Confusion overshadows FDA’s approach to e-cigarettes

E-cigarette makers and anti-vaping groups are similarly confused by previous agency courses. While the industry is looking for a clear step forward, public health groups claim that FDA actions have not helped reduce the appeal of vaping to teens. The agency simply states that it will “quickly” review the rest of the Ark marketing application. And it faces a potential wildcard from the legal challenges posed by pros and cons steaming camps.

“I think we’re facing the challenge of applying new regulations to existing industries,” said Scott Gottlieb, a former FDA commissioner who focused most of his tenure on tobacco control. “I’m going to get the right end result … this is just a challenge.”

Another former agency has expressed confusion about the FDA’s approach. “I don’t know exactly what’s going on here,” said a former senior official at the FDA’s Tobacco Products Center.

An official spokesperson said the FDA had decided “more than 98 percent” of all new tobacco product applications received by the September 9 deadline.

“The FDA promises to complete the review of the remaining applications as soon as possible to provide regulatory certainty and keeps the public informed of our progress,” said a spokesman. rice field. “The FDA is reviewing many different applications at the same time and will continue to publish marketing decisions once the application reviews are complete.”

The FDA’s regulation of the e-cigarette market has long been awaited. In 2016, authorities finalized a rule requiring tobacco product manufacturers to submit a Pre-Market Tobacco Application (PMTA) for products introduced after February 2007. In many cases, companies had to seek permission to continue selling their existing products.

The judge later filed by September 2020, after the anti-tobacco group appealed to speed up the regulatory process, and ordered the FDA to make a decision by September 2021. However, the agency finalized the PMTA rules for e-cigarettes this month, weeks after the mandated deadline for deciding to submit a company.

The new rules will come into effect in early November. They demand that businesses prove that the likely benefits of their products for adult smokers outweigh the risks of seducing teens, children, or other nonsmokers to smoke e-cigarettes. doing. This is similar to the standard previously set by the FDA. When announcing the final rule, the FDA stated that not all pending applications would be bound by the new standards.

To date, the agency has only approved one arc and two tobacco-flavored cartridges from Vuse, a brand owned by tobacco company RJ Reynolds. After the FDA announced its decision on Tuesday, some public health experts questioned whether the item met the authorities’ approval criteria. In particular, it contains levels of nicotine comparable to some of the historically popular Juul and disposable e-cigarette products. teenager.

In addition, according to a federal survey released last month, more than 10% of high school students who vape cite Vuse as their go-to brand.

“I’m deeply concerned that the FDA seems to have little concern about the potential for abuse. [of these products]Matthew Myers, president of the campaign for non-smokers, sued the FDA in 2018 for not requiring e-cigarette makers to submit PMTAs in a timely manner.

“The only way for Vuse [products] If smokers switch from smoking completely or almost completely to using Vuse e-cigarettes instead, it can be used to mitigate the health hazards associated with tobacco, “said a former employee of the FDA’s Tobacco Products Center. Now Georgetown University Law Center wrote to POLITICO by email. “Other uses increase the harm and risk to the user’s health.”

In the meantime, companies that receive notification of marketing refusal orders or incomplete applications may choose to reapply under the new rules. And nearly 12 companies have appealed the FDA’s refusal to market their products.

“It’s all in the air,” said Gregory Conley, chairman of the Vaping Association in the United States. “The FDA has not issued a new one [marketing denial orders] After closing the tobacco-derived nicotine e-cigarette business in the United States non-stop for a month since September 23. And it all stopped. “

The agency overturned a refusal last week issued to TurningPoint Brands, the first company to appeal the vaping decision on hundreds of e-cigarette products. The FDA said it revealed “related information that was not properly evaluated” in its application. This includes randomized controlled trials comparing tobacco-flavored and fruit-flavored ones, and how smokers, steam smokers, and nonsmokers perceive or use the product. Includes research.

These additional data deserve further review by the FDA, officials said the FDA has returned hundreds of Turning Point Brands arcs to the review process. The agency will not punish the company for continuing to sell the product without a sales order during the reexamination.

“They didn’t seem to review any particular part of the application,” said a former CTP official. “When I was at the FDA, we had to do a complete review of everything and respond to everything the company submitted. We had to look at the entire application, even if it had a fatal flaw. To be honest, it felt like a waste of resources. ”

Since then, reviews of cigarette products have taken years, including several round trips to cigarette makers, officials said.

“The FDA doesn’t seem to be doing that anymore,” officials added. “They seem to make the decision after feeding the company a bite of apples,” a source suggested. This is the result of the agency’s one-year deadline for providing decisions on all applications.

Companies are also uncertain whether their menthol products will remain on the market. The Biden administration said the FDA would propose a policy to ban menthol-flavored cigarettes next year.

Meanwhile, the agency told e-cigarette makers that their menthol products would receive “unique considerations,” which means it would take longer to review.Public health group has filed unresolved proceedings against FDA In Northern California over not regulating menthol tobacco.

“More than half of our members have been denied menthol and tobacco applications by the FDA,” said Amanda Wheeler, president of the American Steam Manufacturers Association. “The most generous interpretation is that the FDA made a radical error in denying these products.”

Public health experts want to prevent menthol-loving vape users from switching to cigarettes when menthol vape is removed from the shelves.

The FDA says, “If you ban menthol cigarettes so that menthol smokers don’t go to non-menthol cigarettes, do you need menthol electronic cigarettes on the market?” I think that’s a big problem with the FDA, “says Lindblom.

Regardless of why the FDA rejected Ark, menthol, etc., outsiders are afraid that more companies will continue to appeal to the FDA’s marketing refusal order to continue selling their products.

“If their products are allowed to stay on the market, they want to pull this out for as long as possible,” said a former senior official.

That concept Offend anti-youth vaping supporters. “If these proceedings delay the implementation of FDA orders, it will be a classic example of how businesses have weakened and distorted regulations designed to protect Americans,” Myers said. I did.

However, he admitted that the agency was in a difficult situation. “I don’t think it’s as chaotic as it looks,” Myers said. “In reality, most of the rejected products were flavored products that appealed to children who didn’t have reliable science.”

Myers added that it makes sense for agencies to take time to review applications from large companies, especially in the face of appeals and litigation from other companies. However, he is still dissatisfied with the uncertain pace of the FDA’s decision on large corporate applications and menthol vaping, and behind schedule.

Gottlieb, a long-time advocate of public health restrictions on tobacco products, said this was partly due to the difficulties the FDA faces in curbing the thriving vapor-breathing industry.

“CTP is doing a very good job, systematically walking through the various steps needed to play a tape to put in place a proper regulatory framework.” Things move faster. I think there are many people who want to see it. “

Confusion overshadows FDA’s approach to e-cigarettes

Source link Confusion overshadows FDA’s approach to e-cigarettes

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