After years of debate, research and accumulating data, the FDA has finally approved a vape for commercial use. As the debate continues, children become the new battleground.
On October 12, the Federal Drug Administration (FDA) announced the first vaping authorized for mass marketing and distribution in the United States.
In a press release, the federal agency said it had “given orders to RJ Reynolds (RJR) Vapor Company for its Vuse Solo Closed Ends device and tobacco flavored e-liquid pods.”
The clearance comes after several vape companies turned over samples to the FDA for testing and potential regulation. Only Reynolds’ product Vuse met FDA requirements.
Not all flavors have been approved – only the nicotine flavor which lacks other additives that provide extra taste.
The main reason for the approval of the product is the potential assistance it can provide to people addicted to nicotine products. Other alternatives like nicotine gum do not offer the same physiological link between inhaling and exhaling.
“Today’s approvals are an important step in ensuring that all new tobacco products undergo pre-market scientific assessment by the FDA,” said Mitch Zeller, JD, director of the Center for Tobacco FDA Products, in the press release. “The manufacturer’s data shows that its tobacco flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals.”
The Vuse vape is available at various gas stations, smokehouses, and other convenience stores. Their high availability plays an important role in the overall success of the Reynolds company.
Like many traditional vapers, the Vuse has a refillable cartridge that relies on a liquid, commonly known as “juice,” to deliver the inhalable vapor. This liquid is in replaceable pods. The device has a battery which also allows for greater portability.
The three flavors offered by the company are menthol, golden tobacco and rich tobacco. The pods are placed magnetically in the device. All of the flavors contrast with the fruity flavors that other companies are using to market to a younger audience.
Currently, Vuse has 33 percent of the market share while Juul has 40 percent. With an evolution towards tasteless pods, the market share that Vuse has gained without appealing to a younger audience has played a role in the authorization of the product.
“For these products, the FDA has determined that the potential benefits for smokers who quit completely or significantly reduce their consumption of cigarettes would outweigh the risk to young people, provided the applicant meets post-market requirements to reduce youth exposure and access to products, ”the FDA said in a press release.
While the FDA has ruled that the device would not lead young people to turn to the Vuse product, some health experts are concerned about the negative consequences of authorizing a vape product.
Ryan Barrlett of the Utah Department of Health felt that a “green light” was given to people to consume and use vape products. Young adults, a group of concern for the FDA, may misinterpret the clearance.
“When it comes to e-cigarettes, we’re more concerned about young people, people who are in high school, college and even in the young adult lineup,” Bartlett told Deseret News. “Because this is the age when if you start using it, there is a good chance that you will use it for the rest of your life.”
Aside from the confusion caused by the authorization, the Vuse device is only allowed for people who are trying to quit smoking, not for someone who is starting to vape. There is always a chance that a person who uses Vuse will become addicted to nicotine and then be able to start smoking cigarettes.
Eric Lindlom, former head of the FDA, said the specific use of the device is the only one tolerated. Any other use presents risks for the user.
“The only way for Vuse [products] could be used to reduce tobacco-related health damage if smokers switch almost completely from smoking to using the Vuse e-cigarette instead, ”Eric Lindblom, former head of the Center for Tobacco Products at the FDA, who is now a senior researcher at the Georgetown University Law Center, wrote in an email to POLITICO. “Any other use will increase the damage and risk to the health of users. “
Compliance with the FDA requires multiple checks on a product to ensure that it consistently meets requirements. For the Vuse device, the amount of aerosols the device produces is key. As long as the amount is low enough to warrant use by drug addicts, regulation could continue.
“These products were found to comply with this standard because, among several key considerations, the agency determined that study participants who only used authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs). aerosols versus burnt cigarette users, ”the FDA said in its press release.
In the future, the FDA has yet to decide on products from other companies. The decision on Juul products has been delayed by a decision expected to be implemented in the near future.
With the FDA establishing deterrence of young people as a priority, it said more action was still needed to fully regulate vaping. After several products were decided to be phased out for marketing and sales, more potential actions were on the horizon.
Jody Sindelar, in the New England Journal of Medicine, discussed one of the potential actions that can follow regulatory decisions: taxation.
With increasing taxes on cigarettes to make them more expensive than vapers, nicotine addicts could switch to vaping rather than cigarettes.
Moreover, if the taxes are high enough, the high price of vaping could mean that fewer young people are inclined to spend so much money. The next regulation could be a tax increase as well as a ban on flavored vapers.
Young people might even be deterred from starting vaping with a higher cost of entry and less appealing flavors.
The future of vaping regulation remains uncertain, and multiple avenues may develop depending on the number of additional devices approved by the FDA.
Depending on the evolution of the market, other actions such as those proposed by Dr Sindelar could be instituted as a means of deterring young people. As more and more research is done, more and more strict or loose regulation may soon arrive.
Photo by Sarah Silbiger / Getty Images.