Vicente Sederberg LLP Hemp Update: May 2022
May 27, 2022
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Federal Appeals Court Rules That Delta-8 THC is Legal Based Upon the Facts Presented in the Case
A California federal appeals court ruled last week that delta-8 THC and other cannabinoids derived from hemp are legal under the 2018 Farm Bill, even if the substances have psychoactive properties.
VS partner Shawn Hauser said to Forbes, “Congress clearly did not intend to legalize marijuana/intoxicating consumer products through hemp legalization and tasked FDA with finished product regulation. However, the legalization of hemp allowed businesses to develop and innovate novel cannabinoids, including many beneficial consumer products—and in the FDA’s absence—this has included developing intoxicating cannabinoids through legal hemp derivatives, arguably legalizing marijuana. What is glaringly obvious from this case and the continued consumer market, innovation and product development arising out of hemp legalization is that Congress needs to legalize and regulate all cannabis.”
FDA Announces Public Advisory Committee Meeting
The FDA will hold a virtual public advisory committee meeting of the Science Board on June 14, 2022, from 9 a.m. to 4 p.m. ET. to “consider challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids, as a case study.”
Make your voices heard! Industry stakeholders have the opportunity to present data via written submissions until June 7. This is your opportunity to provide data relevant to CBD and other cannabinoids.
If you need assistance putting together your position and comments, VS’s hemp team is here to help. Contact Shawn Hauser.
FDA releases NDI Enforcement Discretion Draft
The FDA released draft guidance outlining a proposed policy of enforcement discretion regarding the late submission of new dietary ingredient (NDI) notifications. Upon the release of a finalized guidance, companies will be able to electronically submit late NDIs to the agency for a set period (currently 180 days in the draft guidance) without penalty.
FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products
On May 4, 2022, the FDA issued five warning letters to companies for selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has issued warning letters specifically for Delta-8 products.
Consistent with the FDA's approach to CBD and other hemp products, the agency prioritized its limited resources to enforce against companies illegally marketing by making unlawful drug claims. In the warning letters, the FDA cites violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and core consumer protection laws, such as misbranding and adulteration. Read this VS Insights article from Michelle Bodian for key takeaways from these warning letters.
FDA Warns Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals
On May 26, 2022, the FDA issued four warning letters to companies allegedly selling unapproved animal drugs containing CBD that are intended for use in food-producing animals. “The FDA is concerned about these CBD products for food-producing animals not only because CBD could pose a safety risk for the animals themselves, but also because of lack of data about the safety of the human food products (meat, milk and eggs) from the animals that have consumed these CBD products.” Read more.
FDA Commissioner Admits Agency Has Been Slow To Regulate CBD, But Suggests Congress Needs To Do More
Speaking to a congressional panel on Thursday, the head of the FDA that his agency has taken little regulatory action on CBD products in recent years despite the federal legalization of hemp and its derivatives. He stated The bulk of FDA funds spent on cannabidiol so far “has been spent on research to figure out what the risks, if any, are of various uses of this material in its different forms.” Read more here.
U.S. Rep. James Comer Requests Hearing on CBD Regulations
Longtime hemp champion and Ranking Member of the U.S. House Committee on Oversight and Reform, Rep. James Comer (R) is calling for his committee to hold a hearing to examine the failure of the FDA to develop a regulatory regime to oversee the sale of hemp-derived extracts such as CBD.). The hearing would engage the FDA to explain how it plans to resolve the serious issue of mislabeled CBD products. Read the letter here.
Why the DEA Hemp Rule Challenge Really Matters
Check out this blog post for some great insight into why the HIA v DEA lawsuit we are working on really matters. Hint: there is a lot more at stake in this case than the court siding with HIA and striking down the DEA hemp rule. There are implications not just for the hemp industry, but for the entire citizenry.
New Study Demonstrates CBD’s Strong Safety Profile, Amplifies Calls for FDA Regulation
A comprehensive safety study involving 1061 participants recently confirmed prior research that orally-ingested CBD has a strong safety profile. Results indicate that daily consumption across typical CBD retail products and serving sizes is not associated with elevated liver tests, low testosterone levels, or daytime drowsiness. Importantly, these results renew calls from the hemp and CBD industries urging FDA to take steps to regulate CBD now, and call on Congress to act (by passing HR 841, HR 6134 and S. 1698) if the FDA continues to delay. View the full release from U.S. Hemp Roundtable here.
Grain & Fiber Hemp Exemption Campaign Needs Your Help!
Producers who choose to grow hemp for grain and/or fiber purposes are at very low (if any) risk of harvesting an illegal crop. Therefore, federal law should not mandate testing and instead enforce reasonable programs that require harvest designation and visual inspection of hemp fields, both of which are far less burdensome to the American farmer.
