FDA has authorised 22nd Century to claim a reduced nicotine cigarette is a reduced risk product. This will spread confusion and divert smokers from better choices.
In one of its most ill-judged moves to date, the US Food and Drug Administration has today granted 22nd Century Group the right to market its VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products.
It has done this because these products are reduced in nicotine and, FDA concludes, anyone who is willing to smoke them will experience lower exposures to nicotine. But we have known for a long time that “people smoke for the nicotine but die from the tar” (Mike Russell). This is a product that reduces the nicotine but keeps the tar. What could possibly go wrong?
Vaping and other smoke-free products have the potential to reduce the enormous harm of smoked tobacco products. The stakes of getting policy responses to smoke-free products wrong are high, especially if such restrictions stop millions of the world’s smokers accessing safer alternatives. It is disappointing that in its latest tobacco report, WHO clings to outdated orthodoxy when it could embrace innovation. Equating smoke-free products with cigarettes only serves to protect the stranglehold of the cigarette trade on the world’s nicotine users and will nullify the potential of modern tobacco harm reduction strategies.
New data on youth vaping. Time to take a closer look at the disclosure of some 2018 U.S. National Youth Tobacco Survey data (see MMWR). The survey is conducted annually, with field work in February-June. Usually, the results are published in headline form about a year later (2017 data was published in June 2018) and full datasets some time after that. 2018 is different however. CDC and FDA (the co-authors) have rushed out data that they argue supports the claim there is an ‘epidemic’ of teenage vaping use (see FDA chief calls youth e-cigarette an ‘epidemic’, Washington Post).
FDA action in response. In response to the alarm that it has done much to create, FDA has now taken a variety of actions, notably to restrict access to e-cigarette flavours that are not tobacco, menthol or mint – as described in a 15 November statement by Scott Gottlieb, FDA Commissioner.
Backing for the action? But does the data support any of this regulator activity? I conclude that the partial release of data does not provide justification for FDA’s policy. This is because the data required to understand underlying changes in the pattern of tobacco use has been withheld. In other words, the data to create alarm has been released, but the data required to understand if the alarm is justified and the policy is sound has not been released. Continue reading “More heat than light – new US statistics on youth vaping provide no basis for FDA policy”
I was one of those agitating for the FCTC back in 1999-2003. Generally, the FCTC doesn’t do what normal international treaties do – address some transboundary issue like climate change, international trade or intellectual property. It tries to establish norms for regulation of tobacco commerce within countries – a kind of solidarity mechanism for national anti-tobacco policy. The problem is that this idea all goes sour when the WHO, Convention Secretariat and/or Parties agree, in solidarity, to normalise truly terrible policies – for example, to encourage prohibition of e-cigarettes, to treat all smokeless tobacco as though it is the same and just as risky as smoking, or to regulate heated tobacco products as though they are cigarettes. All really harmful ideas that protect the cigarette trade, perpetuate smoking and cause more disease and death.
On 28th July, FDA announced that it wants to hold a “public dialogue” about regulating to reduce nicotine levels in cigarettes to “non-addictive levels”. I’ve previously written about this idea in my critique of ‘tobacco endgame’ ideas, and I was pleased to present on the subject at SRNT 2017 conference. Generally, I’ve taken the view that the idea is crazy, unworkable, unethical and will never happen, and I have a hefty bet against it.
But now that FDA has announced it, everyone should ask: might any good come of it? That has prompted me to reconsider my previously entirely hostile approach. So here are some updated views in a report done in collaboration with Dr Carrie Wade, Director of Harm Reduction Policy at the R Street Institute, Washington DC.