Reynolds recalls 2.6 million Vuse Vibe power units

[5150sick]

http://www.journalnow.com/business/...cle_53d24090-3c08-5fa8-a67d-30550a862a81.html

"The company is investigating the cause of the incidents with the intent to return to the market after the issue has been resolved. It is offering a refund to consumers."

I'll just copy/paste my comment from the article:


Too bad that under the FDA's draconian "deeming" regulations " intent to return to the market after the issue has been resolved" will cause this to become a "new tobacco product" all over again.

This means that even if the device is Aug 2016 compliant it will not be after they fix the problem.

So by FIXING an issue FDA causes you to fill out another $1,000,000 "new tobacco product" application to which the FDA can just say "sorry, this product isn't substantially equivalent to your older model. You can not sell it in the USA any more"
FDA also gets to keep all that money even if (and when) they deny the application. - 5150

 

[Rossum]

Somehow I wonder whether we're getting the whole story here. Are 10 complains, ostensibly with no reports of injury, really enough to recall 2.6 million "power units"?

FDA also gets to keep all that money even if (and when) they deny the application.

I'm afraid I need to get pedantic here. The FDA does not collect the six or seven figure amount that's commonly cited as the cost of submitting a PMTA. That's the estimated cost of preparing a PMTA that the FDA might consider acceptable, but it is not a filing fee, and thus the FDA does not "keep the money" if/when they deny the PMTA. Whoever was paid to help prepare the PMTA gets to keep the money, whether that is an outside consultancy or in-house employees.