FDA bans four cigarette products, rules them “not substantially equivalent” to a product marketed before Feb 15, 2007

[Bill Godshall]

FDA bans four cigarette products (bidis), rules them “not substantially equivalent” to a product on market before Feb 15, 2007 (as manufacturer didn’t identify or conduct studies/tests on predicate products to prove the existing products aren't more hazardous)
FDA issues first orders to stop sale, distribution of tobacco products

News stories
Bidis are first tobacco product banned by FDA using new powers - CBS News
http://www.nytimes.com/2014/02/22/u...emoved-from-shelves.html?hpw&rref=health&_r=0


As I've been saying (and posting on ECF) since 2011, this is the key reason why all e-cig manufacturers, importers, vendors and vapers should be actively exposing and opposing FDA regulation of e-cigs (as these very same regulations, and subsequent FDA ban, would apply to all e-cig products if/when the FDA imposes the "deeming" regulation on e-cigs).

Unlike the vast majority of cigarettes and smokeless tobacco products, no e-cig product on the market today could prove to the FDA that it is Substantially Equivalent to a predicate product (i.e. that was on the market in 2007). Besides, I haven't been able to identify or obtain even one predicate e-cigs product during the past year despite many postings of request on ECF).

Action Alert: Urge Congress to prevent FDA from banning e-cigarettes again and to stop FDA from giving the e-cig industry to Big tobacco
http://www.e-cigarette-forum.com/fo...op-fda-giving-e-cig-industry-big-tobacco.html

 

[Bill Godshall]

Can admin delete one of these duplicate threads. Not sure how that happened.

 

[2coils]

From CBS article :“Companies have an obligation to comply with the law,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, said in a press release. “Because the company failed to meet the requirement of the Tobacco Control Act, the FDA’s decision means that, regardless of when the products were manufactured, these four products can no longer be legally imported or sold or distributed through interstate commerce in the United States.”
Might this be what we have to worry about???

 

[Bill Godshall]

Precisely.

If/when FDA imposes the deeming regulation on e-cigs, Mitch Zeller can truthfully say the same thing about all e-cig products (when FDA orders all e-cig products removed from the market)

That's why e-cig companies, vendors and vapers should NEVER advocate FDA regulation of e-cigs, as doing only endorses an FDA e-cig ban.

Telling a federal judge "But your honor, we didn't know the Tobacco Control Act would ban e-cigs" is a losing argument.

 

[NoVaWolf]

The FDA Not-Substantiantially-Equivalent Draft Guidance (a related link on the bidi stop order) is really scary! It's written so broadly that e-cigs could fall under the definition of NSE, and they're recommending immediate seizure, blocking importation, etc. when they rule a product NSE! It's now published for comments, so we'd better all now comment - yikes!!!

 

[skoony]

may i add it was really clever of the FDA to rule against these particular products.
knowing they are mostly sold in ethnic shops,or in the poorest neiborhoods
and are popular for there lower cost they will still be getting into the country.
ban or not the administration doesn't want to look racist or be against the poor
and actually raid these types of places.
its just a set up for things down the road.

regards
mike
p.s. i might add the manufactuer didn't seem to do any thing on its behalf
to keep there product legal.

 

[Bill Godshall]

Since the companies didn't even identify or compare the product they wanted FDA to approve with a predicate product from 2007, it was an easy decision for FDA to reject the company's SE application.

But since none of the e-cig products now on the market are "substantially equivalent" to a predicate e-cig product from 2007, and since 99% of e-cig companies don't even have any predicate products from 2007 (to conduct a comparison on), it will be very easy for the FDA to similarly deny any SE applications for e-cigs (if/when the FDA imposes those same Chapter IX regulations on e-cigs).

 

[rothenbj]

It's a scary thought and one that can't be ignored.

 

[Bill Godshall]

Just as I predicted would occur back in 2004 (in my letters urging Congress to reject the Tobacco Control Act), FDA's press release about banning four cigarette products from India generated the following news article insinuating that cigarettes made in India are "toxic" (unlike the cigarettes FDA didn't ban).
Cigarettes From India Toxic?

