FDA Proposes First Rules for E-Cigarettes

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FDA Proposes First Rules for E-Cigarettes

News Review From Harvard Medical School

April 25, 2014

News Review From Harvard Medical School -- FDA Proposes First Rules for E-Cigarettes

The Food and Drug Administration (FDA) has announced its first proposed regulations for electronic cigarettes. They include a ban on sales to minors. But the FDA decided not to ban e-cigarette advertising, online sales or flavored products at this time. The new proposed rules also would provide the first federal rules covering cigars, pipe tobacco, nicotine gels and water-pipe (hookah) tobacco. E-cigarettes would be available to adults age 18 or older. People would have to show an ID to make the purchase. Vending machine sales would be allowed only in places that do not allow minors. Manufacturers of products that were not on the market by February 25, 2007, will have to apply for an FDA review. The industry and the public will have 75 days to comment on the proposed rules. Then the FDA will review those comments and issue final rules. HealthDay News wrote about the FDA announcement April 24.


By Mary Pickett, M.D.
Harvard Medical School


What Is the Doctor's Reaction?

The U.S. Food and Drug Administration (FDA) regulates cigarettes. This means the FDA can require health warnings on cigarette packages, ban sales to children and require manufacturers to list added ingredients.

But the FDA does not currently regulate e-cigarettes. Nor does it regulate cigars, pipe tobacco, hookahs or water pipes. Now the FDA is proposing to regulate all of these products.

I am very glad to see this move by the FDA, particularly for e-cigarettes. These products are not a vitamin, and they are not a candy.  They are a vehicle to deliver nicotine. E-cigarettes ("e" for "electronic") are battery-powered devices shaped like cigarettes. They give off a flavored vapor. They give the illusion and feel of smoking a cigarette without burning tobacco.

Some e-cigarette users say that they are "smoking." Others call it "vaping," to distinguish the vapor from smoke.

Doctors have paid little attention to e-cigarettes since they arrived on the scene about four years ago. Why? Frankly, we have felt totally uninformed.

My patients ask me if I recommend them as a stop-smoking aid. My patients ask me if they are safe. Because they deliver nicotine, we can be sure they are addictive. I have told patients, "I don't know much about those, and I can't vouch for their safety, so I would avoid them."

This advice doesn't have much bite in it. My patients, particularly my younger patients, seem to trust that these are innocent devices until they are proven to have risk. By itself, addiction does not seem to worry them. They are inclined to give these cigarette substitutes the benefit of the doubt, as long as there are no other proven harms.

So what am I looking forward to with FDA regulation? More information, and an honest understanding about what risks may come from this new fad.


What Changes Can I Make Now?

I recommend avoiding e-cigarettes while we wait to learn more about them.

In the meantime, what can be said about e-cigarettes and their safety?

  • E-cigarettes contain nicotine. Nicotine results in the release of nerve-stimulating hormones. These include epinephrine ("adrenaline"), norepinephrine, dopamine and serotonin.
  • Nicotine is addictive. E-cigarettes are addictive.
  • Nicotine increases work for your heart. It raises your heart rate, commonly by 7 to 20 beats per minute. It can cause some blood vessels to get narrower (constrict).
  • Nicotine is thought to increase the risk of heart attack and stroke, but this risk is probably small.
  • E-cigarettes contain additives (flavors and others). These are not always displayed on an ingredients list. Risks from the additives in e-cigarette vapors are not known.
  • E-cigarettes are not known to include any carcinogens (cancer-causing chemicals) in their vapor, but no one can say this with certainty. That's because the manufacturers are not currently required to report all of their ingredients.

Can e-cigarettes help smokers to quit?

This is still uncertain. A study published in September suggested that e-cigarettes might slightly help smokers to cut down or quit if they are used as an aid to stopping smoking.

Researchers enrolled 657 smokers who were interested in quitting. Close to half of them were given e-cigarettes with nicotine to use during their quit attempt. The others were given nicotine patches or a placebo e-cigarette. Just over 7% of people in the e-cigarettes group were able to quit smoking. This was similar to the quit rates of people who used nicotine patches. People who got the placebo e-cigarettes had a quit rate of 4%. This was not a very large difference.

Slightly more than half of those in the e-cigarette group were able to cut down their (regular) cigarette smoking by at least half in the six months after starting e-cigarette use.

But a newer study, published last month, did not find any benefit for quitters. This study followed 949 smokers who tried to quit. Of this group, 88 were using e-cigarettes as they began their quit efforts. The e-cigarette group did not quit at a greater rate than the larger group.

In 2012, 10% of high school students reported trying e-cigarettes. Public health experts, doctors and parents are all worried -- with good reason -- that teens who use e-cigarettes might be more likely to take up smoking cigarettes. Most doctors I speak with think e-cigarettes will hook more people on smoking than they will help to quit. This process -- addiction and transition to more harmful nicotine products -- is probably the largest hazard from e-cigarette use.


What Can I Expect Looking to the Future?

The FDA will accept comments from the public and from e-cigarette producers for the next 75 days. Then the FDA plans to make its oversight of e-cigarettes official. It is possible that e-cigarette makers will challenge the FDA in court. It may be several years before we see regulations enforced.


Last updated April 25, 2014

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