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.

Michigan Court Issues Preliminary Injunction Prohibiting State’s Emergency Ban of Flavored Nicotine Products From Taking Effect

By Joe Pangaro, Associate, and Jessica Linse, Law Clerk, Duane Morris LLP

On September 18, 2019, Michigan became one of the first states to impose a ban on flavored e-cigarettes. The Michigan Department of Health and Human Services (“MDHHS”) issued emergency regulations that stated, in part, that a retailer shall not “[s]ell, offer for sale, give, transport, or otherwise distribute, nor possess with intent to sell, give, or otherwise distribute a flavored nicotine vapor product.” The ban went into effect immediately upon the release of the emergency regulations and was supposed to last for six months.

Shortly thereafter a local vape shop owner filed suit in state court against MDHHS, Governor Gretchen Whitmer, and the State of Michigan seeking a preliminary injunction to prevent the emergency rules from going into effect.  See Marc Slis, et al. v. State of Michigan et at., Nos. 19-000152-MZ, 19-000154-MZ (Mich. Ct. Cl., Oct. 15, 2019). At the preliminary injunction hearing, one plaintiff testified the emergency rules forced him to “shutter[] his business and that his customers have been obtaining their flavored vaping products from Wisconsin.”  Id. at 7. Another presented evidence that the emergency rules “ban plaintiff from using its tradename and branding.” Id. The court found both harms constituted “irreparable harm” necessary for preliminary injunction.

The court also found the Plaintiffs established a likelihood of success on the merits of their claims, because the MDHHS rules were procedurally invalid under Michigan law. Id. at 8.  Specifically, an agency must comply with standard procedures for the promulgation of new rules except in “emergency” situations, and the Court did not find there was a “genuine emergency” that warranted circumventing the standard rule-making process with respect to flavored nicotine vaping. “The plaintiffs have convinced the Court that defendants’ proffered reasons for the emergency declaration have fallen short.  It is not enough under [Michigan law] for DHHS to merely identify a problem.”  Id. at 10.

The court also considered the potential harm to the public that would result from allowing the ban to be enacted. After recognizing “compelling interests on both sides of the issue,” the court cited witnesses for the Plaintiffs that testified about their improved health after switching from traditional tobacco products to e-cigarettes. “Thus, plaintiffs have presented evidence that at least some segment of the population will be harmed by the vaping ban.” Id. at 14. Ultimately, after carefully weighing all factors pertinent to granting a preliminary injunction, the court concluded the Plaintiffs carried their burden, and issued a preliminary injunction preventing Michigan’s emergency rules from going into effect.

The Michigan ban of flavored e-cigarettes is significant because many other states around the country have since enacted similar bans, either through emergency regulation or executive order. These states include Rhode Island, Oregon, New York, Washington, Missouri and Montana, and the city of Los Angeles.  Each of these bans may face similar challenges in the near future, and this court’s decision to block the emergency rules, which is in line with another recent ruling by a District Court in Indiana, indicate that such challenges may be successful.

FDA Warns Florida Company: CBD Oil is Not a Dietary Supplement

Despite recent bipartisan calls on the FDA to regulate hemp-derived CBD products, the U.S. Food & Drug Administration appears to be adhering to the status quo, at least with respect to issuing warning letters to companies deemed noncompliant with existing regulations. Case in point: on September 18, 2019, the FDA issued a warning letter (posted to the FDA’s website last week) to Alternative Laboratories, a dietary supplement manufacturer based in Naples, Florida.

According to the letter, the FDA conducted an inspection of Alternative’s dietary supplement manufacturing facility over five days in May and June; the inspection focused on the adequacy of labels for certain products manufactured and distributed by the company.

The letter focuses on Alternative’s allegedly impermissible representation of 2-amino-5 methylheptane and Octodrine (DMHA) as a dietary ingredient in certain products. It also calls attention to the fact that Alternative’s product label for CBD oil distributed under the “Green Roads” brand name runs afoul of the Food, Drug & Cosmetic (FD&C) Act in that the product “cannot be a dietary supplement because … [the] FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under” the FD&C Act.

