The use of e-cigarettes, commonly known as vaping, has been a popular alternative to traditional tobacco products for several years now. Vaping products have proven to be much less harmful than smoking traditional tobacco, providing nicotine to users without the harmful combustion that comes from smoking. However, despite the scientific evidence that vaping is a much safer alternative to smoking, the regulation of vaping products has been subject to much debate and controversy. In this blog, we will discuss the problematic regulation of vaping products by the FDA, the Premarket Tobacco Product Application (PMTA), and how it has led to a disastrous outcome for public health.
The PMTA Pathway- Useless Unless You Are Big Tobacco
The PMTA pathway is the process by which the FDA authorizes vaping products to be sold in the market. Vaping product manufacturers are required to go through the PMTA pathway to prove to the FDA that authorizing a product is "appropriate for the protection of the public health." This process requires significant scientific evidence to prove the safety and efficacy of the vaping product.
Despite the general knowledge that vaping is a much safer alternative to smoking, the PMTA pathway has proven to be a major hurdle for many vaping product manufacturers. The FDA has received around 2 million PMTA applications for vapor products, and of these, only about a dozen unique products have been authorized, all owned by big tobacco companies except for one, NJOY, and none of them in flavors other than tobacco. Side note- NJOY was just bought by Altria, AKA Marlboro. Thats right, 99.999% of PMTA applications are denied, and the only ones accepted were by big tobacco companies who shelled out hundreds of thousands if not millions of dollars in the process. See the problem here? These regulations and regulators are for the big tobacco companies, not with the e-cigarette community.
The Impact on Public Health
Many advocates of harm reduction have noted that this is a disaster for public health, denying smokers access to products that offer a much healthier alternative source of nicotine. Vaping has been shown to be a much less harmful alternative to smoking traditional tobacco, providing nicotine to users without the harmful combustion that comes from smoking. Even the relatively new director of the FDA's Center for Tobacco Products (CTP), Brian King, acknowledged that switching from smoking to vaping is beneficial to health and that many people have successfully quit smoking by vaping. The fact that the FDA has failed to authorize 99.999% of the applications it has received for vapor products strongly suggests that the fault lies with regulations and regulators, not with producers of e-cigarettes.
Impossible for Vape Brands To Be Approved
The problem with the PMTA pathway is that it is a very costly and time-consuming process that requires significant scientific evidence to prove the safety and efficacy of the vaping product. It can take years and hundreds of thousands if not millions of dollars, not to mention thousands of documents and research proof. The process is similar to drug approval and requires randomized control trials (RCTs) or longitudinal studies, which are considered the "Cadillac" versions of scientific studies. It is ludicrous to expect an RCT for every single vaping product, given what we already know about the relative risks of smoking and vaping. The differences between various e-cigarettes are minor when compared to the difference between vaping and setting tobacco leaves on fire to breathe smoke into one's lungs.
The PMTA pathway's high regulatory burden makes it challenging for small vaping product manufacturers to meet the criteria to get their products authorized by the FDA. This has led to many vaping products being sold unlawfully, and the agency has begun issuing fines against small vape companies. This is a significant concern as it denies smokers access to products that offer a much healthier alternative source of nicotine.
The Need for a New Pathway for Vaping Products
The FDA's Center for Tobacco Products needs to consider creating new pathways for vaping products, established based on current scientifically-supportable standards, to illuminate a route forward for discrete categories of products. The FDA should seek statutory change if current authorities are not sufficient to support more streamlined reviews. Vaping products should be treated differently than traditional tobacco products as they are a much safer alternative, and regulations
Currently, nearly ALL vaping products in your typical shop are not FDA approved, primarily due to the fact that it's virtually impossible for companies to do so. If the FDA really wants to ensure the safety of the public and quality of the products, they need to make a more realistic route for vape companies to prove they are legit. This will probably take years to change if it even does, so until then, always ask brands for private lab testing to ensure they're not selling you poison, the real deal companies will almost always have this on hand.