Tag Archives: marijuana

USDA Issues Regulatory Framework for Hemp Production Under 2018 Farm Bill

Seth Goldberg
Seth A. Goldberg

The long awaited regulations establishing a regulatory framework under the 2018 Farm Bill passed last December were issued today (10/29/19).  An Interim Final Rule will be published in the Federal Register later this week, which will make the U.S. Domestic Hemp Production Program effective.   As explained in the Interim Final Rule: “The program includes provisions for maintaining information on the land where hemp is produced, testing the levels of delta-9 tetrahydrocannabinol, disposing of plants not meeting necessary requirements, licensing requirements, and ensuring compliance with the requirements of the new part.”  USDA has published the Interim Final Rule and Guidelines for Sampling and Guidelines for Testing pursuant to the Interim Final Rule on its website.

Among other key provisions, the new regulatory framework provides for USDA’s approval of State and Tribal Land hemp programs established under the 2018 Farm Bill, which will end debate as to whether hemp activities in a State or Tribal Land receiving such approval are federally lawful.  To be approved, those plans will have to contain stringent requirements for testing the THC content of hemp to ensure it does not meet the definition of marijuana, and contain procedures for the enforcement of violations of the State or Tribe’s hemp program.  Importantly, the regulatory framework provides for USDA’s granting of hemp production permits in states and territories that do not establish hemp programs for approval by USDA.

Duane Morris attorneys will be publishing a more fulsome review of the Interim Final Rule.  Please visit our Alerts and Updates webpage, or our cannabis industry webpage for that information.

 

Oregon Court Stays Ban of Flavored E-Vaping Products

On September 26, 2019, the Oregon Health Authority (OHA) issued a public health warning to Oregon citizens “urging people to immediately stop using all vaping products.”  Shortly thereafter, on October 3, 2019, Gov. Kate Brown issued Executive Order 19-09.  EO 19-09 directed the Oregon Health Authority and the Oregon Liquor Control Commission (OLCC) to adopt emergency rules banning the sale of all flavored vaping products for 180 days.

In response, on October 11, 2019, the OHA and OLCC issued temporary rules that banned all flavored vaping product sales in the state.  In a statement announcing the emergency rules, the agencies explained that “[t]he ban covers all tobacco and cannabis (marijuana and hemp) vaping products that contain natural or artificial flavors . . . [t]obacco-flavored tobacco or nicotine products, as well as marijuana-flavored marijuana or THC products that use only marijuana-derived flavorings, including terpenes, are not included in the ban.”  The ban was set to take effect on October 15, 2019, and last for six months.

However, a group of vaping-related businesses filed suit in Oregon state court, seeking judicial review of the emergency rule.  On October 17, 2019, the Oregon Court of Appeals issued an Order that temporarily stayed the enforcement of these rules, pending the court’s ultimate decision on the matter.  Vapor Technology Association, et al. v. Oregon Health Authority, No. A172417 (Or. Ct. App., Oct. 17, 2019).

This stay comes just days after a Michigan court issued a preliminary injunction to prohibit a similar emergency ban from taking effect.  Over the past several weeks states throughout the country, including Rhode Island, Washington, and Montana have issued similar bans on flavored vaping products. New York’s contemplated ban on menthol-flavored nicotine vaping products was put on hold following a temporary stay on the ban issued by a court. These recent court decisions staying and enjoining such bans indicate that additional challenges may be forthcoming in those jurisdictions and any others that institute similar bans.

Cannabis Vaping Health Claims Should Be Taken Seriously by the Cannabis Product Supply Chain

Seth Goldberg
Seth A. Goldberg

Yesterday, I blogged about a Washington Post article that reported that vitamin E acetate in marijuana vaping products is being considered as possibly being linked to alleged vaping related lung injuries.  I cautioned cannabis manufacturers, processors and dispensaries, i.e., the cannabis supply chain, that articles like WP’s, which referred to vitamin E acetate in cannabis vapor as a “contaminant,” could be the impetus for product liability lawsuits.

