It is easy to forget that the PMTA doesn’t only cover vaping products, but also flavored tobacco products. So far, the majority of PMTA submissions have been from tobacco companies and cigar companies in particular. Only last week have we started seeing vape companies submitting their forms for PMTA approval.
Possible FDA Delay
In a letter to a District Judge Paul Grimm this week, the FDA has asked for a delay/deferment for many flavored premium tobacco companies, mainly cigar companies. This would provide an extension to the fast approaching PMTA deadline to the cigar companies, yet it completely excludes any vaping products. The document was approved August 5th, 2020.
This all stems from the FDA’s ability to defer submissions on a “case by case” basis.
“The FDA intends to exercise its retained discretion by deferring enforcement of the premarket authorization requirement for premium cigar manufacturers and importers on a case-by-case basis,” says the letter. “The deferrals are intended to help prioritize the use of the FDA’s limited enforcement resources while the agency undertakes a new research effort to evaluate the public health impact of premium cigars. The FDA intends to describe how manufacturers and importers can submit deferral requests in a guidance document that would take effect immediately upon issuance.”
Why would they do this? Well, the FDA has extremely limited resources when it come to enforcing the PMTA. If they defer more tobacco products, this opens up more resources to enforce the new laws on vaping products. On the other side of that, the FDA says that they will use this extra manpower to “fast track” any vaping applications.
“The FDA’s top priority for pre-market review of deemed products remains products that pose the greatest risk for initiation or use by underage persons, such as flavored, cartridge-based e-cigarette products targeted to or easily accessible to youth. Because the FDA’s current information indicates that youth smoke premium cigars comparatively less than most other deemed tobacco products, like e-cigarettes, premium cigars remain the FDA’s lowest priority for pre-market review.”
Youth vaping is at an all-time low since new regulations forcing people to be 21 years old to even step foot into a vape shop. Let’s also not forget that recent moves by the FDA has also halted importation of popular disposable vapes. Teen vaping is a trend that has pretty much ran it’s course at this point, yet it remains the main argument when it comes to the banning of vape products.
Reaching Out To The FDA
There have been many letters sent by small vape manufacturers over the past month asking to delay the PMTA deadline on September 9th. With Covid-19 looking like it’s here to stay for a while, vape companies have asked for more time to gather documents and research for their submissions. Many companies are working on a small skeleton crew because of the pandemic.
With this new development though, it looks like any delays that would be granted on the vape side of things probably won’t be considered. It would seem that a delay would already be announced considering the deadline is only a month away.
The War on Nicotine
The FDA must have all changes to their timeline approved by Judge Grimm due to last years lawsuit from the many anti-vaping organizations, including the American Academy of Pediatrics. The plaintiffs won the lawsuit, which moved the PMTA deadline to September 9th 2020. The “Youth Vaping Epidemic” was at the forefront of the federal case.
These same associations, as well as many anti-tobacco groups, plan to try and over-turn the exemption/delay for premium tobacco and cigars. The plaintiffs have acknowledged the recent letter to Judge Grimm and will be opposing it on August 17th. However this just seems to be for show, as the plaintiffs include the Campaign for Tobacco-Free Kids. The same group that brought vaping to the forefront last year.
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This move to rise against any PMTA delays will ensure that vaping doesn’t lose any attention when it comes to regulation. Because is certainly doesn’t seem fair to allow cigars and tobacco to delay their submissions, while vape companies have to stick to regulation. This becomes a double-edged sword for us. While tobacco may not get the delay the want, that also means any future vaping delays will be denied as well.
Whether we like it or not, the deadline continues to loom over the heads of vapers all over The United States. While there have been a few submissions, we have yet to see a “big push” from both large and small vape companies. Hopefully this changes over the next few weeks.
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