Category: News This Week

Chinese e-commerce firm Alibaba said on Wednesday cease selling electronic nicotine-delivery system (ENDS) components in the U.S. amid growing regulatory scrutiny and reports of lung disease and some deaths linked to THC vaping.

The move follows announcements by Kroger Co and Walgreens Boots Alliance Inc this week that they would stop selling e-cigarettes at their stores, in line with a similar decision by Walmart, according to a story by Reuters.

Alibaba said it already had a long-standing policy in place to not sell complete e-cigarette products in the United States.

Alibaba Group Holding Ltd said that listings for products such as box mods, vape pens, herbal vapors, heat not burn devices, and empty pod cartridges would not be displayed for users located in the United States, according to the story.

Prior to the suspension, buyers could easily purchase devices, component parts and packaging from sites like Alibaba or Amazon to make their own counterfeit vaping devices.

Amazon.com Inc took down vape paraphernalia in September, although it did not specify the exact products it removed, the story states.

Kroger Co and Walgreens Boots Alliance Inc said on Monday they would stop selling e-cigarettes at their stores, amid heightened regulatory scrutiny of the product and reports of lung disease and some deaths linked to vaping, according to an article in Reuters.

Their move comes weeks after Walmart Inc said it was pulling the plug on e-cigarette sales, citing growing federal, state and local regulatory complexity and uncertainty. The companies will both continue to sell deadly combustible products.

Kroger said it would discontinue sales of e-cigarettes at its stores and fuel centers after selling through its current inventory, according to the article.

Walgreens, which earlier this year set a minimum age to sell tobacco products at 21 years, said the decision was also reflective of developing regulations in a growing number of states and municipalities.

A federal judge denied a vapor industry attempt to put on hold Massachusetts’ four-month ban on the sale of vaping products, keeping intact the nation’s strictest prohibition.

“The court finds that plaintiffs have not demonstrated a substantial likelihood of success on the merits or that the balance of hardships between the parties weighs in (their) favor,” according to the decision.

But the industry may still get relief. The judge scheduled an Oct. 15 hearing for arguments on whether she should issue a preliminary injunction against the ban, according to a story on Reuters.com.

An attorney for vapor industry stakeholders argued that the Massachusetts ban is overly broad and suggested it should instead target “black market products sold by drug dealers.”

The FDA stated that the majority of samples tested by the states or by the FDA “related to this investigation have been identified as vaping products containing THC. Through this investigation, we have also found most of the patients impacted by these illnesses reported using THC-containing products, suggesting THC vaping products play a role in the outbreak.”

Massachusetts Governor Charlie Baker’s ban targets sales of e-cigarettes and vaping supplies, both those used for nicotine and THC, the psychoactive ingredient in marijuana, which is legal in the state, in response to the nationwide outbreak in the sometimes deadly lung disease linked to vaping, according to the story

Several vapor organizations have been granted a Motion to Intervene exclusively for the limited purpose of filing an appeal of the May 15, 2019 Memorandum Opinion and Order and the Remedy Order that forced vapor companies to submit premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration by May 12, 2020.

“The Vapor Associations have no other opportunity to provide their views on the deadline imposed in the Remedy Order; and the Government’s objectives appear to have diverged from the interests of the Vapor Associations that seek to intervene,” Judge Paul Grimm wrote in his ruling.

The judge denied a motion to Stay the order. “I also will deny the Vapor Associations’ Motion to Stay because, as noted, the Remedy Order does not impose immediate deadlines, and the Vapor Associations have not shown that ‘a pressing need exists,’” Grimm wrote.

Lawyers with the law office of Keller and Heckman (KH), a Washington DC law firm that represents the vapor industry, filed Motions to Intervene and Stay with the U.S. District Court for the District of Maryland pending appeal of the July 12, 2019 Memorandum Opinion and Order (Remedies Order) on behalf of several vapor trade associations.

The trade associations represent small U.S. businesses that manufacture, distribute and sell vapor products to adults. A Stay will temporarily suspend the District Court’s initial ruling which started the 10-month PMTA clock.

KH also filed a Notice of Appeal with the United States Court of Appeals for the Fourth Circuit on July 30, informing the appellate court of its intent to appeal the District Court’s order denying the trade associations initial attempt to intervene in the case on the remedies issue.

In its Motion to Stay, KH attorney Eric P. Gotting argued, among other things, that “the remedies issue – and in particular whether the Court properly set a PMTA deadline instead of remanding back to FDA for further consideration – turns on the appropriate application of the D.C. Circuit’s ‘extraordinary circumstances’ exception.” KH stated that it was “not aware of any case in which the Fourth Circuit has applied that principle” previously.

On July 11, Judge Grimm of the U.S. District Court for Maryland ruled in a lawsuit filed by anti-tobacco groups that the regulatory agency had exceeded its authority in allowing electronic nicotine delivery systems (ENDS) to remain on the market until 2022 before companies applied for regulatory approval. The order was filed on July 12.