Today, WP provided an update to yesterday’s article.  WP now states as many as 450 vaping illness cases have been reported across 33 states.  Up from yesterday’s report of 250 cases across 25 states.  WP’s new article refers to the vaping related health claims as possible a “new lung disease” based on a study by the New England Journal of Medicine that reports about a possible lung disorder being experienced by certain consumers of vape.    However,  WP appears to acknowledge  scientists have not yet identified a specific chemical in vape, or whether vaping of nicotine or marijuana, is resulting in an increased risk of the lung disorder reported by NEJM.  Indeed, scientific research and investigation is needed in this area.

Nevertheless, as I explained yesterday, having represented pharmaceutical companies in product liability matters involving alleged “contaminants,” product liability lawsuits are often, if not usually, filed without any scientific proof of injury causation.   Accordingly, the cannabis supply chain should be careful to ensure the safety of their products, and implement necessary compliance measures.

Likewise, cannabis consumers should be mindful that many of the reports of vaping related health issues concern “black market” vape products, not those manufactured by state-licensed cannabis companies who are required by law to maintain strict standards for their products.

 

Will Cannabis Vaping Lead to Products Liability Lawsuits?

Seth Goldberg
Seth A. Goldberg

Today, the Washington Post reported that federal and state regulators have identified the chemical vitamin E acetate as being contained in certain cannabis vaping products allegedly linked to lung injuries.  According to WP,  215 cases possibly arising out of cannabis vapes containing the chemical have been reported in 25 states, and two deaths have been linked to marijuana vaping.

WP refers to vitamin E acetate in cannabis vapor as a “contaminant,” which is a loaded term that could get the attention of the plaintiffs’ product liability bar.   Articles like this are often the impetus for lawsuits to be filed.  Consequently, products’ liability claims may soon become a reality for the cannabis vape supply chain.

However, as even the WP article makes clear, whether vitamin E acetate in marijuana vapor can cause an increased risk of injury of any kind to vaping consumers is being investigated, and has not been proven.   The article also identifies the fact that many users of marijuana vape also vape nicotine, which is likely one of many confounding factors.  Thus, product liability claims asserting injuries from marijuana vaping brought now are likely to be unsupported by science.

Nevertheless, those in the cannabis supply chain, e.g., manufacturers, processors, and sellers,  should be aware of the likelihood of such claims, as product liability claims are often asserted without any scientific evidence of causation.   Those in the supply chain should know that a range of compliance measures can be implemented to better protect against against such claims.

After Legalization: Many Remain Imprisoned For Now-Legal Pot

Neville BilimoriaImagine for a moment that you are arrested for alcohol possession back when alcohol was illegal. Then, imagine you served a sentence in prison for that possession, perhaps an inordinately severe incarceration sentence. Then imagine that you get out of prison and find it almost impossible to find a job, find housing or obtain a loan due to your criminal record. Then imagine, to make things worse, that alcohol is now legal, yet you are still saddled with this criminal history which leaves you no room for social advancement.

Imagine also that in spite of your lack of chances to obtain a job, that the very illegality you were arrested for not only becomes legal through legislation, but also fosters a burgeoning industry in the prohibited substance, primarily by nondiverse corporate entities and persons. Sounds a little bit like a nightmare, but that is exactly the scenario that is developing around cannabis and medical cannabis across the country.

To read the full text of this article written by Duane Morris attorney Neville M. Bilimoria, please visit the Duane Morris website.

FDA Issues Warning Letter to Curaleaf about CBD Products

Seth Goldberg
Seth A. Goldberg

On July 22, the FDA issued a Warning Letter to Curaleaf with regard to Curaleaf’s “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape.”  The Warning Letter explains FDA’s view that Curaleaf’s CBD products are effectively “unapproved new and misbranded human drug products” because the claims Curaleaf has made about them on Curaleaf’s website and social media accounts demonstrate “they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body,” but Curaleaf has not obtained prior approval from the FDA to market them as such.  The Warning Letter also explains the FDA’s view that the subject products are not “dietary supplements” because (i) CBD has already been approved as an active pharmaceutical ingredient (epidiolex), (ii) CBD was not marketed as a dietary supplement or a conventional food prior to such FDA approval of CBD as an API; and (iii) the subject products are not “intended for ingestion,” which is a requirement of a dietary supplement. The FDA also warned about Curaleaf’s products with respect to animals, which I have not summarized.  The FDA provided Curaleaf 15 days to establish a corrective action plan and to report such plan to the FDA.  The Warning Letter demonstrates the FDA is actively monitoring CBD manufacturer websites and social media for over the line claims, and that CBD manufacturers need to follow the FDA’s guidance given the unsettled regulatory structure with respect to CBD.

