FDA New Products?

[aviat0rK]

Hi everyone. I have been a long time lurker here. This is my first post. Not for any other reason than it seems like when I have a question someone else has already asked it for me. . Until now. Maybe I've missed this and if so please let me know.

My understanding was that as of 8/8/16 no new products could be released to the market without first undergoing approval via either a PMTA or SE yet it seems like new devices, liquids, tanks, etc are still popping out every week available from my local vape shops and online vendors. Am I missing something? I thought that went into effect day one. Is there another date for implementation of that part?

Thanks for any insight!

 

[somdcomputerguy]

The 8/8 deadline has been extended until the end of June this year. There is more details than I can't think of right now, search some thru out this forum or the FDA website, someone else will post more here too I'm sure.

 

[LittleBird]

Hi everyone. I have been a long time lurker here. This is my first post. Not for any other reason than it seems like when I have a question someone else has already asked it for me. . Until now. Maybe I've missed this and if so please let me know.

My understanding was that as of 8/8/16 no new products could be released to the market without first undergoing approval via either a PMTA or SE yet it seems like new devices, liquids, tanks, etc are still popping out every week available from my local vape shops and online vendors. Am I missing something? I thought that went into effect day one. Is there another date for implementation of that part?

Thanks for any insight!

Here's a link to the FDA site with compliance dates.
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM501016.pdf
There was no change to the dates for submission of a PMTA exemption request (8/8/17) or a Substantial Equivalence application (2/8/18). Both of these dates refer to products that were manufactured as of 2/15/07. For products that were not yet manufactured as of 2/15/07, PMTAs must be submitted by 8/8/18.

Companies outside of the US are not precluded from developing new products, but those products are (technically) subject to seizure by US Customs. FDA has said they are not allocating resources to these new products at this time. Of course, FDA could change their mind tomorrow.

The same is true for US-domiciled companies, who could export their products. I suppose they could sell those products in the US, but it is highly unlikely (that would be a gross understatement) that such products would be approved. I believe that those few companies who manufacture domestically have not invested in new product development, post deeming. Why would they?

 

[aviat0rK]

Thanks for the replies guys, and thank you for the link LittleBird.

I'm still not understanding though (please don't beat me over the head. ). Regardless of who manufacturers it, the rule plainly states that all products that were on the market on 8/7/16 could continue to be sold during which time the PMTAs are applied for. Any product that was not on the market on 8/8/16 can not enter the market without first being approved.

I completely get that foreign manufacturers can continue to introduce new products. The US isn't their only customer BUT doesn't some responsibility lie on the vendor who sales the product. If they were to be inspected, would they not get in trouble if they couldn't prove the product was on the market as of 8/8? I feel like there are vendors out there just ignoring this part of the rule. I get why. Us vapors want new stuff! If all they continue to sale is pre deeming products sales go down. Vapors shop by hype so there has to be something new to hype.

But if we're ignoring that part of the rule, why not still give free samples or continue making juice behind the counter or ignore any other part as well?

My concern is the attention this could draw to the industry. None of us like what has happened but if we don't work within the rules that can make us look like exactly why the ANTZ say we are. Not even sure if that makes sense as I typed it but it does in my head.

I do feel like US manufacturers are continuing to release new and modify products since the 8/8 as well. I'll use Naked Fish as an example. They just reformulated several of their flavors to comply with TPD guidelines so they could sell in the EU. That would be fine but that is what they are currently offering in the US as well. The names of the flavors haven't changed but the product has. Phil Busardo released his own line of liquids as well (I could be wrong about this one. I just recently learned of these - they may have been available pre 8/8).

Of course, as we all know, nothing is being enforced other than age restrictions currently but what about when the enforcement starts?

Just some thoughts in my head. Like everyone else, I'm watching and hoping this all goes away with the new administration (we have to stay vocal!) but until that happens, we need to dot our i's and cross our t's and comply. This fight won't be won breaking the law, but working on changing it.

 

[retired1]

Foreign companies aren't tied to the FDA deeming regulations. However, if/when the FDA decides they're going to start enforcing the rules, they can seize the foreign products as they're shipped into the US.