To support its contention that CBD products cannot be dietary supplements as defined by federal law, the FDA notes in its warning letter to Alternative that “CBD is the active ingredient in the approved drug product Epidiolex,” designed to treat certain rare, severe forms of epilepsy. Further, the FDA stresses that significant clinical research investigations concerning the use of CBD have been made public, including investigations related to Epidiolex and Sativex, a drug for the treatment of spasticity due to multiple sclerosis (MS) that has been approved for use in 25 countries (outside the U.S.) and for which the drug manufacturer,  GW Pharmaceuticals, plans to seek FDA approval.

The fact that warning letters keep coming–from both the FDA and the FTC–signifies that although there may be a groundswell of public demand for regulatory reform and clarity on the issue of CBD products, the federal regulatory agencies appear to be staying the course. As such, companies operating in the space should remain vigilant and adhere to a compliance policy that reflects–for now–the reality of current regulations and restrictions.

Duane Morris Named One of America’s Top Trusted Corporate Law Firms

Duane Morris has been named one of America’s Top Trusted Corporate Law Firms by Forbes.

The publication writes:

More than 13 million attorneys practice at more than 400,000 law firms in the U.S., according to the American Bar Association, and those firms are becoming increasingly specialized. … Many firms have been expanding into new areas of law necessitated by the emergence of technologies such as blockchain and of state laws legalizing cannabis use. …

[Duane Morris] has a growing and strong focus on the legal cannabis industry, partnering with the American Trade Association of Cannabis and Hemp and representing cannabis companies in one of the first public cannabis industry mergers, a $640 million deal.

For more information, visit the Forbes website.

David Feldman

Cuomo Plans Multi-State Cannabis Coordination; Vape Ban on Hold

In comments last week, NY Governor Andrew Cuomo has called for a multi-lateral meeting with his counterparts in neighboring states, including New Jersey, Connecticut and Pennsylvania, to discuss legalizing adult use of cannabis. As reported by Politico, the Governor noted, “The federal government is doing nothing, what can we do? And what can we do together? Because it makes no sense to pass one set of rules in New York, where they can drive across the border to Connecticut and have a different set of rules and vice versa.” The Governor noted that he believes the states “can do more together than by working alone,” The group plans to meet on October 17.

A multi-state approach could have the benefit of harmonizing the approach to legalization but has the risk of enhancing the political challenges in achieving the goal of these states approving adult use of cannabis. New York and New Jersey both attempted and failed to pass adult use legislation earlier this year despite Democrat control of both state houses and legislatures. Both states’ Governors have indicated their desire to take up the measures again next year. Nearby Massachusetts approved legalizing  adult use in a 2016 referendum.

Separately, on Thursday this week a NY appeals court temporarily blocked Gov. Cuomo’s plan to ban flavored vaping products. The ban was set to begin yesterday. The temporary restraining order only puts the ban on hold for a week to allow vape companies to seek a more permanent injunction stopping the ban. Cuomo and his Health Commissioner have expressed significant concern about respiratory issues connected to vaping.

A  number of industry advocates believe that moving towards a legalized and regulated market for cannabis and vaping could be the most effective approach to the vaping issues that have arisen. Recent reports indicate that over 1000 people have been made sick apparently from vaping. The e-cigarette manufacturers have claimed the issues result from illicit products with additives that state-legal manufacturers generally do not add, but scientific conclusions have not yet been reached.

Duane Morris Partner Jennifer Briggs Fisher Quoted in CNBC Article, “Underbanked Cannabis Industry Struggles to Finance Double-digit Growth, Leaving Business Owners Empty-handed”

Harmony Dispensary, a medical marijuana cultivator and dispensary in Secaucus, New Jersey, has a Zen-looking shopfront with light green walls, clean glass shelves showcasing various offerings, and a line of modern-looking cannabis-related products — a pipe, herb grinder and stash jar — all emblazoned with the Harmony logo.

