Vuse Granted FDA Authorization Despite Unknown Cancer Risks and Popularity With Youths
- The Food and Drug Administration authorized R.J. Reynolds to market its Vuse Solo Power Unit and two tobacco-flavored replacement cartridges – each with 4.8 percent nicotine. The agency also noted that no tobacco product will ever receive agency approval.
- The FDA says that because Vuse consumers are inhaling fewer HPHCs than a person smoking a regular cigarette and the device is releasing fewer toxic aerosols into the environment there is a public health benefit, despite noting 10.8% of youth smokers use Vuse in a study released 13 days prior to this authorization.
- “The FDA is making a conscious choice to put a relatively small number of adults in front of another generation of America’s kids. And that is deeply troubling,” Erika Sward, assistant vice president of national advocacy for the American Lung Association, tells SurvivorNet.
The agency released a statement authorizing R.J. Reynolds to market its Vuse Solo Power Unit and two tobacco-flavored replacement cartridges, each with 4.8 percent nicotine. At the same time, the FDA denied 10 of the company’s applications for flavored products.
Read MoreFDA Authorization of Vuse
The FDA notes that Vuse received agency approval after research revealed that users of the e-cigarette were “exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes” and that the “authorized products' aerosols are significantly less toxic than combusted cigarettes.” Medical experts have told SurvivorNet that the health risks posed by vaping are still unclear. More research is needed, but some say vaping could be worse than standard cigarettes.
R.J. Reynolds also “submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health” ahead of the agency authorizing the marketing of these products in the United States.
The FDA made a point of noting that the Vuse, and any other tobacco products, would never be approved by the agency.
“While today's action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or ‘FDA approved,'” stated the agency. “All tobacco products are harmful and addictive, and those who do not use tobacco products should not start.”
However, the agency believes that because Vuse consumers are inhaling fewer HPHCs than a person smoking a regular cigarette and the device is releasing fewer toxic aerosols into the environment, there is a public health benefit.
American Lung Associations’ Sward disagrees.
“There’s no such thing as a safe tobacco product, and ultimately we don’t know the long-term consequences of e-cigarette use,” says Sward. “What we do know is that Reynolds, the parent company, has been convicted of civil racketeering charges for lying and defrauding the American public. And we remain concerned that any product that has so many dangerous chemicals that are designed to be inhaled into the lungs should remain on the market.”
Sward is referencing a 2006 case against Reynolds and other tobacco giants. A judge ruled that the companies had violated civil racketeering laws (RICO) and engaged in a decades-long conspiracy to deceive the American public about the health effects of smoking and their marketing to children.
Vuse Popularity Among Youths
A study by the FDA and U.S. Centers for Disease Control and Prevention released 13 days before Vuse received agency authorization stated that of the more than 2 million U.S. middle and high school students who reported using e-cigarettes in 2021, 10.8 percent cited Vuse as their brand of choice.
That means over 216,000 U.S. middle and high school students are using Vuse products.
The FDA acknowledges this study and its results, noting: “For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.”
That same study did determine that 84.7% of youths used flavored e-cigarettes, which have not received authorization from the FDA.
“This brand is well known to kids, and the fact that it was given the green light for sale by the FDA is very troubling,” says Sward. “I think the second part of this is the fact that [the FDA] authorized such a high-nicotine percentage product [4.8 percent], and compare that to products sold in Europe that are capped at 2 percent. I think that when you add a high nicotine product with a brand that is known and used by kids, you are asking for the continuation of this youth vaping epidemic.”
Harold Wimmer, president and CEO of the American Lung Association, notes that “completely removing high-nicotine products like Vuse from the market and ending the sale of all flavored e-cigarettes products, including menthol” is the only way that the “epidemic” of youth smoking will come to an end.
At the same time, alarming new research released this summer revealed nicotine use among high school students was at a 20-year-high in 2019, just two years after hitting an all-time low.
Researchers published their findings in The Journal of the American Medical Association. That study examined the smoking habits of between 15,000 and 36,000 students in grades 6 through 12 from 1999 to 2020.
Cigarette smoking was at its peak in 1999, when 12.8% of middle school students and 34.8% of high school students reported having lit up in recent days.
