I own Mapes Vapes in Soldotna, and am writing to express my frustrations with the Food and Drug Administration (FDA), which has been unwilling to budge on the predicate date for the filing date on new or modified vapor products. This is an issue that threatens to put me out of business and significantly limit the choices available to my customers.
The predicate date relates to vaping products the FDA will approve for sale. The problem is that the cut-off date they are trying to mandate is February 15, 2007. This means that any product that has come out since then — which is most of them — will have to be proven to have extensive similarities to pre-2007 products or face the FDA’s lengthy and costly approval process. Changes as small as changing the flavor could cost manufacturers immense amounts of time and money to get approval for products they have been making for nearly a decade. And that’s not even taking into consideration the FDA’s current backlog of applications. Having every vaping manufacturer flooding the FDA with new applications will only further stretch the FDA’s resources.
An amendment has been proposed to fix this problem in the Senate, but it will still need the support of our delegation in D.C. Hopefully they will act to protect your access to healthier tobacco alternatives, as well as my business with this reasonable solution.