SE, NJoy vs FDA -- Discussion
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Yup. At least for now. If the FDA decides not to appeal to the Supreme Court (or if the Supreme Court refuses to grant cert), then the next battleground will be over what constitutes "therapeutic" claims/intent . . . and, of course, proposed regulations for e-cigs.
We're not out of the woods yet, but in my opinion, this is very significant.
(I should also mention that e-cigs that are mislabeled are still subject to seizure. Anyone who has received an order from China marked as "music box" will know what I'm talking about.
)Yup. At least for now. <snip> ...We're not out of the woods yet, but in my opinion, this is very significant.
(I should also mention that e-cigs that are mislabeled are still subject to seizure. Anyone who has received an order from China marked as "music box" will know what I'm talking about.
YES! and TYJ Big Time for that good news!
For those not reading the actual documents, here's a quote from the third PDF:
"When the D.C. Circuit denied the government’s petitions for rehearing on January 24, 2011, FDA
reissued its directive that e-cigarettes should not be detained or refused unless they are
accompanied by labeling that makes therapeutic claims, including electronic cigarettes imported
specifically by Sottera, Inc. d/b/a njoy."
This is very good news Julie, thank you!
This will be interesting times coming, and hopefully everything will pan out.
This will be interesting times coming, and hopefully everything will pan out.
Yup. At least for now. If the FDA decides not to appeal to the Supreme Court (or if the Supreme Court refuses to grant cert), then the next battleground will be over what constitutes "therapeutic" claims/intent . . . and, of course, proposed regulations for e-cigs.
We're not out of the woods yet, but in my opinion, this is very significant.
(I should also mention that e-cigs that are mislabeled are still subject to seizure. Anyone who has received an order from China marked as "music box" will know what I'm talking about.
I just checked the FDA Import Alert 66-41 (Import Alert 66-41) and noted that there are still 48 mentions of electronic cigarette. However, each of these mentions another product name which is, I assume, wording the shipper had used regarding the contents of the package. Here are some examples:
Desonic Industrial
Date Published : 09/30/2009
11 Bl Shiao 2nd In , Shenzhen, CHINA
66 B - - 44 Nicotine Delivery System
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
66 B - - 99 Stimulant N.E.C.
Date Published: 09/30/2009
Desc:Electronic Cigarettes and Electronic Cigarette Components
Notes:4/6/09
77 E - - PN Pump, Nebulizer, Manual
Date Published: 09/30/2009
So it would appear that the manufacturers need to be warned that they should not be mis-labeling their products with wording that sounds like an existing type of medical device (e.g., nebulizer, nicotine delivery system.)
So what? After yesterday's news, who cares?Nothing new on the docket today.
Thank you Julie!
Still happy over yesterdays news so I can handle a no-news day.
TY Julie
And a TY for your computer.
TY Julie
And a TY for your computer.
I missed checking the thread yesterday, wow that's some good news!! Thank you Julie and everyone
I’m just wondering…
Would the FDA be in contempt of court if it seized a non-therapeutic, correctly labeled ecig importation tomorrow?
If not, pretending to lift the alert is a great way to catch more ecig shipments.
Would the FDA be in contempt of court if it seized a non-therapeutic, correctly labeled ecig importation tomorrow?
If not, pretending to lift the alert is a great way to catch more ecig shipments.
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