Wednesday, March 29, 2023

Finally, U.S. House of Representatives Holds FDA Tobacco Officials Accountable for Regulatory Missteps


This blog has long detailed the FDA Center for Tobacco Products’ (CTP) continuing campaign against vastly safer cigarette substitutes. 

Now House Committee on Oversight and Accountability Chairman James Comer (R-KY) has written FDA Commissioner Robert Califf demanding “documents and information regarding CTP’s activities to enable transparency and to ensure the CTP is performing required functions.”  This is a key paragraph:

“In conjunction, FDA must also clearly and accurately communicate information regarding the relative risk that products, to include ENDS [electronic nicotine delivery systems] and smokeless products, pose—and do not pose—to the adult nicotine product user population. Since 2005, the percentage of adult smokers in the United States has fallen from 20.9 percent to 12.5 percent. Nevertheless, there are still 30 million adult smokers in the United States, and nearly half a million Americans die from smoking related disease every year. This is a population that could benefit from accurate information and access to potentially safer FDA authorized products.”

FDA officials will likely deflect and assert that definitive relative risk information for ENDS and smokeless products is uncertain or inconclusive.  In fact, the relative risks for smokeless tobacco products like Swedish snus and American dip/chew products are roughly 2% of those for cigarettes, and 5% or less of those for vapor products. 

I hope Chairman Comer’s letter elicits other important information, such as why FDA officials didn’t publish clear guidelines for pre-market tobacco applications (PMTAs) prior to the deadline for PMTA submissions.  The agency perversely insisted that manufacturers of each new product first prove that it was “appropriate for protection of the public health,” without the benefit of any guidance.  That process resulted in millions of applications and gross review mismanagement by FDA staff.

The agency has until April 11 to respond to Chairman Comer’s demands.  That’s about two weeks, when some 18,400 more American smokers will die.



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