Will someone please give the final info?

[TropicalBob]

Using the "common sense" so common here, we could surmise that "adulterated devices" means they are not for children. They are adult, e-rated devices. Makes sense.

I haven't seen a definition in the drug laws that I can cite, but a guess might be that these e-cigs came with carts of nicotine, a drug.

Actually, this reply is encouraging: They are still acting case-by-case, against misleading or false ad claims, and have not issued a full stop on all shipments.

That could change with a press conference, however. They've announced intent to hold one -- and you just know they've worked a long time preparing for it. There were video clips to be shot, PowerPoint presentations to prepare, text releases to be carefully worded and edited. These things don't just happen. A decision on e-smoking -- not about specific companies -- HAS been made. We just don't know it yet.

 

[Angela]

Disagree with your definition of 'adulterated' there TB. Although I have been pondering just how they apply 'adulterated' to the device rather than the liquid, if you check the dictionary definition of the word, it refers to the addition of things that aren't normally there, altered, impurities, etc.

EDIT: see here: http://www.websters-online-dictionary.org/definition/adulterated

 

[ccure]

Disagree with your definition of 'adulterated' there TB. Although I have been pondering just how they apply 'adulterated' to the device rather than the liquid, if you check the dictionary definition of the word, it refers to the addition of things that aren't normally there, altered, impurities, etc.

EDIT: see here: Adulterated

I agree with you Angela.

But why they are saying e-cigs are adulterated devices?

I can understand the "drug device", the labeling issue, the drug claims, but I can not understand why adulterated device.

I think it is important to find out. I may suggest some of you from USA to try to find out?

 

[katink]

A very long shot (probably not the case but you never know): Ruyan has stayed amazingly quiet through all things happening lately. It wouldn't be so amazing, if they had been working on their devices with the FDA for quite a while allready.. and they do have patents on their products. Wouldn't the 'knock-off's' that chinese companies made, coming from their first-made devices, but of course with some changes, be called 'adulterated devices'? Could FDA be helping Ruyan to get rid of all the other devices for them?

As I said: unlikely. But it could fit into what is happening perhaps?

 

[KatyS]

When I spoke to a FDA agent recently about my shipment. It came out in the conversation that he saw 1 company getting its product thru consistantly, when I
said Ruyan, he was quiet, which spoke volumns. I think Ruyan has worked with the
FDA and done what needs to be done to have their product pass inspections.
The rest of the manufacturers have not. Plain and simple. Until they get what
they need to get this clearance we will continue to have import problems with the other manufacturers. I think Ruyan feels it invented this and no other manufacturers should be selling knock offs.

 

[Boston George]

Ruyan have an FDA lawyer/specialist on retainer. They have also really be pushing their Nic-Free Jazz line. The products that they are getting through may all be nic-free.

 

[TropicalBob]

Angela, gang: Adult-e-rated was a joke. Adulterated means it could be spoiled by some form of contamination. It is carefully spelled out in the Kennedy bill now before the Senate.

To say our liquid might be adulterated is reasonable. We have no knowledge how it's made, what might be in it, etc. That fits the definition of irresponsible manufacturing that could produce an adulterated product. And it's not even tamper-proof in most cases. Anything could be in it, or put in it post manufacture.

 

[RayJ1]

I'm a nicotine addict... and I want it...preferably non-adulterated please.

 

[breakfastchef]

'Adulterated' is clearly defined in the Federal Food, Drug and Cosmetic Act [21 U.S.C. 361] as it pertains to cosmetics. The same basic principles apply to food, medicines and drug delivery devices. Below I have listed the primary components used to determine if a product has been adultered.
(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof...
(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance...
(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health...
(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health...

 

[Angela]

Angela, gang: Adult-e-rated was a joke. Adulterated means it could be spoiled by some form of contamination. It is carefully spelled out in the Kennedy bill now before the Senate.

To say our liquid might be adulterated is reasonable. We have no knowledge how it's made, what might be in it, etc. That fits the definition of irresponsible manufacturing that could produce an adulterated product. And it's not even tamper-proof in most cases. Anything could be in it, or put in it post manufacture.

SorryTB - I did wonder TBH

'Adulterated' is clearly defined in the Federal Food, Drug and Cosmetic Act [21 U.S.C. 361] as it pertains to cosmetics. The same basic principles apply to food, medicines and drug delivery devices. Below I have listed the primary components used to determine if a product has been adultered.
(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof...
(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance...
(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health...
(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health...

Thanks for that. However, the fact that FDA are marking shipments as 'adulterated devices' not 'may be adulterated device' is interesting - since they state no tests have been done. Is there an assumption in US law that all such devices are adulterated until such time as they are proved otherwise? This should be a fairly simple requrement for the manufacturers to satisfy and would at least clear one hurdle

 

[ccure]

'Adulterated' is clearly defined in the Federal Food, Drug and Cosmetic Act [21 U.S.C. 361] as it pertains to cosmetics. The same basic principles apply to food, medicines and drug delivery devices. Below I have listed the primary components used to determine if a product has been adultered.
(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof...
(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance...
(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health...
(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health...

