Troublesome issues in e-cigarette policy in America

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Black and white picture of woman smoking e-cigaretteThe Tobacco Harm Reduction (THR) and e-cigarette policy scene continues to evolve in a direction that will result in substantially more tobacco-related addiction, illness and death, than what would likely occur with the skilled addition of a THR component to tobacco control programming, writes public health physician Dr Joel Nitzkin for Nicotine Science and Policy. With the major objection to e-cigarettes being their use among youth, last month JUUL Labs temporarily halted sales of some flavours, just ahead of Food and Drug Administration restrictions aimed at combatting vaping among the young.

A THR component could highlight e-cigarettes and related vapor devices as harm reduction modalities, recognizing the evidence to date as to their efficacy for smoking cessation and for diversion of teens away from a lifetime of nicotine addiction, writes Nitzkin.

At this stage in our policy development, it appears that most tobacco control authorities recognize that e-cigarettes and related vapor products are almost sure to be far less hazardous than cigarettes.

Their remaining major objection to endorsing them for THR is based on the perception that they are or might be recruiting significant numbers of teen non-smokers to a lifetime of nicotine addiction.

This perception, in turn, is based on deeply flawed published papers, disregard of contrary evidence, and disregard of the fact that the “epidemic” of e-cigarette use in federal surveys published to date has been almost entirely in teen smokers and has not increased the total number of teens using tobacco products.

The root of this problem, as I see it, continues to be traditional perceptions in the tobacco control community that rule out any consideration of THR as public policy. This is reflected in the goal of a “tobacco-free-society”. This orientation has distorted the process by which the findings of scientific studies and government-sponsored surveys are translated into policy.

Rather than consider all options, and let the science drive policy, there seems, at least in the United States, a zeal to take bits of data out of context to justify pre-determined anti-tobacco policies while disregarding evidence to the contrary.

The main perception in question seems to be the view that all non-pharmaceutical nicotine delivery products are so addictive that none can be tolerated, and that once addicted, the user will then transition to cigarettes for a better and faster nicotine hit, negating any personal or public health benefit from the low risk product.

A second perception is that the “tobacco industry” is monolithic, cannot be trusted, and is intent on addicting our children to deadly substances to assure future profits.

These perceptions fail to recognize what we have learned about smokeless tobacco products and e-cigarettes in recent years, and fail to recognize the true structure, function and motives of a complex and highly competitive set of tobacco-related industries.

None of this is new. What is new, however, are current developments which deserve the attention of all concerned:

  1. Conflict between rhetoric and action:Within the FDA, Dr Gottlieb and Mr Zeller continue to talk about the need for innovation and the need to consider the role low-risk nicotine delivery products can play in reducing tobacco-related illness and death and do so in a manner that will not increase teen recruitment to nicotine addiction.

Unfortunately, none of this rhetoric seems reflected in current FDA policy, especially their current attack on JUUL e-cigarettes and their continuing failure to propose a regulatory structure that will enhance the development and delivery of the low-risk products.

  1. Probably unjustified attack on e-cigarettes:The FDA’s all-out attack on JUUL and on e-cigarette flavours is being done without prior public release of the full set of national survey data pertinent to this issue. The data available from prior surveys and other sources leaves the impression that, while many kids experiment with these products, remarkably few continue their use, and that the vast majority of continuing vapers are smokers in the process of switching to these low-risk and easier-to-quit products.

In other words, this image of an “epidemic” of non-smoking kids being recruited to nicotine addiction might be in error. Since the FDA declared the “epidemic,” the burden of proof lies with them. Their failure to date to release the full data set prior to announcing the “epidemic” is troublesome.

  1. Importance of industry sponsorship of THR-related research:We need to consider the possibility that investigators working with tobacco companies should not be considered any more conflicted or biased than investigators funded by federal agencies dedicated to the goal of a “tobacco-free-society”.

We need to recognize that the THR “debate” is not between public health science and industry greed. Despite hype to the contrary, there is now overwhelming evidence from federal survey data and published literature (none of which was sponsored by tobacco companies) demonstrating major personal and public health benefits of e-cigarette products and snus as THR modalities.

The problem here is not lack of scientific evidence. It is substantial bias on the public health side, apparently based on tradition within the public health community.

  1. Dysfunctional FDA Policy not enshrined in law:A “Spotlight on Tobacco” article in the current (October/November 2018) issue of theFDLI Member Journal highlights the absurdity of the current FDA approach to THR and low-risk nicotine delivery products.

Based on the FDA presumption that all smoking is a disease, not a behaviour, the article recommends licensing e-cigarettes as over-the-counter drugs rather than tobacco products, apparently recognizing that it is a physical impossibility for any single product to “prove” that, if approved, it will not recruit non-smokers to a lifetime of nicotine use.

Since approval as a drug carries no such requirement, licensure as a drug would provide a regulatory pathway to FDA approval, without the FDA having to admit that their current smoking-cessation policy guideline makes no sense in the real world.

Adjustment in FDA thinking to correct this policy error could be done without congressional action to amend the Tobacco Control Act. Such adjustment in thinking could also pave the way for FDA consideration of the possibility that the greatest public health benefit of e-cigarettes might be the diversion of teen smokers and would-be smokers away from a lifetime of nicotine addiction.

