AMARILLO, TX (KFDA) - Vape shop owners across the nation fear new FDA regulations may force them to close down.
On May 5, the FDA finalized a rule extending its authority to regulate all tobacco products including e-cigarettes, hookahs, cigars, pipe tobacco and nicotine gels, claiming the changes stem from its right to "improve public health and protect future generations from the dangers of tobacco."
Under the new regulations, the FDA now requires vape shops to register as tobacco manufacturers, which isn't sitting well with realtors like Chris Goodwin, who owns Southern Clouds Ejuice. He says that clause is his biggest qualm with the regulations, because e-cigarettes use water vapor instead of tobacco.
"I think the FDA has overreached in its regulations in the fact that they're classifying electronic products as tobacco products," Goodwin said. "Our product has nothing to do with tobacco. I don't feel good about it of course, and neither does anybody else in this industry or anybody that has stopped smoking and started vaping."
The new regulations include requiring all products - new electronic cigarettes, vaping liquids, and nicotine levels - to be approved by the FDA prior to hitting retailer shelves: A costly venture for many small businesses.
Back in December we told you about Frank Blankenship, a local shop owner and vaping activist who traveled to Washington D.C. to fight these exact regulations.
Now that they have been approved, he feels many stores - including Lucky Ruckus Vape Shop, his own - may not survive.
"Over 10,000 small businesses are going to be out of business and over 100,000 employees are going to be out of work due to these regulations," Blankenship said.
Each item would require a separate application to be approved, a costly venture for any small business owner.
The FDA estimates each application will cost $300,000, but other professionals like Jeff Stier, an electronic advocate at the National Center for Public Policy Research, believes each application could cost $1 million or more.
Blankenship's shop sells roughly 2,000 products. If the application cost $300,000 for each product, that's $600 million coming out of his pocket. That, or, close the doors for good.
"We're going to see companies going to one or two products, the regulations are going to divert people from a healthy alternative to smoking by taking the variety out," Goodwin said. "Variety is very important to smokers that start vaping, you have options. You're not just stuck with a tobacco or a cigarette flavor."
The FDA is also requiring shops to change their labeling process by submitting a list of ingredients in their e-liquids. The sale of e-cigarettes to those under the age of 18 will continue to be strictly prohibited, while a photo ID will be required for those under the age of 26.
While retailers are panicking over some of the regulations, the age restriction is one they agree with.
"Respectable vape businesses are all for reasonable regulation," Blankenship said. "Reasonable regulation is childproof caps, warning labels, and manufacturing for e-liquids."
Retailers say they are most upset the government is making it harder to sell a product created to help people quit smoking.
"The FDA has blatantly ignored readily available scientific data supports vape products," Blankenship said.
An independent study conducted by Public Health England in 2015 concluded e-cigarettes are 95 percent safer than tobacco cigarettes and could be "game-changer" for getting people to quit smoking.
"Our whole purpose of being here is to help people quit smoking and to save lives," Goodwin said. "The quit-rate from vaping is 85 percent, 85 percent of the people that vape instead of smoke quit smoking cigarettes. People that use Nicorette, Chantix, and other patches...only 8 percent of those people quit smoking. This is the public health miracle we've been looking for the last 30 years."
However, not everyone dislikes the new regulations.
The American Lung Association supports the changes, claiming uncertainty about the safety of e-cigarettes. The ALA said "it is urgent for FDA to begin regulatory oversight of e-cigarettes, which would require ingredient disclosure to FDA, warning labels and youth access restrictions."
Retailers say there may be hope on the horizon to reduce the severity of the regulations.
"The Agricultural Appropriations Bill has some language in it that will move what's called the predicate date or grandfather date to the effective date of regulation," Blankenship said.
Meaning any products on the market before that date could remain on the market without going through the application process.
For now, Blankenship says he won't stop fighting.
"In the immediate future it's business as usual at Lucky Ruckus for our customers. There are somethings going on behind the scenes," Blankenship said. "We're working with industry groups to determine what our long-term plan is."
The new regulations will go into effect on Aug. 8. At that point, retailers will have 2 years to make the case that allowing their products to stay on the market would be "appropriate for the protection of public health."
If they meet that deadline, they would be allowed to sell their products for another year while the FDA reviews their applications.