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The FDA Fined Four Firms For Selling Unauthorized Vapes And Granted MRTP For Copenhagen Snuff

This unprecedented move by the FDA’s Center for Tobacco Products, comes after the CTP has been criticized for allegedly standing by as vape and tobacco companies ignore its regulations.

Diane Caruana

April 19, 2023

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An MRTP authorization means that manufacturers can claim that anyone switching to the product from smoking greatly reduces their risk for lung cancer.

Two of the fined companies which the US Food and Drug Administration (FDA) fined, VapEscape and Great American Vapes, were listed in an investigation looking into which vape companies were ignoring the agency’s regulatory requirements. The investigation had revealed that more than half of the 120 companies that the FDA had already warned, were still selling illicit products.

Meanwhile, it has been observed that the FDA has a pattern of rejecting PMTAs for vaping products manufactured by small businesses selling solely the safer alternatives, and authorizing more heated tobacco products produced by tobacco companies, even if the latter are proven to be less safe than the former.

On January 26th, the FDA authorized three heated tobacco products manufactured by Philip Morris International (PMI). The agency issued marketing granted orders (MGOs) for three tobacco-flavored heat sticks—Marlboro Sienna, Marlboro Bronze and Marlboro Amber, all of which can be used with PMI’s IQOS device.

In 2019, the FDA had granted PMTAs for IQOS and several Marlboro HeatSticks, meaning that PMI would have demonstrated that these products would be “appropriate for the protection of public health.” Meanwhile a number of studies have indicated that while safer than cigarettes, heated tobacco products are not as safe as vapes. Yet the latter keep getting the rejected by the thousands. Filter had highlighted that such moves keep indicating that the PMTA process seems biased in favor of “well-financed manufacturers, mainly with ties to the tobacco industry.”

Snuff granted reduced risk label

Last month, the US Food and Drug Administration (FDA) authorized that U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff, may be marketed as a modified risk tobacco product (MRTP). An MRTP authorization means that manufacturers can claim that anyone switching to the product from smoking greatly reduces their risk for lung cancer.

The MRTP authorization, does not allow the company to make any other reduced risk claims, besides the lung cancer risk. It also does not mean that the product is in any way endorsed or approved by the FDA, and/or that the company can make any such claims.