  1. Claims of brain damage to teens due to nicotine:Of late, much of the anti-e-cigarette rhetoric has included claims that nicotine causes permanent damage to the brains of teens. While all agree, for other reasons, that teens should not consume nicotine delivery products, the claims of brain damage should be either discontinued or be qualified by a statement that this only refers to the brains of mice and rats, since no such damage has ever been demonstrated in humans.
  2. Credibility of the public health establishment:As a public health physician, I have always been extremely careful to make sure that any declaration of a public health emergency or other policy pronouncement is fully justified by the best of available science. If our public health infrastructure is to effectively guide public health policy, we must do everything in our power to assure the public that our pronouncements are credible.  As I see it, the widening gap between current anti-e-cigarette rhetoric and scientific fact is putting this credibility at risk.

The previous statement is my personal opinion and does not reflect the policy or opinion of any organization I might be affiliated with.

* Dr Joel Nitzkin is a public health physician in the United States who has been involved in tobacco control since the mid 1970s. He has served as Senior Fellow for Tobacco Policy for the R Street Institute since 2012, and has been president of two national public health associations.

Current troublesome issues in E-cigarette Policy, October 2018

 

FDA seeks restrictions on teen access to flavoured e-cigarettes

The US Food and Drug Administration on 15 November announced a series of restrictions aimed at combating a growing public health menace – flavoured e-cigarettes and tobacco products that have lured young people into vaping and smoking, write Sheila Kaplan and Jan Hoffman for The New York Times.

And in a bold regulatory move, the agency said it would move to outlaw two traditional tobacco products that disproportionately harm African-Americans: menthol cigarettes and flavoured cigars.

The proposed menthol ban would be the most aggressive action the FDA has taken against the tobacco industry in nearly a decade, and it was notable given the Trump administration’s business-friendly approach to regulatory issues. But the proposal is likely to face a protracted legal battle, so it could be years in the making.

The effort to cut off access to flavoured e-cigarettes stopped short of a ban that the FDA had threatened in recent months as it sought to persuade e-cigarette makers like Juul Labs to drop marketing strategies that might appeal to minors. The agency said it would allow stores to continue selling such flavoured products, but only from closed off-areas that would be inaccessible to teenagers.

Some 3.6 million people under 18 reported using e-cigarettes, the agency said.

“Almost all adult smokers started smoking when they were kids,” Dr. Scott Gottlieb, the agency’s commissioner, said in a statement. “Today, we significantly advance our efforts to combat youth access and appeal with proposals that firmly and directly address the core of the epidemic: flavors.”

Still, the plan to sequester flavored e-cigarettes in stores, rather than ban selling them, was surprising to many people since details of a stronger proposal leaked out widely from the agency over the past week. Members of Congress sent out news releases, praising the agency for a ban that did not materialize. Federal law already prohibits the sale of cigarettes and e-cigarettes to anyone under 18.

But lawyers said the agency did not have the legal authority to impose such a ban without going through a long, complicated process that would have inevitably ended up in court.

In trying to navigate between public health concerns about nicotine addiction among teenagers and a reluctance to heavily restrict e-cigarettes that can help adult smokers quit, Dr Gottlieb urged manufacturers to police themselves.

Full article on The New York Times site

 

JUUL suspends flavoured e-cigarette sales to curb teen use

E-cigarette maker JUUL Labs agreed in mid-November to temporarily halt sales of certain flavours in a bid to curb teenage use of their product, reports BBC News.

Sales of all flavours except tobacco, menthol and mint will be halted in all retailers – except on JUUL’s website – until shops can verify the buyer’s age.

Chief executive Kevin Burns said JUUL did not want to be “an on-ramp for America’s youth” to take up smoking.

The company is under pressure to curb its popularity among the young.

In September, the US Food and Drug Administration (FDA) said it was considering banning the sale of flavoured e-cigarettes, citing an “epidemic” of use among teens.

The FDA gave the five biggest agencies – JUUL, Vuse, MarkTen, blu e-cigs, and Logic – 60 days to come forward with plans to address the concerns, or face penalties.

Under its new rules, JUUL will no longer sell products to anyone under 21 years of age – even in states where the legal age to buy such products is lower.

The company will halt sales of the flavoured products in all retail outlets until those shops can prove they have a system in place to verify consumer’s ages.

Moreover, JUUL is shutting down its Instagram and Facebook social media channels, and said it would work with companies to take “unauthorised, youth-oriented content” from these platforms related to its products.

There were however concerns the company is not going far enough.

JUUL was expected to permanently discontinue its fruity flavours, rather than merely halting their sales temporarily, according to a report by US broadcaster CNBC last week.

Altria, the tobacco firm which owns Marlboro, announced it would stop selling several of its e-cigarette products altogether in October in response to FDA concerns.

The JUUL’s small size, multiple flavours and discrete shape – it looks somewhat like a USB drive – has made it a hit among teens in the US.

“In my opinion it looks like the coolest thing ever,” one student told the New York Timesin an article on the new phenomenon. “Almost futuristic.”

JUUL has cornered close to 75% of the e-cigarette market in the US, up from 13.6% early in 2017.

The appeal of e-cigarettes to teens is widespread and has raised alarms in other countries, including the UK.

However, there is little consensus about how to regulate the industry.

In August, a parliamentary committee in the UK issued a report calling for rules regarding e-cigarettes to be relaxed.

It cited estimates from Public Health England that e-cigarettes are 95% less harmful than normal cigarettes.

JUUL suspends flavoured e-cigarette sales to curb teen use

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