US FDA bends to external pressures and lobbying over following science, says VTA

The opinions within this blog reflect those of Tony Abboud and the Vapor Technology Association.

US Food and Drug Administration (FDA) actions in the name of public health threaten to have the opposite effect by leaving the vaping sector in the hands of big tobacco, a vaping association claims.

FDA requirements for premarket tobacco product applications (PMTAs) means that it is almost entirely tobacco companies only that have the resources to complete a successful application.

This means that millions of products which could help smokers move away from conventional cigarettes are now barred from the market, while the few that have been approved are largely from the same companies selling the conventional cigarettes, according to the Vapor Technology Association (VTA)’s executive director Tony Abboud (pictured).

“Thus far the agency has only approved a mere handful of the millions of products that are on the market that could be used to enable adult smokers to quit,” Abboud told ECigIntelligence. “We’re now moving towards a marketplace that will be devoid of options for adult smokers and an industry that is controlled by the cigarette companies.”

Abboud accused the FDA of not following the science and bending too easily to pressure from external forces such as campaigners and political lobbyists.

“The FDA is at a crossroads,” he said. “It has enormous power which could hasten the end of combustible smoking because the fastest way to do that is to approve less harmful products that help smokers quit.”


Politics over science


He added that the recent decision to treat synthetic nicotine the same as tobacco-derived nicotine was an example of external pressures from lobbying leading to politics being chosen over science. The change was included in a sweeping $1.5tn omnibus spending bill, and became effective on 14th April.

“Some companies announced they were moving towards synthetic nicotine because it wasn’t regulated by the agency. That caught [regulator] attention so, instead of examining the innovation behind it, they decided to regulate synthetic nicotine as tobacco-derived nicotine under the cover of night,” said Abboud.

This was demonstrated by the very short timeframe given to companies for submitting PMTAs for their products. “The actors behind the push to regulate synthetic nicotine offered a short timeframe because they’re not interested in these products being on the market – they want to remove them from the market,” he said.

The decision failed to consider the potential benefits to consumer health that would result from having “a cleaner and purer form of nicotine in the industry”, according to Abboud.

“Because of the manner in which synthetic nicotine is manufactured it’s a patented scientific process that is replicable and traceable down to batch level. It’s devoid of the impurities that plague tobacco-derived nicotine,” he said. “All the innovation to date has been about the way in which we can deliver nicotine. This is the first innovation in the active ingredient.”


Lobbying is crushing vaping

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    He also claimed that the move was made to specifically benefit the companies using tobacco-derived nicotine as they had undertaken the time-consuming and costly scientific testing required for the PMTA process. “It’s an intentional use of the legislative process to control the marketplace because [synthetic nicotine products] will be competition,” he said.

    He said he believed vaping products were being crushed by lobbying from both sides. Lobbying had led to the decision on synthetic nicotine being unilaterally made by congress, otherwise it would have gone through a public hearing process.

    But at the same time, lobbying from anti-tobacco organisations is also the cause of heavy restrictions on things such as flavours in e-liquids. There should be two pillars of concern for public health when it comes to vaping: youth uptake and adult smoking cessation. The one should not be considered without the other.

    But millions of dollars are being spent by groups such as Parents Against Vaping (PAVE) and the Campaign for Tobacco Free Kids (CFTFK) that have taken a strict prohibitionist narrative which ignores the role vaping could play in the second pillar to concentrate solely on the dangers it poses for youth uptake of nicotine.

    “We have a group of nicotine and vaping nihilists who have ignored the notion that vaping is a tool for harm reduction,” he said. “Even some of the pro-vaping scientists find themselves being attacked within the scientific community because of the money and funding behind some of the science.”


    Lack of choice could lead to black market expansion


    Ironically though, Abboud has much the same criticism of the FDA as those same health lobbyists, with both sides critical of the amount of time the FDA has taken in approving PMTAs. The FDA’s latest status report said it wouldn’t finish reviewing the remaining PMTA applications until at least June 2023.

    Not only are these delays crippling firms that have invested in developing new products, it’s also reducing the element of choice of approved products on the market for consumers and creating a more robust black market, Abboud said.

    In the absence of choice in a disorderly and unregulated marketplace, consumers will turn to illicit products and unscrupulous firms will benefit if the FDA fails to take enforcement action to clean up the marketplace.

    “There are 10m vapers out there – they’re not going to stop vaping,” he added. “They’ll find a way and look for their product of choice elsewhere.”

    Despite this, Abboud believes the US vaping industry will soldier on.

    “Given the array of money and slanted and misleading media attention and the number of interest groups that have aligned against this product segment, it’s amazing that we’re still in business today,” said Abboud. “But, as dire as it seems, this industry will always punch above its weight and the one thing we do know is that there are more than 10m consumers, adult smokers who are committed to this segment. The industry will not go away despite the best efforts of these groups to make it go away.”

    Tony Abboud will be speaking at the Next Generation Nicotine Delivery (NGND) USA 2022 event at the Hilton Miami Airport Blue Lagoon from 22nd to 23rd June 2022.

     Lorraine Mullaney ECigIntelligence staff

    • Do you want to know more about FDA and its premarket tobacco product application progress? You can now download for free our full briefing “US FDA under fire after it forecasts work until June 2023 on final PMTA reviews” using the form at the top of this page.
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    Lorraine Mullaney

    Senior writer
    Lorraine is responsible for writing news analysis and assisting with copy-editing. Lorraine is a copywriter and editor who has written and edited words for a wide range of audiences, from local community newspapers to consumer magazines and trade websites.