FDA Rejects Vaping Products
- The Food and Drug Administration (FDA) announced that it had rejected more than 5 million applications submitted by e-cigarette manufacturers.
- Among the applications rejected were 946,000 for flavored electronic nicotine delivery systems, including Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.
- “It’s not a great leap to think that inhalation from vaping could trigger lung cancer down the road or other inflammatory lung diseases,” said Dr. Brendon Stiles, chief of thoracic surgery & surgical oncology at Montefiore and Albert Einstein College of Medicine. More research is needed to understand the ramifications of vaping.
This sweeping move comes amid growing concerns about the cancer risks associated with vaping, increasing in popularity among adolescents.Read More
Those products will now be removed from shelves after being allowed to stay on sale while the FDA reviewed applications for more than 6.5 million products submitted by the Sept. 9, 2020 deadline. A federal judge had given the FDA one year to review applications submitted by vape companies in a decision stemming from a lawsuit brought by anti-tobacco groups.
The agency stated in rejecting those applications that the products “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
In a release obtained by SurvivorNet, the FDA also notes that it refused to approve “one company’s applications for approximately 4.5 million products because required contents were missing.”
Combined with the flavored ENDS (electronic nicotine delivery systems) products, those rejections mean that very few of the 6.5 million applications reviewed by the FDA passed muster with the agency.
The agency hinted at its concerns when the agency issued its first-ever marketing denial orders for 55,000 new flavored e-cigarettes from three companies earlier this month.
Also surprising on Thursday was the decision by the FDA to delay its ruling on the applications submitted by the three biggest companies in the market.
“There’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States,” acting FDA Commissioner Janet Woodcock and Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a joint statement.
This move comes on the heels of alarming new research that 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 after examining the smoking habits of between 15,000 and 36,000 students in grades 6 through 12 from 1999 to 2020.
This is cause for concern as there is still not enough information to know for sure if vaping may also cause lung cancer or other forms of the disease.
That does not mean that there is no risk, something that could be of concern if vaping continues to grow in popularity at its current rate for the 10 years it will likely take until there is a definitive study on vaping and cancer.
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.
In fact, 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
“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 just 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 Lung Cancer 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.”
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 people have been hospitalized due to vape-related illnesses.
The CDC said that data show that an additive called vitamin E acetate, which is included in some vaping and e-cigarette products that contain THC (the psychoactive compound in marijuana), is strongly linked to the outbreak of vaping-related illnesses. However, the organization also notes that there could be other chemicals contributing to the outbreak.
“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. Brendon Stiles discusses the possibility that vaping can lead to serious lung illnesses
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.”