- The Washington Times
Tuesday, September 10, 2019

Alarm over the potentially harmful effects of e-cigarettes grew Tuesday, as Kansas reported its first vaping-related death, and Alabama and Delaware reported a total of eight new cases of vaping-related respiratory illnesses.

The uptick in cases comes as the Food and Drug Administration is accusing Juul, a leading e-cigarette maker, of illegally marketing its merchandise as “unauthorized modified risk tobacco products.” The FDA also is requesting information about the company’s marketing practices, particularly those targeting students, tribes, health insurers and employers.


A Juul Labs spokesman told The Washington Times on Tuesday the company is reviewing the FDA’s warning letters and will fully cooperate. The Federal Trade Commission also is reportedly investigating the e-cigarette makers’ marketing practices.

Meanwhile, public health officials around the country are urging people to stop vaping, and Michigan has become the first state to ban the sale of flavored e-cigarette products.

On Tuesday, Kansas health officials confirmed that state’s first death tied to a vaping-related lung illness, following similar deaths in Minnesota, Indiana, Oregon, Illinois and Los Angeles.

In addition, Delaware reported three new cases and Alabama five — joining the ever-increasing number of states with fresh instances of severe lung injuries linked to e-cigarettes, more than 450 possible cases nationwide.

Amid the rapid increase in vaping-related lung injuries, health experts are investigating what’s causing the illnesses. New York health officials are turning their attention to vitamin E acetate, a common additive for skin creams and dietary supplements that has been found in cannabis-containing products, as a possible cause.

But federal health agencies say they have not yet pinpointed a cause and are looking into a wide variety of substances including nicotine, cannabinoids such as THC, opioids, pesticides and poisons.

More state officials are taking action against flavored e-cigarettes. New York Gov. Andrew Cuomo said Monday he is advancing legislation to ban flavored e-cigarettes, following Michigan’s move last week.

“Common sense says if you do not know what you are smoking, don’t smoke it, and right now we don’t know what you are smoking in a lot of these vaping substances,” the New York Democrat said.

Mr. Cuomo said he has ordered the state health department to issue emergency regulations that mandate that vape and tobacco shops post warning signs to address the increasing number of cases of respiratory illnesses and the e-cigarette youth epidemic.

Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids, said Juul helped hook kids on e-cigarettes by combining high-tech designs and sweet flavors such as mint and mango with a nicotine-salt formulation or salt-based nicotine e-liquids.

Last year, 3.6 million middle and high school students across the country used e-cigarettes, up 1.5 million from the previous year, the FDA reported.

Tony Abboud, executive director of the Vapor Technology Association, has argued that science demonstrates that flavors are not the reason youth illegally use vaping products, but science shows that flavors play a “critical role” in helping adult smokers quit traditional cigarettes.

E-cigarettes entered the Chinese marketplace in 2003 and were patented internationally in 2007, according to the American Heart Association.

The U.S. began importing the products in 2008, said Erika Sward, national vice president for advocacy for the American Lung Association.

The first vaping product to enter the U.S. market was a Ruyan e-cigarette imported by Mark Weiss, founder of e-cigarette company NJOY.

But no one really cared about the product until the FDA tried to ban its importation in 2009, according to Gregory Conley, president of the American Vaping Association.

That year, the FDA had denied the import of electronic cigarettes into the U.S. from a couple of manufacturers, considering the products unapproved drug-delivery devices intended to help treat withdrawal symptoms of nicotine addiction, according to the Public Health Law Center.

The manufacturers, Smoking Everywhere and NJOY filed a federal lawsuit stating that e-cigarettes are not intended to treat withdrawal symptoms of nicotine addiction but for smoking enjoyment similar to traditional cigarettes. The two companies sought an injunction, which would stop the FDA from blocking imports of the products until a court ruling.

The court granted a motion for a preliminary injunction in 2010 and found that e-cigarettes are intended to encourage nicotine use rather than prevent or mitigate it. Under the court ruling, e-cigarettes could be regulated as tobacco products and not as drug-delivery devices unless they were marketed with a therapeutic purpose such as cessation.

E-cigarettes have been under the Tobacco Control Act since August 2016, the FDA said.

Currently, there are no authorized e-cigarette products on the market.

The American Vaping Association estimates there are more than 500 manufacturers or importers registered with the FDA, but believes there are between 8,000 to 10,000 vaping or tobacco shops that feature e-cigarette products.

Under the Tobacco Control Act, e-cigarette makers are supposed to submit product applications to the FDA for approval to stay on the market. However, the FDA tried to delay the review process until 2021 and 2022, prompting outcry from advocacy groups such as the American Lung Association and the Campaign for Tobacco-Free Kids.

Ms. Sward of the American Lung Association said inhaling chemicals is not safe, commenting on how troubling it is that the products have gone unregulated for so long. She said the FDA’s delay of the review process has partially contributed to the youth epidemic.

E-cigarette makers now have to submit pre-market product applications to the FDA by May 2020, the result of a federal lawsuit filed by advocacy groups against the federal agency last year.

The vaping industry is fighting back and suing the FDA for its “grossly accelerated” timeline for e-cigarette makers to submit premarket product applications.

E-cigarettes are battery-powered devices that have cartridges or refillable tanks containing a liquid mixture that may contain nicotine in combination with propylene glycol, vegetable glycerin, flavoring and other chemicals such as acetaldehyde (also found in cigarette smoke).


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