The New York State Appellate Division granted a temporary restraining order in a lawsuit brought by the Vapor Technology Association (VTA), Benevolent ELiquids and Perfection Vapes regarding a proposed flavor ban in New York State, which was set to be enforced Oct. 4, 2019.

The Order entered by four appellate judges ruled that the State is “temporarily enjoined and prevented from enforcing” the flavor ban until a ruling on the motion for a preliminary injunction is determined. That motion is scheduled to be heard on October 18, 2019.

Tony Abboud, executive director of the VTA, said he was pleased with the court’s decision, which acknowledges the strength of the VTA’s claim concerning “the State’s executive overreach, and which preserves the ability of hundreds of small businesses to remain open and continue to serve” adult customers.

“The New York State Legislature, instead of enacting a flavor ban, already has decided to address concerns about youth vaping by raising the minimum age for vapor products from 18 to 21 and imposing a major tax increase,” Abboud said. “We continue to stand ready to work with the State of New York and all interested stakeholders on the many real solutions that should be implemented to achieve the twin goals of restricting youth vaping, which already is illegal, and preserving flavored alternatives for adults desperately trying to quit smoking.”

A product liability lawsuit has been filed in Washington state court against several manufacturers of THC vape cartridges. The case, Charles Wilcoxson v. Canna Brand Solutions LLC et al., was filed on September 23, 2019, in the Superior Court of Pierce County, Washington, according to a posting on lexology.com.

The complaint alleges that the plaintiff, a 44-year-old police officer and former member of the U.S. Army Special Forces, had consumed various THC vape products between January 2018 and September 2019. He purchased several cannabis brands, including Conscious Cannabis, Rainbows Aloft, Leafwerx, MFused and Jane’s Garden, all of which are named as defendants. Also included as a defendant is Canna Brand Solutions, the distributor of plaintiff’s vaporizer device (called a “pen” or “battery”), which was manufactured by C-Cell, a Chinese corporation, according to the post.

According to the complaint, plaintiff vaped on September 11, 2019, and woke up with severe wheezing that night. He continued to have difficulties through the weekend and on Monday morning presented at the emergency room. Plaintiff was diagnosed with lipoid pneumonia caused by vaping.

A pathology report noted “numerous lipid laden macrophages” on his lungs, “reactive endobronchial cells” and disease-fighting cells called eosinophils that are seen in reactive airway disease. Plaintiff spent three days in the hospital before being discharged home and allowed to return to work on light duty with the police department.

The complaint states that “since the injury, plaintiff has been unable to run, work full-time or participate in physical activities with his young daughter,” and that “the full extent of the injuries caused by defendants’ products is not yet known,” according to the post.

The complaint asserts causes of action for strict liability and negligence against the various defendants. It is alleged that the vape cartridges were not reasonably safe and were not fit for human consumption “as a result of being flooded with particles.” The plaintiff similarly alleged that the vaporizer pen was defectively designed and that the distributor “knew or should have known that the product was not safe for human consumption,” according to the post.

It is further alleged that the defendants are jointly and severally liable for the entire damages suffered by the plaintiff due to their alleged status as successive tortfeasors. This strategy of alleging joint-and-several liability is often seen in tobacco, asbestos and other “toxic tort” litigation, where the plaintiff sues all potential defendants and attempts to shift the burden to those defendants to disprove that each is partially responsible for the injuries alleged.

Here, plaintiff may be using the joint-and-several liability strategy due to the fact that establishing medical causation against any specific vape manufacturer may prove difficult in the absence of reliable scientific evidence of what is causing these illnesses, according to the post.

A group of broad industry stakeholders concerned with two false claims regarding the vaping industry: (1) FDA regulated vapor products have caused acute pulmonary diseases and multiple fatalities, and (2) youth initiation is driven by flavored nicotine-containing e-liquids have submitted a white paper to state attorney generals and the FDA.

“Each claim will have significant negative public health and economic impacts. Further, the consequences of the political action taken in response to these two fabrications have not been duly taken into consideration. Together, our group represents multiple domestic and foreign hardware and e-liquid manufactures and more than 600 vape retail stores in 35 states who serve approximately one million customers a year, of which over 85 percent have used vaping to quit or substantially reduce smoking combustible cigarettes,” the paper states. “The companies described in the introduction below represent approximately 5 percent of the vape store market and employ approximately 2,700 employees who earn $63 million in annual wages.”

Claim 1: Vaping creates acute pulmonary disease and has led to multiple fatalities. There is no evidence that FDA regulated vapor products have resulted in any of the recent pulmonary disease-related deaths and the overwhelming majority of the patients suffering from respiratory illness have reported the use of only THC vaping products, with or without nicotine. CDC has failed to properly distinguish illegal black-market THC vaping cartridges from legally purchased nicotine-containing e-cigarettes. This oversight has caused significant consumer confusion, resulting in customers returning to cigarettes and economic hardship for vape retail store operators.

