Self-Help: How State-Legal Cannabis Operators Can Respond to the Vaping Crisis

Over the last decade, there has been a remarkably swift rise in the popularity of vaporizers and vaping products. As reported by the BBC, the number of people using vaporizers increased from 7 million in 2011 to over 41 million in 2018. But in 2019, consumers began suffering from a rash of vaping-related lung injuries—according to the Centers for Disease Control and Prevention, as of February 18, 2020, there have been approximately 2,807 vaping-related injuries in the United States, occurring in all 50 states.

Highly publicized reports of these injuries raised serious concerns among the public and policymakers and threatened to halt the explosive growth of the vaping industry. State governments across the country issued emergency rules and executive orders to ban some, or all, vaporizer products. Even as courts issued injunctions prohibiting these bans from taking effect, more states moved forward with bans of their own. Within a few months states as diverse as Washington, Oregon, Montana, Michigan, Rhode Island, Massachusetts and New York had instituted some version of a vaporizer ban, mostly targeted at the highly popular flavored e-liquids.

To read the full article, visit the Duane Morris website.

NIH-Funded Study Reveals Historic Rise in THC Vaping Rates Among Adolescents

One day after a federal judge dismissed a lawsuit challenging the U.S. Food and Drug Administration’s (FDA) regulatory authority over e-cigarettes, a published study funded by the National Institutes of Health (NIH) reported that more than 20% of High School seniors in the U.S. reported vaping THC (the psychoactive cannabinoid found in marijuana) in 2019.

According to the study, 20.8% of 12th graders reported marijuana vaping in the past 12 months, while 14% reported marijuana vaping in the past 30 days. (These figures, in 2018, were 13.1%, and 7.5%, respectively.) According to the report, the absolute increases from 2018 to 2019 in 12th graders who reported vaping marijuana within the previous 30 days were “the second largest … ever tracked by Monitoring the Future for any substance in its 45-year history[,]” only outpaced by the increase in nicotine vaping from 2017 to 2018.

Other age groups showed increases in THC vaping as well; the percentage of 10th graders who reported marijuana vaping in the past 12 months increased from 12.4% in 2018 to 19.4% in 2019 and the percentage of 10th graders who reported marijuana vaping in the past 30 days increased from 7% in 2018 to 12.6% in 2019. Moreover, the percentage of 8th graders who reported vaping marijuana in the past 12 months increased from 4.4% in 2018 to 7% in 2019; for use in the past 30 days, the percentage increased from 2.6% to 3.9% over the same time period.

Based on the results of the just-released study, Judge Guirola’s opinion–in which the court held that the delegation of authority to the FDA under the Family Smoking Prevention and Tobacco Control Act was not unconstitutional–could be afforded renewed significance. Both the federal court’s order and the NIH-funded study documenting the rise in THC vaping among adolescent come in the midst of heightened scrutiny of e-cigarette and vaping products generally, in light of the widely reported lung-related health issues stemming from use of certain vaping products.

Given the new data from the NIH-funded study and the FDA’s recently confirmed regulatory authority over the products alleged to be causing the lung-related illnesses, it appears likely that calls for regulators to scrutinize and crack down on the manufacture and sale of e-cigarettes and vaping products will only grow.

 

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

By Joe Pangaro and Jessica Linse

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.

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.”

FTC Warning Letters and Reports of Vaping-Related Illnesses Hit Cannabis Industry

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.”

View the full Alert on the Duane Morris LLP website.

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.