 

 

CBD’s Big Week – Now Walgreens to Sell in Select States

Seth Goldberg
Seth A. Goldberg

Last week, I wrote about CVS Pharmacy’s decision to sell hemp-derived CBD products in eight states, Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee.  Today, one of its competitors, Walgreens announced a similar decision – Walgreens will be entering the hemp-derived CBD space Walgreens in Oregon, Colorado, New Mexico, Kentucky, Tennessee, Vermont, South Carolina, Illinois and Indiana, where it will sell CBD creams, patches and sprays in nearly 1,500 stores.

As with CVS, Walgreen’s decision to sell hemp-derived in CBD in select states, as opposed to rolling those products out nationally, is likely the result of the still developing federal regulatory framework for hemp, which includes forthcoming regulations and guidance from USDA and FDA, and differences in the laws pertaining to hemp and hemp-derived CBD products from state-to-state.

Notwithstanding the challenging regulatory environment, the mass marketing of hemp-derived CBD, now that hemp is no longer a federal controlled substance, provides a lucrative opportunity for the hemp-derived CBD supply chain – cultivators, processors, and retailers, including the major pharmacy chains.  However, the “select state” approach Walgreens and CVS have taken demonstrates that careful is analysis of the federal and state laws and regulations at play is necessary before entering the hemp-derived CBD market.

 

The Light is Still Yellow, but Hemp-Derived CBD Hits The Mass Market

Seth Goldberg
Seth A. Goldberg

CVS Pharmacy’s announcement  that it will be selling hemp-derived CBD topicals, including creams, sprays, roll-ons, lotions and salves in Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee, should really come as no surprise, as the mass marketing of CBD has been an eventuality since hemp was removed from the Controlled Substances Act’s definition of marijuana with the signing of the 2018 Farm Bill in December 2018.  CBD’s therapeutic benefits, without the psychoactivity of THC, have made products containing CBD the darling of the cannabis industry.

However, as CVS’s decision to market hemp-derived CBD products in select states demonstrates, the 2018 Farm Bill was not a total green light.  USDA has yet to establish regulations fully implementing the federal hemp program, which would allow states to establish their own rules for cultivation, processing and sale of hemp, meaning state-by-state differences in the laws concerning cannabis, including hemp, must be assessed before marketing products like hemp-derived CBD.  Such federal regulations should be promulgated later in 2019, ahead of the 2020 growing season.

In addition to USDA, FDA has authority over CBD-containing products under the Food, Drug and Cosmetics Act, adding another layer of regulatory complexity that makes the 2018 Farm Bill’s removal of hemp from the CSA more of a yellow light for marketing hemp-derived CBD. Thus, manufacturers and distributors of CBD products must assess how CBD fits in with FDA and state rules concerning drugs and drug approvals, active pharmaceutical ingredients, health claims and labeling, and foods and beverages. FDA has said it is evaluating CBD closely, and should be providing guidance later in 2019.

Because the light is still yellow on the marketing of hemp-derived CBD, manufacturers and distributors should carefully evaluate the federal and state regulatory framework before marketing their CBD products.

Gotham Green makes $250M investment in Medmen – Brad A. Molotsky, Esquire

Per MJBiz, MedMen, a California-based multistate marijuana operator, will receive an investment of up to $250 million from private equity fund Gotham Green Partners (GGP).

The investment – a convertible credit facility – is believed to be the largest to date by a single investor in a publicly traded cannabis company with U.S. operations.

The money will go toward a number of corporate activities, including potential acquisitions, investment in technology and increased cultivation and production, MedMen said.

“More than having adequate growth capital to fund all of their current operational needs (and eliminating the lingering overhang of future tag on offerings), we believe the GGP investment comes with many lateral strategic benefits, as they are the preeminent investor across the cannabis supply chain,” Paul Penney, managing director at Northland Securities, wrote in an email to Marijuana Business Daily.

After the news, MedMen, which trades on the Canadian Securities Exchange as MMEN, saw its stock rise more than 6% over its price at close the previous day.

-Brad A. Molotsky, Esquire, Duane Morris