The Grain & Fiber Exemption Campaign hopes to create an exemption framework for grain and fiber industrial hemp. Learn more about the campaign at https://www.hempexemption.com/
- Draft legislation and pass a bill creating an exemption for industrial hemp grain & fiber
- Educate lawmakers about the need for exemptions and opportunities with grain & fiber
- Secure bipartisan support for the exemption framework
- Unite and mobilize advocates!
California AB-45 Update! CDPH Publishes Proposed Emergency Regulations and FAQ Update for Hemp Manufacturers
On April 27, 2022, the California Department of Public Health (CDPH) published proposed emergency regulations detailing the registration requirements and annual fees for hemp extract and hemp products manufacturers. CDPH is accepting public comments through May 31, 2022. Please contact a member of the VS California team if you would like assistance in submitting public comments.
Additionally, the CDPH updated its FAQ to remove the prohibition on the importation of final form hemp products from other states to California and to clarify that no registration is required for out-of-state manufacturers of final form products. Read this VS Insights post from Andrea Golan for more details.
State lawmakers passed Senate Bill 22-205 on the final day of the legislative session, following months of debate. The measure establishes a task force to recommend an appropriate regulatory framework for intoxicating cannabinoids, and it authorizes the Colorado Department of Public Health to promulgate rules to prohibit the production of unsafe chemical modification, conversion, or synthetic derivation of intoxicating hemp products (such as delta-8 and delta 9 THC). It also appropriates funds for enforcement and includes provisions aimed at protecting consumers against deceptive marketing and trade practices. Read this article for more details, including quotes from VS partner Christian Sederberg. Additional reading: Clearing the Air: VS’s Position on Intoxicating Hemp Products, written by Shawn Hauser.
Law enforcement raided Topeka, KS CBD shops in an effort to seize illegal products. Each business visited by the Shawnee County Sheriff’s Office were served cease and desist notices calling for the immediate stop to the sale of all Delta-8, Delta-9 and Delta-10 THC products. Read more here.
148 hemp cultivators in New York state have been licensed to grow cannabis under the conditional cultivator license.
Originally seeking to ban Delta-8 THC, House Bill 1927 was amended with language to instead regulate the compound. If the bill passes, it would prohibit the sale of Delta-8 THC (and Delta-10, THCo) products to anyone under 21 years old, impose a 5% tax on the products, and require businesses manufacturing or selling the products to be licensed, and requires specific packaging and labeling. The Senate bill has not amended their bill.
State-by-State Hemp & Cannabinoid Compliance Guide
VS’s State-by-State Hemp & Cannabinoid Compliance Guide is an affordable, easy-to-use compliance solution to help your business navigate the ever-changing regulatory environment of hemp-derived products. Take the guesswork out of ensuring compliance with all aspects of selling hemp-derived products in different states—from packaging and labeling, to testing, distribution, and more.
Request a complimentary consultation with an attorney to discuss a customized package that best fits your needs.
UK Extends CBD Food Deadline After Complaints
The UK’s Food Standards Agency (FSA) has reopened the window for CBD companies to submit food safety applications as some stakeholders continue to question the credibility of the certification process. The new deadline is May 26, 2022. (The original deadline was March 31, 2021.) Read more here.
INCBA Cannabis Law Institute
June 11 | 10:40 a.m. ET | Washington, DC
Emerging Cannabinoids: Unique Legal and Regulatory Issues; Featuring: Shawn Hauser
This panel at INCBA’s Cannabis Law Institute will cover the rapidly expanding market for cannabinoids other than CBD, including intoxicating cannabinoids from hemp. We will discuss the cannabinoids most likely to emerge on the market and describe how they are produced, marketed, and their effects on humans. Panelists will review the unique legal and regulatory issues that emerging cannabinoids present to lawyers and strategies for addressing them. Throughout this presentation, the experts will engage substantively with each other about differences in opinions in an effort to tease out nuanced, often overlooked, and unsettled areas of law. Learn more and register here!
ACI-CRN Legal, Regulatory, and Compliance Forum on Dietary Supplements
June 29 | 3:30 p.m. ET | New York, NY
Solving the CBD Stalemate; Featuring: Shawn Hauser
It has been over 3 years since the passage of the 2018 Farm Bill that legalized the production and sale of hemp, and we are still not any closer to finding a legal path forward for hemp-derived CBD as a dietary supplement ingredient. This panel will look at current state and federal activity and how the industry, legislators, and regulators can move forward. Register here!
Webinar Replay | Intoxicating Cannabinoids: The Science & the Law
Watch this recorded session for a timely discussion exploring intoxicating hemp-derived products. Panelists from a cannabis business, a hemp and dietary supplement company, a scientist, and an FDA regulatory attorney discuss how “intoxicating” consumer products are generally regulated, how these principles may be applied to cannabis, what the science says, and the potential future regulatory landscape for these intoxicating hemp-derived products.
Contact our hemp team with any questions.