Since its opening in 2018, the dispensary has serviced thousands of customers, but it has struggled to hold on to a bank account. “We approached six institutions to support our banking needs and were eventually dumped from all three that agreed to work with us,” Shaya Brodchandel, chief executive of Harmony Dispensary, said. In each case, Harmony received no warning from the banks, just a check in the mail, forcing them to scramble for solutions to pay suppliers, bills, staff and conduct general business.

[…]

“Cannabis is already a risky environment, and you face additional risk when engaging in new solutions that are brought into the market and not necessarily backed by solid financial institutions,” said Jennifer Briggs Fisher, partner at Duane Morris in San Francisco, who leads the firm’s cannabis industry group.

[…]

To read the full article, visit the CNBC website.

SAFE Banking Act Passes the House – Cannabis Banking May Soon Be Reality

By Joseph J. Pangaro, Justin M. L. Stern, David E. Landau, Seth A. Goldberg and Michael S. Zullo

On Wednesday evening, September 25, by a vote of 321 to 103, the United States House of Representatives took a meaningful step toward easing federal restrictions that have limited the access of cannabis businesses to banking services notwithstanding the growth of the cannabis industry by passing the Secure and Fair Enforcement Banking Act of 2019 (“SAFE Banking Act”). The public safety concerns resulting from the dearth of cannabis banking has led dozens of state Attorneys General, the American Banking Association, and numerous other voices to urge the passage of legislation like the SAFE Banking Act so that the U.S. cannabis industry, which now exceeds $10 billion in annual sales revenues, not to mention hundreds of millions in state tax revenues, will benefit from the same banking services – checking accounts, payroll, and credit cards, to name a few – that are common to virtually all other U.S. businesses.  Passage of the SAFE Banking Act in the Senate would be liberating for the cannabis industry, as banking services will stimulate even more growth and better business practices, while eliminating the overhang of public safety concerns relating to large cash transactions.  Below is: (i) a brief summary of the history leading to this point; (ii) the key provisions of the SAFE Banking Act of 2019; and (iii) a preview of what comes next.

History of Marijuana Regulation and Banking Implications

  • Controlled Substances Act (“CSA”):[1] Marijuana is a federally unlawful Schedule I drug under the CSA, 21 U.S.C. § at § 841(a), and direct and indirect (conspiracy and aiding abetting) violations carry stiff criminal and civil penalties, including forfeiture. at §§  841(b), 853.
  •  Bank Secrecy Act (“BSA”) and Money Laundering Control Act (“MLCA”): The BSA and MLCA obligate banks to root out financial transactions involving “unlawful” activities and thus banks must comply with BSA reporting requirements for suspicious transactions and must have robust customer diligence and MLCA programs.
  • 2014 FinCEN[2] Guidance: In an effort to stimulate cannabis banking, FinCEN issued Guidance in 2014 that clarified BSA expectations of financial institutions by describing how financial institutions can provide services to cannabis businesses consistent with their BSA obligations. This Guidance included stringent customer due diligence obligations and a special category of suspicious activity reporting (SAR) for marijuana-related businesses. The 2014 Guidance created three types of marijuana SAR filings: (i) “Marijuana Limited”; (ii) “Marijuana Priority”; and (iii) “Marijuana Termination.”

Reluctant Banking and Public Safety Concerns

Notwithstanding FinCen’s Guidance, the CSA, the Bank Secrecy Act, and the MLCA have presented significant obstacles for banks interested in providing their services to cannabis companies that “touch the flower” and even companies that provide ancillary services to the cannabis industry. Most financial institutions, including commercial banks, investment banks, and insurance companies, have avoided the core and ancillary cannabis companies.  For example, FinCen last reported that as of March 2019, only 633 of the 8,700 FDIC insured or supervised financial institutions are servicing marijuana-related business.

