Will FDA regulation change e-cigarettes’ billion-dollar industry?

For a long time, e-cigarettes existed in a very lightly regulated world.

The battery-operated device, which uses heat to turn a liquid containing nicotine into a vapor, has skyrocketed in popularity, with more than 200 brands, millions of users and $2 billion in sales.

On Thursday, the Food and Drug Administration (FDA) proposed new regulations for the emerging industry, setting a foundation to oversee e-cigarettes as well as cigars, pipe tobacco and several other alternatives to cigarette smoking. 

Some of the proposals include an 18-plus age restriction for buying the product, a disclosure of ingredients by manufacturers, an end to vending machine sales and a mandate to back safety claims with scientific evidence.

The suggested rules, however, did not touch on flavored “vaping” or on advertising, which critics say attracts minors to tobacco use.

Are these suggestions enough? If they’re implemented, will the industry suffer? We consulted two experts for the Inside Story.

Why regulate e-cigarettes?

I have done most of my work with kids. They are my biggest concern. I am happiest about these developments limiting e-cigarettes’ access to kids, because it could be a way for them to start.

My biggest concern, and [that of] just about any researcher who works for kids, is that if you restrict access to a nicotine product to a certain age, then chances of them becoming addicted are much, much lower.

This is a very healthy move toward delaying nicotine use by young people. Once you get hooked on nicotine, we don’t know what the trajectories are — whether they switch to other, more combustible tobacco products or not. Some of these e-cigarettes are designed to resemble conventional cigarettes. My concern is that [with] unregulated e-cigarettes, once they get hooked on nicotine, it is much easier to get hooked on tobacco products.

Is there any evidence, to your knowledge, that it helps people quit smoking?

I have read some papers showing it potentially could be helpful to adult smokers. But the effect of e-cigarettes was not tremendously more substantial than from FDA-approved quitting aids you can get in the pharmacy. One study compared e-cigarettes to the patch, and they were very comparable.

I cannot deny that when you have an e-cigarette, you have both nicotine and the ritual of smoking. But I wonder if this can even delay quitting. The temptation would be to stay with this product once you have quit combusted tobacco products. You never know if you are going to return to the old products. 

Will regulation make it easier to amass research on cessation?

I am not really a cessation expert. We have specialists on cessation, and they could tell you more on that. But I can only say from prevention research it is a very good move.

We are trying to do our best to debunk the myths of the safety of new and emerging tobacco products, on the one hand, and persuade kids to avoid trying this nicotine-containing product.

Do you support banning its indoor use?

Of course, yes, I do. Even though they say there is no secondhand smoke, there is still an exhalation of 80 percent of the nicotine you inhale. So it is comparable to the conventional cigarette. It is not as innocent as it seems. It is all about renormalizing the use of tobacco products. Society is moving toward denormalizing it. We have seen a lot of very positive health trends in this regard including secondhand smoking. For example, in terms of e-cigarettes you might not see it, but it is about renormalization. 

The Food and Drug Administration says it will formally propose regulating e-cigarettes. How significant is this?

In 2009, I was manufacturing and selling e-cigarettes in the U.S., and the FDA shut me down. Then the agency put a nationwide import ban on the product. I sued the FDA at that time, and the Department of Health. I defeated them in 2010, and since then we've had no regulations.

I’m obviously concerned about some of the issues coming up — substantial equivalency. New tobacco products may not be legally marketed in the U.S. unless the FDA has issued an order permitting their marketing.

The process of getting market authorization is going to be extremely difficult, restricting and making it only available to big tobacco companies who have monster cash flow — one of the issues that could be troublesome.

Age verification is a must; 18 years old or older. Safety packaging and providing an ingredients list on packaging are all fantastic. Manufacturing standards: fantastic. We welcome that. All  of the responsible players in the industry welcome it.

What about e-cigarettes' harmful effects?

That was a big part of my court case in 2009. We’re not making any claims. To make a claim you’d fall under the medicinal category.

We can state this: it’s just a fact — e-cigarettes are less harmful due to the fact that it doesn’t contain certain ingredients and carcinogens of conventionally burned tobacco. Once you burn something, that’s when you cause carcinogens and toxins that we know are in conventional tobacco cigarettes. 

The main ingredients in e-cigarettes have all been on the market for 30 to 40 years without harm. Nicotine isn’t the culprit here. Nicotine is found in many natural products. It’s one hydrogen away from being identical to caffeine. It’s not a drug. It’s a second-class stimulant. My point is, nicotine is addictive, no question. So is caffeine. So that’s why we welcome the regulatory process.

We are seeing examples of big tobacco companies taking on the e-cigarette market. What does this indicate?

Big tobacco is seeing a serious decline in its current business model. My point is when you look at the business model, it obviously needs to switch. I think the industry welcomes that this is a less harmful alternative. They're also still able to maintain the same platform of distribution for their conventional tobacco products. It’s a good move for them.

The problem with these larger companies is that they have the money, but to get up to speed to try to provide their own products that can compete with what’s on the market — that's going to to be a challenge to them. They’re the 800-pound gorilla in the room. They don’t move very fast and jump through hoops to make sure the entire team is on the same page. Smaller businesses will have the ability to continuously be able to come up with new products, and the product will evolve. Conventional tobacco will be surpassed by the e-cigarette industry in the next decade.

What about Big Tobacco's influence in politics?

Big Tobacco has an image problem. Nobody really in the political process wants to attach their name to Big Tobacco because it’s a stain. So Big Tobacco has to work very carefully to get their position across. That is something that’s never going to change.

By now, coming out with some of these new products that they’re trying to come up with, they’re going to try to work very slowly to hope for regulation and doing plenty of things on the sidelines to try to retain the best possible platform for their category.