FDA Webinar

[YoursTruli]

I was surprised by this although I don't know why any of this surprises me anymore....I think the small-ish shops that import their products direct from china to sell are going to be (even more) over than some of them might realize because that makes them an importer, importers are also considered manufacturers by the FDA (no, they do not even have to make anything) and it makes them subject to manufacturer's laws/license/permits at the Federal and State levels as well as retailing laws/license/permits.

 

[zoiDman]

@zoiDman right toward the beginning at 9:50 she says
Online retailers must comply with the same requirement as brick and motor retailers must comply with once the deeming rule takes effect

BTW - Have you ever Meet someone who works 9 to 5 doing Rules and Regs? And they become so Emerged in the Complexities and Specific Details of the Rules and Regs that they Lose Sight of what the Rules and Regs even Do? Or how they can Negatively Impact people?

Sometimes I wonder if these FDA Worker Bees ever stop and think.... "Ya know, all this is going to set the e-Cigarette Market back to the Stone Age. And that will cause a lot of Smokers to just keep Smoking. And Dying."

 

[Kent C]

I was surprised by this although I don't know why any of this surprises me anymore....I think the small-ish shops that import their products direct from china to sell are going to be (even more) over than some of them might realize because that makes them an importer, importers are also considered manufacturers by the FDA (no, they do not even have to make anything) and it makes them subject to manufacturer's laws/license/permits at the Federal and State levels as well as retailing laws/license/permits.

Not sure if that is all true. At federal level, no licenses are required - that's addressed late in the video. Also if no manufacturing, but just selling stuff from China, (no repackaging, mixing, making 'kits' other than what may already be a kit from China), while that makes you an importer, no registration is required by the FDA. However, if you sell anything related to ecigs, you will have to submit all PMTA's in order to continue selling.

 

[sofarsogood]

It appears US eliquid makers can export their products without any of this FDA interference. Evolve can make their boards and sell them outside the US without FDA approval. America is rich, lots of disposable income, but it has only 40 million (4%) smokers. A high quality vape costs less than the cheapest quality cigarettes in the world (Cambodia). I predict the manufactuers in China and the US will pass on the FDA crap and focus on the other 960 million smokers.

 

[salemgold]

Dozens of questions about Free Samples, 2 Question about Age Verification for Online Sales.

One answer was... "Yes"
The other answer (the 2nd to Last Question in this Webinar, 1:07:43) was... "Yes, it has to be a Photo ID."

Yep, I caught that as well, ZM. I thought of several people on this forum that really need to hear that part.

 

[YoursTruli]

Not sure if that is all true. At federal level, no licenses are required - that's addressed late in the video. Also if no manufacturing, but just selling stuff from China, (no repackaging, mixing, making 'kits' other than what may already be a kit from China), while that makes you an importer, no registration is required by the FDA. However, if you sell anything related to ecigs, you will have to submit all PMTA's in order to continue selling.

I am not sure about this Kent

https://www.ttb.gov/tobacco/manufacturer_products.shtml
Manufacturer of tobacco Products
The law requires that everyone who intends to manufacture tobacco products obtain a permit from TTB.

listen at at 46:00
twice in the video Swati stated under the statue

a manufacturer is defined as anyone manufacturing fabricating,assembling, packaging, relabeling or importing a tobacco product so if you are importing a tobacco product you are a manufacturer under the statute.

...in response to if I am buying my products from china to sell in my store.....

 

[salemgold]

That's my understanding. If the vendor has not submitted PMTA, they can't sell. That's what the 90 days period until Aug 8th is for, although considering what is necessary for a PMTA, that really isn't enough time either. I'd say the enforcement crew may not be sent out until after the year end, but that's just a guess. Store 'checks' will be made for B&M as well as online vendors as of Aug 8. 42:35

Maybe but, I remember reading somewhere in all of this mess the FDA saying that they will be ready to enforce on August 9. That I am positive of. What part they are talking about enforcing, I am unsure of.

 

[YoursTruli]

Maybe but, I remember reading somewhere in all of this mess the FDA saying that they will be ready to enforce on August 9. That I am positive of. What part they are talking about enforcing, I am unsure of.

I think enforcement will begin on 8/9/16 it was stated several time in this video they will start paying visits to stores as well as online only sellers to make sure they are in compliance.

