Seth A. Goldberg, Duane Morris partner and team lead of the Cannabis Industry Group, spoke with Law.com’s Higher Law on the health issues surrounding vaping and implications for the cannabis industry.
Over the last few weeks, numerous media reports have focused on the alleged though unverified link between vaping products and certain health-related issues, including what have been described as “lung illnesses.”
While reactions have surfaced quickly (among them President Trump’s statement this week that his Administration will move to restrict the sale of certain e-cigarettes), the blowback can also be seen in the market, too. According to a new report by Marijuana Business Daily, “since the first vape-related death was reported in late August,” there has been a significant drop-off in purchases of vaping-related cannabis products among consumers in the adult-use cannabis space.
According to the report, based on a study conducted by Seattle-based Headset, the percentage of vaping-related cannabis products in the adult-use (or recreational) cannabis market fell in California from 32.8% (just before the first vape-related death) to 28.9% (as of September 11)–amounting to about a 12% drop in market share. In Colorado, the drop was from 19.5% to 15.4%–a slide of more than 20%. The two other states covered in the study were Nevada, whose drop-off was from 22.3% to 19.2% and Washington, whose drop-off was from 17.8% to 14.6%.
It’s worth noting that the fall of sales in the vaping category appears to have been matched with an increase in sales of other cannabis-related merchandise, including flower and pre-roll products. Further, as the chart contained in the report shows, while the sale of vape-related cannabis products as a percentage of sales does fluctuate from week to week, the recent drop-off reflects a significant departure from the normal ebb and flow.
Finally, all of this comes amidst the CDC’s recent announcement narrowing the parameters of its vape-related health inquiries. Whereas reports last week indicated that the CDC was reviewing 450 possible cases of vaping-related health issues, the CDC’s announcement on Thursday clarified that “[t]here are 380 cases of lung illness reported” and acknowledged that the CDC does “not yet know the specific cause of these illnesses” nor has the inquiry “identified any specific e-cigarette or vaping product (devices, liquids, refill pods, and/or cartridges) or substance that is linked to all cases.”
The past week has shown the challenges that the cannabis industry supply chain—manufacturers, processors, distributors and dispensaries—faces, as regulators target claims relating to the health benefits of CBD and media outlets report, without any scientific evidence, that cannabis vaping may be linked to lung illnesses, and, as of the issuing of this Alert, the Trump administration is reported to be poised to ban flavored nicotine vaping. These kinds of issues could spur claims against cannabis industry participants for consumer fraud, personal injury and products liability, and heighten the scrutiny of cannabis products by federal and state regulators.
On September 10, 2019, the Federal Trade Commission announced that it had sent warning letters to three unidentified businesses “that sell oils, tinctures, capsules, ‘gummies,’ and creams” containing hemp-derived CBD, concerning health-related claims about the benefits of their CBD products. Although the FTC did not release the warning letters or identify the recipients, the FTC’s press release announcing the warning letters explained that the letters were issued to reinforce that “it is illegal to advertise that a product can prevent, treat, or cure human disease without competent and reliable scientific evidence to support such claims.”
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.
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.
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.
On September 4, 2019, the Ninth Circuit issued its ruling in Big Sky Scientific LLC v. Jan Bennetts et al, the case involving the seizure of an interstate shipment of hemp that occurred after the enactment of the 2018 Farm Bill. In a three-page opinion, the court sidestepped the substantive issues presented on appeal and held that the parties should pursue their claims in state court.
In January 2019, a hemp cultivator in Oregon attempted to ship a truckload of hemp to a processor in Colorado. But as the cargo passed through Idaho, the Idaho State Police seized the shipment and arrested the driver, alleging violations of Idaho state law. The Idaho police charged the driver with a crime and filed a civil complaint in state court against the hemp itself. The Idaho civil case was stayed pending resolution of the criminal proceeding.
On August 26, 2019, the Drug Enforcement Agency (DEA) issued a press release announcing “it is moving forward to facilitate and expand scientific and medical research for marijuana in the United States.” This announcement comes in the midst of a growing demand for marijuana for medical and scientific research. Several years ago, in an August 11, 2016, press release, DEA first announced its intention to “expand… the number of DEA-registered marijuana manufacturers” because “only one entity was authorized to produce marijuana to supply researchers in the United States: the University of Mississippi.” Since that announcement, 33 entities have applied to DEA for a marijuana manufacturer registration. However, the approval process was stalled during Attorney General Jeff Sessions’ term in office, and to date no new applications have been approved. Meanwhile, the number of entities registered by DEA to conduct research on marijuana, marijuana extracts or marijuana derivatives has jumped from 384 in January 2017 to 542 in January 2019. Thus, while demand for marijuana for research purposes has increased sharply, the number of suppliers has remained stagnant.