By banning some tobacco products while approving other tobacco products, the Tobacco Control Act and the FDA are deceiving the public to inaccurately believe that banned tobacco products are more hazardous than FDA approved tobacco products.


Anyone who still believes that FDA regulation of e-cigs might be beneficial, I strongly suggest they carefully review the following FDA documents confirming that FDA regulation of e-cigs under Chapter IX of the TCA would ban all e-cig products because they missed the 2007 and 2011 deadlines.


FDA: Misbranded and Adultered NSE Tobacco Products
Misbranded and Adulterated NSE Tobacco Products

FDA: New Tobacco Product Review and Evaluation
New Tobacco Product Review and Evaluation

FDA: Substantial Equivalence
New Tobacco Product Review and Evaluation

FDA: Exemption from Subtantial Equivalence
New Tobacco Product Review and Evaluation

FDA: Premarket Tobacco Products
New Tobacco Product Review and Evaluation

FDA: Applications for Premarket Review and New Tobacco Products
Applications for Premarket Review of New Tobacco Products

FDA: Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent
Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM386629.pdf

 

[JasonV]

I don't have time to read through all these links, but let me touch on something from OP and tell me if I'm wrong.
He said that the product needed to either be better than product before 2007 (first ecig was made 2003, so as long as our JUICE isn't worse than original juice then we are ok) which e-cigs do make the cut. They can't ban the device itself, just like they can't ban glass pipes typically associated with illicit drugs, because it has other uses. It would be the juice they would ban, however, there are FDA approved ingredients that juice makers can use, so regulation would prevent something like Titanium Dioxide that was discovered in Unicorns Milk recently from happening again.
I am for regulation, but only way to make sure vapers don't get the short end of the stick is to be proactive in helping set what those regulations are. Fear-mungering and paranoid-ramblings of (unrealisitic) WORST case scenario won't help.

 

[Sundodger]

I don't have time to read through all these links, but let me touch on something from OP and tell me if I'm wrong.
He said that the product needed to either be better than product before 2007 (first ecig was made 2003, so as long as our JUICE isn't worse than original juice then we are ok) which e-cigs do make the cut. They can't ban the device itself, just like they can't ban glass pipes typically associated with illicit drugs, because it has other uses. It would be the juice they would ban, however, there are FDA approved ingredients that juice makers can use, so regulation would prevent something like Titanium Dioxide that was discovered in Unicorns Milk recently from happening again.
I am for regulation, but only way to make sure vapers don't get the short end of the stick is to be proactive in helping set what those regulations are. Fear-mungering and paranoid-ramblings of (unrealisitic) WORST case scenario won't help.

With all due respect, you really need to do more reading/research before calling what is being discussed fear-mongering and paranoid rambling.
Mr. Godshall is/has been dedicated to tobacco control for many years, testified before many committees and knows what he's talking about. He's helped write laws that were passed against smoking, look at his signature line.
This fight has been going on a lot longer than I've been around this forum, wish I had known about it years ago, I would have been involved then.
I will give you a thumbs up for at least reading the legislative news though. A lot of members don't get any further down the forum than how to not poison themselves with DIY or blow themselves up modding something. Congrats!

And as far as 2007 goes, that's the date set by the FDA for equivalency of products, not the OP. Nothing today was made in 2007, well very little is going to be equivalent in the eyes of the FDA if that's the route they go. Most delivery devices are different, you couldn't buy a bottle of eliquid, only the cartridges pre-filled. Do you really want to have to go back to cig-a-likes only? Because that's the best case if they (the FDA) holds true to the 2007 date.

 

[Mutescream]

I'm guessing we might be reduced to making our own NET juices down the road. It's going to be a bit hellish, considering that it will be difficult to determine how much nicotine will be in it to dose properly.

 

[pamdis]

I don't have time to read through all these links, but let me touch on something from OP and tell me if I'm wrong.
He said that the product needed to either be better than product before 2007 (first ecig was made 2003, so as long as our JUICE isn't worse than original juice then we are ok) which e-cigs do make the cut. They can't ban the device itself, just like they can't ban glass pipes typically associated with illicit drugs, because it has other uses. It would be the juice they would ban, however, there are FDA approved ingredients that juice makers can use, so regulation would prevent something like Titanium Dioxide that was discovered in Unicorns Milk recently from happening again.
I am for regulation, but only way to make sure vapers don't get the short end of the stick is to be proactive in helping set what those regulations are. Fear-mungering and paranoid-ramblings of (unrealisitic) WORST case scenario won't help.