Those numbers have decreased every year since, and in 2020 only 1.6% of middle school students and 4.6% of high school students were smoking cigarettes.
The use of all tobacco products had been on a steady decline until 2017 when things suddenly shifted, and numbers began to rise again.
Since 2014, e-cigarettes have been the most commonly-used nicotine or tobacco product among middle school and high school students.
Usage steadily rose until 2018, when the number of students vaping jumped from 11.7% to 20.8% among high school students and from 3.3% to 4.9% among middle school students.
That was just a preview of what was to come as those numbers soared higher the following year, with 27.5% of high school students and 10.5% of middle school students vaping in 2019.
The Risks of Vaping
Dr. Sheela Ahmed, a pulmonologist at Fox Chase Cancer Center, previously told SurvivorNet that e-cigarettes are in many ways much worse than actual cigarettes.
“E-cigarettes don't burn tobacco, so they are marketed as containing fewer toxic chemicals than regular cigarettes,” said Dr. Ahmed. “However, this is not true. In the short term, vaping has caused acute lung injury and respiratory failure, which is something not attributed to regular cigarette use.”
As for the chemicals in those e-cigarettes? A “cocktail of nicotine, toxic metals, propylene glycol and glycerol, flavorings, and other chemicals that can reach deep into the lungs,” according to Dr. Ahmed.
There is also much concern around a 2019 study published in Proceedings of the National Academy of Sciences of the United States of America that examined the effect of vaping on mice. That study revealed that vaping caused cells to change in a matter of months.
That would suggest DNA is being injured and the body is failing to repair those injured strands, which is how cancer begins to form in the human body.
"As a cancer center, we are very concerned about the animal studies showing that e-cigarette smoke caused cancer in mice and, in the future, we want to study DNA changes in the cells of people who vape," explained Dr. Ahmed.
She suggested that the “establishment of community education programs regarding the risks of vaping” would be helpful until that time.
A study published earlier this year in Lung Cancer Journal detailed the oncogenic effects of e-cigarettes. Oncogenes are genes that have the potential to cause cancer.
The piece cited nicotine derivatives and heavy metals as just two of the problematic ingredients in e-cigarettes that could cause concern.
That study closed with a warning.
“Although research remains somewhat equivocal, there is a clear reason for concern regarding the potential oncogenicity of E-Cigarettes/E-Liquids with a strong basic and molecular science basis,” read the study. “Given lag times (extrapolating from tobacco smoke data) of perhaps 20 years, this may have significant future public health implications. Thus, the authors feel further study in this field is strongly warranted, and consideration should be made for tighter control and regulation of these products.”
The Issue With Vaping: Doctors Don't Know How Dangerous It Is Yet
What Has Been Confirmed About Vaping-Related Illness?
According to the Centers for Disease Control and Prevention (CDC), there have been 68 vaping-related deaths in the U.S. as of February 2020 and another 2,807 hospitalizations due to vape-related illnesses.
The CDC said that data shows the presence of an additive called vitamin E acetate in some vaping and e-cigarette products that contain THC (the psychoactive compound in marijuana). That additive is strongly linked to the outbreak of vaping-related illnesses, though the organization notes that there could be other chemicals contributing to these illnesses.
“The big problem with vaping and JUUL is that we just really don’t know what’s going to happen with it,” Dr. Brendon Stiles, chief of thoracic surgery & surgical oncology at Montefiore and Albert Einstein College of Medicine, told SurvivorNet when discussing the issue in a previous interview.
Dr. Stiles noted it’s essential to research vaping because, like smoking cigarettes, there’s a chance that this will be a lifestyle factor that leads to lung disease down the line. Considering the number of teens who currently admit to vaping (about 1 out of 5 high school students), there’s a chance that a health crisis is coming in the next decade or so.
“Are there compounds in vaping that we’re just not regulating, and we don’t know anything about that may cause secondary insults or inflammation in the lungs? There’s plenty of history of other inflammatory lung conditions causing or triggering lung cancer,” Dr. Stiles said. “So, to me, it’s not a great leap to think that inhalation from vaping could trigger lung cancer down the road or other inflammatory lung diseases.”
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