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FDA finally considering action on e-cigarettes

The Food and Drug Administration (FDA) appears to be almost ready to declare that e-cigarettes are dangerous and should be regulated. This was the announcement by the FDA on Wednesday, April 24, 2014 that it is considering proposing new limitations on the sale and advertising of e-cigarettes.

That glamorous moment of exhaling e-cigarette smoke
Photo by Joe Raedle

After five years of unregulated sales of e-cigarettes, the FDA has awakened to the fact that e-cigarettes are a nicotine dispensing method that provides an addicting drug that has been sold to minors and advertised as a health aid. The vapors exhaled by the users still contain nicotine and the propellant that constitute a danger to others from the secondhand smoke.

Claims that e-cigarettes are safe is patently illogical given that nicotine is a poison and in the same addiction classification as heroin. Some researchers, including a professor from Duke University, have claimed that the dangers of e-cigarettes are unknown. The tobacco industry made false safety claims for decades for regular cigarettes.

The claims that the full dangers of e-cigarettes are unknown are partially true since the FDA has not required the contents of e-cigarettes to be disclosed. E-cigarettes have also not been clearly labeled with warnings on the health consequences of inhaling nicotine and the propellant that are being vaporized in the heating element.

The new proposal to regulate e-cigarettes does not force the suppliers to stop using flavors such as cotton candy and pina colada to entice minors to try the e-cigarettes and to hide the tastes of the nicotine and propellants. E-cigarettes sales were over $2 billion dollars in 2013. Major growth segments are in the middle school and high school student populations, with a doubling of users in one year.

One justification of keeping e-cigarettes available has been that it is a way to wean smokers off of tobacco cigarettes. Heroin was once promoted as a substitute drug that could be used to wean opium users off smoking opium. E-cigarettes provide a highly effective and concentrated delivery system for nicotine. The exhaled smoke contains nicotine, which still represents a secondhand smoke danger to pregnant women, small children, asthma and COPD sufferers.

Because there have been no restrictions by the FDA, companies have been free to advertise on TV and radio, and there are no federal age restrictions on sale of e-cigarettes to minors.

A direct quote from the FDA website provides the following information.

“Only e-cigarettes that are marketed for therapeutic purposes are currently regulated by the FDA Center for Drug Evaluation and Research (CDER). Currently, the FDA Center for Tobacco Products (CTP) regulates

  • cigarettes,
  • cigarette tobacco,
  • roll-your-own tobacco, and
  • smokeless tobacco.

FDA has issued a proposed rule that would extend the agency’s tobacco authority to cover additional products that meet the legal definition of a tobacco product, such as e-cigarettes. FDA’s Extending Authorities to Additional Tobacco Products webpage offers more information on the proposed rule, including how to submit comments.”

The FDA page goes on to report some of the adverse effects that have been submitted by health care professionals through the FDA’s own adverse effects procedure. The FDA has added the disclaimer that these adverse effects could be due to preexisting conditions. This shows the lack of commitment by the FDA to act against the tobacco industry when a known addictive drug has been sold for over five years.

“Adverse Event Reports for E-cigarettes

We regularly receive voluntary reports1 of adverse events involving e-cigarettes from consumers, health professionals and concerned members of the public. The adverse events described in these reports have included hospitalization for illnesses such as

  • pneumonia,
  • congestive heart failure,
  • disorientation,
  • seizure,
  • hypotension, and
  • other health problems.

Whether e-cigarettes caused these reported adverse events is unknown. Some of the adverse events could be related to a pre-existing medical condition or to other causes that were not reported to FDA. You can review the adverse event reports for e-cigarettes that were voluntarily reported to FDA from 6/22/2009 to 3/12/2014 at the CTP FOIA Electronic Reading Room.

  1. Under the Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, FDA may accept voluntarily submitted information related to tobacco products, even if some of the information concerns tobacco products that are not yet regulated by FDA. “

If any e-cigarette supplier, FDA or collegiate research scientist wants to prove that e-cigarettes are not dangerous, a simple proof is suggested. Let them inject 25 milliliters of the liquid contents of an e-cigarette into one of their veins and record the results for public posting. This will provide conclusive results on the safety of e-cigarettes. Don’t hold your breath waiting for someone to actually do this.

Use your favorite search engine to get the contact information for Senator Sherrod Brown, Senator Rob Portman, Congressman Pat Tiberi or Congressman Steve Stivers.

Send these elected officials your request to increase pressure on the FDA to act immediately to stop the sale of e-cigarettes to minors, stop the addition of “flavoring agents” that are specifically attracted to minors, and to force labeling of e-cigarettes to have warnings similar to conventional tobacco cigarettes.

The FDA will eventually ignore the tobacco and e-cigarette lobbyists and declare that e-cigarettes are dangerous and should be treated just like regular cigarettes. The fact that e-cigarettes use pure nicotine instead of tobacco cigarettes with tar, menthol and other "added ingredients" does not make them any less poisonous.

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