This widespread abstention has had a significant impact on the cannabis industry. An overwhelming portion of the $10 billion plus cannabis industry is comprised of cash transactions — purchases are made in cash, employees are paid in cash, accounts payable, including rent and other bills are paid in cash, even state taxes are paid in cash. Cannabis businesses may not have checking accounts or payroll services, cannot process credit cards, and are forced to find private lenders at high interest rates.

Public safety is at risk due to the volume of cannabis cash that is going untracked by the U.S. banking system.  There is an increased risk of theft, and there have even been claims for ransom and violent crimes. Businesses may not carry enough insurance for their premises and products. Accurate record-keeping, accounting, and the calculation and payment of state and local taxes is challenged. Most importantly, the transparency objectives of the BSA are undermined, as cannabis companies often engage in corporate structuring intended to provide some access to banking, even if not directly. In addition, it is widely understood that some FDIC banks simply turn a blind eye, and provide services to cannabis businesses without reporting.

Key SAFE Banking Act Provisions

Although the SAFE Banking Act contains numerous important provisions, below are three of the most significant.

SAR Filings

The SAFE Banking Act does not do away with the requirement to file SARs. However, it does mandate that FinCEN issue revised guidance concerning SAR filings that “is consistent with the purpose and intent of the SAFE Banking Act of 2019 and does not significantly inhibit the provision of financial services to a cannabis-related legitimate business or service provider in a State.”

Protections for Financial Institutions

Further, the SAFE Banking Act would protect financial institutions against adverse actions by federal banking regulators—such as limiting or terminating the insurance provided under the Federal Deposit Insurance Act or the Federal Credit Union Act—taken solely on the basis of the financial institutions’ provision of banking services to cannabis businesses operating in accordance with state law or their service providers. The bill also prohibits regulators from discouraging institutions from providing financial services to such businesses or from incentivizing banks or credit unions to refuse, terminate, or downgrade accounts held by those engaged in the cannabis industry (such as owners or employees of cannabis businesses). Similarly, the bill provides that banks or other financial institutions providing financial services to legitimate cannabis businesses in states or jurisdictions where the cannabis business is lawfully operating will not, because of their dealings with such cannabis businesses, be held liable under federal law either for providing the financial services or for investing income derived from the provision of such services. The result of these protections is that financial institutions would, under the SAFE Banking Act, be able and thus more willing to provide cannabis businesses with routine services that companies in other industries take for granted, i.e., the processing of credit card transactions, the maintenance of operating and payroll checking accounts, etc.

Protections for Ancillary Businesses

The bill also provides protections for so-called “ancillary” businesses; under the SAFE Banking Act, receipt of money by a legitimate business or service provider, through a transaction with a cannabis business, would not on that basis result in the ancillary business’ violation of 18 U.S.C. §§ 1956 and 1957, concerning transactions involving the proceeds of illegal activity. This protection would extend to ancillary business service providers such as accountants, lawyers, bankers, and landlords, as well as to sellers of goods or services to cannabis businesses, such as cable and internet providers.

Conclusions – What to Expect

Having passed the House, the bill now moves to the Senate where, despite its bipartisan support, its fate is unclear. Senator McConnell, the Senate Majority leader who was instrumental in the passage of the 2018 Farm Bill, has not shown much interest in the bill yet. Yet Senator Crapo, Chairman of the Banking Committee, however, has hinted he may be interested in the legislation. Given the strong vote count with which the House passed the bill, pressure may start to mount for Senate action, particularly in light of the broad based coalition that came together to pass the House bill. The Senate should have the very real public safety concerns resulting from the dearth of cannabis banking in plain view when it votes.

[1] 21 U.S.C. § 801 et. seq.

[2] Financial Crimes Enforcement Network

Federal Court Halts Indiana’s Ban on Smokeable Hemp

On September 13, 2019, a federal district court in the Southern District of Indiana issued an Order regarding Indiana’s treatment of “smokeable hemp” that could have far-reaching consequences for the hemp industry.  C.Y. Wholesale Inc. et al. v. Holcomb et al., 1:19-cv-02659 (S.D. In., Sep. 13, 2019). The court issued a preliminary injunction against the state of Indiana that prohibits the enforcement of certain provisions of a new Indiana law that regulated criminalized the manufacture, finance, delivery, or possession of “smokeable hemp.”  Id.