 

[Kent C]

I think enforcement will begin on 8/9/16 it was stated several time in this video they will start paying visits to stores as well as online only sellers to make sure they are in compliance.

With the same 'undercover' teen schemes that they used for cigarettes. Local vape shops should be notified.

 

[Kent C]

a manufacturer is defined as anyone manufacturing fabricating,assembling, packaging, relabeling or importing a tobacco product so if you are importing a tobacco product you are a manufacturer under the statute.

Actually that's what I meant by the parenthetical 'no repackaging, no mixing, no making kits', etc. If you sell them as you go them from China, (and you don't make your own eliquid), then you're not a manufacturer - but you still have to PMTA stuff you sell.

eta: you're right, but just before that at around 45:00 "if you are strictly a retailer, you do not have to register with the FDA. So what I said about no repackaging, no mixing, no making kits would refer to US products.

 

[salemgold]

I think enforcement will begin on 8/9/16 it was stated several time in this video they will start paying visits to stores as well as online only sellers to make sure they are in compliance.

I agree. I don't think that they will wait until the end of the year.

 

[Kent C]

I agree. I don't think that they will wait until the end of the year.

Which is why I 'striked' that out If I were a vendor, I'd expect them on Aug 9.

 

[Jingles]

I think all of us "oldsters" should make sure we are in a B&M on August 9th, so we can laugh in their faces. I would also think it really funny if online stores submit stacks of Photo ID's with most people being 30+ in age! And the taxpayers are going to pay someone to go through these stacks of ID's or we'll buy the computer that can scan them! Lovely-great use of our tax dollars!

 

[Rossum]

Having finally watched this, it's becoming clear to me that the FDA is painfully aware that the definition of the "tobacco product" in the Tobacco Control Act is deeply flawed (by being circular). Their repeated refusal to provide clear answers regarding stuff that contains no nicotine and isn't made from tobacco (e.g. zero-nic liquids) other than "If it meets the statutory definition" tells me they don't know themselves whether it does or not and what they're really doing is punting the question back to Congress, or more likely the Courts.

There is one bit of good news in that webinar: DIY using stuff you already own remains entirely OK, provided you don't sell it. Right around 30:00 "FDA does not regulate the personal use of tobacco products". So those who've stocked up for personal use don't need to worry about FDA SWAT teams doing no-knock raids in the middle of the night.

 

[retired1]

Having finally watched this, it's becoming clear to me that the FDA is painfully aware that the definition of the "tobacco product" in the Tobacco Control Act is deeply flawed (by being circular). Their repeated refusal to provide clear answers regarding stuff that contains no nicotine and isn't made from tobacco (e.g. zero-nic liquids) other than "If it meets the statutory definition" tells me they don't know themselves whether it does or not and what they're really doing is punting the question back to Congress, or more likely the Courts.

I'm not so sure. I think they are fully aware that e-cigarette products don't fall under the act, but can't come up with a valid reason (other than they're in the back pockets of those who desperately want e-cigarettes gone) for slamming e-cigarettes the way they did.

It's painfully obvious they have an agenda. They just can't come up with facts to back it up.

 

[zoiDman]

I'm not so sure. I think they are fully aware that e-cigarette products don't fall under the act, but can't come up with a valid reason (other than they're in the back pockets of those who desperately want e-cigarettes gone) for slamming e-cigarettes the way they did.

It's painfully obvious they have an agenda. They just can't come up with facts to back it up.

The FDA knows Exactly how far their Authority extends. And Califf and Burwell both know that they have Overstepped it.

But they Also know that in an Election Year, there are Very Few who have the Spine to stand up and say Something if that Something could cause them to Lose Votes/Money for Votes.

Does anyone Really think the FDA gives a Tinker's Damn if "Deeming" has to go all the way to the SC? All the way to the SC while these Regs are Still in place.

 

[YoursTruli]

...through the court system.... years in the undertaking.... meanwhile back at the ranch deeming stands as is

 

[zoiDman]

...through the court system.... years in the undertaking.... meanwhile back at the ranch deeming stands as is

EXACTLY.

That is why People shouldn't be sitting back seeing Litigation as the Savior.

Keep the Letters going to House and Senate Reps. Support Sen. Roh Johnson's and the Oversight Committee. Support the Cole-Bishop AG Amendment and HR2058. And pray to whatever Higher Power you believe in that the Next Congress and the Next President will see things (at least in part) like We do.