There have been two very encouraging initiatives in the United States in the last month, both captured in the form of letters to recently-appointed FDA Commissioner Scott Gottlieb.
Some of the most experienced US tobacco control experts are showing support for tobacco harm reduction and calling for a rethink of the approach to regulating low-risk nicotine products, such as vaping technologies. I see this as an emerging second front in US public health tobacco policy – one that is more pragmatic and focussed on tackling disease as effectively as possible than the established coalition. Continue reading “American experts call for risk-based reform of FDA regulation of tobacco and nicotine”
Can the impending near-complete destruction of the U.S. vaping market be averted? A group of public health experts believes it can – though time is running out. Led by Iowa Attorney General Tom Miller (@AGIowa) they have written to the new Commissioner of the Food and Drug Administration, Dr Scott Gottlieb (@SGottliebFDA) with proposals and supporting material. The focus is on what can be done by the FDA itself, without Congress amending the Tobacco Control Act.
Many variations, all much safer than cigarettes – but what does FDA/CDC do about that?
Welcome to a new report written by me, Clive Bates, with David Sweanor of Ottawa University, and Eli Lehrer, President of the R Street Institute. The fully designed report is available at R Street with press notice.
Reshaping American Tobacco Policy
Eight federal strategies to fight smoking and ignite a public health revolution
The report is an unforgiving and but fair critique of the United States’ federal approach to tobacco policy, which we think is an unmitigated regulatory disaster. Whatever the stated intent, the effect is to protect the cigarette trade from competition, damage pro-health American businesses, mislead and harm consumers and add unnecessarily to healthcare costs. Federal agencies are preoccupied with negligible or imaginary risks at the expense of great opportunities to address the health risks to America’s 38 million smokers. Around nine million vapers are already taking action to protect their health, the federal bureaucracy is set to block their efforts.
So far smart, self-interested consumers, innovative producers and disruptive technologies have interacted in a lightly regulated free market to begin to tackle the huge burden of disease arising from smoking. That is about to change: the dominant reaction of the federal government is to choke these highly positive developments with huge regulatory burdens, opaque authorization procedures, impossible evidential tests and misinformation about risks.
American federal tobacco policy couldn’t be much worse, but it could be a lot better. The fundamental change required is to embrace and maximise the huge opportunity of vapor and other low-risk nicotine products, while keeping a sense of proportion about minor risks.
Quite simply the best speech I have ever heard on tobacco and nicotine policy, science and ethics. From Tom Miller one of the architects or the United States Master Settlement Agreement and Chair of the Truth Initiative. A model of decency, humility and rigorous scientific reflection, in my opinion.
FDA is ‘anti-proportionate’ in its approach to smoking and vaping
A recent article in the New York Times (A Lobbyist Wrote the Bill. Will the Tobacco Industry Win Its E-Cigarette Fight?) falsely suggested that opposition to FDA’s deeming rule for e-cigarettes is all about tobacco industry interests. It quoted Mitch Zeller of the FDA on the e-cigarette industry. Zeller is the federal official responsible for regulation of vaping and tobacco products in the United States (see my Bluffer’s Guide). It struck many of us that this was a hostile and one-sided statement that sits uneasily with Zeller’s call for a debate about nicotine just 16 months ago. So we have written to Director Zeller making seven observations in response to his quote in the NYT.
A typical day at the FDA Center For Tobacco Products
The FDA’s deeming rule went live yesterday, 8th August 2016. You will see a blizzard of expert comment about what it all means (feel the pain of Phil Bursado – see 8/8). In essence, FDA requires an enormously burdensome Pre-Market Tobacco Application (PMTA) to be filed and accepted by FDA for any new product from now on. So that’s the end of innovation, including pro-health and pro-safety innovation. For all products currently on the market, a PMTA has to be filed within two years, with a further year for FDA to review – that will wipe out most products and most smaller firms and open the way to the black market. (For the official view, see FDA overview and Q&A)
A recent editorial in the journal Tobacco Control discusses what’s wrong with the FDA. In fact, the editorial is more telling about what’s wrong with tobacco control.
A recent editorial in the journal Tobacco Control discusses what’s wrong with the FDA. In fact, the editorial is more telling about what’s wrong with tobacco control.