Bill Exempting Vaping From FDA Regs To Be Introduced This Week
The vaping community has not yet given up hope of reversing the Food and Drug Administration’s so-called deeming rule that serves to hurt the industry, and legislative supporters in the House of Representatives are gearing up for another battle.
Late last month, Reuters broke the news that a bill will be introduced on the floor this week, which we have written about here, that will render the deeming rule null and void and give the vaping community a major victory.
The bill, which was written and is being sponsored by Representative Duncan Hunter, Republican of California, would reverse the “deeming rule” and give the new administration time to review potential regulations to put into place for the burgeoning industry, which at last count, is estimated to be worth $4.4 billion in annual sales. It was announced months after the Cole-Bishop amendment was introduced in the House, and would give the vape industry a better chance at a future in the American market.
While discussions of the vape bill had been put on hold in the last few weeks, it seems that the bill is now going forward. This is great news for the vape industry, as the Cole-Bishop amendment, which would have exempted thousands of vaping devices and accessories from the deeming room, has already been rejected from President Trump’s first spending plan. There are already plans to revive it as a rider for the next proposed budget from the Trump Administration.
The deeming rule, which was put into place by former president Barack Obama and his administration, was formulated as part of the 2009 Family Smoking Prevention and Tobacco Control Act, which can be read here. This act states that since vape products contain nicotine, which can be naturally derived from tobacco, it was reasonable to have all vape products placed under the same regulations as tobacco products.
The issue with the deeming rule is simple: the rule covers every facet of the vape method, including vape devices, batteries, e-liquids, and accessories. Mechanical devices, batteries, and accessories do not contain tobacco products or by-products, so their inclusion in the deeming rule is ridiculous. Another issue with the rule is that while nicotine is naturally found in tobacco, the industry has created synthetic nicotine, rendering the rule completely useless in the face of the question, how does America regulate vaping?
Regulation of the vape industry has never been called into question; the industry wants and has called for self-regulation since it was created in late 2009. In fact, two trade associations, the Vapor Technology Association and the Smoke-Free Alternatives Trade Association, both exist to provide a standard of regulation within the industry; many of these regulations are already supported by federal and state guidelines.
Members of these associations include e-liquid manufacturers, vape device manufacturers, small businesses, distributors, wholesalers, and retailers, encompassing the entirety of the vape industry. In order to enjoy the benefits of the association, members must comply with the regulations put forward prior to obtaining membership.
Self-regulation is not always perfect and can indeed be problematic from a public policy point of view, however, it stands that the industry has already taken steps to regulate itself in order to prove to the federal government that vaping can be a benefit to public health.
The over-regulation at the hands of the FDA, however, is not only unjustified but unwarranted; the regulations were not created for vaping, which is fast becoming a mainstream smoking cessation method aimed at making it easier for smokers to quit. If the FDA continues to over-regulate the industry, vaping will disappear and the smokers who were using vaping to quit will revert back to smoking, reversing the trend in America that has seen the levels of smokers in the country decrease dramatically in the last ten years.
Hunter’s bill, as the piece of legislation is called, would exempt vape devices and products from more than just the “deeming rule.”
If the bill is made law, vape companies will not be required to undergo the Pre-Market Tobacco Application, which any new tobacco product must undergo prior to hitting the open market. This application process can take up to six months to complete and is estimated to cost, per product, around $250,000. This cost does not cover legal fees and is required for every individual type of product sold, which can cost small businesses around $2 million, a price they simply cannot afford.
Many vape device and e-liquid makers state that the process is too expensive; the application is also meant for tobacco products, not products that contain nicotine not derived from tobacco plants.
The distinction here is important: the PMTAs were designed to help the FDA evaluate and make a recommendation about whether or not a product should be sold on the open market due to public health value, safety, and other regulations concerning smoking traditional tobacco products. Because vape products do not contain nicotine, the application is invalid for assessing the health and safety of the products.
If the FDA wants to require an application process, it must first build one that addresses the specific concerns of vaping. This can only be done after a thorough review of the studies and reports done by the scientific community, a task that the FDA has yet to undertake under the new administration.
Hunter’s bill adds to the growing chorus of both vaping advocates and Big Tobacco companies, which have been making investments into the industry, that has reached Washington. Many legislators are heeding the call and hitting back at what they claim is a move by the FDA to cripple small businesses within the country.
The legislation comes just as President Donald Trump is in the middle of creating his administration. The new president has already begun instituting new rules for regulations, specifically signing an executive order that requires that for every new regulation, two must be rolled back. To add to that, Dr. Scott Gottlieb, who once held a financial interest in the vape company Kure, has just been confirmed as the FDA Commissioner.
During his testimony before the Senate, Gottlieb resisted calling for more vape regulations, instead stating that vaping, under the right circumstances, could be a safer alternative to smoking. He also stated that more research must be done on vaping as a potential smoking cessation method prior to the FDA decreeing it as a danger to public health.
Joe Kasper, Hunter’s Chief of Staff, commented on the bill and the concerns raised by anti-vaping advocates who claim that it is a gateway to smoking traditional cigarettes by saying that: “While we’re always going to have some concerns about kids accessing either cigarettes or vaping pens, that should not motivate the federal government to go in the complete opposite direction and say nobody can have them.”
The bill has not yet been debated on the floor; this publication will update readers on further developments.