Claim 2: Youth initiation is driven by flavored electronic nicotine delivery systems (otherwise known as ENDS, e-cigarettes, or nicotine-containing vapor products). Flavored ENDS products have existed worldwide for more than a decade. The acceleration of youth consumption only became an epidemic in the last two years along with the increased popularity of high-nicotine, closed-pod systems. This youth initiation closely follows JUUL’s growth and market penetration. Flavors are not the underlying cause of the increase in youth uptake.

“These two claims are having significant negative impacts with respect to public health (sending people back to smoking and black markets), as well as significant economic (80,000+ potentially lost jobs and $24 billion industry economic output) and political impacts (8 million upset, passionate vapers who feel vaping has improved their lives),” the paper states.

KEY TAKEAWAYS FROM VAPING INDUSTRY POLICY WHITE PAPER: 

1. An e-Liquid Flavor Ban is Vastly Misguided.  • Youth are attracted to high nicotine concentrations in e-liquids, not flavors.

Call to reform and limit youth initiation • Limit flavors to lower nicotine levels in adult- only, retail facilities using age verification methods. 

2. The recent reports of an acute vaping-related lung illness have been in relation to THC cartridges bought on the black market, not the FDA regulated vapor products that millions of smokers have stopped smoking cigarettes with. 

• There is no evidence that FDA regulated vapor products have resulted in any of the recent pulmonary disease-related deaths and the overwhelming majority of the patients suffering from respiratory illness have reported the use of only THC vaping products, with or without nicotine. 

• CDC has failed to properly distinguish illegal THC vaping cartridges from legally purchased nicotine-containing e-cigarettes.

3. CDC’s misguided vaping recommendations and state flavor bans have resulted in a negative public health and economic impact. 

• Consumers are going back to smoking cigarettes or looking to the black market.

• Thousands of small businesses are faced with having to close their doors.

Washington state Governor Jay Inslee has ordered state officials to impose an emergency ban on flavored vapor products, reports The Seattle TImes.

The move comes in response to the mysterious lung illnesses that have rippled the United States.

As of Sept. 30, the U.S. Centers for Disease Control and Prevention had recorded 805 lung injury cases and 12 deaths.

If adopted during the health board’s Oct. 9 meeting, Washington state’s ban would go into effect the next day, last 120 days and could be renewed.

Michigan and New York have also banned flavored vapor products. Massachusetts has banned all vapor products until Jan. 25, 2020.

A court has denied a request by the vapor industry to delay New York’s emergency ban on flavored e-cigarettes sales.

Acting state Supreme Court Justice Gerald Connolly on Friday refused to issue a temporary restraining order on the regulations approved on Sept. 17 by Governor Andrew Cuomo.

The 90-day emergency regulations ban possession, manufacturing, distribution and sale of all vape flavors except tobacco and menthol.

The temporary injunction had been requested by the Vapor Technology Association and two retailers.

The latest findings from the investigation into lung injuries associated with e-cigarette use, or vaping, suggest THC products play a major role in the outbreak, according to the US Centrers for Disease Control (CDC).

The major majority of people (77%) in this outbreak reported using THC-containing products, or both THC-containing products and nicotine-containing products, according to a report published today in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Though the investigation is ongoing and the cause remains unknown at this time, today’s report provides the first national comprehensive data on the characteristics of cases reported to CDC, including sex, age, and select substances used in e-cigarette, or vaping products. A second MMWR released today from Wisconsin and Illinois had similar findings regarding THC use and contains more details on the characteristics of cases in those states, including demographics, as well as substances and product types used.

“CDC is committed to finding out what is causing this outbreak of lung injury and death among individuals using vaping products” said Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention. “We continue to work with FDA and state partners to protect the nation from this serious health threat.”

More information is needed to know whether a single product, substance, or brand is responsible for the lung injuries. Unraveling outbreaks such as this requires the collection and analysis of complex information. This epidemiologic investigation is particularly challenging given that it involves hundreds of cases across the country, and patients report use of a wide variety of products and substances.

In addition, the report from Illinois and Wisconsin showed that nearly all THC-containing products reported were packaged, prefilled cartridges that were primarily acquired from informal sources such as friends, family members, illicit dealers, or off the street.

As of September 24, 2019, 805 confirmed and probable cases of lung injury associated with e-cigarette product use, or vaping, have been reported to CDC by 46 states and the U.S. Virgin Islands. Those cases included 12 deaths in 10 states (CA (2), GA, FL, IL, IN, KS (2), MN, MO, MS, OR). More than two-thirds of patients are male. The median age of cases is 23 years, with about 62 % of patients aged 18-34 years, according to the new report.

More information about the investigation is available on the CDC website at www.cdc.gov/lunginjury.