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FDA moves to expand authority over electronic cigarettes

Proposed rule would prevent sales to those under 18, require makers to report ingredient listings

April 24, 2014
Electronic cigarettes

The U.S. Food and Drug Administration proposed asserting its authority over new tobacco products, including e-cigs, on Thursday.

Christophe Ena / AP file

 Electronic cigarettes may soon be regulated by the Food and Drug Administration, just as traditional smokes are.

It isn’t official yet but the FDA suggested Thursday that it would expand its authority over tobacco to include electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe tobacco and dissolvables not already under the FDA’s authority.

The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.

“This proposed rule is the latest step in our efforts to make the next generation,” Health and Human Services Secretary Kathleen Sebelius said in a statement.

E-cigarettes were originally marketed as an aid in quitting cigarette smoking, but over the last decade they’ve grown in cache to the point where celebrities are often seen taking a puff.

While they do not contain many of the known carcinogens that traditional cigarettes do, nobody knows whether they present any health hazards. There have been few evidence-based studies about them.

“The fact is, this is not just a way to deliver nicotine,” said Jonathan Bricker, psychologist and smoking cessation researcher in the Public Health Sciences division of Fred Hutchinson Cancer Research Center. “The nicotine is being delivered in combination with other chemicals that cause the ‘smoke.’ And those chemicals are potentially carcinogenic.”

Until those chemicals are studied, no one can say whether they are hazardous to inhale.

“We won’t know for a while,” Bricker said. “We need to do extensive laboratory research and have to observe their effects over time on the human body. Cancer doesn’t show up immediately. It takes years to develop.”

Now the FDA is proposing some sweeping changes to the way it regulates tobacco products. Though it is not suggesting an outright ban the proposed rule will require the makers of these tobacco products to:

  • Register with the FDA and report product and ingredient listings
  • Only market new tobacco products after FDA review
  • Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing of the product will benefit public health as a whole; and
  • Not distribute any free samples

The FDA would also set a minimum age for purchase of these products as well as require identification restrictions to prevent sales to underage youth.

“Right now anybody can buy them,” said Donna Manders a tobacco cessation specialist at Seattle Cancer Care Alliance. “This will curb sales to minors.”

The proposed regulations will also protect Americans from product variability. “When a product is unregulated, you don’t know what’s in there,” Manders said. “If, for example, there is supposed to be 4 mg of nicotine in each e-cigarette, there might in fact be 8. Right now there’s no way someone can know that what is on the label is what is in the product. And that puts the consumer in a vulnerable position. So regulation would protect consumers from variation in the product.”

Like cigarettes, the newly regulated products would also be required to carry health warnings. Plus, there would also be a prohibition against selling them in vending machines unless the machine was in a facility that never admits young people. 

Some states didn’t wait for the FDA to get involved. New York, New Jersey, Utah and North Dakota have already banned e-cigarettes.

Up until now it’s been a virtual Wild West situation with respect to e-cigarettes, which have been growing in popularity. Like most supplements, they came with no regulation or testing requirements.

Though it’s a health plus that they are smokeless, e-cigarettes  do contain liquid nicotine which is converted into a vapor that can be inhaled. And while nicotine doesn’t cause cancer, it is highly addictive.

One big question that hasn’t been answered is whether inhaling the vapor, which does leave a residue on drapes, carpeting and furniture, has any effect on health. Another unknown: whether e-cigarettes help people kick the habit or just make them more nicotine addicted.

One thing experts are sure of—e-cigarettes aren’t going to be banished with the stroke of a pen any time soon.

“The e-cigarette business is booming,” Manders said. “The tobacco industry is heavily invested in them at this point so they’re probably not going to go away.”

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Fred Hutchinson Cancer Research Center is a world leader in research to prevent, detect and treat cancer and other life-threatening diseases.