FDA Urged To Scrap Vape Regulations By Senator
As Dr. Scott Gottlieb begins his tenure as Commissioner of the United States Food and Drug Administration, one senator is calling for him to review and then scrap current vape regulations that are threatening to wipe out the industry.
The Washington Examiner is reporting that Senator Ron Johnson, a Republican from Wisconsin who is also the chairman of the Senate Homeland Security and Governmental Affairs Committee, has written a letter expressing this very desire to the FDA Commissioner.
The letter reads in part the Senator’s hope that: “As you begin your tenure as commissioner of the FDA, I respectfully urge you to review the FDA’s e-cigarette regulation so that the industry can continue to innovate and offer vapors [as] an alternative to smoking.”
The Hill is reporting that the body of the letter also includes mentions of the FDA regulations acting as a possible death knell for the industry and the former smokers relying on it. The letter states that:
“The rules threaten an emerging industry as well as former smokers who have switched to vaping…the regulations require e-cigarette manufacturers to complete costly and time-consuming applications to get federal approval to sell e-cigarette products.”
The letter alludes to the regulations that came as a result of the FDA handing down the so-called “deeming rule” that made vape products, in the eyes of the government, the same as tobacco products. The regulations that came after have been detrimental to the industry and has already caused at least a dozen vape businesses to close, a direct result of over-regulation.
The regulations, which this publication has spoken about before at length, include the widely criticized Pre-Market Tobacco Application, a process that is estimated to cost vape business owners, on average, more than a quarter of a million dollars for each individual product, including vape devices and accessories; e-liquids, which come in a variety of flavors and nicotine levels, will be required to undergo separate PMTAs for each nicotine level.
The application process was put into place by the Family Smoking Prevention and Tobacco Control Act of 2009, which was signed by then-president Barack Obama. The act, which can be viewed here, cites the need for the FDA to evaluate any tobacco product going on the market for public health and safety standards.
The vape industry is not disputing the fact that the vape market should be regulated, but the application cost alone for vape manufacturers is thought to total over one million dollars for e-liquids alone, something that is unsustainable for small businesses, which are the majority of vape sellers in the market right now.
“Based on some estimates, these applications could cost manufacturers, many of which are small businesses, more than $1 million to complete,” Johnson said in the letter. “That is a cost that these businesses cannot afford.”
If vape businesses cannot afford the application process, which many have been cited in major publications that they cannot, then the industry will disappear. That leaves one of two options: former smokers, who make up the vast majority of vapers in the country, will be left without a smoking cessation method that has already been proven to be successful in Europe, or tobacco companies will be the only businesses in the vape industry, a move that is considered suspicious by both industry experts and anti-smoking advocates.
To add to the over-regulation by the FDA, including increasing the minimum age of vaping to 18 and marketing restrictions, many states are now instituting their own sales and wholesale taxes on vape products. These taxes, which on average target e-liquids, are claimed by state governments to dissuade young people from using the products as well as to add to a state budget’s bottom line.
However, the use of state taxes has backfired for many; in Pennsylvania, the 40 percent wholesale tax that was proposed and implemented saw vape businesses move across state lines, leaving a hole in the state’s budget. Other states, like California, are taking their time to figure out a vape tax; this is most likely due to the knowledge that vape businesses can simply move to the internet to avoid double taxation.
While critics of the vape industry claim that the market, which has been present in America since 2009, has gone too long without any regulation, there are advocates who say that companies are regulating themselves.
The American Vaping Association was created in order to help begin standardized vape regulations, such as requiring child-proof locks on bottles, limiting the size of bottles, and other rules that members must comply with. The industry has also welcome critical studies done by independent researchers to improve vape technologies to ensure the health of consumers.
But the self-regulation, which was always assumed by the community to be followed with federal regulation, seems inadequate for anti-vaping advocates.
The Campaign for Tobacco-Free Kids, one of the most ardent critics of vaping, has released a list of 51 health groups and organizations that demand that the FDA put additional regulations on the industry with the claim that vaping targets kids.
There is no evidence to suggest that the vape market, which has only recently seen tv commercials aired in favor of it by Big Tobacco companies, targets children; there is only the summation that the large variety of e-liquid flavors that exist, including candy flavors, are seen as an affront to those who are squarely in favor of abstinence of all nicotine.
This implication is squarely disputed by the fact that smoking and vaping levels among high school students and young adults is at its lowest levels since the formation of the market. This could be in part because students have been educated about the long-term effects of smoking or it could be because students view vaping as a novelty that has worn off.
Even the U.S. Surgeon General’s Office report on vaping provides evidence for this, although it neglects to make the fact that students who try vaping in high school rarely become regular vape users apparent to its audience. It also refused to measure how many students who were former smokers switched to vaping completely after trying it out.
There is good news on the horizon for vape manufacturers, one that comes with the new Trump Administration; the FDA has instituted a three-month delay to give the new government time to review the regulations that were put into law by the previous administration. Since the regulations are also facing on-going court challenges, the delay could not have come at a better time.