“Credit unions may provide the customary range of financial services for business accounts, including loans, to lawfully operating hemp related businesses within their fields of membership,” says the National Credit Union Administration (NCRU) in its recently released guidance 19-RA-02.
While this is a significant step for hemp businesses seeking banking outlets, it is far from the relief proposed by Secure and Fair Enforcement Act (“SAFE Banking Act”) and does not represent a blanket permission. Still, the NCRU Guidance signals a recognition of the growing Cannabis industry and the practical need to provide financial services to businesses in the industry. Here are some key takeaways.
First, the guidance only applies to Federally Insured Credit Unions, not national banks.
Second, the guidance explicitly relates to credit unions serving “hemp” businesses as defined in the Agricultural Improvement Act of 2018 (2018 Farm Bill), which removed hemp from Schedule I of the Controlled Substances Act. Marijuana remains a Schedule I drug, which restricts banking access of marijuana businesses.
Third, because the USDA has yet to promulgate regulations and guidelines to implement the hemp production provisions of the 2018 Farm Bill, credit unions must ensure members in hemp-related business are operating under the industrial hemp pilot provisions of the Agricultural Act of 2014 (2014 Farm Bill).
Fourth, credit unions that elect to bank hemp-related businesses must maintain robust Bank Secrecy Act (BSA) and Anti-Money Laundering (AML) compliance programs. This includes:
- Maintaining appropriate due diligence procedures for hemp-related accounts and complying with BSA and AML requirements to file Suspicious Activity Reports (SARs) for any activity that appears to involve potential money laundering or illegal or suspicious activity.
- Remaining alert to any indication an account owner is involved in illicit activity or engaging in activity that is unusual for the business.
- Staying on top of state and tribal laws, regulations, and agreements under which each member that is a hemp-related business operates.
- Verifying that the member is part of the pilot program created in the 2014 Farm Bill.
- Adapting ongoing due diligence and reporting approaches to any risks specific to participants in the pilot program.
- Being familiar with any other federal and state laws and regulations that prohibit, restrict, or otherwise govern these businesses and their activity.
In sum, banking hemp-related businesses is permissible for credit unions. But they must be diligent in crafting BSA/AML policies. This is not a complete solution to the existing banking problems facing the Cannabis industry, but it does evidence a growing regulatory desire to provide access for the industry, which could sway policy makers down the road.
 The 2018 Farm Bill defines “hemp” as: “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
At the end of last month, on July 23, 2019, the New York City Council passed two cannabis reform resolutions focused on issues facing parents. These were two resolutions out of ten that were first introduced on February 13, 2019.
The first resolution (Res. No. 740) calls on the New York City Administration for Children’s Services to implement a policy that states that a parent’s mere possession or use of marijuana does not itself create an imminent risk of harm to a child that would serve as the basis for a child’s removal from the parent’s custody.
The resolution cites reports of racial inequity in the enforcement of marijuana laws and identifies NYPD guidance from 2011 that recommends an individual in possession of small amounts of marijuana be issued a court summons instead of being arrested. The Council acknowledged that New York State has legalized medical marijuana and decriminalized the possession of small amounts of marijuana. Given the trend to accept cannabis usage in New York and beyond, the Council passed this resolution, in part, to ensure that the child welfare system is consistent with this emerging acceptance.
The second resolution (Res. No. 746) calls on the New York State Legislature to pass, and the Governor to sign, a law requiring the New York State Department of Health to create clear and fair regulations for hospitals on drug testing pregnant or birthing parents. The resolution states that these regulations should include the requirement for hospitals to inform patients of their rights before discussing drug use or testing with the patient.
The Council stated that the current policy for hospitals allows them to drug test patients who are giving birth and report positive tests to the Statewide Central Register of Child Abuse and Maltreatment (“SCR”), such report would be required if the patient tested positive for marijuana alone. This mandated report triggers a child welfare investigation by the NYC Administration for Children’s Services. Currently, the hospital has discretion over the individuals it chooses to test and it is unclear whether the hospitals are notifying patients that there are potential child welfare ramifications for drug tests and the disclosure of drug history to their health care provider. Similar to the first resolution, the Council is calling on the State to ensure a fair policy for drug testing patients that aligns with the legalization and decriminalization of cannabis.