FDA side vs. SE

[TropicalBob]

Interesting response interpreting FDA vs. SE:

FDA Law Blog: FDA Explains the Import Alert Process in Electronic Cigarette Company Suit

 

[RatInDaHat]

good read. I wonder if the zero nicotine use of the e-cigs would hold any ground at all.

 

[Vicks Vap-oh-Yeah]

SE submits that Congress has clearly indicated that FDA does not have the authority to regulate the non-therapeutic use of nicotine or its delivery systems.

This is what it will come down to, I think...and SE would be right in that assumption. Non-therapeutic use of nicotine (read recreational) is NOT under the thumb of the FDA, because this usage has been traditionally associated with tobacco, under the jurisdiction of ATF. IF this is the spirit and letter of the law, as written, I think they have their case.

They will have to remove all wording of health claims to placate the FDA, but the FDA can claim this is why they got involved to save face. After all, the demand they gave GM is to "remove the claims from your packaging OR submit a new drug application."

So, as I've said before many times......if you are using any "healthy" sounding words, KNOCK IT OFF!!!!

 

[Elendil]

It appears that the FDA is using potential for addiction as the litmus test for issuing the "alert". Boy, there should be an alert for many items then...........

 

[westcoast2]

Even if the FDA has classified the e-cig correctly, did they violate the Administrative Procedure Act by issuing an Import Alert that left no enforcement discretion?

SE also argues that the inclusion of electronic cigarettes on Import Alert 66-41 is tantamount to a substantive rule, which required FDA to first use notice and comment rulemaking

Bellarno held that FDA violated the Administrative Procedure Act by issuing an Import Alert that left no enforcement discretion

In its opposition brief, FDA distinguishes Import Alert 66-41 from the Import Alert at issue in Bellarno, asserting that the language used in Import Alert 66-41 permits districts to use their discretion when determining whether a product subject to the alert should be detained

The concept of district discretion contradicts FDA’s stated reasons for the creation of the Import Alert system

The FDA created the alert system to remove discretion. The wording of the Alert is irelevant since its mere issuance is designed to remove discretion.

If seems the FDA is hoist by their own petard.

 

[harmony gardens]

This is what it will come down to, I think...and SE would be right in that assumption. Non-therapeutic use of nicotine (read recreational) is NOT under the thumb of the FDA, because this usage has been traditionally associated with tobacco, under the jurisdiction of ATF. IF this is the spirit and letter of the law, as written, I think they have their case.

They will have to remove all wording of health claims to placate the FDA, but the FDA can claim this is why they got involved to save face. After all, the demand they gave GM is to "remove the claims from your packaging OR submit a new drug application."

So, as I've said before many times......if you are using any "healthy" sounding words, KNOCK IT OFF!!!!

Readers Digest has a joke section that's labeled "Laughter is the Best Medicine". OMG,,, Readers Digest is then peddling jokes as a drug.

 

[MaxxVapor]

I knew the word "healthier" would be a topic for the FDA.

My juice order was siezed 2 months ago and while mitigating the release it came down to if the agent could use her discretion to release the order. 48 hours later she said the FDA took away her discretion and that my shipment would be returned or destroyed.

The process took a month for the decision and then two weeks to get the decision letter.

What they are saying about giving discretion does not jive with my personal experience.

 

[Krakkan]

Thanks TB for posting

 

[Cancer]

The words Alert and FDA seem to mean anything but discretion. Yet, we all must remeber that this judge is one of the most free thinking of his elk. This means i believe, that if he can find a way to rule in our favor...he will. We should have his opinion and ruling by Friday.