FDA Will the FDA regs apply to orders from overseas?

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hoogie76

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Just my take on things... Buying for US from US where states have banned vape products or have shipping restrictions:

1) Shippers really do nothing about this (Although cases like this may change that: smokeasy
2) State AG's or other watchdog groups will report or request info, if they legally can.
3) They will subpoena your sales and shipping records.
4) If you don't have them, guilty.
5) If you do have them and you did ship to a restricted state, guilty.
6) Same with age verification. Guilty if not doing it correctly. 'I'm over 18' checkbox is not a correct method of age verification and does not meet the requirements of most state laws now. There will be heavy fines and lots of 'url not found' messages soon :(

So for international, it's a mixed bag.. There is a possibility that the FDA, through CBP could stop all imports of vaping products as mis-branded or adulterated as of August 8th, 2016. Nothing says they won't and nothing in the guidance or deeming says they won't. Anything not approved is adulterated or mis-branded.

Importing & Exporting

Under section 801 of the FD&C Act, imported tobacco products, are subject to refusal of admission if, among other reasons, they are, or appear to be, adulterated or misbranded.

It's unclear if they will do this though but what a kick in the seat if they did. There is nothing clear in any documentation if they will stop imports but what is clear is that they don't say they won't. A process for foreign manufacturers to submit product information is being developed but not yet available..

When you read all the FDA docs and guidance they use the word 'Domestic' many many times.. But not much for international :(

A shipment will get through here and there, mostly for personal use type of stuff..

Color me conspiracy blue, but I think this could happen..

hoog
 

YoursTruli

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LOL. How are they going to enforce that one?

States cannot regulate interstate commerce, & it's a federal crime for them to mess with the US mail.

....most US vaping shop vendors just will not ship to you if you live in Utah...or Indiana...Arkansas or....
so there is your local enforcement, as for intenational imports, the FDA has the rest of the US covered. Anyone importing vaping products is now considered a tobacco manufacturer, and will have to registered as such by December 31st this year per FDCA. This language doesn't make any distinction as to whether these imports are for-profit or not. It's safe to assume that post December 31, anyone who imports any products and ships them on will be committing an offence if they haven't registered as a tobacco manufacturer.
 

KentA

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The FDA has already sent out letters to the various shipping agencies (USPS, Fed Ex, UPS, etc.). As of August 8th, I suspect that all shipments relating to e-cig sales will be automatically forwarded for customs inspection.
Foreign shipments already pass through customs.

The question is how customs agents will react to hardware. If they were on the market before August 8th & haven't been altered since then they legal. Otherwise they are to be confiscated. Most of us don't know all the answers so how can customs?
 
Foreign shipments already pass through customs.

The question is how customs agents will react to hardware. If they were on the market before August 8th & haven't been altered since then they legal. Otherwise they are to be confiscated. Most of us don't know all the answers so how can customs?

There was no legal status for US Customs to detain or confiscate hundreds, if not thousands of international shipments back in the 2010 time frame, but that did not stop them from doing so. That was when, some may recall, the FDA was attempting to regulate e-cigarettes as 'combination drug delivery devices'.

If I were a betting man, my money would be on seeing the FDA swiftly and completely shut down e-cigarette commerce beginning August 8. They have the mandate, the power, the money and the cooperating affiliate government agencies all in place. Given the history of FDA, why would they hesitate and not immediately begin suppressing all ecig commerce? Hopefully I'm wrong...
 

retired1

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....most US vaping shop vendors just will not ship to you if you live in Utah...or Indiana...Arkansas or....
so there is your local enforcement, as for intenational imports, the FDA has the rest of the US covered. Anyone importing vaping products is now considered a tobacco manufacturer, and will have to registered as such by December 31st this year per FDCA. This language doesn't make any distinction as to whether these imports are for-profit or not. It's safe to assume that post December 31, anyone who imports any products and ships them on will be committing an offence if they haven't registered as a tobacco manufacturer.

Yep. Pretty much. And this is going to have a HUGE impact on co-ops as well. We're still looking at the legal aspects of it, but it's not looking good at all.
 

Lessifer

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Has anyone asked the FDA if there will be interference with consumer orders from off shore after 8-8 beyond new products and underage?
I tweeted them about a week ago asking about samples in store. They tweeted back to email my question to AskCTP@fda.hhs.gov so I did. I got an email a couple days later saying my question would be routed for appropriate response. I'm still waiting for a reply.

