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In its announcement Thursday, the FDA said the manufacturers of the banned products “had not provided sufficient evidence” that the benefits for adult smokers, for whom vapers are a less damaging alternative to traditional tobacco, outweighed the “documented risks for young people”.
“We are committed to working as quickly as possible to move the current market for reputable new tobacco products to a market in which all products available for sale have been subjected to careful and scientifically sound scrutiny,” he said. Acting FDA Commissioner Janet Woodcock and the agency’s Center for Tobacco Products director Mitch Zeller said in a statement. “Continuing to take appropriate regulatory action to protect the public, especially young people, from the harms of tobacco products remains one of the agency’s highest priorities.”
Woodcock and Zeller also noted that the banned products included flavors such as “Apple Crumble, Dr. Cola and Cinnamon Toast Cereal”.
In numbers : The FDA has received approximately 6.5 million demands from manufacturers of electronic cigarettes, who had to demonstrate by September 9, 2020 that their products were “appropriate for the protection of public health” and would be safe for current smokers and unattractive for non-smokers. The agency said it could continue to sell these products for a year while the FDA reviews their applications.
The FDA said Thursday it had acted on about 93% of those requests, but had yet to make rulings on products from Juul, Reynolds American’s Vuse and NJoy, which control the largest shares of the Marlet.
The still pending FDA applications are in “final stages of review,” the agency said.
Background: Electronic cigarettes have grown in popularity in recent years, but have operated in a gray area without many of the rules and restrictions that the FDA applies to traditional tobacco products like cigarettes.
The agency finalized a rule in 2016 that gives it full regulatory control over tobacco products, including e-cigarettes, but its implementation has taken years. The rule requires that all companies offering products introduced before February 15, 2007 or later, including e-cigarettes, cigars, hookah, pipe tobacco, nicotine solvents and gels, apply to stay in the market.
The FDA began making decisions on e-cigarette applications this summer ahead of its Thursday deadline. In August, the agency issued a “denial of deposit” notice to a company whose application covered 4.5 million products but lacked key information. As of the September 9 deadline, it has issued 132 denial-of-market orders that covered approximately 946,000 flavored e-cigarette products.
The last product will receive FDA clearance through its pre-market review channel by Thursday’s deadline was Philip Morris International’s IQOS heated tobacco system in 2020.
And after: The FDA is working to complete its review of the remaining e-cig applications. It also complements the review of applications filed under the “substantial equivalence” standard for products such as cigars, pipes and shisha tobacco. In total, the agency has granted marketing orders for 350 of these products.
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