All posts by Seth A. Goldberg

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.”

 

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.

 

Will Ban on Flavored Nicotine Encompass THC or CBD Vaping?

Seth Goldberg
Seth A. Goldberg

I have been writing about the recent reports of vaping related deaths and illnesses, and allegations that in some instances cannabis vaping could be a contributing factor, with a focus on the heightened risk of personal injury/product liability lawsuits.  Amidst those reports it is now being reported that the Trump Administration is preparing to ban flavored nicotine products.  Because THC is federally unlawful, it us unlikely that such a ban would explicitly prohibit THC vaping products, but it could include federally lawful hemp-derived CBD vaping. The absence of an explicit reference to THC vaping by the Trump Administration should not be deemed a clear runway for THC vaping manufacturers, as federal prosecutors who have discretion to take enforcement action for public safety concerns may use that power against THC vape manufacturers.   Cannabis vaping manufacturers need to be very mindful of the current climate with respect to vaping. I will continue to monitor and update our Cannabis Industry Blog on this issue.

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.

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.