There are plenty of US manufacturers/retailers who are pretty much turning a blind eye to the existing rules as they stand. I suspect they're going to push things as long as they can and when the FDA comes a knocking on the door, they'll fold up shop and disappear.

 

[skoony]

@retired1 I believe your assessment is correct.
Not to mention any names but,there seems to be
a few vendors that are just asking for a friendly
visit form their neighborhood federal rep. .
regards
mike

 

[MMW]

I would say a good majority of online vendors. I haven't noticed any slowing of any new products.

 

[aikanae1]

I think the FDA is taking a tiered approach. I know some vendors got warning letters over online age verification and usps is randomly pulling foreign shipments to send to FDA with new label coding. There's been spot checks in b&m's too. I suspect controlling vaper products has been more complicated than the FDA expected = cause of the delay. I hope there will be many more delays.

Eliquid manufacturers have to reformulate if one of their suppliers change in any way. There's a lot of products that just don't fit into regulations, so it's undefined what to do.

Sent from my LGLS992 using Tapatalk

 

[juicynoos]

I see a plethora of products this year that are designed in the USA or Europe ie, flawless(USA) or Lost Vape(UK)but manufactured in China and selling like hotcakes worldwide! The FDA, wishing to be cost effective with tax payers money, can't possibly go after individual company's just yet but can prevent us from making payment for said goods through payment systems and shipping agents regulation and restriction.
Their focus, for now, will be to prevent underage purchase of any Vapor products. Payment methods will be fewer and more tightly controlled as we see already with Mastercard etc and their age verification requirements.

So, they can make what they like but will you be able to pay and ship it- NO

 

[aikanae1]

Bitcoin remains unrestricted and I see more and more shops accepting it. I just wish I understood it better.

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[Str8vision]

......There are plenty of US manufacturers/retailers who are pretty much turning a blind eye to the existing rules as they stand. I suspect they're going to push things as long as they can and when the FDA comes a knocking on the door, they'll fold up shop and disappear.

Standard American business model these days, hit it while you can and bail out when things get dicey. I really don't blame the "hit and run" small business startups, compliance in the U.S. is cost prohibitive for all but the largest of corporations.

I know some vendors got warning letters over online age verification and usps is randomly pulling foreign shipments to send to FDA with new label coding. There's been spot checks in b&m's too. I suspect controlling vaper products has been more complicated than the FDA expected = cause of the delay. I hope there will be many more delays.

I certainly hope to add to their unexpected complications/chaos by continuing to import whatever I please until shipments no longer get by customs.

 

[sofarsogood]

The 8/8 deadline has been extended until the end of June this year. There is more details than I can't think of right now, search some thru out this forum or the FDA website, someone else will post more here too I'm sure.

Are you saying the deadline change applies to new products too? New devices, new flavors? If yes are you sure about that?

 

[somdcomputerguy]

No. There is a different grandfather date for the products that qualify for the deadline date extension. This second grandfather date is a later date than the original grandfather date, but by far not as far back as it. I'm not sure of all the details, they can be found on the FDA site. See LittleBird's post above and other posts here on ECF also.

 

[WorksForMe]

Are you saying the deadline change applies to new products too? New devices, new flavors? If yes are you sure about that?

AFAIK, the only deadline that got extended was the "Establishment Registration and Product Listing" deadline that got a 6 month extention from 12/31/2016 to 6/30/2017.

All new products introduced after 8/8/2016 must have a prohibitively expensive PMTA. It looks to me like the FDA doesn't yet know which products are new, or how to enforce the rule. After they get the product listings from manufacturers(and retailers if they mix juice) they can start to figure it out.

Right now, I'd bet that there won't be much enforcement until 8/8/2018. After that, ALL products will need a PMTA unless they were marketed before the grandfather date(2/15/2007). Hopefully, the grandfather date will get moved to either 5/5/2016(Deeming announced) or 8/8/2016(effective date).

