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The result is widespread confusion, with industry watchers predicting that many small manufacturers will likely continue to sell banned products until the FDA’s enforcement strategy becomes clearer.
With the limited enforcement capabilities of the FDA, “I guess most places would continue to sell [denied products]Said Desmond Jenson, an attorney at the Public Health Law Center at the Mitchell Hamline School of Law, which focuses on tobacco trade policy. States may step in to add another layer of regulation, but this is far from guaranteed.
“If you give [vape shops] a choice between shutting down the business and filing for bankruptcy and continuing to sell their products to adult consumers… ongoing relationship with the FDA. The agency has asked the Ohio firm to stop selling flavored products, but the company is waiting to see if it can continue to sell menthol and tobacco e-liquids.
The likelihood that many vaping stores will continue to carry banned flavors – like strawberry and watermelon – has raised doubts among industry and tobacco control advocates as to whether recent regulatory decisions by the FDA will benefit public health.
“The agency has taken a big step backwards in harm reduction,” said a senior tobacco industry official who requested anonymity because the FDA is still reviewing applications for e-cigarettes. “If there’s no one who has a flavored product that can pass, people will be less likely to change. “ cigarettes, he said. “Or the manufacturers – like the little ones – will find a workaround.”
This attitude plays into the thinking of some store owners who are considering continuing to sell their banned flavors of electronic cigarettes. “In the grand scheme of vices, [vaping] is probably worse than coffee, but better than cigarettes, ”said an Arizona vaping store owner who still carries flavored products the FDA has ordered in the market. “I never said it was healthy… I don’t think I’m doing anything ethically or morally wrong.”
The Arizona store owner, who requested anonymity for fear of retaliation from the FDA, received a warning letter from the agency in late August regarding the sale of his e-cigarette products. Warning letters are the first enforcement action the agency can take against e-cigarette manufacturers who sell products without FDA clearance.
An FDA spokesperson said the agency employs around 5,000 regulatory compliance officers, as well as subject matter experts. They work together to perform unannounced inspections on all kinds of manufacturers, some of which specialize in tobacco. The agency also partners with third-party subcontractors to perform inspections at vape shops that are manufacturers and retailers. Although unannounced physical inspections declined during the pandemic due to safety concerns for FDA officials, online surveillance and monitoring has not stopped.
The FDA can send warning letters to companies that sell banned electronic cigarette products or products that they have never submitted to the agency for marketing approval. In a July letter, the FDA asked a company to stop selling 15 million e-liquids for which it had not sought federal review. If the FDA determines that the company has continued to offer these products after receiving the letter, the agency may impose escalating financial penalties in the hundreds or thousands of dollars. Finally, he can order offenders to stop selling tobacco products altogether for a period of time.
But less than a month after the September 9 decision deadline, it’s hard to say how aggressively the agency will act to enforce the new limits on flavored vaping. So far, the agency has struggled to verify that e-cigarette companies take its application into account.
“Overall, the inspectors haven’t done much,” said Gregory Conley, lawyer and president of the American Vaping Association. But he said that could change now that so many companies have received official orders to take their products off the market.
Mitch Zeller, The FDA’s main tobacco regulator said the agency would not be able to guarantee that every affected vaping manufacturer complies with FDA rules. Instead, Zeller said in its Sept. 9 statement that the agency will focus on products the agency rejected and those for which it never received a request, followed by products the FDA considers the more likely to appeal to young people.
An FDA spokesperson declined to say whether the agency has any further plans to speed up in-person inspections of vaping manufacturers or retailers.
The owner of the Arizona vape store who received a warning letter from the FDA said he never applied for his products because they were unaffordable. “It would be incomplete and a joke,” they said. The agency then ordered the company’s products from the market because it never examined them. Technically, the store owner could apply – but they doubt any of their products will ever receive marketing authorization because they contain the kind of fruity and sweet flavors that the FDA is working to eliminate.
Arizona store owner still sells some of his products in defiance of the order of the agency. Although the store’s website says it no longer sells the products online, it does offer bracelets for $ 19.99 and stickers for $ 21.99 – substitutes for the vape products that the store owner will sell. always to customers that he knows personally. “They’re long-term customers… and the average age of my web customers is probably 50,” they said. But, they added, “I will definitely lose any potential new business.”
The Arizona store owner also plans to continue selling his vape products in person – secretly. “My wife is from Senegal, so we’re going to turn this place into an African market… everything is going to be out of sight,” said the owner. Customers who know the store owner should come in and ask for it by name.
Many small vape makers say they can’t afford to stop selling products the FDA has ordered on the market. They also see a double standard at work as the agency failed to act on the vaping demands of the biggest players in the industry.
“The simple fact is, Juul and Vuse are still for sale,” the Ohio-based e-liquid maker said, arguing that the vaping products from these big companies are the most attractive and accessible to minors. If the FDA uses its enforcement discretion for these brands, “then we should be able to continue to be sold so that we can continue to fund our studies and our science, which the FDA says we cannot,” said the Ohio maker.
Other vape store owners are looking for legal ways to bypass FDA orders. Some people are fond of the idea of using synthetic nicotine in their e-liquids instead of nicotine derived from tobacco. This is because the FDA’s Center for Tobacco Control defines tobacco products as those that contain ingredients from the plant itself. And if the vaping liquid does not contain natural nicotine, it would not be under FDA oversight.
“I’ve heard of several companies that have plans to do this,” said a Texas vape store owner. In February, Puff Bar, a leading manufacturer of electronic cigarettes, used this strategy to resume selling its flavored products online, despite receiving orders to take them off the market in 2020.
But it’s not clear whether switching to synthetic nicotine is a viable long-term strategy. A 2010 court ruling gave the FDA the power to regulate all nicotine as a drug, even when it appears in products, such as gums or patches to quit smoking. Synthetic nicotine would technically fall into this category, although the agency did not say so explicitly.
Earlier this month, several public health groups, including the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, and the American Lung Association, wrote a letter to the FDA urging the agency to regulate nicotine. synthetic as a drug to stop vaping stores. to sell it without authorization.
In the meantime, the vape shops that are shutting down product sales following recent FDA rulings plan to sue the agency. “In our association, the most important thing we hear is the desire to pursue all available remedies,” said Amanda Wheeler, president of the American Vapor Manufacturers Association.
“We are very committed to obeying the law,” said Wheeler. But she added that “there has been a definitive shift in focus that has occurred through the FDA throughout the PMTA process,” which she and her member organizations have found “concerning.” .
Jenson, the lawyer for commercial tobacco, believes the legal path forward for vaping manufacturers will not be easy. “It’s a very difficult battle,” he said. The onus would be on companies to prove that the FDA acted in an “arbitrary or capricious” manner, which is nearly impossible, he said.
Ultimately, public health experts believe the FDA will need the help of states and the public to significantly crack down on unauthorized e-cigarettes.
“Like any public health problem, there must be several mitigation strategies,” said Mary Hrywna, assistant professor at the Rutgers-School of Public Health and founding member of the Rutgers Center for Tobacco Studies. “We can’t just rely on the federal government to regulate what is a very complicated market that continues to evolve.
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