SILVER SPRING, Md. — More than two months after premarket tobacco product applications (PMTAs) were due to the U.S. Food and Drug Administration (FDA), the agency is still sifting through the applications and working on a public list of which companies have submitted applications.
The FDA’s Center for Tobacco Products Director Mitch Zeller told CSP Daily News the FDA remains committed to releasing a public list of the new tobacco products deemed to be subject to a an FDA review, were on the market as of Aug. 8, 2016, and for which a premarket application was submitted by Sept. 9. The list will help convenience-store retailers know which tobacco products to keep on their shelves.
First, though, the FDA must sort through thousands of applications which came in all different forms, including CDs, DVDs, hard drives and some hard copies, Zeller said. And within those applications, some companies are seeking authorization of thousands of products. The FDA will also need to ensure the publishing of any information complies with federal disclosure laws and regulations.
The result is an “extremely labor-intensive manual exercise of unpacking every single application,” Zeller said. “But we have lots of people working on this, and we absolutely intend to provide such list.”
Zeller would not say exactly how many applications the FDA received to date, only noting it is in the thousands, and would not say when he expects the list to be made public.
There are several ways the agency is prioritizing which applications to process first, Zeller said.
“One of our goals is to transform the marketplace for these unauthorized products into a regulated marketplace,” Zeller said, noting in particular that e-cigarettes are among the unauthorized products until they've gone through the application process. “And the principle that we came up with is to devote a certain percentage of the reviewing resources to those products that have, or are having, the greatest impact on public health, either positive or negative, simply by virtue of share of market.”
The other aspect Zeller said the FDA is considering is fairness, giving priority to companies that submitted applications on time, regardless of that company’s size or market share. The FDA is also prioritizing e-cigarettes and electronic nicotine delivery systems (ENDS).
One question retailers and manufacturers have raised is if a company turned in its application by Sept. 9 and the FDA requests more information, will those products be legal to sell until Sept. 9, 2021, or at some point when the FDA might issue a negative action against the company?
The answer is the latter, Zeller said. If there is something deficient in an application, the FDA will point that out to the company—and Zeller expects that to happen a lot. The companies will then have time to respond, and the product can remain on the market until the FDA takes final action.
“Simply getting a deficiency letter, simply knowing that there are issues and things that need to be addressed, does not mean the end of enforcement discretion. That's part of the review process. We want to give the companies a shot at responding to our questions. And the product in question gets to remain on the market, as long as that 12-month period hasn't expired," Zeller said.
There is a chance companies can have longer than Sept. 9, 2021, to legally sell products even if the FDA hasn’t made a decision on their application.
Companies facing challenges with COVID-19 or natural disasters can explain why they weren’t able to give the FDA certain information on time and give the FDA a plan to get them that information. If a review is sufficiently far along, the FDA on a case-by-case basis can decide to extend enforcement discretion for those products beyond that date, Zeller said.
Click here for more information about the PMTA process.
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