Tag Archives: marijuana

Is this a Trend? A Third Court Stays Class Action Given FDA’s Primary Jurisdiction Over CBD

Seth Goldberg
Seth A. Goldberg

Yesterday, the U.S. District Court for the Eastern District of California stayed the matter styled Glass v. Global Widget d/b/a Hemp Bombs, a consumer class action alleging that Hemp Bombs, which manufactures CBD-infused edibles, tinctures and capsules, falsely advertised the amount of CBD in its gummies, and thereby sold products that were misbranded and adulterated under the Food, Drug & Cosmetics Act (FDCA), on the basis that the regulation of CBD is withing the primary jurisdiction of the FDA, which is in the process of developing regulations and guidance over CBD. We have previously written about two other consumer class actions arising out of similar clams of misbranded CBD products that have also been stayed recently under the “primary jurisdiction” doctrine.

Three decisions staying CBD class actions in two months may signal a trend, especially considering that the Courts in these cases refer to the other’s decisions. Such a trend may keep the plaintiffs’ bar at bay, as it would cast doubt on the viability of consumer class actions asserting CBD violations, or at least it could make the cases less appealing to the plaintiffs’ bar because a stay makes the timing of a settlement or resolution even more uncertain.  

Commercial Litigation in the Cannabis Space: Resolving Disputes Like Every Other Industry Does

Seth Goldberg
Seth A. Goldberg

As a commercial litigator who has handled a broad range of claims in highly regulated industries over the past 20 years — particularly in complex matters such as class actions involving claims brought by consumers and shareholders — and given my experience spearheading the development of Duane Morris’ cannabis industry group, which has included providing regulatory and business advice to a number of businesses and individuals with cannabis-related interests, I have been expecting the maturing cannabis industry to eventually mirror other industries when it comes to using commercial litigation to resolve disputes between businesses and to address claims of injury allegedly experienced by aggreived consumers and shareholders. It appears the time has come. Now, as opposed to even just a few months ago, not a day goes by when the daily legal news outlets that report on litigation matters filed in federal and state courts around the country do not include matters pertaining to adult use marijuana, medical marijuana, and/or hemp.

Today alone, legal news outlets are reporting about a shareholder deriviative action being filed against the manufacturer of cannabinoid-containing transdermal patches, a maker of mobile hemp dryers suing a distributor for alledgedly stealing trade secrets, a publicly-traded company that owns cannabis brands being sued for breach of contract by an MSO arising out of a failed merger agreement. Claims like these are among the many product liability, stock-drop and securities fraud, tradmark infringement, FLSA, and employment litigation matters to be filed in 2020 relating to cannabis; not to mention the federal and state regulatory cannabis-related enforcement actions also commenced. Just as in other industries, COVID-19 is likely to spur litigation in the space because of strains on resources and performance caused by business disruptions and the slower economy.  To be sure, the plaintiffs’ bar has cannabis on its radar.

Thus, now more than ever, it is critically important for cannabis businesses to implement the necessary compliance measures, including making sure appropriate insurance coverage, e.g. premises, products, and D&O, has been obtained, that could protect their businesses from the cost and disruption of commercial litigation. Likewise, cannabis-specific nuances, such as the enforceability of contracts and jurisdictional questions, require careful evaluation by experienced counsel advising plaintiffs and defendants who are considering filing, or who have been brought into, a commercial litigation.

 

 

FDA’s CBD Enforcement Continues

Seth Goldberg
Seth A. Goldberg

On April 20, the FDA issued warning letters to two CBD companies – BIOTA Biosciences and Homero Corp., dba Natures CBD Oil Distribution – directing them to remove statements from their labeling and advertising on websites and social media claiming that CBD can cure opioid addiction among other illnesses.   I am attaching the FDA’s warning letter, as it provides very useful information to the market as to the FDA’s current views of CBD products.  As set forth in the warning letter, the FDA continues to view CBD as (1) an unsafe food additive; (2) not satisfying the definition of a “dietary supplement,” and (3) as unapproved new drugs if marketed as “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.”  In the case of Homero, the CBD products were advertised with the following claims, among others:

  • “Natures Pure CBD Oil has been effective in the treatment and eradication of opiate use.”
  • “CBD Oil Inhibits the reward-facilitating effect of morphine”
  • “Vaping CBD Oil to Treat Asthma . . . Your best best [sic] to combat Asthma is by vaping CBD Oil.”
  • “Natures Pure CBD is a strong anti-oxidant that can alleviate lower epileptic seizures, psychotic disorders, and has neuroprotective qualities.”

 

Essential Yet Illegal: COVID-19 Shows Fed Cannabis Policy is Unsustainable

Seth Goldberg
Seth A. Goldberg

Although the cannabis reform movement has made incredible strides over the past 25 years, our industry and the medicinal potential of the plant are still not recognized at the federal level. The COVID-19 pandemic is drastically altering our lives but difficult times are able to expose many truths, including the understanding that legalization and safe access to cannabis is critical, especially during a crisis.

Thankfully, many states already have come to the realization that cannabis, especially medicinal use, is not a luxury but a necessity. Although states are restricting access to public places and prohibiting gatherings, many governors have designated cannabis dispensaries as an “essential service.” […]

“Opponents of federal legalization are likely to argue the categorization was merely a natural extension of the law in states that have already legalized medical marijuana to treat certain conditions, and that the uniqueness of the COVID-19 situation limits the ‘essential’ designation to that very urgent and unprecedented fact pattern,” Seth Goldberg, attorney and partner at Duane Morris LLP told mg.

To read the full text of this article, please visit the mg website.

NJ Legislators Opt to allow Voters to Decide on Cannabis Legalization in NJ instead of Legislating such a Change – Brad A. Molotsky, Esq. – Duane Morris LLP

New Jersey’s top lawmakers have decided to let voters decide on legalization of cannabis during the 2020 presidential elections.

The constitutional amendment introduced today, November 18, 2019, by Senate President Stephen Sweeney and Senator Nicholas Scutari would legalize the use of recreational marijuana for anyone at least 21 years of age, and establish a Cannabis Regulatory Commission to oversee the new market.

The amendment does NOT detail the taxation rate, which was $42 an ounce in the original bill. It is also not clear if the commission will have 5 members, like the original bill.

According to NJBiz., Gov. Phil Murphy and legislative leadership long-resisted pursuing legalization via a ballot question because any, inevitable, changes to the program would have to go before voters in yet another ballot referendum.

“We made further attempts to generate additional support in the Senate to get this done legislatively, but we recognize that the votes just aren’t there,” reads the joint statement from Sweeney, D-3rd District, and Scutari, D-21st District.

To appear on the 2020 ballot as a constitutional amendment, both houses would need to pass the measure by a super-majority by the summer, or they would need to pass it 2x in both houses by a simple majority for 2 years in a row.

Just hours earlier, several progressive and social justice groups made a plea to legislative leadership to push through a legalization bill, pointing to a growing increase in low-level cannabis offenses which have disproportionately affected people of color.

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.