FDA Establishes Four Performance Measures to expedite tobacco application/review process

[Bill Godshall]

FDA Establishes Four Performance Measures to expedite tobacco application/review process after agency failed to act on vast majority of applications submitted since 2011.
Establishing Four Performance Measures?

Some interesting things

As of March 31, 2014, FDA has received 61 Exemption from SE Requests, to which 36 Refusal to Accept letters were issued as manufacturers did not meet the requirements for such exemption. FDA has also begun review of provisional SE Reports and issued the first decisions on these reports on February 21, 2014.

Seems like instead of reviewing most Exemption from SE Requests, FDA is now refusing to accept most of the requests.

Of the seven MRTP Applications received as of December 31, 2013, FDA refused to file/accept for a substantive review six of the seven applications because they failed to include information required under the TCA and/or were about products that CTP does not currently regulate; the seventh was withdrawn by the manufacturer.

FDA has refused to accept 6 of the 7 submitted MRTP applications, and the seventh was withdrawn by the manufacturer (which probably occurred after the FDA demanded a truck load of additional documents that the manufacturer either didn't have, or would have cost another several million dollars to develop). If this continues, FDA may get around to approving a MRTP application by 2025.

Additionally, last month the FDA announced that it refused to file (i.e. accept) four Premarket tobacco Applications (thus keeping the products banned), which may be the only Premarket tobacco Applications that were submitted to the agency so far.
http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM389515.pdf


Since the FDA deeming regulation already bans all e-cigs, and since FDA is now refusing to accept many tobacco product applications and reports, perhaps the e-cig companies that have endorsed the FDA regulation of e-cigs can explain how their products are going to remain on the market after FDA imposes the deeming regulation and other regualations for e-cigs.

 

[Jman8]

It would seem this would (rather easily) establish a black market, which I'm thinking FDA would not wish to be seen as the cause of.

Either FDA finds a way to streamline the process of application review, or a black market would ensue, and I'm fairly certain FSCPTA speaks squarely to that issue (as in not allowing government to be the cause).

 

[Bill Godshall]

Except the FDA already knowingly and intentionally created a huge black market for e-cigs in 2009 (after I repeatedly pleaded with the agency to not do) and US Customs Agents seized nearly a thousand e-cig shipments from US Ports. And of course, at the time, the FDA claimed it was just regulating e-cigs to protect the children and public health.

About $25 million e-cigs were sold in 2008. After FDA banned e-cigs, about $50 million were sold in 2009, about $100 million were sold in 2010. So FDA's previous attempt to ban e-cigs sharply increased black market sales of e-cigs (and shifted most sales to the Internet because most brick and mortar stores would allow them to be sold as long as they were banned by FDA).

 

[Kent C]

It would seem this would (rather easily) establish a black market, which I'm thinking FDA would not wish to be seen as the cause of.

Really hasn't stopped them before - many drugs available in Canada and Mexico but not US.... I doubt if it even crosses any mind in the FDA. Gov't types never think of 'unintended consequences'/externalities of their actions, but think of and make up fake unintended consequences of stuff they're wanting to ban, tax or regulate.