The FDA and E Cigs

Blog Post created by Thomas3.20.2010 on Feb 17, 2014

Medscape spoke with Mitch Zeller, JD, Director of the FDA's Center for Tobacco Products:

Medscape: Can you speak a little more about electronic cigarettes? E-cig use by students in grades 6-12 has essentially doubled  in the past few years, and there are many unanswered questions regarding their safety. Can you speak specifically about concerns regarding the use of e-cigs by teens and, for that matter, adults? Are there specific plans to address their use?

Mr. Zeller: The reality is that the marketplace for e-cigarettes today is what I would call the Wild, Wild West. We do not regulate them, but we have announced our intention to create that regulatory framework. Until we do, we need to monitor the behaviors that are going on in the marketplace and better understand the products, and we are funding a lot of research to get a better handle on the safety and the toxicity profile of these cigarettes. We want to answer 2 fundamental questions about behavior: Who is using e-cigarettes, and how are they being used?

What is going on with currently addicted adult smokers of conventional cigarettes? Are they completely switching to e-cigarettes, or are they engaging in what we call "dual use" -- continuing to smoke some combusting cigarettes while also using e-cigarettes? If that dual-use behavior is going on, does that mean that addicted adult smokers who might otherwise have been more motivated to quit are losing that motivation, because now they can use e-cigarettes as a bridge to get from their last burning cigarette to their next burning cigarette?

We have a lot of questions about the products and behavior at the population level. We're funding the research to try to get those answers. The bottom line is that we do not currently regulate e-cigarettes, but as I mentioned, we have submitted proposed regulations. This is all as a result of a court decision, so let me provide a little more historical context and then put it in terms of the statutory definition.

In 2009, the FDA took an enforcement action against e-cigarettes and tried to prohibit the import of e-cigarettes from abroad on the grounds that they were unapproved drugs and devices -- unapproved nicotine delivery products. One of the importers sued the FDA and actually won in both the Federal District Court and the Federal Court of Appeals.

Here is what the court ruled. It sounds a little counterintuitive, but when you understand the definition of a tobacco product, hopefully it will make some sense. The court ruled that as long as an e-cigarette product is not making a therapeutic or cessation claim, which would put it squarely under the drug and device laws of our statute, the only way that that FDA can regulate e-cigarettes is under the Family Smoking Prevention and Tobacco Control Act. Here's the counterintuitive part: E-cigarettes do not contain any tobacco, so how could 2 courts rule that that is the only way that the FDA could regulate them?

They ruled that way because of the definition of a tobacco product under the law. The definition is, basically, anything that is made of or -- and here are the key words -- derived from tobacco. And it turns out that all of the nicotine in e-cigarettes is derived from the tobacco plant. The companies are not manufacturing or synthesizing nicotine. They are deriving nicotine in the same way that nicotine-replacement therapy products come up with nicotine.

It's on that basis that the courts ruled. And the FDA has announced the intention to create the regulatory framework under the tobacco authorities to regulate the manufacture, sale, and distribution of e-cigarettes.