FDA Regulations Impact Myrtle Beach-area Vape Retailers

By Roger Yale

For The Sun News


Over the past decade, the electronic cigarette industry in the United States grew from a cottage enterprise to a $3.7 billion juggernaut in 2015, according to ECigIntelligence – a UK-based organization focused on tracking regulatory changes and market intelligence for the e-cigarette and tobacco-alternatives sector.

On Aug. 8, the FDA rolled out what it calls its “Deeming Regulations,” a laundry list of edicts that all players in the industry must abide by in order to stay in business – impacting things like labeling of e-liquids, sampling, modification of vaping devices, age verification and more.

All US vape shops that produce e-liquids were required to register with the FDA and provide detailed listings of each such product by Dec. 16.

The FDA now considers e-cigarettes and e-liquids to be tobacco products – and additional regulations are coming down the pike soon, unless the Trump administration quashes them altogether.

But that remains to be seen, and to hitch that proverbial wagon to a mere possibility is simply bad business.

Local entrepreneur Orit Deverell and her employees at Zuluvape in Myrtle Beach and Charleston have been navigating the changing vape landscape and working to remain compliant in front of any future regulation.

“At this point, we are following everything that we are required to do – and one of these things is to register with the FDA,” she said, adding that every one of her e-liquid products – 2,500 variations in this case based on nicotine levels, vegetable glycerin [VG], food-grade propylene glycol [PG] combinations and flavorings – needed to be listed and submitted to the agency as well.

The next step will be to register the ingredients used in her e-liquid production in February. By 2018, all e-liquid labels must clearly display an FDA warning.

Because Zuluvape also does business online, the age verification process needed to become compliant online as well.

“I use a company called [AgeChecker.net], and when you purchase on my website now, you have to go through an added step and put in all of your information to get approved. It’s costing me a good bit of money, but it protects me and we know that we have verified the age,” she said.

Deverell told the Sun News that Mastercard Incorporated has also thrown itself into the regulatory fray for non-face-to-face transactions, which obviously protects the credit card company from liability.

“We had to do adult signature on delivery and had to submit an attorney opinion letter to Mastercard that we are following all FDA regulations,” she said.

Mastercard will charge Deverell and all other vape businesses an additional $500 per year for the privilege.

“What the FDA has done has opened up a lot of other things. The next thing you know, it’s going to be Visa and American Express,” she said.

A huge issue for vape retailers is the predicate date, also known as the grandfather date for all products under the Deeming Regulations, which include traditional tobacco products. That date is currently February 15, 2007 – meaning that products introduced to market after that would need to undergo premarket testing. Manufacturers would have to submit premarket testing applications – or PTMAs – for every tobacco product after that date to be evaluated by the FDA – a lengthy and costly process.

But vape products were not even introduced to the US until late 2006, and the technological advances on devices since then have been staggering. The predicate date as it stands could put an end to the vape industry as we know it - particularly those manufacturers without the deep pockets of Big Tobacco.

Cigarette companies are indeed in the vape game, but produce “cigalikes” – vape devices that are made to look and feel like traditional cigarettes as opposed to the more popular open tank systems. Reynolds American produces Vuse and Imperial Tobacco manufactures Blu.

Last year, the House Appropriations Committee voted in favor of a piece of legislation called the Cole-Bishop amendment, which would change the predicate date for vapor products to the effective date of the FDA’s final rule on Deeming Regulations. It has not yet been voted on by the full House and Senate.

Deverell seems to have taken all of this in her stride, looking forward with a wait-and-see mindset.

“What we have done is added things that we had in the pipeline, and we deleted things that didn’t sell – and kind of decided on what products we were going to have that were going to be registered with the FDA,” she said. “This is basically all we are doing now.”

Gone are the days of free samples. Deverell now offers a membership at $5 a year or 25 cents per visit – giving customers the ability to taste products. Also, building coils or modifying vape kits are no longer allowed.

Troubleshooting devices and setting up vape kits are allowed, according to a guidance document draft recently issued by the FDA.

That Trump could overturn these seemingly overreaching and draconian regulations remains a distinct possibility, given his stated aversion to wasteful and unnecessary regulation.

