JOHNS HOPKINS UNIVERSITY

Gottlieb hinted at preliminary FDA data, not yet published, indicating that e-cigarette use is soaring among high school students. In August, the CDC reported that e-cigarette use increased 900 percent among U.S. high schoolers from 2011 to 2015, making them the most commonly used source of nicotine in this group, driven by aggressive marketing and appealing flavors.

Officials say that e-cigarettes may be a safer way to deliver nicotine and may help smokers reduce their risk of smoking-related illnesses and death, but they worry about the rapid rise of e-cigarettes among teens and young adults.

The Vapor Technology Association, a trade group representing more than 600 members, accused the FDA in a statement of “kowtowing to hysterical public health groups,” taking a “giant step backwards” in smoking prevention and reinvigorating “Big Tobacco.”

Joanna Cohen, the Bloomberg professor of disease prevention at the Johns Hopkins Bloomberg School of Public Health and director of the Institute for Global Tobacco Control, spoke to U.S. News about the FDA’s growing authority to rein in e-cigarette manufacturers and retailers and the difficulty of regulating such a complex and growing industry. The interview has been edited for length and clarity.

How would you characterize the FDA action?

I’m impressed by the strength of the commissioner’s statement. There’s been a lot of media for a number of months about use of e-cigarettes, particularly Juul, among teenagers across the country. It appears, based on the statement today, that (the FDA is) privy to new national data about use among teens. It sounds like it will be a while before those data will be made public, but it seemed an opportune time to take additional steps and make a public statement.

The enforcement action against retailers seems to send a signal that the agency is serious.

Commissioner Gottlieb said in his statement that undercover (FDA agents) had been doing some purchase attempts – there’s no information on how they did that – and they found many retailers, brick-and-mortar stores as well as online outlets, are selling electronic cigarettes to kids. Armed with the new survey data and proof that retailers are selling e-cigarettes to kids, the commissioner clearly felt he had enough evidence to call e-cigarettes epidemic among young people.

What are the demographics of e-cigarette use?

That’s a great question. It’s unclear. From media reports, it seems that products like Juul, which is smaller than a flash drive and can be charged through your laptop, are used predominantly by young people. But again, e-cigarettes is a very (broad) class of products. Different people have different preferences.

There are e-cigarettes that look a little like regular cigarettes. Blu is an example of the first generation of e-cigarettes, with a blue light at the glowing tip. The next generation of e-cigarettes are more sophisticated. They’re rechargeable. You can refill them rather than throwing them out. The third-generation e-cigarettes are called Mods. They’re a little bigger. You can adjust them in many ways – the resistance, the voltage and the e-liquid that you put in them. You hold them differently, like a flask of alcohol. They are much better at delivering nicotine to the user.

Then you’ve got these Juul-type products, which some people call pods. They’re a little bit different. At least in the Juul, there’s a formulation of a nicotine salt. It’s different from the other fluids you put into e-cigarettes. They seem to be extremely effective at delivering doses of nicotine. There are stories about kids getting addicted to Juul. I can’t speak to the data on that or how widespread it is. Theoretically that is something that could easily happen because of the release of nicotine from those systems.

I wonder whether e-cigarette use is more common among people who can afford them, though cigarettes are also expensive.

One of the underlying issues is that if e-cigarettes are the Holy Grail to get smokers to stop smoking cigarettes, you want to make sure that the technology is distributed equitably. What you don’t want is the most well-off people to be attracted to e-cigarettes and, because they can afford them, use them to get off cigarettes while more vulnerable populations don’t. You don’t want disparities increasing with the introduction of these products.

Most people think of FDA as an agency that oversees the food supply and regulates pharmaceuticals. When did it begin regulating tobacco products – and now nicotine delivery devices?

FDA was given the authority to regulate tobacco products through the Tobacco Control Act of 2009, before e-cigarettes became a thing. To regulate tobacco, FDA had to come up with a different standard than the one used to regulate drugs. Pharmaceutical products, when they come to market, have to be proven effective and they have to be safe. They can’t be making people worse. The trouble with tobacco products is that, by definition, they make people worse. They can’t be regulated as safe and effective because they aren’t. FDA needed a different standard to regulate tobacco products; they call it the public health standard. It’s really quite powerful.

