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The White House Steps In: A Proposal to Ban Flavored Vaping Products

A PUBLIC HEALTH CRISIS

In our August 23, 2019 blog titled “A Mysterious Illness“ we discussed the vaping-related respiratory illness that is fast becoming an epidemic across the country. Since posting that blog, the number of reported cases of vaping-related acute respiratory distress and potential long-term lung damage has risen to approximately 450 cases in 34 states; 6 deaths have occurred. The Centers for Disease Control and Prevention is investigating, trying to determine the exact cause of the awful illness, but so far, one has not been determined. As of now, health departments are urging people not to vape.

Meanwhile, cities and states have reacted to the growing epidemic in different ways. San Francisco has banned the sale of vaping products. New York raised the minimum age to purchase e-cigarettes from the federally mandated age of 18 to 21 years old. Several state attorneys general are calling for the federal government to ban the sale of flavored e-cigarettes. But it is Michigan’s complete ban on the sale of online and retail sales of flavored nicotine vaping products, and the prohibition against advertising or marketing of products using terms such as “clean,” “safe,” or “healthy” that has made the industry and advocates take notice.

Michigan Governor Gretchen Whitmer issued the ban on September 4, 2019, and the rules implementing it will be put in place in the next few weeks. Vaping companies will be given one month to comply with the new rules. Michigan’s Chief Medical Executive Dr. Joneigh Khaldun called youth vaping a public health crisis, and the legal justification for the ban is the state government’s ability to respond to a public health emergency. But will this be sufficient to withstand the legal challenges that are sure to follow? And will the ban hurt small business owners and create a black market for flavored e-cigarettes?

THE ROLE OF THE FDA

The source of the FDA’s regulatory power over e-cigarettes is the Tobacco Control Act of 2009, which gave the FDA power to regulate tobacco products. In 2010, U.S. Court of Appeals, D.C. Circuit, ruled that the FDA can only regulate e-cigarettes as tobacco products and not as drug-delivery devices, as the FDA had argued. What followed was a number of years in which e-cigarettes went unregulated for all practical purposes, since there were no regulations on how to control e-cigarettes as tobacco products.

In 2014, the FDA proposed sweeping new regulations for all existing products, requiring premarket tobacco applications (PMTAs) within 2 years after the final rule was issued; the proposed rule was called the “Deeming Rule” because it allowed the FDA to “deem’ any new product containing nicotine made or derived from tobacco to be a tobacco product and therefore under the FDA’s regulatory jurisdiction.

In 2016, the final Deeming Rule was issued. The deadline for PMTAs for existing products was set for 2 years from the date of issuance, or August 2018. PMTAs were required for products introduced going forward. A federal minimum age for purchasing vaping products was established at 18 years old. A ban on free samples of vaping products in vaping stores took effect immediately.

THE VAPING EPIDEMIC

Before the PMTA deadline of 2018 arrived, things at the FDA took an unexpected turn: Dr. Scott Gottlieb became the Commissioner of the FDA. Gottlieb postponed the 2018 deadline for PMTAs by 4 years, to August 2022. More importantly, however, Gottlieb announced a plan to regulate nicotine levels in combustible cigarettes to render them minimally or non-addictive. He also promoted e-cigarettes as smoking cessation devices. By targeting nicotine levels in traditional cigarettes and promoting the use of e-cigarettes to quite smoking, while simultaneously rolling back the regulations on vaping products, an epidemic was born.

The reality is that the nicotine levels in e-cigarettes are as high and therefore as addictive as in combustible cigarettes. One Juul pod (Juul is the best-selling e-cigarette device and e-juice brand) contains as much nicotine as a whole pack of cigarettes. Flavored juices such as fruit medley, mango and creme brûlée hook middle school and high school kids, and nicotine is particularly harmful on adolescent brains, leading to attention problems and learning issues. As the ultimate sign of history repeating itself, Big Tobacco has moved into the less-regulated space of vaping and bought e-cigarette companies. With a whole new generation addicted to nicotine and legal challenges to proposed regulations still pending in court, a comprehensive federal response from the FDA seems unlikely in the near future.

A POSSIBLE WAY FORWARD

Much has happened since Gottlieb resigned as Commissioner of the FDA in March of this year. The number of cases of vaping-related respiratory illnesses, and the severity of the illnesses in previously healthy, mostly young people has raised the alarm across the country. The tragedy of acute illness and potential permanent lung damage may point a path forward in regulating this virtually uncontrolled market.

Kevin Burns, the CEO of Juul, made a remarkable statement in a recent interview when asked his opinion of the illnesses. Burns stated bluntly that non-smokers should not use vaping products. That simple statement from the CEO of the leading e-cigarette brand has profound implications for the vaping industry. If e-cigarettes were restricted to and marketed as smoking -cessation devices, flavors could be banned (except possibly tobacco), thereby limiting the number of teens who get addicted to nicotine.

On September 11, 2019, the White House proposed just that: a ban on flavored e-cigarette products. Citing the alarming increase in high school students who report vaping, and the spreading outbreak of a vaping-related respiratory illness that has claimed 6 lives and affected 450 people in 34 states, the Trump Administration announced that the FDA would be releasing guidance on removing all flavored vaping products (except tobacco) from the market. The guidance will be issued in the next couple weeks, upon which companies will be given 30 days to comply.

In addition to banning flavored products, warning labels should be added to all vaping products, similar to those on traditional cigarettes. All vape juice ingredients and the amount of nicotine delivered compared to combustible cigarettes should be listed as well. Health warnings must be given regarding the risks associated with vaping so that the notion that e-cigarettes are safe is debunked.

Even the marketing of e-cigarettes as a safer alternative to combustible cigarettes has now come into question due to the severity of the vaping-related illness and resulting lung damage that occurs after such short exposures to vaping. Touting e-cigarette use as an off-ramp from traditional cigarette use may no longer be a viable strategy, and the FDA and CDC should be consulting with local health departments and doctors about revising recommendations.

CONTACT YOUR ATTORNEY

If you or someone you know has become ill after vaping, contact Dave Thomas at The Thomas Law Firm for a free consultation regarding your legal rights.

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