Even though the FDA seems to be determined to prohibit nearly every nicotine vaping product currently in use in the United States of America, it recognizes that they can reduce harm and offer an alternative for combustible cigarettes. The FDA has limited e-cigarette authority under the current law to nicotine derived tobacco. This means that the FDA is not able to regulate synthetic nicotine found in products such as PuffBar. Congress is set to approve a spending bill fast tracked by Congress by Friday. It includes a provision to close the escape hatch and redefine “tobacco product” to encompass products that do not have anything to do with tobacco.
Amanda Wheeler (president of American Vapor Manufacturers Association), stated in a press statement that FDA has been under heavy scrutiny for its unlawful regulation overreach regarding nicotine. “Giving the agency more power to stop Americans switching to vaping would be like giving the keys to a bartender to the city drunk.” This legislation will allow FDA to regulate products with no physical or alleged connection to tobacco. The Cigarette Protection Act should be named this bill, as it will result in countless Americans being forced to quit nicotine vaping for combustible cigarettes.
Rep. Frank Pallone (D–N.J.This redefinition was included in the Omnibus Spending package because of the efforts by Frank Pallone, a Democratic Representative from New Jersey. He says, “This is a huge win for American consumers and public health.” I’m thankful to both the left and right for their cooperation in closing this loophole.
Pallone describes “this loophole” as the language Congress used in the Family Smoking Prevention and Tobacco Control Act (the 2009 law that permitted the FDA to regulate tobacco product) That category is defined as any product “made in America.”
Anything derived or made from tobacco and intended for human use, such as any part or accessory to a tobacco product. Although the law did not mention e-cigarettes at that time in America, they were readily available elsewhere. However, FDA expanded the definition of vaping to include products that do not contain tobacco, but contain nicotine derived therefrom.
FDA is aware that “tobacco product” should not be interpreted to mean synthetic nicotine. It says that it is aware of Puff Bar and other companies claiming to have synthetic nicotine. This could raise different regulatory or legal issues, and the FDA is looking into how to best address them. The FDA has provided the following description of those “regulatory or legal issues”.
Any product made, derived, or manufactured from tobacco is considered a “tobacco product”. This definition includes any part or component of any tobacco product. Even if e-liquids do not contain nicotine, or any other substance made from tobacco, they may still have components and parts that are subject to FDA’s control.
The FDA could not regulate any disposable closed-system device that contains nicotine (or synthetic nicotine), if the product isn’t intended to be used in that manner. These determinations will be made on an individual basis and will take into account all circumstances.
FDA views even nicotine-free E-liquids as tobacco products, because they may be used in devices that also allow for the delivery of tobacco-derived nicotine. Any device which can provide tobacco-derived nicotine, even if not being used in that capacity, and any accessories or parts for it would be covered. Even that logic is not applicable to disposable devices, such as Puff Bars. Puff Bars claim they contain nicotine “crafted using a patent manufacturing process and not from tobacco.”
The “loophole” for smokers who switch to vaping is an absolute blessing. They love a range of flavors and this loophole can be a boon. Pallone claims that it is part a plot to “hook” a new generation into an addiction to nicotine. These nicotine liquids are in flavor other than tobacco and are therefore not permitted.
Similar views are held by the FDA. About 6 million people have applied for FDA approval to “premarket” vaping products. It was supposed that it would act by September. Although it has received millions of applications, the FDA has only approved three products so far: R.J. Reynolds Vapor Company’s Vuse Solo vape cartridge and two tobacco-flavored cartridges. FDA continues to consider whether or not menthol-flavored Vuse carts should be permissible. The FDA has expressed its doubts repeatedly that nicotine liquids other than those preferred by adults, as per the Tobacco Control Act, “appropriate for protection of public health”.
The FDA states that nearly all vaping products have been “marked illegally” and are subject to FDA enforcement actions. Vuse Solo is an exception. Products that exclusively deliver synthetic nicotine are another—but not for long, assuming that the spending bill, the full text of which is not yet available, passes in its current form.
Puff Bar had to discontinue selling flavor vaping products by 2020 after the FDA issued an order. Puff Bar began producing them using synthetic nicotine. “People always say, like, ‘You guys are trying to sidestep…laws,'” Puff Bar Co-CEO Patrick Beltran told CBS News in December. “And we’re not…If there’s a law that would order us off the market tomorrow, we would pull our products off the market tomorrow.”
Beltran stated that it’s perversely harder for vapers to get cigarette sales than it is for them to sell their products. Cigarettes are much more hazardous. “Traditional cigarettes on the market right now…are not safe,” he said. Why would people trust the FDA to approve safety products, he asked?
Anti-vaping legislation never seems to take seriously this question. How is it possible to create “public health policies” that discourage people from quitting smoking and encourage them to switch to healthier habits. Pallone and other politicians seem to favor teens vaping over smoking, even though it is not medically necessary. According to recent trends, e-cigarettes have accelerated the decline in teenage smoking.
Rep. Raja Krishnamoorthi (D–Ill.) Rep. Raja Krishnamoorthi (D-Ill.) is outraged that Puff Bar has a wide variety of flavor options. According to him, he knows exactly who Puff Bar is targeting when he sees strawberry banana, raspberry and banana ice being sold on their website. This is mainly for kids.
Krishnamoorthi falsely asserts that “there is simply no evidence” that an e-cigarette helps smokers quit. Therefore, it’s not surprising that his ignorance of research that shows adults like the apparently juvenile flavours that are offensive to him is also evident. They are not important in this mindless campaign against products with the potential to decrease smoking-related deaths.