NACS sent a letter to the U.S. Food and Drug Administration on October 14 to provide comments on the proposed rule regarding the requirement of submission tracking numbers (STNs) for the import of electronic nicotine delivery systems (ENDS) (the Proposed Rule).

The letter states that requiring STNs is an important and necessary step toward ensuring that illicit products do not reach the U.S. market and that NACS appreciates the Food and Drug Administration (FDA) taking this important step. Given the scope of the problems of illicit products coming into the United States, NACS recommends that the proposed rule be expanded to cover additional products and that additional actions be taken to stem the tide of these illicit products.

The letter reads in part:

The Proposed Rule would require importers of ENDS products to provide STNs which would allow Customs and Border Protection in conjunction with FDA to ensure that the manufacturers of those products have followed the rules requiring timely submission of premarket approval applications (PMTAs) for their products. Large numbers of ENDS products are flowing into the country today even though manufacturers of many of those products have not followed FDA’s rules requiring timely applications.

The Proposed Rule, however, does not address the risk of other deemed products entering the market (such as, but not limited to, nicotine pouches) that are not in compliance with FDA rules. FDA should do what it can to preempt this risk. The history of deemed products shows that many manufacturers are willing to take advantage of any loopholes they can find in the relevant regulatory and enforcement regime. Doing so has proved lucrative for those businesses. It would be far easier and less costly for FDA to act before such risks manifest themselves in large numbers rather than waiting for an illicit market to develop which may prove difficult to unravel.

Read the full text of the letter here.