FDA to propose e-cig regulations for first time

FDA to propose e-cig regulations for first time

WASHINGTON — The federal government wants to ban sales of electronic cigarettes to minors and require approval for new products and health warning labels under regulations being proposed by the Food and Drug Administration.

While the proposal being issued Thursday won’t immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry.

The agency said the proposal sets a foundation for regulating the products but the rules don’t immediately ban the wide array of flavors of e-cigarettes, curb marketing on places like TV or set product standards.

Any further rules “will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits,” Commissioner Dr. Margaret Hamburg said.

Once finalized, the agency could propose more restrictions on e-cigarettes. Officials didn’t provide a timetable for that action.

Members of Congress and public health groups have raised concerns over e-cigarettes and questioned their marketing tactics.

“When finalized (the proposal) would result in significant public health benefits, including through reducing sales to youth, helping to correct consumer misperceptions, preventing misleading health claims and preventing new products from entering the market without scientific review by FDA,” said Mitch Zeller, the director of the FDA’s Center for Tobacco Products.

The FDA said the public, members of the industry and others will have 75 days to comment on the proposal. The agency will evaluate those comments before issuing a final rule but there’s no timetable for when that will happen. The regulations will be a step in a long process that many believe will ultimately end up being challenged in court.

E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. That creates vapor that users inhale.

“Right now for something like e-cigarettes, there are far more questions than answers.”

 - Mitch Zeller, director of FDA's Center for Tobacco Products

Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn’t contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there’s not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it’s unclear how safe they are.

The industry started on the Internet and at shopping-mall kiosks and has rocketed from thousands of users in 2006 to several million worldwide who can choose from more than 200 brands. Sales are estimated to have reached nearly $2 billion in 2013. Tobacco company executives have noted that they are eating into traditional cigarette sales, and their companies have jumped into the business.

Some believe lightly regulating electronic cigarettes might actually be better for public health overall, if smokers switch and e-cigarettes really are safer. Others are raising alarms about the hazards of the products and a litany of questions about whether e-cigarettes will keep smokers addicted or encourage others to start using e-cigarettes, and even eventually tobacco products.

“Right now for something like e-cigarettes, there are far more questions than answers,” Zeller said, adding that the agency is conducting research to better understand the safety of the devices and who is using them.

In addition to prohibiting sales to minors and requiring health labels that warn users that nicotine is an addictive chemical, e-cigarette makers also would be required to register their products with the agency and disclose ingredients. They also would not be allowed to claim their products are safer than other tobacco products.

They also couldn’t use words such as “light” or “mild” to describe their products, give out free samples or sell their products in vending machines unless they are in a place open only to adults, such as a bar.

Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold.

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4 comments

john bodily

May 23, 2014

June 3rd 2013 is when I got introduced to the industry and I haven’t had one cigarette since that day. Now I own 2 stores and my main focal point is to help people with health issues. The Dr’s are backing them I have 3 displays in there office. Not only that it is also used to help people lose weight by curbing their appetite so they Vape a birthday cake or dessert. So this is not just a tobacco only used product . Thanks John Bodily

Yalisa

March 16, 2015

Thanks for the review. Just quit citgeeatrs for New Years. However, I think it will be nice to still have something to hold and puff on, as odd as that sounds. I ordered the $49 combo pack w/ mango flavor (everyone seems to really like the mango ones!). I got $10 off too using a coupon code too. I told them RealCigReview via YouTube sent me How has your battery been holding up? I’ve read about a few cases where some people got faulty ones. Thanks again & happy new year!

Maricela

March 17, 2015

I’m from the UK and really want an ecig but beacsue this is an American website, I don’t think I can order from it without the cost being so high to deliver and everything. Anyone from the UK know where I can get an ecig that looks like a cigarette, and where I can get flavours? (like in this video exactly, but from the UK)?

Yosi

March 22, 2015

I live in Australian capital tertrroiy only just realized ciggies world is based here gonna see if i can get them to post to me cause tobacco in stores here and plain packaging suck.

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