American experts call for risk-based reform of FDA regulation of tobacco and nicotine

Note to FDA – this means you!

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”

Reckless and pointless at the same time – FDA proposes NNN standard for smokeless tobacco

Just looking for our submission to FDA’s consultation? Here it is: Submission by Clive Bates & David Sweanor – PDF

But carry on below for some discussion and explanation of the chart. Continue reading “Reckless and pointless at the same time – FDA proposes NNN standard for smokeless tobacco”

Avoiding bureaucratic destruction of the US vaping market – proposals for a new approach by FDA

Anti-proportionate regulator?

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.

This is the package. Continue reading “Avoiding bureaucratic destruction of the US vaping market – proposals for a new approach by FDA”

Democrats press FDA to proceed with destruction of the vaping market – we respond

Nobody knew nicotine policy could be so complicated

Earlier in May, eleven Democrat senators appeared to be channelling talking points from the Campaign for Tobacco Free Kids when they wrote a letter to the incoming FDA Commissioner Dr Scott Gottlieb.

Together with my co-conspirator, Sally Satel from the American Enterprise Institute, we have responded firmly but fairly with an article in Forbes: Senators’ Letter To FDA Commissioner Gottlieb Perpetuates Misconceptions About E-Cigarettes [pdf] Continue reading “Democrats press FDA to proceed with destruction of the vaping market – we respond”

Reshaping American tobacco policy: eight proposals for the Trump administration

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

[PDF – 23 pages]

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.

The eight proposals to reshape policy are listed below. The report provides a context, summarises the proposals and provides two pages on each. Continue reading “Reshaping American tobacco policy: eight proposals for the Trump administration”

Iowa Attorney General Tom Miller gives outstanding speech on smoking, vaping and public health – listen

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.

The speech was given over lunch at the Food and Drug Law Institute Tobacco Conference, 27 October 2016 in Washington DC.

General Miller’s speaking notes are available here (check against delivery).

You want a debate about nicotine? Let’s have one. Letter to Mitch Zeller, America’s vape regulator

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.

  1. The growth in e-cigarette use – a threat or a threat disruptor?
  2. The dramatic decline in adolescent smoking
  3. The (in)frequency of adolescent e-cigarette use
  4. The limited use of nicotine by adolescent vapers
  5. The situation with fires and explosions
  6. The trends in adult smoking
  7. FDA’s approach is “anti-proportionate”

Here’s the letter, jointly from me and Eli Lehrer at the R Street Institute, an American think-tank. Continue reading “You want a debate about nicotine? Let’s have one. Letter to Mitch Zeller, America’s vape regulator”

FDA shoots itself in the foot, cigarette trade celebrates, public health loses – a summary in two quotes

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)

When thinking about this regulation from a public health point of view, there are two quotes I think everyone should have in mind: Continue reading “FDA shoots itself in the foot, cigarette trade celebrates, public health loses – a summary in two quotes”

Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China

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99% nicotine e-liquid bought from China

How easy will it be to sidestep European Union and U.S. FDA regulation? To find out, I bought some high strength e-liquid from the internet. The problem is that bad regulation doesn’t attract compliance, it attracts non-compliance. Continue reading “Regulators and the compliance fallacy – buying 99% nicotine e-liquid from China”

The tobacco control high command has lost its way – what we learn from its views on FDA priorities

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.

Update: my e-letter in Tobacco Control – Missing the point  Continue reading “The tobacco control high command has lost its way – what we learn from its views on FDA priorities”