After the FDA's regulations take effect on August 8, e-cigarette companies will have two years to make the case that letting their products remain on the market is "appropriate for the protection of public health." If they hit that deadline, they will be allowed to continue selling their products for another year while the FDA reviews their applications.
The FDA is not promising to respond within a year, however, and if it doesn't the products will be "subject to enforcement action." The FDA might make an exception if "review of a pending marketing application has made substantial progress toward completion," meaning the survival of e-cigarette companies depends on the efficiency and benevolence of an agency not known for either. Each application is expected to cost $1 million or more, and a separate application is required for every product variation. That requirement will be fatal for thousands of vape shops across the country that offer a wide variety of custom-made e-liquids in different flavors and nicotine strengths.
The regulations also dooms businesses that let customers assemble their own vaporizers by choosing batteries, tanks, and heating elements, because the FDA wants information on how every possible combination interacts with every possible e-liquid. Similarly, the FDA wants to know how every e-liquid interacts with every vaping system, and it expects applicants to compare the health risks posed by their products to those posed not only by cigarettes, which are indisputably much more dangerous, but by "similar products in the same category" and by "never using tobacco products."
Even the few companies that can afford to file applications may not be able to persuade the FDA that their products should stay on the market. In making that judgment, the agency will take into account "the risks and benefits to the population as a whole," including not just smokers who switch to vaping but nonsmokers and former smokers who try it, like it, and eventually switch to the real thing.
BUT THERE IS HOPE THROUGH CONGRESS!!!!!!!!
Both HR 2058 and the Cole-Bishop amendment are vehicles for language that would change the predicate date in the Tobacco Control Act (TCA) from February 15th, 2007 to the effective date of the deeming regulations (August 8th, 2016). This change would allow for all vapor products currently on the market to remain on the market without being subject to the burdensome and prohibitive pre-market FDA approval application process. If Congress does not act to change the predicate date established by the TCA, the wide variety of vapor products we love will be gone forever.
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