One of the latest jabs against the independent vaping industry comes, once again, from the mouth of outgoing Food and Drug Administration commissioner Scott Gottlieb. Gottlieb, who is due to vacate his position officially in early April, has recently renewed calls for manufacturers to remove liquid nicotine pods from the market.
Citing claims that youth are more likely to use cartridge-based electronic nicotine delivery systems like a Juul device, the latest push marks the beginning of another chapter in marginalizing the broader industry for the wrongdoing of a select few.
According to a wire report published by the Los Angeles Times earlier this week, Gottlieb announced that he might need to pull nicotine pods after an apparently aggressive meeting between Juul Labs and major investor Altria, the maker of Marlboro cigarettes. Altria took a near $13 billion stake in Juul late last year, automatically growing the popular e-cigarette manufacturer to hold a private equity valuation of $38 billion–billions more than the valuations of companies like SpaceX and Airbnb.
Both Juul and Altria have been main points of focus in Gottlieb’s related regulatory crackdowns, thus insinuating to external actors that these multi-billion dollar powerhouses supposedly represent the tobacco-free, independent vaping industry. By consequence, according to my previous reporting, such an investment and similar deals tied to large tobacco manufacturers don’t bode well for independent vaping and e-juice manufacturers seeking their own identity. Nonetheless, per the mentioned wire report, Gottlieb and his team recently met with executives from Juul and Altria to discuss the collective self-regulatory actions both companies claimed to have taken.
“Yanking pod-based products from the market could kill entire brands and companies while discouraging others to create new and innovative lower-risk products.”
“The e-cigarette industry has been overly dismissive” Gottlieb decried in an address at the Brookings Institution. “We’re capturing an exploding epidemic right now.” During this address, he recollected the transaction between Juul, Altria, and his agency as a “difficult meeting” because these companies have not made noticeable efforts to remove their pod-based products from the market. In turn, Gottlieb revealed that the FDA is considering banning the entire category of pod-based devices and flavors. Gottlieb made this announcement, even though independent manufacturers other than Juul and Altria’s NuMark division (including other tobacco-owned e-cigarette companies) make pod-based products.
The approach that Gottlieb wishes to take is that if his agency does ban pod-based products, the holds will only be temporary. This is only provided if a company who wishes to sell such products get approval through the FDA’s costly premarket approval process. Under the existing premarket approval process, e-cigarette manufacturers of all stripes must submit new and potentially safer products through a scientific review that could cost millions of dollars and take up to 60 days at a minimum. Just by the nature of the process for premarket approval, yanking pod-based products from the market could kill entire brands and companies while discouraging others to create new and innovative lower-risk products.
“Congress did not authorize the FDA to arbitrarily ban products based only on questionable survey data or political whims. It authorized a regulatory framework that the agency must follow,” writes Jeff Stier, a senior fellow at the conservative Taxpayer Protection Alliance, in an email. “Dr. Gottlieb’s approach runs counter to the authority granted to the FDA by Congress in the Tobacco Control Act.”
“A pod-based ban would be the latest restriction against vapes further limiting access and leaving combustible tobacco cigarettes the most accessible non-medical nicotine product.”
The Tobacco Control Act really only grants the FDA the power to regulate electronic nicotine delivery systems and flavors as tobacco products. Bans are not necessarily prudent policies. If you consider the context, a pod-based ban would be the latest restriction against vapes further limiting access and leaving combustible tobacco cigarettes the most accessible non-medical nicotine product. Such a case would threaten population-level public health gains for the millions of adult consumers who rely on vaping as a safer alternative. A case can additionally be made that Gottlieb’s intentions are to further consolidate the availability of non-tobacco flavors which he continues to claim directly appeal to minors despite evidence suggesting otherwise.
“Removing flavored pods from the market would be nothing short of public health vandalism,” says Guy Bentley, the Reason Foundation’s director of consumer freedom. “The key to the success of vapor products is not just that they’re dramatically safer than cigarettes but that they’re part of a dynamic market which is shaped by the preferences of real-world adult smokers trying to quit.”
He adds: “Restricting these safer options is not a solution to the problem of youth vaping, especially as cigarettes will be sold just as freely as before.”
If the FDA chooses to limit or outright ban the sale of pod-based products, it is likely to be at the hands of Gottlieb’s replacement, Norman “Ned” Sharpless of the federal National Cancer Institute. Once Sharpless assumes the position of acting FDA commissioner, he will maintain the same level of power as Gottlieb did and will likely remain in the position for the remainder of the term since the Trump administration has been historically slow in choosing agency heads and other political appointees. The position of FDA commissioner, even the director of the National Cancer Institute, are political appointments from the White House and are subject to U.S. Senate confirmation. Nevertheless, a proposed pod ban would carry negative impacts regardless of who is in the role as FDA commissioner.