So... be my guest.
 

sofarsogood

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I tweeted them about a week ago asking about samples in store. They tweeted back to email my question to AskCTP@fda.hhs.gov so I did. I got an email a couple days later saying my question would be routed for appropriate response. I'm still waiting for a reply.

So... be my guest.
If there were going to be changes in procedure a week from now wouldn't they need to inform the people responsible for this? It seems unlikely this happened and it's some how being kept secret. I supposed they might have the authority to severely disrupt trade and fail to give a warning to be vindictive but how would they be helping themselves?
 

Lessifer

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If there were going to be changes in procedure a week from now wouldn't they need to inform the people responsible for this? It seems unlikely this happened and it's some how being kept secret. I supposed they might have the authority to severely disrupt trade and fail to give a warning to be vindictive but how would they be helping themselves?
IDK, what does "boots on the ground 8/8" mean?
 

Lessifer

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They've said no more sales to under 18 (that will be new law in michigan but not most states), child resistant packaging (didn't congress already cover that), no "new" products. Have I missed anything?
Maybe I didn't understand your original question. What interference would there be other than new products and underage sales?
 

sofarsogood

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Maybe I didn't understand your original question. What interference would there be other than new products and underage sales?
A lot of stockpiling happening now is motivated by a concern that after 8-8 there will be interference with adults buying existing products. I don't see evidence of that, do you?
 

Lessifer

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A lot of stockpiling happening now is motivated by a concern that after 8-8 there will be interference with adults buying existing products. I don't see evidence of that, do you?
I can only speak for myself, but any stockpiling I may have done is not in direct response to the deeming regs taking effect 8/8. It is an indirect result, based on my anticipation of cumulative effects of businesses deciding it's just not worth it, worry of how the USPS will decide to deal with delivery of e-liquid, state laws, and whatever guidance the FDA decides to issue.
 

retired1

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If there were going to be changes in procedure a week from now wouldn't they need to inform the people responsible for this? It seems unlikely this happened and it's some how being kept secret. I supposed they might have the authority to severely disrupt trade and fail to give a warning to be vindictive but how would they be helping themselves?

It's my understanding that the FDA has already sent letters to UPS, FedEx, USPS, etc.

I'm aware of UPS jumping the gun on this letter and forwarding shipments for FDA inspection. It was only after being called and pointed out that it was too soon to act on the letter that they released the shipment.
 

sofarsogood

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It's my understanding that the FDA has already sent letters to UPS, FedEx, USPS, etc.

I'm aware of UPS jumping the gun on this letter and forwarding shipments for FDA inspection. It was only after being called and pointed out that it was too soon to act on the letter that they released the shipment.
A couple of issues. The vape mail I receive, foreign or domestic, has no marking that indicates vaping products. May be large commercial shipments have more detailed shipping documents. I read somewhere that there is no customs catagory for vaping products. I believe they use miscellaneous electronic devices or something like that. If that were changed suppliers and retailers would have to be notified. I picture this, 'boss, I think I've found a suspicious drip tip'.
 

Chemical Bromance

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A couple of issues. The vape mail I receive, foreign or domestic, has no marking that indicates vaping products. May be large commercial shipments have more detailed shipping documents. I read somewhere that there is no customs catagory for vaping products. I believe they use miscellaneous electronic devices or something like that. If that were changed suppliers and retailers would have to be notified. I picture this, 'boss, I think I've found a suspicious drip tip'.

Regardless of category of declaration, customs checkpoints do scan parcels. Given the huge volume that comes through the US, I expect it's a somewhat random sampling.
Furthermore, I understand that the big courier companies, like FedEx and DHL, have their own internal clearances where they scan their own shipments and redflag or reject orders. That's how they ship internationally in just a couple of days.


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sofarsogood

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Regardless of category of declaration, customs checkpoints do scan parcels. Given the huge volume that comes through the US, I expect it's a somewhat random sampling.
Furthermore, I understand that the big courier companies, like FedEx and DHL, have their own internal clearances where they scan their own shipments and redflag or reject orders. That's how they ship internationally in just a couple of days.


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"Internal clearances" and 'redflags' and 'reject orders' and other such jargon avoid the question. Will there be interference with adults buying pre 8-8 products OR NOT. So far I'm not finding evidence there will be interference from the Feds. If people here want to create that concern perhaps show some evidence a step up from hearsay.
 
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