Bradenton e-cigarette manufacturer gets smoked out by FDA

A melange of fruity smells permeated through the corporate headquarters of Totally Wicked. The tangy flavors emanated from e-liquids with names like Patriot Range, Sahara and Tutti Frutti.

Employees of the U.K.-based e-cigarette liquid manufacturing company based in Bradenton calmly continued business as usual Friday, answering customers’ questions over the phone and restocking hundreds of flavors of e-cigarette liquid while Aerosmith’s “Dream On” played in the background.

But after months of deliberating the Food and Drug Administration’s new ruling, Totally Wicked decided to close its American doors.

The FDA began to hold e-cigarettes to the same standards as tobacco in August, considering all e-cigarettes, e-liquids and their mechanical mod battery components as tobacco products unless manufacturers make a therapeutic claim.

E-cigarettes are battery-powered devices that heat up liquid nicotine mixed with other chemicals, for flavors, and release a vapor. Many smokers have used e-cigarettes to replace their traditional cigarette habit.

For two more years, Totally Wicked can continue to sell the products it has — no new ones — and has to charge for samples in its shops. Unless the company submits pre-market tobacco applications, which are full reports of each individual product, including testing for all current and new products, it can’t sell anything after August 2018.

With each test costing a minimum of $300,000, Totally Wicked chief operating officer Jason Malartsik said testing all of the products would cost the company in the range of $60 million.

Having been the first e-cigarette company in Bradenton since 2010, Totally Wicked had a four-year advantage before the industry boomed.

“That’s when things kind of went sideways,” Malartsik said. “People started making e-liquids in their bathtubs. They started doing it in their garages. They weren’t doing it in a laboratory.”

Malartsik said he’s in favor of regulations, just ones that are fair. He said he doesn’t smoke, so there’s no need for him to be using an e-cigarette — a platform the company stands by — but he tests his products without nicotine. His argument is how can an e-cigarette be considered a tobacco product if it doesn’t have tobacco in it?

The American Lung Association lists concerns about e-cigarettes to include the possibility of second-hand emissions, nicotine in e-cigarettes comes from tobacco and is unsafe and that e-cigarettes are not FDA approved to be a safe manner to quit smoking.

Also, the Association argues that it doesn’t know what other chemicals are in e-cigarettes, but that a study from 2014 found a higher-voltage e-cigarette had more formaldehyde, which is a carcinogen.

Malartsik said he thought a Republican government could help Totally Wicked make its case. Then again, vice president-elect Mike Pence recently signed a law in Indiana that would place restrictive requirements on e-cigarette retailers, essentially putting them out of business. The constitutionality of those requirements recently was challenged.

Stacey Cropper, whose brother started the company in England in 2009, said he was devastated.

“We’re all pretty proud of the company,” Cropper said. “There comes a point when you realize you can’t fight what can’t be fought again.”

Cropper assured that Totally Wicked products could still be sold in the U.K. and in Europe, after the company fought back against restrictive rules in 2014.

Barbara Hogan, the COO of Vapin Lizards in Bradenton, has a more positive outlook on the rules since she just sells product, getting her supply from wholesalers. She said she would “ride the storm.”

“I personally think things will change either through the courts or through Congress,” Hogan said. “It’s a safer alternative to smoking — the science is out there.”

Hogan said she has been vaping for five years after she quit her 30-year smoking habit. After a recent visit to the doctor, she said she could stop using the blood-pressure medicine that she’d been taking for 15 years.

Vapin Lizards’ CEO Cheryl Landers deals with the manufacturers on her end.

“Some just don’t have the capital to go forward and the industry’s really going to thin out,” Landers said. “It’s going to be a waiting game.”

Although manufacturers will be taking the brunt of the hit, Hogan said shops like hers will still be affected due to a more limited supply.

“We may have less product to choose from,” she said. “There’s so much product out there, I’ve hardly touched all of it.”

This story was originally published November 11, 2016 at 3:08 PM with the headline "Bradenton e-cigarette manufacturer gets smoked out by FDA."