PMTAs and new tobacco products

On Sept. 9, a new law went into effect requiring all companies to file premarket tobacco applications. This rule applies to tobacco products such as cigarettes, cigars and snuff as well as vaporizers and vape cartridges. As of Sept. 10, any product that doesn’t have a PMTA must be removed from store shelves.

The PMTA process is relatively straightforward, but it also presents challenges. For example, the FDA hasn’t yet released a list of products that are no longer available. As a result, convenience store and gas station owners must reach out to their suppliers, wholesalers and distributors.

On Aug. 31, the FDA announced that it would release a list of all the tobacco products and electronic cigarettes currently available. In addition, the agency announced that it had only received applications for about 2,000 electronic cigarettes and newly regulated tobacco products. That’s a pretty significant number, but it’s only a small fraction of the more than four million products that would need to apply in order to remain on store shelves.

A comprehensive list from the FDA will certainly assist convenience store owners, but there’s still not an official date for when the list will be made available.

In a recent letter to the FDA, the National Association of Convenience Stores highlighted the importance of an official list: “The PMTA list will be critical to support compliance across the tobacco trade channel, helping inform distributors, wholesalers, and retailers which ENDS products are being marketed legally in accordance with FDA’s compliance policy. Relatedly, such a list also would facilitate enforcement against those manufacturers that continue to introduce illegally marketed products without premarket authorization or, in the case of deemed, currently marketed products, without a PMTA submitted by the deadline.”

Once an application is submitted, the FDA has a full year to review and approve the PMTA.

To learn more about the PTMA program and submission process, click here. In the meantime, make sure to do your research. Continuing to carry products that haven’t received PTMA approval could put you at risk of fines or penalties. In an already challenging economy, that’s the last thing you want.