On May 2, 2019, Indiana Governor Eric Holcomb signed Senate Enrolled Act No. 516 (the “Act”) into law.  Among other things, the Act made it a Class A misdemeanor to manufacture, deliver, finance the manufacture or delivery of, or possess “smokeable hemp.” Ind. Code § 35-48-4-10.1. The Act defined “smokeable hemp” as “a product containing not more than three-tenths percent (0.3%) delta-9-tetrahydrocannabinol (THC), including precursors and derivatives of THC, in a form that allows THC to be introduced into the human body by inhalation of smoke.” Ind. Code § 35-48-1-26.6.

The Act’s prohibition on “smokeable hemp” is not unique.  For instance, Kentucky’s industrial hemp regulations list products that are not to be sold to the public, and those products include “Hemp cigarettes” and “Hemp Cigars.” 302 Ky. Admin. Regs. 50:070. And the North Carolina legislature is considering a bill that would similarly ban “smokeable hemp.” Such bans are viewed as assisting local law enforcement in the performance of their duties.  As federally lawful hemp and federally unlawful marijuana have the same appearance and a virtually identical smell, police officers throughout the country often have trouble distinguishing between the two.  A ban on “smokeable hemp” would help officers and citizens avoid the waste of time and resources that could be caused by confusing unlawful marijuana and lawful hemp.

However, on June 28, 2019, a few days before the Act became effective, a group of Indiana businesses that sell hemp products at wholesale or retail filed a motion for a preliminary injunction to prohibit enforcement of the smokeable hemp ban.  The plaintiffs argued Indiana’s smokeable hemp ban was unconstitutional because it was preempted by the 2018 Farm Bill and because it violated the Commerce Clause of the Constitution. The Court agreed.

First, the court held that Indiana’s “smokeable hemp” ban was impermissible because it was not limited in scope to intrastate activities, and as such interfered with interstate commerce.  The 2018 Farm Bill explicitly provides “No State or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with,” federal or state law.  2018 Farm Bill § 10114.  By criminalizing the delivery and possession of “smokeable hemp,” the Act precludes transportation of hemp or hemp products through Indiana “and thus impede[s] the interstate commerce of hemp in contravention of the 2018 Farm Bill’s express prohibition on state laws that do so.” C.Y. Wholesale Inc. et al., 1:19-cv-02659 at 8. For instance, the court explained, “a driver traveling along I-74 from Ohio to Illinois who passes through Indiana with smokeable hemp in the vehicle, including hemp bud or hemp flower, would be in ‘possession’ of smokeable hemp and thus subject to arrest and criminal penalties under SEA 516.” Id.

Second, the court held Plaintiffs had shown a likelihood of success on the merits of their conflict preemption claim.  “[T]he plain language of the 2018 Farm Bill, as well as statements from its legislative sponsors, reflect Congress’s intent to de-stigmatize and legalize all low-THC hemp, including its derivatives and extracts, and to treat hemp as a regulated agricultural commodity in the United States.” Id. at 10. However, Indiana’s smokeable hemp ban would “criminalize the manufacture, finance, delivery, and possession of hemp bud and hemp flower—hemp derivatives of the kind specifically legalized under the 2018 Farm Bill—[which] frustrates these congressional purposes and objectives.” Id. at 11.

Although the dispute has not been finally resolved, in granting the plaintiffs’ motion for a preliminary injunction, the court has given a strong indication of its view on the matter. If the court ultimately finds Indiana’s law unconstitutional, it is likely to impact other federal court analysis of similar state laws across the country. Duane Morris will continue to monitor this case and will provide additional updates as necessary.

Cannabis Vapor Sales Fall in Midst of Health Scare, Though CDC Revises Scope of Inquiry

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.”