Vapers Win Big: House Committee Passes Amendment To Save E-Cigarettes

WASHINGTON - JUNE 5:  The U.S. Capitol is shown June 5, 2003 in Washington, DC. Both houses of the U.S. Congress, the U.S. Senate and the U.S. House of Representatives meet in the Capitol.  (Photo by Stefan Zaklin/Getty Images)

The House Appropriations Committee passed an amendment Tuesday that could save 99 percent of e-cigarette products from prohibition.

The Food and Drug Administration (FDA) is set to announce its so-called “deeming” regs, which would require all e-cigarette products that came on the market after February 15, 2007 (predicate date), to go through the onerous Pre-Market Tobacco Application (PMTA) process — which could cost millions of dollars per product.

Since almost all vapor products on the market were released after February 2007, hardly any would avoid a PMTA and almost no businesses, with the exception of major tobacco companies, would be able to bear the regulatory burden.

Only one product in the last six years has passed the PMTA, according to House Appropriations chairman Rep. Robert Aderholt

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Congressional action on electronic cigarette regulations may save vapers

The Food and Drug Administration (FDA) is in the final stages of announcing a new set of regulations for all electronic cigarettes (e-cigarettes) and vapor products. Free-market innovation has resulted in significant developments in the number and quality of these tobacco-free products that are helping Americans kick the unhealthiest habit known to man – smoking. The FDA’s proposal, however, threatens the very survival of the vast majority of the vapor product industry.

For large tobacco and pharmaceutical companies, this is great news. The FDA’s proposed regulations stand to benefit both industries, which represent some of the most well-funded and powerful lobbying interests in the United States.

Vapor devices compete with products marketed by pharmaceutical companies to help people quit smoking, like Nicorette gum and the nicotine patch. These nicotine replacement products have taken a hit in recent years as many consumers have turned to vapor products after pharmaceutical options have failed them.

The emergence of vaping also has Big Tobacco concerned. America’s largest cigarette companies have released e-cigarette products, but have thus far been unable to establish dominance in the market. Overly burdensome FDA rules could be just the ticket they need. Bonnie Herzog, a senior analyst with Wells Fargo Securities, commented last week that that the FDA’s proposal is “broadly positive for the big tobacco manufacturers since it will increase the barriers to entry.”

Under the FDA’s proposal, all vapor products on the market will have to retroactively undergo a “premarket” review process. For a single product application, the FDA estimates that a manufacturer will need to put out $330,000. Within the industry, the real cost is expected to easily run into the millions of dollars. Even with the lower cost estimate, the agency’s own economic analysis spells doom for all but a couple companies. That analysis predicts that approximately 99% of products on the market will not even attempt the application process, let alone gain approval.

The FDA claims that it does not have the authority to modify the premarket review requirement under the 2009 Tobacco Control Act, which gave the FDA the authority to regulate tobacco and nicotine-containing products. The agency says that the statute requires them to consider any product that has come to market since February 15, 2007 as a “new” tobacco product. The FDA calls this February 2007 provision the “predicate date.” It is this date that would needlessly roll back technology almost a decade and close businesses.

This week, members of Congress have an opportunity to change the FDA’s direction in a way that will benefit consumers, small business, and public health. On Tuesday, the House Appropriations Committee is scheduled to take up an agriculture spending package. Harm reduction advocates are hopeful that the committee will take up and pass an amendment to the bill to modernize the February 2007 predicate date for vapor products.

Changing the predicate date will not interfere with the FDA’s ability to establish rigorous safety and manufacturing rules for vapor products. The agency will retain their existing power to set product standards. If the FDA takes this route, any standard issued would apply to all products within the agency’s jurisdiction.

Without a modification of the February 2007 predicate date, Marlboro and Camel cigarettes will remain legal, but it will become a federal felony to sell tens of thousands of vapor products that are currently legally available and helping smokers quit. The status quo in the United States – smoking – will remain.

Approximately two-thirds of the vapor market is held by companies with no connections to Big Tobacco. That’s because the tobacco companies offer very few options to consumers looking to customize their quit journey. But given their ability to afford onerous regulation, Big Tobacco could be the only player left standing in the e-cigarette market.

Last year, attempts were made to change the predicate date by members of both the House and Senate. Congressional Democrats successfully killed the amendment and attacked Republicans for siding with Big Tobacco. They were misguided in that accusation. This shouldn’t be a partisan fight. Both parties should celebrate the prospect of a creation of the free market helping make cigarette companies a relic of the past.

