Electronic Cigarettes: When Will FDA Regulate Them? | Wing (Bernadette) Cheung, PharmD | RxEconsult

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Electronic Cigarettes: When Will FDA Regulate Them? Category: Cancer by - May 7, 2015 | Views: 24311 | Likes: 1 | Comment: 0  

Electronic cigarettes ruling

Electronic-cigarettes (e-cigarettes) are battery-operated smoking devices that convert nicotine and other chemicals into vapor. Currently, the FDA does not regulate e-cigarettes. However, there is an increasing concern that e-cigarettes are harmful and addictive.

Since electronic cigarettes contain nicotine users are exposed to harmful and highly addictive nicotine. In addition, the amount of nicotine in each product is not regulated because there is no federal oversight. Claims that e-cigarettes are effective in helping current smokers quit smoking are not supported by evidence. Lastly, there is concern that electronic cigarettes are a gateway for teenagers to start smoking regular cigarettes. In the 2014 National Youth Tobacco Survey, the use of electronic cigarettes has tripled from 4.5% to 13.4% over the previous year among high school students. Electronic cigarette usage also tripled in middle school students from 1.1% in 2013 to 3.9% in 2014. 

The FDA has set up workshops to gather public opinions on the topic and proposed to extend its authority to cigarette-related products including electronic cigarettes. Here are requirements for electronic cigarette manufactures in the FDA proposed ruling.

  • Manufacturers of e-cigarettes will register with the FDA and report all the ingredients in their product. 
  • They will only be able to sell their products after the FDA has reviewed and approved their application. 
  • They will not be able to make claims about the safety and the benefit of the product without concrete scientific data. 
  • They will not be allowed to distribute free products. 
  • E-cigarettes will not be sold in vending machines except in a facilities that do not admit youths. 
  • There will be age restrictions on e-cigarette.

The final public workshop on electronic cigarettes is in June. Several groups are asking the FDA to finalize its decision on e-cigarette regulations. On April 28, thirty-one medical and healthcare organizations including the American Academy of Family Physicians, American Academy of Pediatrics, and American Lung Association issued a letter to President Obama on this matter. The letter urged the president to put pressure on the FDA and expedite electronic cigarettes regulations. This letter pointed out that electronic cigarettes have been marketed to youths with enticing candy and fruit flavors. It noted the increasing number of youths using e-cigarettes and also the rise in reported calls to poison centers regarding exposures to e-cigarette devices and liquid nicotine. According to the American Association of Poison Control Centers (AAPCC), 3783 e-cigarette device and liquid nicotine exposures were reported to the poison centers in 2014. As of March 31, 2015, the AAPCC has already received 975 related calls. 

More research will be needed to evaluate the harm and benefits of electronic cigarettes. Before then, FDA regulations should restrict access to these products, especially to the youth. Hopefully, along with the public workshop, the support from healthcare organizations should push through electronic cigarette regulations. 

Read more about E-Cigarettes

Chantix (Varenicline) Interaction with Alcohol and Risk of Seizures

 E-Cigarette Claims Get Closer FDA Scrutiny

Electronic Cigarettes and Smoking Cessation Strategies

 Are Electronic Cigarettes Really Safe?


Leading Health Groups Urge President Obama to Issue Final Rules Regulating All Tobacco Products, Including E-Cigarettes and Cigars. Campaign for Tobacco-Free Kids. Tobacco-Free Kids

E-Cigarettes. Smokefree.gov. National Institute of Health.

E-Cigarette Devices and Liquid Nicotine. American Association of Poison Control Centers. 

E-cigarette Use Triples among Middle and High School Students in Just One Year. Centers for Disease Control and Prevention

Health Experts Angry FDA Still Doesn't Regulate E-Cigarettes. Time. 

Issue Snapshot on Deeming: Regulating Additional Tobacco Products. FDA.gov. FDA Center for Tobacco Products 

Tobacco-Free Kids

US Food and Drug Administration. Electronic Cigarettes (e-Cigarettes). 


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