Could the FDA’s electronic cigarette regulation help more people quit smoking?

Electronic cigarettes smoke hot. These are the most popular nicotine delivery products used by children and the majority of adult smokers have tried them. Electronic cigarettes are a multi-billion dollar industry. The Yelp website has more than 10,000 vape shops across the country. Wall Street analysts predict that electronic cigarette revenues will exceed traditional cigarettes in a decade.

Given the size of the company, one would think that there are policies and rules to ensure the safe use of electronic cigarettes and to promote them as a tool to quit smoking. After all, the vast majority of long-term adult smokers desperately want to quit this habit. Although vaporization is not without risk, almost everyone agrees that electronic cigarettes are almost certainly better than smoking, if only for the simple reason that smoking is so harmful because of the tars and toxins contained in the smoke that are created by the burning of tobacco in traditional cigarettes.

Surprisingly, despite the size of the market and the millions of smokers (and some non-smoking children and former smokers) who have tried the electronic cigarette, there are virtually no federal rules or regulations governing any aspect of the industry.

This may change soon. Federal officials are expected to make a decision today that could give the FDA the authority to develop regulations. But finding ways to regulate electronic cigarettes to maximize their benefits and minimize their risks is more difficult than it seems.

Issues for cigarette smokers

Cigarettes are the leading cause of preventable death in the world, killing nearly 500,000 Americans and six million people worldwide each year. The causes of death and chronic diseases include, of course, lung cancer, but also heart disease, diabetes mellitus, colorectal and pancreatic cancers, as well as a range of medical problems related to chronic obstructive pulmonary disease (COPD).

Most adult smokers took their first puff of cigarettes in their teens. And most of them wish they had never started and consider it one of the worst decisions they have ever made.

More than half of middle-aged smokers have quit. Quitting smoking can be extremely difficult. The average 40-year-old smoker who started in adolescence will have made more than 20 unsuccessful attempts to quit smoking. Although there are aids to help people quit smoking, such as nicotine replacement therapy (NRT) and the prescription drugs Chantix and Zyban, their effectiveness varies considerably. There is certainly room for a more effective method. But we don’t know if electronic cigarettes are the answer.

Some research suggests that electronic cigarettes are as effective as other smoking cessation approaches. But research is limited and leading health and medical organizations are not currently recommending electronic cigarettes as a way to quit smoking. The United Kingdom is a notable exception. An electronic cigarette was included in the National Health Service’s tobacco cessation program in January.

Meanwhile, American smokers are victims of conflicting messages. Vaping advocates promote electronic cigarettes as a life-saving product, but the industry cannot make health claims without going through an FDA review process. (And the FDA currently does not have the authority to conduct such a review.) We are currently waiting for the Office of Management and Budget to approve the FDA’s request to extend its current authority to cover cigars and other innovative products.

For the first time in generations, there are glamorous ads on television for what seems to smoke (but is evaporating). One electronic cigarette company has even launched a marketing campaign called “Welcome Back” to encourage former smokers to start marvelling, a decision that may encourage them to continue using nicotine and eventually smoke again.

How electronic cigarettes are currently regulated?

The federal government has been slow to regulate the rapidly evolving electronic cigarette industry, but it has tried. In 2009, the FDA attempted to regulate electronic cigarettes as a drug-device combination, which would require FDA monitoring. But the courts did not understand this and ruled in 2010 that electronic cigarettes are tobacco products and should be regulated as such. When President Obama signed the [Family Smoking Prevention Act], he complicated things by allowing the FDA to regulate certain tobacco products, but it did not explicitly include electronic cigarettes (or hookahs, cigars and cigarillos and other new tobacco products).

This meant that for the FDA to regulate electronic cigarettes, it had to extend or “presume” its authority to include these new products. The FDA indicated its intention to do so in early 2014 and received more than 100,000 public comments on the proposed rules, which we are awaiting today the final decision of the Office of Management and Budget.

The net result is that there are currently no federal rules and that the electronic cigarette industry is fundamentally free. The only exception to this rule is a new law signed by President Obama last January requiring child-resistant capsules for liquid nicotine containers used in electronic cigarettes. More than 3,700 calls had been made to containers in 2014, more than half of them in cases involving children under 6 years of age.

Some states and local governments have intervened to adopt laws and policies within their jurisdiction. For example, most states have passed minimum purchase age laws, many jurisdictions require that electronic cigarettes be subject to the same restrictions as tobacco products, and some states also impose excise taxes on electronic cigarettes.

Are electronic cigarettes tobacco products or not?

The burning question (intended pun) is whether electronic cigarettes should be treated in the same way as tobacco products (as judged by the courts and the fears of the e-cigarette industry) or whether they should benefit from preferential policies because they are less harmful than traditional methods.

Creating a regulatory framework that varies according to the risk of the product makes sense, but faces many challenges; mainly because electronic cigarettes are relatively new and scientific knowledge is mixed. It will have to be decided whether electronic cigarettes should benefit from differential tax policy, marketing regulations and, perhaps most difficult of all, how they can be used. California Republican representative Duncan Hunter tried to argue that steaming should be allowed on planes, spectacularly blowing a cloud of steam during a hearing before Congress last week. (He lost this debate.)

Some argue that electronic cigarettes should be used to keep smokers away from traditional cigarettes, which could be achieved by making public policies differ according to the harm caused by the product. For example, electronic cigarettes and other non-combustible tobacco products could be taxed at a lower level and allowed to advertise to the extent of the harm caused. Advertising for combustible cigarettes would still be strictly limited, but electronic cigarettes could be marketed as an alternative treatment to nicotine.

Some have even suggested that, rather than raising the minimum age for purchasing tobacco products to 21 years (as many jurisdictions do), the minimum age for selling electronic cigarettes was 16 years, so that young people looking for nicotine can start with a less “harmful” product.

We don’t know all the answers, but we do know that smokers have an urgent need (and want) to quit smoking. The FDA’s political challenge is to have the wisdom to put in place the rules and regulations that will achieve the greatest benefit to the health of the population and lead to the beginning of the end of smoking as we know it.