 

[skoony]

As far as I understand the extension is for products on the market prior to 8/8/16.
Products introduced after that date have to go through the process and can not sell
product until authorized by the FDA to do so. In other words the extension allows
products on the market prior to 8/8/16 more time to keep selling and get the
proper paper work filled.
I think.
Mike

 

[aikanae1]

As far as I understand the extension is for products on the market prior to 8/8/16.
Products introduced after that date have to go through the process and can not sell
product until authorized by the FDA to do so. In other words the extension allows
products on the market prior to 8/8/16 more time to keep selling and get the
proper paper work filled.
I think.
Mike

I don't think the FDA knows what products were on the market 8/8. I am guessing their estimates were off by a half million or so. [emoji48]

12/31 worried me more because that's when importers needed to file as manufacturers or stop importing, but that's come and gone too. So idk?

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[r055co]

A lot of companies put up for sale their prototypes just before the deadline, like maybe an hour. They then took them off line, thus technically they were for sale. They're now releasing their products but that is going to dry up soon.

The other company's that didn't do that and are still releasing, they're poking the hornets nest and hoping they won't get caught for a while. When they do, yep they'll just fold up shop and/or just stop selling to the US.

 

[endlessendres]

The other company's that didn't do that and are still releasing, they're poking the hornets nest and hoping they won't get caught for a while. When they do, yep they'll just fold up shop and/or just stop selling to the US.

It's definitely this. Most companies don't plan on being around once regulations go into effect, so they are making the most of it hoping there won't be any serious repercussions for breaking the law now.

 

[motordude]

12/31 worried me more because that's when importers needed to file as manufacturers or stop importing, but that's come and gone too. So idk?

That was the date that changed recently to add 6 more months. So as it stands the new deadline for manufacturers is 6/31/17.

 

[collinsmcrae]

Thanks for the replies guys, and thank you for the link LittleBird.

I'm still not understanding though (please don't beat me over the head. ). Regardless of who manufacturers it, the rule plainly states that all products that were on the market on 8/7/16 could continue to be sold during which time the PMTAs are applied for. Any product that was not on the market on 8/8/16 can not enter the market without first being approved.

I completely get that foreign manufacturers can continue to introduce new products. The US isn't their only customer BUT doesn't some responsibility lie on the vendor who sales the product. If they were to be inspected, would they not get in trouble if they couldn't prove the product was on the market as of 8/8? I feel like there are vendors out there just ignoring this part of the rule. I get why. Us vapors want new stuff! If all they continue to sale is pre deeming products sales go down. Vapors shop by hype so there has to be something new to hype.

But if we're ignoring that part of the rule, why not still give free samples or continue making juice behind the counter or ignore any other part as well?

My concern is the attention this could draw to the industry. None of us like what has happened but if we don't work within the rules that can make us look like exactly why the ANTZ say we are. Not even sure if that makes sense as I typed it but it does in my head.

I do feel like US manufacturers are continuing to release new and modify products since the 8/8 as well. I'll use Naked Fish as an example. They just reformulated several of their flavors to comply with TPD guidelines so they could sell in the EU. That would be fine but that is what they are currently offering in the US as well. The names of the flavors haven't changed but the product has. Phil Busardo released his own line of liquids as well (I could be wrong about this one. I just recently learned of these - they may have been available pre 8/8).

Of course, as we all know, nothing is being enforced other than age restrictions currently but what about when the enforcement starts?

Just some thoughts in my head. Like everyone else, I'm watching and hoping this all goes away with the new administration (we have to stay vocal!) but until that happens, we need to dot our i's and cross our t's and comply. This fight won't be won breaking the law, but working on changing it.

IMO, playing nice and bending over to take it all up the ..., is not what we should be doing at all. The strongest move is to ignore the most oppressive aspects of the regulations and caryy on as if they don't exist. The tougher we make things for the FDA, the better. I would like to see continued creative exploitation of every single loophole anyone can think of, because overwhelming the FDA until they realize what an impossible crusade it is that they have embarked on here, is the only possible chance of ridding ourselves of all this horse ..... Playing nice is just the fastest way to hand the FDA and their cronies exactly what they want. If we are gonna go down, we might as well go down swingin.