COLORADO SPRINGS — The Food and Drug Administration delayed a long-awaited decision Thursday whether to allow e-cigarettes products sold by vaping brand Juul to stay on the market, along with millions of others.
The agency said in a statement it needed more time to finish reviewing the more than 6.5 million premarket tobacco product applications submitted by e-cigarette makers. The FDA had faced a court deadline to review e-cigarette products and decide if they were appropriate for the protection of public health, safe for current smokers, and not appealing to non-smokers.
To stay on the market, e-cigarette makers had to show their e-cigarettes benefit public health by submitting an application to the FDA. One of the vape businesses awaiting the decision from the agency is Absolute Vapor in Colorado Springs.
"We've been calling it Doomsday. The day the FDA is supposed to give us a response to a huge application we submitted a year ago," said Joshua Sprague, Owner of Absolute Vapor. "The process was super expensive, super time consuming, we spent the better part of four months and all of our resources."
Included in the application were studies based on their products, customer surveys, health research, and environmental assessments.
"They want our products that are proven to be 90 percent safer to go through the same process of a traditional cigarette to get on the market. In that application, our small company was, unfortunately, missing multi-million dollar clinical studies and certain things they would require a tobacco product to go through. The potential harmful consistent testing, arousal testing, and invitro testing. All of the clinical trials that cost millions of dollars that we can't afford," said Sprague,
According to the FDA, they've already issued marketing denial orders for more than 946,000 flavored vaping products because their applications "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." They also issued 170 warning letters to the businesses that haven't submitted applications yet.
"We continue to work expeditiously on the remaining applications that were submitted by the court's Sept. 9, 2020, deadline, many of which are in the final stages of review," the FDA said.
In response to the decision, the American Vaping Association released the following statement.
“Zero product authorizations, millions of banned products, and hundreds of thousands of products left in limbo by the agency’s failure to do their job. That is the end result of the FDA’s multi-year campaign to destroy the vaping industry and hand the remains over to large tobacco companies.
“America’s tobacco and nicotine regulatory system is broken beyond repair. It is absolutely absurd that the same agency that found time to ban over six million vaping products manufactured by small businesses is now indicating they need more time to review products with massive market shares. Even worse, after spending five-plus years peddling false hope to businesses across America, the FDA now can’t even be bothered to grant formal extensions to the remaining pending applicants. This decision brings even more uncertainty on the day FDA had previously pledged to provide the public with answers.
“If smoking rates go up in 2022 and beyond, do not blame the tobacco industry. This predictable result will entirely be the fault of elected officials and regulators who have utterly failed to protect public health.
“The FDA’s opaque review process was intentionally designed to eliminate all but the largest players from the market. We look forward to lending our support to future court challenges.”
Anti-Tobacco organizations say it is time vape products are regulated the same as tobacco.
"The way they are able to advertise, they can advertise in ways traditional tobacco hasn't been able to in years," said Dacia Hudson, Program Manager for Tobacco Education and Prevention Partnership at El Paso County Public Health. "Kids are growing up and it is in their face. They can't get away from it, it is on the radio, every station I listen too it seems like they are sponsored by a vape shop. They are also allowed to have all of these flavors that traditional tobacco is not allowed to have. The only flavor for traditional tobacco is menthol which is very concerning as well but that is one flavor versus thousands in the vaping industry."
Hudson says youth vaping has increased over the last five years.
"It is something that we are very concerned about and it's definitely on our radar to help kids prevent them from using and helping them quit if they've already started," said Hudson.
She says vaping is especially harmful to kids.
"Their brains are still developing, we know their brains are still developing till the age of 25. They are more susceptible to becoming addicted and having harmful health effects related to using vaping or any other tobacco product. We know 1 in 5 high school students in Colorado report using a vape device and that's largely due to their enticing flavors and marketing tactics of the industry. They are very appealing to young people, all of the flavors," said Hudson.
Following the FDA's decision, the Colorado Department of Public Health and Environment made the following comment.
CDPHE is closely following FDA’s final decision regarding the review of applications for new tobacco products, but the FDA’s review is not complete. In the meantime, CDPHE remains concerned about children and youth having easy access to flavored tobacco products for whom no level of nicotine use is safe.
We affirm and celebrate smoking cessation -- and understand that some adult smokers may prefer to use e-cigarettes as a resource. Colorado has many free, safe, effective options for Coloradans who use tobacco and who are seeking help for their use, including the Colorado QuitLine at 1-800 QUIT NOW or COQuitLine.org.
Sprague says he expects to get his denial letter in a few weeks, but he does plan to appeal the decision in hopes of proving to the FDA that they are a smaller company and shouldn't be held to the same standard as the tobacco industry.
"We've been here several times, we've kept pushing, we've changed our business model and done a lot of things, but at what point as a business owner do you give up hope, say this isn't worth it. At what point as a business owner, do you tell all of your employees who've worked with you the better part of eight years that this is the end of the road and they need to find something else, " said Sprague.
The FDA didn't specifically say the number of applications denied, but their website shows the last premarket tobacco product application was approved last year.