Thank you! Now I understand why they classified e-cigs as "adulterated devices" and what they mean with it.

So from Literal a) we can presume that since the cartridge has Nicotine (poisonous) the device can be classified as adultered.

Also, from a) if there is some lead in any electric connection of the e-cig.
If there is a chance that any leak/fume from the battery can reach the mouth.

c) may apply if the factories do not have the proper sanitary measures. But also, even if the factory has the proper sanitary measures, since the box of the e-cig is not sealed, it can be easily contaminated after it leaves the factory. And also there is no packing for the spare parts, so they can be contaminated at any moment.

I do not see b) is an issue.

And d) I do not know...

I think our spare parts and e-cig will need to come in a blister packing or something like that.

But again, I think Nicotine is the main issue.

 

[TropicalBob]

Here's the adulterated definition from the Kennedy bill now before the Senate. Keep in mind this bill does not define drugs. It's a tobacco and smokeless bill. If SmokingEverywhere should pull off a miracle and get its devices declared by a judge to be tobacco products, then this definition below will become the new definition. Either way, drugs or tobacco, e-cigs don't meet the law.

‘SEC. 902. ADULTERATED TOBACCO PRODUCTS.

‘A tobacco product shall be deemed to be adulterated if--

‘(1) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;

‘(2) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;

‘(3) its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

‘(4) the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 919 by the date specified in section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;

‘(5) it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 907 unless such tobacco product is in all respects in conformity with such standard;

‘(6)(A) it is required by section 910(a) to have premarket review and does not have an order in effect under section 910(c)(1)(A)(i); or

‘(B) it is in violation of an order under section 910(c)(1)(A);

‘(7) the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 906(e)(1) or an applicable condition prescribed by an order under section 906(e)(2); or

‘(8) it is in violation of section 911.

 

[eric]

'Adulterated' is clearly defined in the Federal Food, Drug and Cosmetic Act [21 U.S.C. 361] as it pertains to cosmetics. The same basic principles apply to food, medicines and drug delivery devices. Below I have listed the primary components used to determine if a product has been adultered.
(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof...
(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance...
(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health...
(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health...

In this flex of muscle, I hope the FDA doesn't ban mushrooms...

 

[LaceyUnderall]

Even though this thread pertains to the original Cinco de Mayo hoolala... I thought I would add here that:

as of yesterday, nJoy entered into the SE lawsuit, so for those who haven't heard where we are in the next phase of our roller coaster ride... this is where we are. As soon as I have more to post, I will!

 

[ramblingrose]

What do they means with:

"they were also adulterated devices."

Anyone has a clue? Why adulterated devices?

I think that should be challenged if anything in the adulteration rules applies to the hardware, as they are manufactured and sold as per the patented invention. If nicotine is the problem (and this may cover more than one issue), maybe its time to ship kits and parts/accessories without carts that contain nicotine. Separate the problem 'drug' from the hardware.
Other than that, I'd like to see the Association deal QUICKLY with advertising claims that are clearly a big problem.

 

[MEMPHIS_MARK]

If they ban it I will not go back to smoking analogs!!!! and paying a very unfair tax rate. I live close enough to Kentucky to make my own juice LOL and guess what I will sell it on the black market at cost just to put a finger in the eye of the run away US government.

 

[Hrulia]

Yes,but black market no solution

 

[MaxxVapor]

A decision on e-smoking -- not about specific companies -- HAS been made. We just don't know it yet.

I think it was pushed back by the suit. Excellent timing by SE if an announcement was coming.

 

[tokarev]

I think "adulterated device" in this case means "adulterated medical device", which apparently has a very specific meaning. I found this on a medical device reference site:

"A device in distribution without a device history record is technically adulterated. Distributing an adulterated device, or causing a device in distribution to be adulterated, is a prohibited act under section 301 of the Federal Food, Drug, and Cosmetic Act. Anyone who violates a provision of section 301 may be imprisoned for not more than one year or fined not more than $1000, or both. The guilty party doesn't get to choose between the penalties."

For more information, see the site:
(Help Desk) Clarifying Device History Record Issues (MDDI archive, Nov 98)

I guess if the device in question is deemed NOT to be a medical device, then it can't be "adulterated"?

EDIT> This is better; "Adulterated (device)" is defined in the Federal Food, Drug, and Cosmetic Act.

http://books.google.com/books?id=0c...m8mhBg&sa=X&oi=book_result&ct=result&resnum=7

TT33

 

[TropicalBob]

Good find and that explains the bottom line on the ban: These did not have pre-approval and thus are defined as adulterated devices. That, of course, assumes they are indeed medical devices, as the FDA claims them to be.