E-Cigarette Suppliers Fear FDA Rules Could Shut Them Down

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A move by the Federal Drug Administration to regulate alternative tobacco products like electronic cigarettes has the owners of e-cigarette stores fuming.

They claim, the proposal will ultimately shut-down their stores and leave thousands of people who use their liquid nicotine products-- as an alternative to smoking cigarettes--with nowhere to go.

Karin Assenhiemer of Hilliard says she desperately wanted to kick her smoking habit.

"I've been a smoker since my 20's," she said.

The 40-year old says she turned to electronic cigarettes, and has never looked back.

"I stopped immediately and never bought more cigarettes," she said. 

E-cigarettes work by heating the drug nicotine. It's vaporized then inhaled.

But store owner James Jarvis fears that if the FDA has its way, he'll be put out of business.

"We are saving people's lives every day and they want to take that away from us?” Jarvis, owner of Vapor Station, said.

The FDA wants all e-cigarettes manufactured prior to 2007 to be tested. Those proposed regulations are under review by the White House.

The agency says to date: "the FDA has not been able to fully assess the public health impacts of unregulated tobacco products."

Jarvis believes this isn't about health; it's about competition from big tobacco.

"This is big tobacco walking the FDA through the process and sticking the middle finger up at us because we found something to give somebody something safe and safer alternative to smoking,” he said.

Because the FDA has not fully studied e-cigarettes consumers don't know the potential health effects.

E-cigarette owners say they welcome the new regulations but the cost could drive them out of business.

"This device here the drip would have to file a pre-market application, the tank itself would have to file a pre-market application, the liquid that's inside so just in my hand you're talking between $5 to $25 million to get this product on the market, " Dimitris Agrafiotis of the Tennessee Smoke Free Association said.

As for Karin Aseenheimer who believes in the product, she hopes new rules for e-cigarettes won't keep others from reaping the benefits.

"It was actually the easiest way to quit smoking," she said. "I think everybody has the right to do what they need to do to stop smoking," she says.

The FDA says once its rules are approved stores will have two years to comply.

The FDA wants to require the following from stores that sell e-cigarettes:

  • Register with FDA and report submit product and ingredient listings;
  • Adhere to minimum age and identification restrictions to prevent sales to underage youth;
  • Include health warning labels;
  • Not distribute free samples;
  • Not be sold in vending machines unless in a facility that does not admit youth;
  • Only market new tobacco products after FDA review; and
  • Not make reduced risk claims like “light” or “mild” unless the manufacturer provides valid scientific data to support such a claim and is granted a market authorization by FDA.

The House Appropriations Rural Development, Food and Drug Administration and Related Agencies Subcommittee approved a $20.65 billion agriculture appropriations bill Thursday that would make it harder for the Food and Drug Administration to remove electronic cigarettes on the market now from store shelves.

If enacted, the bill would keep the FDA’s Center for Tobacco Products from forcing e-cigarettes already on the market to go through a lengthy and potentially costly Premarket Tobacco Review application process under the Federal Food, Drug and Cosmetic Act. The FDA would still be allowed to regulate how the products are made, packaged and sold.