“I am pretty optimistic when it comes to that. It’s up in the air, and we just have to wait and see what happens,” she said.

Trade organizations and advocacy groups abound, unifying the business community and giving a voice to the vaping masses – notably the American Vaping Association, American E-Liquid Manufacturing Standards Association (AEMSA), CASAA – The Consumer Advocates for Smoke-free Alternatives Association, NOT Blowing Smoke, and the Vapor Technology Association, or VTA.

South Carolina has a dog in the fight too, the South Carolina Vapor Industry Association [SCVIA] – and its primary purpose is summed up on the association’s website:

“There is currently a lot of misinformation about the vapor industry being spread to the general public. By educating both smokers and non-smokers about the truth and science in the vapor industry, we gain valuable allies who will assist us in putting pressure on our elected officials to listen to fact and science rather than propaganda spread by big pharma, big tobacco, and poorly informed government agencies.”

SCVIA executive director John Boynton also owns a vape shop called Vapor Tek USA in Aiken. He said he believes the FDA has overstepped its boundaries tremendously.

“I don’t feel like they are looking out for the best interests of Americans. I am not going to make any health claims because I can’t do that – but I honestly feel that if the FDA was truly concerned about the health and well-being of Americans, they would have listened to a lot of the research that has already been done – very specifically what came out of the UK,” he said.

Boynton acknowledged that the research he referred to was in the form of a report released in April by the Royal College of Physicians, which looked at vaping from a harm-reduction standpoint and famously asserted that “the hazard to health arising from long-term [vapor] inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco.”

Boynton said he believes the FDA knew that report was about to break.

“I think they knew that particular study was coming,” he said. “That’s why they got the broom and swept us under the umbrella of Big Tobacco – so that would make it a lot more difficult for the vaping industry and the vaping advocates to fight against the Deeming Regulations.”

Boynton rallied SCVIA members on a conference call earlier this month.

“We’re pressing forward in 2017 to make sure that the entire vape industry in South Carolina has a voice at the State House. If there is some sort of legislation put forth – that we will be aware of it on the state level, being reactive and proactive in making sure that some of those bills don’t get pushed through,” he said.

SCVIA is affiliated with the Vapor Technology Association, which lobbies at the federal level to defend the vape industry. Its website states that, “by treating vapor products like traditional combustible tobacco cigarettes, the FDA does not address the need for responsible regulation of vapor products independent of the tobacco industry. E-cigarettes constitute an entirely new technology and should be treated as such.”

Local family practitioner Dr. Victor Archambeau told The Sun News that vaping might be considered harm reduction, but not elimination.

“Nicotine is still an addictive component. There is vasoconstriction and the risk of heart and vascular complications. It is probably safer for the lungs, but there’s still a possibility of lung problems – but not as much as smoking tobacco. Also, while smoking among teens is down, they are picking up vaping,” he said.

To combat underage vaping, the FDA mandated that vape shops check photo ID of anyone under age 27 - although the legal age to vape is 18 in South Carolina.

Zuluvape’s Deverell said having this regulation in place is a good thing.

“We were self-regulated before and carded people – but now we know that the industry as a whole will follow and will do the right thing. It’s really nothing new for us at all,” she said.

Although the report from the Royal College of Physicians has painted vaping in a safer light, Coastal Carolina University associate professor of public health, Dr. Michael S. Dunn, said there is no hard evidence to suggest that e-cigarettes are a viable method for smoking cessation.

“Smokers that switch from regular cigarettes to e-cigarettes as a method of smoking cessation are eliminating exposure to the most harmful components of tobacco smoke, but there has been limited regulatory control over e-cigarettes until now. More research will be needed on e-cigarettes in order to truly understand whether these products are a better choice than regular cigarettes,” he said.

Boynton said that he quit cigarettes and chewing tobacco completely the first day he picked up an e-cigarette more than four years ago. He never turned back.

“I don’t have the hacking cough, I don’t spit up green stuff – and I honestly haven’t been as sick as I used to get when I smoked cigarettes. That’s speaking for myself and my own experience. I am sure there are many other people who are saying the same thing,” he said.