By Mitchell Scacchi
The Food and Drug Administration recently sent a flurry of warning letters targeting small retailers with unapproved vape products on their shelves. But the retailers — many mom-and-pop shops and locally owned convenience stores — say the problem is the FDA’s foot-dragging approach to approving legitimate e-cigarette products their customers demand.
The agency’s warning letters, sent to more than 200 retailers, referenced specific e-cigarette products that are popular with teens: Elf Bar and Esco Bars products and those under the Puff and Hyde brand labels.
“Protecting our nation’s youth from tobacco products — including disposable e-cigarettes — is a top priority for the FDA,” Commissioner Robert M. Califf said in a statement. “We’re committed to holding all players in the supply chain — not just manufacturers but also retailers and distributors — accountable to the law.”
The FDA failed to mention that the agency is part of the problem, critics say. While the FDA has disapproved countless legitimate products from U.S. vaping companies like Puff Bar and Juul, Chinese manufacturers have stepped into the U.S. market with copycat, disposable vape products.
The debate over regulating e-cigarettes in the United States has focused mainly on concerns over teen vaping. In Great Britain, the priority has been harm reduction: Getting adult smokers to shift from tobacco cigarettes to vaping and other alternatives that present far fewer health risks.
Advocates for the harm-reduction approach agree teen vaping is a concern. But they argue that the FDA’s approach has resulted in a heavy-handed regulatory regime that keeps safe e-cigarette products off the market — leaving untested mass-produced Asian products to flood in and fill the void.
Clive Bates, former director of Action on Smoking and Health U.K. and now the director of Counterfactual, identified the crux of the problem at a recent public-health roundtable hosted by InsideSources.
“The FDA had 6 million applications for new products to come onto the market, these safer products,” Bates noted. “So far, it’s rejected nearly all of them, well over 5 million, and it’s accepted seven. Just seven distinct product systems have been accepted.”
Meanwhile, unauthorized manufacturers in Asia continue to dump products into the U.S. market. “Manufactured by Chinese firm iMiracle Shenzhen, Elf Bar is part of a wave of copycat e-cigarettes that have followed a path paved by Puff Bar, a popular brand of disposable e-cigarettes that briefly racked up hundreds of millions in sales after regulators cracked down on older vaping products like Juul,” the Associated Press reported.
U.S. retailers are caught between FDA regulators keeping products off the market, customers looking for legitimate alternatives to tobacco cigarettes, and a massive black market willing to sell any product to anyone.
“What I hear from my members is just a general frustration that the FDA hasn’t done a good job in giving them guidance for what they can sell and what they can’t,” said Mark Griffin, president of the Michigan Association of Convenience Stores.
Asked about the FDA blaming the retailers, Griffin viewed it differently. “The FDA says, ‘It’s not our fault; it’s the retailers selling products they’re not supposed to.’ But what are we not supposed to be selling?” Griffin asks. “They say, ‘All retailers are unscrupulous, and we’re doing something wrong.’ We’re really not — we want to sell something that’s approved.”
Ned Bowman, executive director of the Florida Petroleum Marketers Association, expressed similar frustrations. “I think the issue with the FDA is that we haven’t gotten a list of everything that’s been approved and disapproved,” Bowman said. “We haven’t seen the information. We need to know which products are legal and which are illegal.”
And, critics say, it’s a lot easier to send letters to local retailers than to fight the flood of illicit vapes at U.S. ports of entry or to invest the time and resources to approve applications from legitimate vendors.
“All we want to sell is a legal product. We’re not interested in selling Chinese products or products out of India,” Bowman said.
Both executives expressed retailers’ willingness to cooperate with the FDA. “Send us a quarterly press release saying, ‘Here are the products we’ve approved,’ and we’ll get the word out,” Griffin said. “We’re willing to react and always willing to do the right thing.”
But because they are in the “convenience” business, Griffin said, “When customers are asking for a product, you’ll try to get it to them. Especially if there’s a lack of guidance from above.”
Bates said if the United States would follow the approach of other nations, it could be “harnessing the processes of innovation, creative destruction and market forces” to drive tobacco use down and improve health outcomes for more Americans. Instead, its priority is restricting access to vape products.
“About 480,000 people die from smoking each year,” Bates said. “Another 16 million people live in some sort of misery from smoking-related diseases. There are pronounced socioeconomic, educational and employment differences (between smokers and non-smokers), and the problems are concentrated in the poorest in society.
“So if you can do something about the problem, you can do something about health disparities as well, which is a good thing.”
Mitchell Scacchi writes about public policy for InsideSources.com.
