In a span of two years, smokers wishing to quit may have many less options than they do today, as brand new FDA regulations on e-cigarettes and related products are already causing harm to the vaping industry. This FDA censorship, which took effect August 8, will drastically reduce the size of the vaping market, limit consumers’ options, and generally discourage them from trying to find an alternative to smoking.
The first major action the FDA took against the vaping industry is requiring all manufacturers to obtain FDA approval for any product they wish to carry for longer than two years. In order to do this, manufacturers must submit a “premarket tobacco product application” (PMTA) for each product they wish to continue selling, the cost of which the FDA estimates to be from $12,000 – $2.6 million. Due to this harsh restriction, some larger manufacturers have already filed federal lawsuits against the FDA. One of these companies, Nicopure, has stated that it would have to submit thousands of PMTAs to keep all of its current products on the market, but will not be able to manage more than a dozen in the next two years. This demand in itself will diminish the number of e-cigarette manufacturers, and will reduce the amount of products available to the public.
Aside from these giant issues the larger “formal” manufacturers will have to face, there are the thousands of vape shops across the country that will likely diminish. Vape shops custom mix e-liquids for their customers, as well as assemble and fix e-cigarettes, but these actions will now cause shops to qualify as manufacturers under the FDA’s new rules. The shops will be unlikely to bear the monetary weight of FDA regulation as manufacturers, and then will be forced to no longer offer these customer services. Custom mixing e-liquids is the main draw and major selling point of vape shops, and with no longer being able to offer custom fluids, many shops will likely run out of business.
The FDA is giving the grace period of two years for manufacturers to seek its approval of products, however, it does not apply to variations introduced after the August 8 deadline, in effect banning product improvements. Even small changes in a current product’s size, flavor, ingredients, etc. after August 8 will constitute a brand new product that will require FDA approval. This means that any larger changes, such as improvements, to a current product are also banned without approval- improvements that could make e-cigarettes easier or cheaper to use, or could cause them to be more appealing to smokers wishing to quit.
In addition, the FDA has placed speech restrictions to prevent fraud. However, these restrictions prohibit statements and explanations that are true and accurate, and that would benefit consumers trying to decide between smoking and vaping. Since the FDA has placed tobacco-free e-cigarettes into the tobacco products category, manufacturers are not allowed to advertise their products as “smoke-free”, “ash-free”, “tar-free”, etc, as that would be promoting a “tobacco product”. Therefore, e-cigarette companies will not be able to promote the main goal and advantage of their products- being less harmful than tobacco cigarettes.
Up until now, manufacturers of e-cigarette products have gone largely unregulated. The harmful effects of vaping may not be fully known or scientifically proven, however, the fact that e-cigarettes contain only a fraction of the harmful chemicals as do conventional tobacco cigarettes, makes them a less-harmful option. Only time will tell, but the FDA has already caused the future to look bleak for this alternative to tobacco smoking.