FDA Review On Vapor Products Delayed Due To Crisis
Ongoing Outbreak Pushes Back Federal Ban
The ongoing global pandemic has delayed or outright canceled, pretty much every conceivable event planned this year. From festivals to conferences, to even entire sports seasons, it seems like nothing is going to go ahead as scheduled this year.
Adding to the growing list of delays and cancellations are critical steps to implementing what is, in effect, a full federal ban on vapor products. The Food and Drug Administration announced they would be delaying its review of vapor products due to complications caused by the coronavirus crisis.
Manufacturers had previously had until May 12th to submit applications for their devices to the agency for review. The agency has now pushed the deadline back until at least September 9th and may be further delayed as the crisis continues to unfold.
The review is a part of the FDA’s larger effort to regulate the vaping industry, following concerns over youth access and questionable marketing practices. Last year, anti-vaping activists successfully sued the agency to speed up its review process, establishing the May 12th deadline.
In line with everything else scheduled this year, the Food and Drug Administration has announced a delay to their review process for vapor products and devices. The agency had previously given manufacturers until May 12th to submit applications for their products, the new deadline has been pushed back until at least September 9th, and may be delayed further.
In a statement, FDA Commissioner Dr. Stephen Hahn stated that vaping companies had reported problems completing research for their applications due to various travel restrictions and limitations on laboratory access. The commissioner also stated that many staff within the FDA who would have otherwise taken part in the review process are currently tasked with assisting the agency’s response to the pandemic.
The FDA premarket process requires vaping manufacturers to provide detailed information on the design and effects of their products to determine if they’re appropriate for the protection of public health. The review is expected to take a minimum of 12 months from the application deadline, during which time the products are continuing to be sold. The FDA has stressed that products currently being sold are being illegally marketed, and are only permitted as an exercise of enforcement discretion.
A series of studies have highlighted the efficacy of vaping as one of, if not the most effective, smoking cessation aids available. According to a study published in the New England Journal of Medicine, researchers found that vaping was more effective than traditional nicotine-replacement therapies in helping people quit smoking and remain tobacco-free.
Vaping is already responsible for saving thousands of lives throughout the world every single year. According to a study from University College London, researchers found that vaping was responsible for helping up to 70,000 British smokers quit in a single year.
In addition to being one of the most effective smoking cessation aids available, vaping has also been proven to be a reduced harm alternative to tobacco. Studies from both Public Health England and the Roswell Park Comprehensive Cancer Center found that vaping is 95% and 93% safer than smoking, respectively.
Not only is vaping an effective smoking cessation aid and reduced harm alternative to tobacco, but there has been no evidence of long-term harm to users of vapor products as well. Research published by the National Academy of Sciences found that vaping is less harmful than smoking, and there are no known long-term health effects associated with prolonged usage as well.
The focus and priorities of enforcement agencies are rapidly shifting as the coronavirus crisis continues to unfold. What was once decried as an epidemic by anti-vaping activists, has taken a backseat to the very real pandemic unfolding before our very eyes.
While the FDA premarket process is expected to be costly to the industry not only in the long-term but during the application process as well, the delay extends a lifeline to an industry that has been devastated by regulatory crackdowns and quarantine orders.
The vaping community must do its best to stand behind the industry as the crisis continues. Consider supporting your local vape store in any capacity you can. These small mom-and-pop shops need your patronage now more than ever amid these trying times.
What are your thoughts regarding the FDA delaying its review process? What do you think its impact will be on the broader vaping industry as a whole? Let us know what you think in the comments below, be sure to like us on Facebook and follow us on Twitter to receive all the latest vaping news!
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