FDA FDA rejects dozens of Substantial Equivalence (SE) reports in May

[Bill Godshall]

FDA reports that, in May, FDA issued 11 Not Substantially Equivalent (NSE) orders, FDA issued 1 Refuse-to-Accept letter for SE, and that companies withdrew 29 SE reports from the review process (that were likely due to FDA intimidation)

Tobacco Product Marketing Orders

This Week in CTP – June 12, 2015

 

[Firestorm]

It looks like 10 of the 11 NSE orders are from Eagle River Importers Inc. it seems that they specialize in combustibles. Here's an NSE letter from the FDA to Eagle River Importers that lists one of their products as a roll-your-own tobacco product:

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM449459.pdf

 

[DC2]

Substantial Equivalence attempts continue to be EXTREMELY hard to pursue.

Or should I say nearly impossible.
Not to mention expensive.

But most of us that frequent this subforum should already knew that.

 

[twgbonehead]

OK, but the real story is how many they approved, and how many are still outstanding.


Bueller?........Bueller?

No doubt they're cherry-picking ones they can find an excuse to dismiss. Wow, they actually managed to process 12 of them, and 3 times that many companies decided it just wasn't worth it???????

Would be interesting to see the times when these rejected applications were submitted (vs. the times when un-acted submissions were processed). I would ask them what is the criteria for consideration; if it's not "First file, first served" then what is it, who makes the decision, and what is the basis for that decision?

 

[DC2]

I believe how many they have approved could be counted on one or both hands.
I don't have any links to back that up, just from what I remember reading over the years.

 

[twgbonehead]

I believe how many they have approved could be counted on one or both hands.
I don't have any links to back that up, just from what I remember reading over the years.

Actually I believe the number they have approved could be counted on my arms, with room for 2 more.

(Figured that was a bit more appropriate than the first thought that came to mind..... Yeah, my nose, that was it!)

 

[DC2]

Actually I believe the number they have approved could be counted on my arms, with room for 2 more.

Perhaps counted on my excretory orifices would...
Oh, never mind.

 

[Firestorm]

Given the addition in the recent US House Appropriations Committee bill that would prohibit the FDA from enforcing the February 15, 2007 grandfather date for newly deemed tobacco products (US House Appropriations Cmte bill would prevent FDA from banning e-cigs now on the market | E-Cigarette Forum), it probably makes sense for companies to withdraw any substantial equivalence submissions that haven't yet been reviewed (despite the time and effort that was used to compile them).

I'm not sure what it would mean if the FDA determined that a submission is not substantially equivalent and instructed a company to immediately stop all distribution,
importation, sale, marketing, and promotion of a product in the United States if the grandfather date is later pushed back and no submission would have been required in the first place. Regardless, I imagine that it would take more money and lawyering to figure it out.

 

[caramel]

Oh, never mind.

Indeed....