Up in smoke? Vape dealers say new FDA regulations will damage businesses

Earlier this month, the federal government announced sweeping new rules for electronic cigarettes that for the first time will require the devices and the ingredients to be reviewed by the FDA.

The rules are making local vendors of e-cigarettes and vaping products concerned about their future.

Before brands are allowed to stay on the market, regulators will check the e-cigarettes’ design and the liquid nicotine they contain.

Kelly Flieg installs a new coil on a rebuildable drip atomizer for a vapor smoking device Thursday in Jackson.GLENN LANDBERG ~ glandberg@semissourian.com

The new rules will affect all electronic nicotine delivery systems (ENDS) including vaporizers, vape pens and hookah pens.

The rules will not apply to products that are “grandfathered in” by being on the market by Feb. 15, 2007, and remaining unchanged since then.

E-cigarettes lack the chemicals and tars of burning tobacco, but the cigarettes have not been studied extensively, and there’s no scientific consensus on the risks or advantages of vaping. FDA commissioner Dr. Robert Califf said the new rule will allow the FDA to prevent misleading claims and provide consumers with information to help them understand the risks better, the Associated Press reported.

“There just hasn’t been enough science,” Terry Baker of the American Lung Association said. “The goal is to protect public health.”

The new rules essentially treat ENDS like other tobacco products and will require the same level of federal regulation, warning labels and restrictions regarding age.

But what concerns local vendors of ENDS most is the costs involved with the regulation.

Bottles of e-juice rest on a counter at Premier Vapors on Thursday in Jackson.GLENN LANDBERG ~ glandberg@semissourian.com

“If this regulation continues unchecked, 99.9 percent of vaping manufacturers and businesses will go under because they cannot afford the premarket testing the FDA requires,” said Roger Peterson, the owner of Mr. White’s Vapors LLC and the president of the Missouri chapter of the Smoke Free Alternatives Trade Association.

He said the testing required would cost the stores and manufacturers millions of dollars to complete.

The regulations are set to take effect in August, and companies have two years to submit their information to the FDA and another year while the agency reviews it.

“After two years, pretty well everything will go under,” said Taylor Moore, district manager of Soo Vape Vapor Shops.

Kelly Flieg, owner of Premier Vapors, is concerned about the regulations, but she doesn’t see it as the end of the industry.

Though it may stop her from manufacturing her own liquids, she said she still will be able to carry the products manufactured by larger businesses that already have applied for FDA approval.

“It’s going to take a lot of money to get to where they need to be, but they’ve already started working on it,” Flieg said. “So as far as putting us out of business, no, I don’t see that, but it could definitely limit us.”

A sign filled out by a customer rests on the counter at Premier Vapors on Thursday in Jackson.GLENN LANDBERG ~ glandberg@semissourian.com

The costs are particularly concerning to business owners because it’s not clear how much premarket testing will cost them.

“It’s very extreme vague right now. It says $1 million dollars per juice, per [nicotine] level. It could be anywhere from a thousand dollars to a million, which is a huge gap,” Flieg said.

Michael Felberbaum, press officer for the FDA, said the agency estimates the costs “in the low hundreds of thousands of dollars, not in the millions or tens of millions of dollars estimated by some others.”

Felberbaum said the FDA recognizes the strain the new regulations could put on small businesses and has provided guidance on submitting the required form.

The agency also plans to “hold training webinars, meet with companies at their request and increase staffing in the Center for Tobacco Product’s Office of Small Business Assistance” to help small businesses, Felberbaum said.

Along with the premarket review and regulation, ENDS devices and their associated products must carry warning labels, and sale of them is restricted to customers over the age of 18.

The Associated Press reported more than 15 percent of high-school students admit using e-cigarettes, up more than 900 percent over the last five years, according to federal figures.

Locally, ENDS vendors say this is not a common occurrence.

Moore said his average customer is male and in his 30s.

He said vape pens are used mainly as a smoking-cessation tool, and it’s uncommon for people to take up the practice of vaping for the sake of vaping.

Flieg said she has people under the age of 18 who come in looking for materials, but she already IDs customers before selling.

“As a parent, I have young children. I wouldn’t want my children to pick up vapor just because their friends are doing it, just like I wouldn’t want them to do it with cigarettes,” she said.

Peterson said it’s a matter of harm reduction.

While it would be better to avoid nicotine altogether, he said e-cigarettes lack the chemicals added to traditional cigarettes, making them a better choice.

“We’re a semi-self-regulated industry to a degree already,” Moore said. “We’re not against regulation.”

Peterson said he has no problem with the labeling requirements, age restrictions, packaging standards or testing of materials, but the extent of the new FDA regulations are too far-reaching and too costly, and the 2007 grandfather date is set too far back, causing it to exclude most products on the market.

“They go too far,” Peterson said.

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products said in a news release the agency believes its approach to be reasonable and balanced.

“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” Zeller said in the release.

Some lawmakers agree with the vendors. There are two efforts within the House and Senate to push back against the regulation — House Resolution 2058 and the Cole-Bishop Amendment to the Agricultural Appropriations Bill — by prohibiting the FDA from requiring retroactive safety reviews of e-cigarettes already on the market.

Oklahoma Congressman Tom Cole, who introduced the House resolution, called the current regulations “another example of the Obama Administration’s regulatory overreach and nanny-state mentality.”

“Either one of those will change the predicate date. They will change the grandfather date from February 15, 2007, to sometime in August of this year,” Richardson said. “If these do not come about, the industry is basically doomed.”

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