Just got this from the FDA

[daisyd]

Well, since addiction is now considered a disease, I suppose you could extend that to nicotine addiction, but then you'd have to include caffine too. Pretty soon they'll have us living a temple worthy Mormon lifestyle. (NOTHING is wrong with that, it's just not MY lifestyle. )

 

[yvilla]

This is the regulation that I pointed out back when the FDA sent letters to the five electronic cigarette and/or liquid sellers and the (then already defunct) ECA - the one that deems any product that claims to help stop or reduce smoking to be a "smoking deterrent drug product", which thus according to the FDA requires an approved new drug application before it can be sold:

TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 310 - NEW DRUGS

subpart e - REQUIREMENTS FOR SPECIFIC NEW DRUGS OR devices

310.544 - Drug products containing active ingredients offered over - the - counter (OTC) for use as a smoking deterrent.

(a) Any product that bears labeling claims that it helps stop or reduce the cigarette urge, helps break the cigarette habit, helps stop or reduce smoking, or similar claims is a smoking deterrent drug product.

21 CFR 310.544 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent. - Code of Federal Regulations - Title 21: Food and Drugs - Subpart E: Requirements for specific new drugs or devices - vLex

This helps to explain the FDA's rigidly held position that e-cigs were an unapproved new "drug product" (at least until Judge Leon and the DC Circuit Court of Appeals disabused them of that notion ).

 

[Demarko]

This helps to explain the FDA's rigidly held position that e-cigs were an unapproved new "drug product" (at least until Judge Leon and the DC Circuit Court of Appeals disabused them of that notion ).

Yeah. "It walks like a duck, quacks like a duck, it must be a Kangaroo!"

 

[Vocalek]

Thanks! I tried searching for it, but came up empty-handed. You rock!

 

[Izatech]

Thank You, Vocalek, Justjulie and Yvilla. Unless I am reading the documents posted by Justjulie completely wrong, it would appear there will be no FDA intervention in the import of ecigs so long as they make no therapeutic claims. It appears to me that the FDA will need to decide if they will take the matter to a Higher Court. They will be required to remain hands off until that happens.

 

[Traver]

Thank You, Vocalek, Justjulie and Yvilla. Unless I am reading the documents posted by Justjulie completely wrong, it would appear there will be no FDA intervention in the import of ecigs so long as they make no therapeutic claims. It appears to me that the FDA will need to decide if they will take the matter to a Higher Court. They will be required to remain hands off until that happens.

I wouldn't count on it.

 

[Vocalek]

I wouldn't count on it.

Oh, don't be such a pessamist, Traver. Over here in East Virginia we see this as a very good sign.

 

[Traver]

Oh, don't be such a pessamist, Traver. Over here in East Virginia we see this as a very good sign.

Actually I don't believe that the FDA will win and get what they want in the long run. I do think they going to keep trying.

 

[GMoney]

Thank You, Vocalek, Justjulie and Yvilla. Unless I am reading the documents posted by Justjulie completely wrong, it would appear there will be no FDA intervention in the import of ecigs so long as they make no therapeutic claims. It appears to me that the FDA will need to decide if they will take the matter to a Higher Court. They will be required to remain hands off until that happens.

I have only taken a cursory look at all the relevant court documents, but: I don't see the Supreme Court granting Writ; I don't think the FDA would want to fight a battle they "could" lose at this stage of the game(although WTH it's just our money they would be wasting).

Regardless of what happens in the courts, Congress can, at any time, change the rules and let FDA do whatever it wants.

 

[Traver]

So does anybody know if Customs is seizing any shipments? Customs can easily make life difficult for vendors just by holding and examining shipments from China for extended periods of time. I am asking not saying they are doing it.

 

[skinny]

Currently they seem to checking shipments. They hold it, send a letter asking for verification, then releasing it. All within a few days. Much better than a year ago