The infamous JUUL e-cigarettes are being tried by the US Food and Drug Administration to be removed from the US market by rejecting the applications by the company, which is 35% owned by Philip Morris’ parent company Altria, to continue promoting its electronic vaporizers. The news from June 23, 2022 was first reported by the Wall Street Journal and received extensive coverage by most media outlets.
The FDA cites the existence of minimal evidence demonstrating the absence of toxicological recommendations that are not recommended for the health of users, however, according to the agency, which needs to approve the product for its category after 2020, there was no evidence of an immediate health risk arising from the products that’s all.
The FDA concluded that “After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications did not have sufficient data on the toxicological profile of the products to demonstrate that the marketing of the products would be appropriate to protect public health; some of the company’s study findings raised concerns because of insufficient and conflicting data — including genotoxicity and potentially harmful chemicals leaching from the company’s improperly treated proprietary e-liquid pods and prevented the FDA from completing a full toxicological risk assessment of the products named in the company’s application.”
In a press conference given by Commissioner Robert Califf MD, he said, “Today’s action is further progress in FDA’s commitment to ensure that all e-cigarette and electronic nicotine delivery system products currently on the market to consumers meet public safety standards for our health. The organisation has devoted significant resources to evaluating products from the companies that represent most of the US market. We recognize that these are an important part of the products available and many have played a disproportionate role in increasing youth vaping.” referring to JUUL products with the above characteristics.
The reaction of JUUL Laboratories as the company is typically called (Juul Laboratories Inc.) was that “We respectfully disagree with the FDA’s findings and decision and continue to believe that we have provided sufficient information and data based on high-quality research to address of all issues raised by the organisation. In our applications submitted two years ago, we believe we adequately characterised the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapour products, and believe that these data, together with the body of evidence, meet the statutory standard that they are appropriate to protect public health; we intend to request a stay and are exploring all of our options under FDA regulations and law, including appealing the decision and working with our regulator,” concluded Joe Marillo by Jull Laboratories Inc.
Development – latest: The federal appeals court to which Juul Laboratories Inc. appealed accepted a temporary extension to sell its products until July 12, when the extension either expires or is renewed by the appeals court while Juul is in legal proceedings to overturn the FDA’s decision not to grant a license to sell vaporizers. JUUL is considering filing for so-called bankruptcy if the FDA’s decision is not reversed. They also announced that the manager intends to resign and be replaced by an Altria executive position.
Juul’s decision “marks an extraordinary failure of objectivity and competence by the FDA,” Clive Bates, former director of UK Action on Smoking and Health, told Filter magazine. “Under the FDA’s jurisdiction, 3,000 cigarettes are allowed on the market virtually untouched by any kind of regulatory hassle. The FDA even came out and declared a cigarette fit to protect public health. Yet here we have Juul, the most successful anti-smoking product ever seen, and the FDA’s decision is to try to kill it. This can only be a political move, driven by political pressure from well-funded elitist activists, their billionaire supporters, and their bigwigs in Congress. It is a dark day for science, regulation and public health,” concluded Clive Bates, who ran Britain’s biggest anti-smoking organisation from 1997 to 2009.
Philip Morris parent company Altria acquired 35% of Juul in 2018 for $12 billion and was forced to sell most of the profits as shares of the most successful US vaporizer company fell 9%.
The two founders of JUUL, which was still under Pax Laboratories as of 2017, former smokers James Monsees and Adam Bowen, had a particularly hard time quitting until they came up with their e-cigarette recipe. JUUL’s first e-cigarette, the JULL original, was developed by the two Stanford University graduate students who founded the largest vaporizer company in the US, offering a “chopped” feel of vapour with minimal interference to the respiratory system, especially the throat, and was first released in the United States in 2015 pushing the rates of vaping to unimaginable levels especially among young students and college students and spreading the so-called vaping epidemic for the USA and crisis of trying different aromas and flavours possibly simultaneously contributing substantially to the reduction of smoking levels up to 12.5% where it is also at the 2019 record of 13% for the first time.
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