What it says is that whenever FDA is going to issue a (tobacco) regulation, the regulation has to have a net benefit at the population level. Let’s say that a randomized clinical trial shows that e-cigarettes help people quit smoking. That’s only part of the puzzle that the FDA has to consider. Under the public health standard, they also have to ask: Are more kids starting to use the product? Are more kids starting to smoke? They have to weigh all those trends together to make a determination on what’s best for the public’s health.

When did FDA extend the regulations to include e-cigarettes?

In 2016. They’re regulated as a tobacco product, not as a pharmaceutical product.

It seems almost as if the FDA’s role in regulating tobacco is so broad that the name FDA should be amended to include tobacco.

Just over a year ago, Gottlieb announced a comprehensive tobacco regulatory plan that’s still in the planning stages. He said there’s a continuum of harm. You’ve got cigarettes, which are the worst for you, and at the other end of the spectrum you’ve got nicotine replacement therapy. Nicotine replacement therapy – the gum, the patch – is regulated as a pharmaceutical product. It’s very safe and helps people to quit smoking. Also, on the continuum are e-cigarettes.

It’s currently quite irrational because cigarettes, which are very harmful, have the fewest regulations even though they cause so much death and disease. Nicotine replacement, because it’s treated as a pharmaceutical, has much stronger regulations. You can’t put attractive flavorings in nicotine replacement therapy or do aggressive advertising, because you don’t want people to abuse them and become addicted to them. It doesn’t make sense that the safest products have the strongest regulations and the most harmful products have the least.

Gottlieb wanted to bring rationality to regulation of tobacco and related products and try to move people from the most harmful to the least harmful. As part of that, they’re considering reducing nicotine level in cigarettes to non-addictive levels. They’re doing research and getting comments to figure out how to actually move forward with that plan. No specific regulatory steps have been taken but they’re moving forward exploring options.

Are these systems more or less addictive than cigarettes? That would depend on the nicotine dose, correct?

We have pretty standard measures for cigarettes; they haven’t been applied very much to e-cigarettes. I haven’t seen much research yet. For something like Juul, which is delivering quite a high dose, it seems like it certainly has a lot of addictive potential. To ask how addictive it is, you have to survey a lot of people and ask how addicted they are and take an average. You need big numbers. I don’t think we’re able to answer that question yet. But I think, anecdotally, some high school kids using Juul are exhibiting addictive behavior.

For cigarettes, you can ask people how addicted they think they are. It’s the simplest measure and it doesn’t do badly. At the next level you can ask the number of cigarettes they use a day. You can ask how soon, after waking up, do they smoke their first cigarette. If it’s within five minutes after waking up, that’s someone who’s quite addicted. There isn’t that kind of systematic research for these e-cigarette systems.

We know that nicotine is addictive and that these devices are extremely effective delivery systems. We know they’re appealing and status symbols. Do we have the time to wait before we should act?

This is the United States. We believe in free markets. We’re hesitant to regulate. Currently, regulation is a bad word. That’s the context we live in. Some countries have banned them. Having more forms of nicotine products can complicate the market, and once products are available for sale, they’re harder to get out; it’s easier to ban them.

I’m at the Institute for Global Tobacco Control. We do a lot of global work. On one of our websites, we have an updated e-cigarette policy scan. We categorize and report on what different countries are doing to regulate them.

Is there a global consensus on this?

No. The proliferation of types of e-cigarette products is like a runaway train, and it takes a while for research to catch up. People bring their opinions and are trying to extrapolate from their knowledge. There’s no consensus on what to do. In the U.S., there’s a lot of pushback against an outright ban. Some people say, “You have to help smokers. You have to give them an alternative to cigarettes.” You can’t just say, “You must quit cold turkey, on your own, and if you don’t, you’re a bad person, and it’s your fault.” You have to give them something else.
 

Still others say we have enough nicotine products out there. There’s not just nicotine in e-cigarettes. There are other things, and it takes time to figure out the health risks for each of them. Take propylene glycol, for instance. It is one of the solvents used to carry nicotine in e-cigarette liquids. Propylene glycol is considered safe for consumption, but no one has studied inhalation. There’s a lot that we still don’t know.

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