ATR Leads Coalition Urging PMTA Enforcement Extension

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Posted by Karl Abramson on Thursday, July 1st, 2021, 1:44 PM PERMALINK

Americans for Tax Reform today led a coalition of 23 organizations urging the Food & Drug Administration (FDA) to follow the common-sense recommendations of the Small Business Administration and seek a court order to allow vaping manufacturers to keep products on the market while their Pre Market Tobacco Authorizations (PMTA) reviews are in progress.  The FDA has acknowledged it is unlikely to complete all authorizations by the September 9 deadline, meaning thousands of businesses, who did the right thing, and completed all legal requirements, would be prohibited from selling their life-saving products merely due to FDA delays in processing their application. 

The letter acknowledged that FDA has promised to exercise discretion in enforcement, but asserted that, “This does not provide the degree of certainty necessary for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by FDA. If an extension is not granted, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality.” 

The letter continued, “There is no final rule in place governing the PMTA process and therefore it is possible that a significant number of products may be removed from the market following the deadline. Millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty. The only sure way to avert a disastrous outcome is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year.” 

The vaping industry,” the letter notes, “unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market. Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.” 

The letter concluded by drawing attention to the science on vaping, which shows e-cigarettes to be 95% safer than combustible cigarettes and two to four times as effective at helping smokers quit than traditional nicotine replacement therapies. With the potential to save 6.6 million American lives, according to an analysis from Georgetown University Medical Center, and reduce socioeconomic disparities in healthcare, adult access to vaping must be preserved.  

The full letter and list of signatories can be read here

Photo Credit: ABC News

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