As CSP went to press, official details of the U.S. Food and Drug Administration’s (FDA) final regulations for electronic cigarettes and vaping products had not yet been made public. Still, that hasn’t quelled concern from vaping advocates fearful of what the rumor mill is reporting.
Big players such as Logic and blu are holding o on commenting until a final version of what’s being called the FDA’s “deeming regulations” surface.
“We take at face value the FDA’s denial of the authenticity of the document which was supposedly ‘leaked,’ ” says blu spokesman Marc Michelsen, who deemed it inappropriate for the company to speculate.
But others aren’t holding back from offering their perspective of what deeming should include—and what it should not.
John Wiesehan III, vice president of sales for Mistic E-Cigs, Charlotte, N.C., believes the deeming regulations are likely a positive sign for large manufacturers like his, and doesn’t mind saying so. He also believes that vape shops will take a gut shot under a new, and more regulated, landscape.
“Vape shops offer a great service,” Wiesehan says. “They educate the consumer. Quite frankly, we’ve needed vape shops to bring vaping to others. They’ve advanced the knowledge base. But once customers have that knowledge, usually wherever they can get it the cheapest and quickest wins.”
That’s where Mistic and their retailers will survive and succeed, he says. Mistic’s distribution channels are diverse, but Wiesehan is particularly pleased with what the deeming regulations could do for significant convenience chains such as Speedway and Circle K. With vape shops having dominant market share, c-stores have become more niche-focused. “Retailers are doing due diligence to make sure they’re building relationships with brands that will be around. It’s a good change,” he says.
David Graham, senior vice president of global regulatory affairs for NJOY, Scottsdale, Ariz., also feels confiident in the “preparation and capability NJOY has built in anticipation of the regulations.” He says NJOY has met several times with the FDA and the White House Office of Information and Regulatory Affairs, which is currently reviewing the regulations.
Indie manufacturers and retailers are itching to talk, but they see very different outcomes in their business futures. They’re frustrated by the federal regulatory arm and scared by what might be coming down the pipeline.
Scary Days Ahead
While the major e-cig and vape companies are armed with the necessary millions of dollars in research and legal muscle, other vendors fear final federal restrictions will slash critical competition.
Gal Cohen heads scientific and regulatory affairs for San Francisco-based vape manufacturer PAX Labs. Like many, he supports some existing legislation as a necessary safeguard to ensure healthy long-term growth in the vaping segment, which, at least in the convenience channel, has stalled after several years of double-digit growth.
“The Tobacco Control Act allows for different categories of tobacco products to be regulated differently,” Cohen says. The FDA has identified a “continuum of risk” for tobacco products, meaning certain products may pose less risk than others.
This sliding scale of risk could spell good news for vaping if, as industry players predict, it falls on the low-risk end of the tobacco spectrum.
Then again, Cohen quickly adds, “It appears that the FDA has also been exploring potential restrictions to vapor product availability.”
The biggest threat in the deeming regulations is the FDA’s alleged choice of grandfather date—Feb. 15, 2007. Products on the market from that day on would be required to undergo a potentially lengthy and expensive premarket review process. And many stakeholders, PAX included, believe the date to be arbitrary and unfair.
Flavored products have also been under increased FDA scrutiny, and Cohen worries the agency may act to limit the availability of flavored products. “There is a need for better scientific evidence to understand how flavored products may help smokers displace their use of combusted tobacco products with vapor products,” he says.
If passed as proposed, these deeming regulations would create an industrywide standard for manufacturing quality, something PAX already supports. “Appropriate levels of regulation can help protect consumers from products with substandard or questionable materials or parts. It can provide guidance for the majority of manufacturers and retailers that actually want to do the right thing, and help keep any unscrupulous players off the market,” Cohen says. So no harm there.
He also doesn’t expect the regulations to force a shift in PAX’s branding, a common concern of other manufacturers. But if the 2007 date is not amended, PAX and countless other e-liquid and vape producers fear the prohibitive cost and approval time will put many of them out of business.
“The FDA has expressed interest in an ‘expedited approval pathway’ for vapor products, consistent with the FDA’s concept of the ‘continuum of risk,’ ” says Cohen. That could be PAX’s silver lining. The company would also like to see the FDA employ a post-marketing surveillance methodology to understand the effect of vapor products on the broader population, rather than asking small manufacturers to develop evidence around this in advance of product launch, “which could result in an effective ban of small manufacturers,” he says, PAX potentially being one of them.