The FDA’s current proposal will freeze innovation and kill jobs through unnecessary and costly paperwork. For the millions of Americans who try to quit smoking every year, Congress should act to ensure that overregulation does not prevent smokers from accessing effective and safer alternatives. Republicans and Democrats should welcome this much needed change.

Can we wait for e-cigarette trials?

Around 30% of current cancer deaths in the US are caused by tobacco. According to the World Health Organization, tobacco is ‘the only legally available product that kills up to one half of its regular users when consumed as recommended’.

Although nicotine is addictive, it’s tar that kills. A meta-analysis of 35 clinical trials found no evidence of cardiovascular or other life-threatening adverse effects caused by nicotine intake, and nicotine did not increase cardiovascular risk, even in patients with established cardiovascular disease.1

This is perhaps why e-cigarettes have been proposed as a harm reduction option when it comes to smoking. If all smokers switched to e-cigarettes, and if current estimates about the risk of these products are accurate, cancer deaths would fall to only 1–2% of users.2 Sure, it’s not advisable to regularly inhale nicotine, and my nine-year-old will not find an e-cigarette under the Christmas tree, but what makes e-cigarettes so controversial when it comes to public health?

Matter for concern

One key aspect is whether e-cigarettes represent a gateway to regular smoking, and are making tobacco products more acceptable again. According to the US Centers for Disease Control and Prevention, around 2.4 million middle and high school students in the US were current users of e-cigarettes in 2014. Yet studies suggest that one in three smokers who switch to e-cigarettes reduce their consumption, and one in nine quit for good – numbers that will only rise as manufacturers increasingly make the experience mimic actual smoking. Whether e-cigarettes are a potent weapon for smoking cessation, or are simply a way for big tobacco to remain in business, depends on which studies you read.

The chemical picture is even more complex. E-cigarette aerosol is not water vapour as is often claimed; it can also contain heavy metals and ultrafine particles, as well as carcinogens such as formaldehyde, acetaldehyde and acrolein (albeit at levels significantly lower than in cigarette smoke).3

Reproduced from M Goniewicz et al, Tob. Control, 2014, 23, 133 with permission from BMJ Publishing Group Ltd

The range of additives and flavours used by the devices also presents a challenge. Two years ago, one count came up with more than 3700 flavours available, including cheesecake and strawberry. Essentially, none of these flavourings has been tested to assess their risk to health; while many are food additives, just because they are safe when swallowed does not mean they are safe when inhaled chronically.

A good example is diacetyl, a compound found in 75% of e-cigarettes tested. The substance is quite well known – it is the butter flavour of popcorn. Although apparently safe when consumed, it is worth noting that inhalation of diacetyl has caused lung disease in workers producing the snack (known as ‘popcorn lung’).4While it is not clear whether the amounts inhaled by e-cigarette consumption could cause such conditions, diacetyl shows that there can be surprises when inhaling food flavours.

Testing challenges

In a perfect world, we would embark on extensive trials of each and every one of these additives used. However, there are practical concerns that make this option difficult to achieve. Inhalation toxicity studies are very expensive, and rodent cancer tests even more so, costing around $1 million (£700,000) per substance in the current standard method. This would amount to $4 billion to test all the flavourings available. In addition, trials using rats are not always predictive of human physiology, and there is no generally accepted animal model of smoking-induced lung cancer.

It also takes four years to get the results from cancer studies and they notoriously err on the side of safety. For example, of more than 30 ingredients of coffee tested for carcinogenicity in rodents, more than 70% had a positive result. Does this mean we are regularly enjoying a brew of carcinogens? No – there is no such evidence. Some studies even show that coffee may reduce cancer risk.

In the short term, self-restricting the use of additives and using fast cell- and computer-based evaluations of safety will help clarify the safety of e-cigarettes. And in the medium term, controlled trials will be necessary. But if we wait for this evidence to emerge and prohibit or hinder the use of e-cigarettes, we would probably miss a tremendous opportunity to save lives on a large scale.

Thomas Hartung is Doerenkamp-Zbinden professor and chair for evidence-based toxicology at Johns Hopkins Bloomberg School of Public Health, US.

REFERENCES

1 K Farsalinos and R Polosa, Ther. Adv. Drug Saf., 2014, 5, 67 (DOI: 10.1177/2042098614524430)

2 E-cigarettes: an evidence update, Public Health England, 2015

3 M Goniewicz et al, Tob. Control, 2014, 23, 133 (DOI: 10.1136/tobaccocontrol-2012-050859)

4 D Egilman, C Mailloux and C Valentin, Int. J. Occup. Environ. Health, 2007, 13, 85 (DOI:10.1179/107735207800244893)