Posted by Jason B. on Aug 21st 2020
PMTA Nearing Deadline
The PMTA is how the FDA responds to a supposed need for ENDS regulation, applying to products established in the tobacco market following the Family Smoking Prevention and Tobacco Control Act in 2009 allowing the FDA to enact regulation standards to all 'tobacco-derived' products.
Why the PMTA Could Be Benefical in The Long Run
Posted • 21 Aug • Jason B.
The PMTA is how the FDA responds to a supposed need for ENDS regulation, applying to products established in the tobacco market following the Family Smoking Prevention and Tobacco Control Act in 2009 allowing the FDA to enact regulation standards to all 'tobacco-derived' products.
Back in 2016, the Food and Drug Administration made an announcement stating all tobacco products not present in the market prior to February 15, 2007 would need to have approval through a PMTA prior to entering the tobacco market. Additionally, all products introduced before that date would be given a grace period where they would have the ability to prep a PMTA for submission. The PMTA deadline is getting very close for products in the grace period who still want to legally sell their products on the market, September 9th 2020 to be exact. Moreover, the FDA made a commitment to review each and every PMTA application within a single year, during this time enforcement will be deferred on no-sale orders for products that are considered 'under review'.
If any company is seeking to receive approval of their PMTA, each manufacturer is required to show the marketing and display of their products in question would be deemed 'appropriate' for protecting the public health, whatever that means. This standard created by the FDA means a required consideration of the possible risks and rewards to our population, like if the product exists on the market will non-users start using them because they're there.
The FDA's evaluation process involves a review of a tobacco products: additives, components, ingredients, health impact, and toxicological profile. Their standards have been considered 'too high' seeing as how only three companies have accomplished 2019 Premarket Tobacco Product Marketing Orders.
New Branding for PMTA Approval
Slow PMTA Process Leads to Statewide Bans
Though the purpose of the PMTA is to keep the health of the general public protected, it is moving along far too slow. Some states including New York, New Jersey, Massachusetts, Rhode Island, Michigan, Washington, and Oregon have at one point enacted some kind of unjust ban on vaping products. Though the intentions of a few of the government officials were good, they were entirely misguided. The blanket ban states have faced has put an unfair limit to access of vape products for people who either want to quit smoking with an effective alternative, and individuals who enjoy vaping and should have the option to freely choose what products they want to buy.
The best way to ensure the safety of a tobacco product is to allow the FDA to conduct a thorough investigation of its safety and public health merit
Chelsea Boyd - Research Fellow, Harm Reduction
On a positive note, through time the FDA will approve more PMTA submissions for e-cigarette products because they will be considered to be demonstrating that their product being available on the market will be ultimately beneficial to public health. Another positive is when vaping products receive PMTA approval, they will be compliant with federal regulations leading to state-level government laws having a more difficult time enacting state-wide vaping bans.
It makes sense in a very small way for states to enact bans due to laws moving much faster on the state level compared to federal, but they are far too short-sighted for the law-abiding citizens having a legitimate product they enjoy or need to improve their health being taken away. So in short, though the states want to ban vaping products the federal government is going to be balancing out the pros and cons of vaping and enact a more positive law than just a full ban.