E-Liquidity
To Cohen’s concern, vape activists are legitimately worried about what will happen to e-liquid companies, most of whom were born only in the past five to seven years. Stacey Cropper, e-commerce manager for Totally Wicked, a vape shop and e-liquid manufacturer based in Bradenton, Fla., agrees.
For Cropper, the gravest impediment to deeming is the 2007 grandfather date—a time that basically precedes the vaping industry. “We started trading in 2008 and were one of the first,” she says. “The date just makes no sense whatsoever. The compliance process will likely be very difficult ... and would affect all of the products we currently sell.”
Cropper says she’s 100% behind more transparency and regulation, but the 2007 date gives the misimpression that everything out there on the market already is poor quality.
Regarding the e-liquids Totally Wicked manufactures, Cropper says the company is beginning to take a scrupulous look at its product range. “Because of the potential cost involved, we couldn’t go through the compliance process with all of our products,” she says. “I think this will narrow the product range more than anything else.”
She believes Totally Wicked would hold up reasonably well relative to the regulations. The company childproofs its bottles and uses pharmaceutical-grade nicotine.
She’s also unsure whether Totally Wicked’s branding might have to be altered in order to comply. “Some people would say our logo is cartoonesque,” she says, “but the branding was developed in 2008 when the industry was in its infancy.” Internal debates about altering the Totally Wicked branding already are underway and changes are likely coming regardless of regulations.
Closing Shop
Maria Verven, owner and CEO of Verve PR, was formerly the owner of Vaping Vamps, an online vape retail store tailored to women. She decided not to renew Vaping Vamps’ license and instead concentrate on the public-relations business she’s been running off and on for decades. Verven sheds light on what might be coming for small vape retailers, namely, closing up shop due to increased competition with bigger distributors that have deeper pockets and closer relationships with the large-scale manufacturers who survive the FDA’s regulations.
“I just looked at the future and knew there was going to be a lot of consolidation in the industry,” she says. There are many unknowns about the effects of FDA regulations, but Verven believes they could help the industry’s big players just get bigger.
“Vape shops should be looking at this very closely,” she says. “You have to make sure that what you’re selling is compliant.”
Toward that end, Verven exhorts vape shops to pay greater attention to the manufacturing side, rather than merely accept product without certain safeguards. “The FDA could knock on your door and shut you down if you don’t,” she says. “You can’t hide under the rock of ‘I didn’t know.’ ”
The other major impact Verven predicts for retailers is the potential ban on sampling. If vaping products are pushed to behind the counter, “it’s too bad for the vape shops and customers,” she says.
“Some of the shops will now spend up to an hour with a customer helping them sample e-liquids. There’s a learning curve with the open-system products that require a bit of skill and know-how. Most vape shops are dedicated to helping people make that transition and use devices. They won’t be able to do that anymore.”
Activism for All
Whether you’re a large manufacturer, indie or vape shop, ensuring a vibrant vaping industry is most critical.
Understanding that for the FDA public health is priority No. 1, PAX’s Cohen insists innovation doesn’t have to be discouraged. “We think that innovation can be a force for good,” he says. “And regulations should reflect that opportunity.”
As CSP went to press, Smoke-Free Alternatives Trade Association (SFATA) was mobilizing vocal stakeholders in a massive “fly-in” at the beginning of February in Washington, D.C., to press Congress on the effect burdensome regulations would have on the vaping industry. Specifically, SFATA is lobbying on behalf of House measure 2058, legislation that would change the grandfather date from February 2007 to whatever date the final deeming rule is issued—a move that would breathe life to the vaping industry.
“Not giving consumers choice and variety for vapor products will only lead smokers back to smoking,” says SFATA president Cynthia Cabrera. “Scientific research has demonstrated that vapor products have helped smokers replace combustible tobacco as less harmful alternatives. … Censoring the ability to advertise vapor products to adult smokers and vapers adds yet another obstacle to help reduce the pubic harm caused by smoking.”
Cabrera insists that the vaping industry supports sensible regulations, such as prohibition of selling to minors, reasonable licensing requirements and child-resistant packaging. But wiping out an entire category of innovative products? Cabrera, like others, can’t see the good in that.
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.