U.S. Senator Asks FDA to Release List of PMTA Filers

U.S. Senator Dick Durbin urged the U.S. Food and Drug Administration (FDA) to strongly enforce its own regulations “to protect kids from addictive e-cigarettes” by publishing a list of products that submitted premarket tobacco product applications (PMTAs). The Illinois senator wants to remove products that did not submit PMTAs from store shelves.

“After years of delayed regulatory oversight, which fueled the explosion in youth e-cigarette use, FDA finally required e-cigarette PMTAs to be submitted for review on September 9. It has now been more than one month, and the agency has yet to publish a comprehensive list of products that submitted applications,” according to a press release.

Durbin said he was concerned that the delay to publish the list of products that have submitted applications will allow products that remain out of compliance and illegally on the market to proliferate.

“In order to protect public health and uphold the duty to enforce against products on the market that are out of compliance, I urge FDA to immediately publish a comprehensive product listing of all relevant e-cigarette applications received by FDA. While I appreciate the sheer volume of applications submitted to FDA, and the agency’s intention to prioritize review of those with the greatest market share and public health impact, we know from recent years that youth shift patterns of e-cigarette use based upon what products are available to them,” Durbin wrote in a letter to FDA Commissioner Dr. Stephen Hahn.

Vapor and e-cigarette products can remain on the market while the FDA determines whether to approve or reject PMTA applications. The agency has up to one year to make these determinations.

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