Is the FDA Prepared for a Deeming Wave?
Agency anticipating just 25 e-cigarette product applications
CHICAGO -- Talk about good timing: while the 2014 NATO Show missed the U.S. Food and Drug Administration’s (FDA) long-awaited proposed deeming regulations announcement by mere weeks, CSP’s Tobacco Category Review Meeting took place just days before the deadline to submit public comments on the proposal. It gave advocates like NATO executive Thomas Briant the opportunity to make one more push on why it’s so important for our industry to speak out. (For details on how to submit comments to the FDA, click here)
Although at first glance the proposed regulations on cigars, pipe tobacco, hookah, electronic cigarettes and other nicotine alternatives seem rather retailer-friendly—lacking the flavor or self-service bans many had anticipated—Briant outlined many areas of concern during his legislative and regulatory general session.
Perhaps most glaring concern Briant covered was the fact that, if the proposed deeming regulations are enacted as-is, manufacturers will have to submit a premarket tobacco application (PMTA) to the FDA for every cigar, pipe tobacco, electronic cigarette or vaping product that was not on the market as of Feb. 15, 2007.
“The PMTA process allows the FDA to authorize the introduction of products into the market where appropriate for the protection of the public health and prevent introduction of products that are detrimental to the public health,” Briant said. “However, a PMTA requires an application be submitted for each new tobacco product that did not exist prior to Feb. 15, 2007.”
In other words, it applies to every electronic cigarette or vaping product currently on the market, which could spell trouble for any electronic cigarette company that’s not part of Big Tobacco.
The FDA estimates that an application will take roughly 5,000 man hours to complete and may require companies conduct studies, clinical trials and testing for harmful constituents. And that’s just for one application. In theory, manufacturers will need to submit applications not just for different products (for example, disposables verses rechargeable), but different flavors as well.
“(This) may result in newer products being removed from the market if a manufacturer is unable to afford the time and cost of compiling PMTAs,” Briant cautioned.
Even more troubling is whether the FDA is actually prepared to review the applications that do make it through. When the agency released the proposed deeming regulations, it estimated just 27 PMTAs will be filed: one cigar, one pipe tobacco and 25 electronic cigarette applications.
“I find these estimates very hard to believe,” said Briant. “There have been more than just one new cigar introduced in the marketplace after Feb. 15, 2007, more than one pipe tobacco brand, and certainly more than 25 brands of e-cigarettes.”
These lowball estimates are more than a little concerning given the FDA’s current track record with the significantly less complex substantial equivalent (SE) applications. Of more than 4,000 SE applications filed with the FDA, the agency has approved 17 and denied 17, leaving 4,177 SE applications still pending. This despite the fact that the Government Accountability Office (GAO) has twice issued reports instructing the FDA to speed up its SE review process.
One potential solution would be to push back the Feb. 15, 2007, deadline for substantial equivalency to a later date.
“In the comments being filed by NATO and other industry members, we are urging the FDA to more recent date than Feb. 15, 2007, so that such products as e-cigarettes would not need to have a PMTA submitted.”
After all, at least the FDA has ruled on 34 SE applications. And in the meantime, substantial equivalence is significantly less expensive and time consuming for manufacturers, meaning some of the smaller, more profit-friendly players could hope to stay in business.