Supplements

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On July 23, 2021, the U.S. Food and Drug Administration (“FDA” or “Agency”) rejected two New Dietary Ingredient (“NDI”) notifications to market full-spectrum cannabidiol (“CBD”) as part of dietary supplements. This move...more

Foley Hoag LLP

The Not So Weaved Web: The Fate of CBD Products is in FDA’s Hands

Foley Hoag LLP on

More than two years have passed since hemp-derived cannabidiol (CBD) was legalized in the United States under the Agriculture Improvement Act of 2018 (also known as the “Farm Bill”). The Food and Drug Administration (FDA) has...more

Womble Bond Dickinson

Six Things You Need to Know About CBD and Other Hemp-containing Pet Products

Womble Bond Dickinson on

The trend toward state-level legalization of cannabis has led to a surge in cannabis-derived products and a continually evolving market with many types of cannabis products for people as well as their pets. Analysts predict...more

Vicente LLP

Minor Cannabinoids: Exploring the Science, Legality, & Opportunities

Vicente LLP on

While THC and CBD are the two most commonly known and sought-after “major” cannabinoids, several “minor” cannabinoids have been getting a lot of attention lately (we’re looking at you, Delta-8!). Despite the increasing buzz...more

BCLP

Fast Growing CBD Market Continues To Create Regulatory Challenges and Litigation Opportunity

BCLP on

CBD and CBD-containing products are ubiquitous, yet there is significant misunderstanding about their regulatory status. CBD is cannabidiol, one of more than a hundred different active compounds that can be derived from the...more

Fox Rothschild LLP

Labeling Considerations For Cannabis Pet Products

Fox Rothschild LLP on

With the passing of the 2018 Farm Bill, the market for cannabis pet products has rapidly grown. As a result, broad-reaching marketing campaigns highlighting the available products and the claimed benefits have become much...more

Rivkin Radler LLP

Cannabis Investors and Producers Face Need for Due Diligence

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The cannabis industry is growing in leaps and bounds, but entrepreneurs interested in developing cannabis companies – as well as business people interested in investing in them – must make certain that they know what they are...more

Rivkin Radler LLP

Cannabis Investments and Exit Strategies: A Case Study

Rivkin Radler LLP on

It is relatively easy for investors to make investments in cannabis companies. Given the risks, however, they would be well-advised to have an exit plan in the event their investment does not live up to their expectations....more

ArentFox Schiff

TTAB: Hemp Oil Extracts Marketed as Dietary Supplements Are Ineligible for Trademark Registration

ArentFox Schiff on

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

King & Spalding

FDA Releases Progress Report Regarding Enforcement Discretion Policy on Hemp-Derived Cannabidiol (CBD)

King & Spalding on

Last week, FDA submitted a report to Congress detailing the Agency’s progress on developing an enforcement discretion policy (i.e., a policy of not taking enforcement action) on hemp-derived cannabidiol (CBD). At the same...more

Haug Partners LLP

Global Developments and Considerations for Registering Cannabis and Cannabis-Related Trademarks

Haug Partners LLP on

This article discusses the global developments for the registration of cannabis and cannabis-related trademarks in the United States, Canada, Mexico, and the European Union....more

Burns & Levinson LLP

CBD as a Dietary Supplement – A Potential Regulatory Avenue for Retail Hemp Operators Selling THC Extracts

Burns & Levinson LLP on

On January 13, 2020, Representative Collin Peterson, the Chairman of the House Agricultural Committee, introduced a new bipartisan bill, H.R.5587 (Bill 5587), in the U.S. House of Representatives that would potentially...more

Robinson+Cole Health Law Diagnosis

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all of the other applicable...more

King & Spalding

Congress Holds Hearing on Current & Future Federal Cannabis Policies

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On January 15, 2020, the House Energy & Commerce Committee, Subcommittee on Health held a hearing entitled “Cannabis Policies for the New Decade.” Government witnesses testified from: • the Drug Enforcement...more

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