Regarding the 2007 date, let's assume as you say that it will only be about the juice. Do you have access to any mfg information to juices produced before this date? Because detailed information about it (what the FDA calls a predicate product) would need to be submitted along with information about your current juice to PROVE that it is the same.

But it won't be only about the juice, it will be about the devices too.

Bill has spent several years trying to find an actual e-cig that was sold in the US prior to 2007 so he could try to get the information from the original mfg. Unsucessfully.

So there will probably not be anything allowed to be sold as substantially equivalent because it's impossible to prove. Everything would be pulled until they, each and every device, liquid, etc., individually are approved by the FDA as new. Most likely even a separate application for each individual flavor/nic level combination.

And have you looked at the information and study requirements FDA has set for new products? Impossible for anyone other than the big tobacco companies to be able to provide.

What exactly about this very realistic scenerio is fear-mongering? It's easy to SAY that there were e-cigs prior to the date, it's easy to SAY today's products are even better, but it need to be PROVEN - to FDA - under THEIR rules.

 

[wv2win]

Wake up ECF. Especially those "usual suspects" on this forum who think that bans, restrictions and regulations are a good thing.

Why have you not yet joined CASAA? Why are you not supporting CASAA?

Thank you Bill, for staying diligent on our behalf.

 

[InfernoOrangeSS]

I, for one, am very glad we have people working to keep vaping legal. I am in the process of reading through these legislative threads. I am very new to the vaping culture. It has broken my need to smoke deadly cigarettes and has me feeling better than I have in 20 years. I will do all I can to help preserve vaping. I am one small voice, but together we can be loud and vocal. I am a member of CASAA. My point in this post is I want to thank those who go above and beyond in helping and watching.

 

[zapped]

I don't have time to read through all these links, but let me touch on something from OP and tell me if I'm wrong.
He said that the product needed to either be better than product before 2007 (first ecig was made 2003, so as long as our JUICE isn't worse than original juice then we are ok) which e-cigs do make the cut. They can't ban the device itself, just like they can't ban glass pipes typically associated with illicit drugs, because it has other uses. It would be the juice they would ban, however, there are FDA approved ingredients that juice makers can use, so regulation would prevent something like Titanium Dioxide that was discovered in Unicorns Milk recently from happening again.
I am for regulation, but only way to make sure vapers don't get the short end of the stick is to be proactive in helping set what those regulations are. Fear-mungering and paranoid-ramblings of (unrealisitic) WORST case scenario won't help.

No offense but you have a join date of this month and a whopping 9 posts.While I admire your courage in admitting that youre in favor of FDA regulation on these forums, I submit that you dont have nearly enough information to make an informed decision that affects the rest of us.

Bill has been working tirelessly for our cause since before I first met him in Fredericksburg Va almost 5 years ago and I know I'm not alone when I say he has my deepest gratitude and admiration. He also knows more about vaping and politics than almost anyone I know and Ive had the privilege to meet a lot of people in our community in the handful of years Ive been here.

His words carry a lot more weight than yours do and are echoed in the sentiments of the majority of people who post here.

If you haven't done so already you really need to visit the CASAA website and read the studies and information they have listed there. Knowledge is power and the key to making a decision that's based on fact instead of feelings or political stance.

 

[etherealink]

OK, I'm a bit new here to ECF as well but not to vaping. Quick question as I read and work up a decent post though, any comments on the National Vapers Club and their actions? I am finding a lot of two-sided or misinformation about them.

 

[zahzoo]

This FDA direction is quite concerning and certainly something we should all be vocal in expressing our opposition to.

I spent a few hours searching and reading material on the FDA Tobacco Products website. I was wondering if someone can point me to information on proposed regulation in two specific areas?

Hardware... this is a rapidly growing segment of the e-cigarette market. But specifically the components that are made and sold but contain no pre-filled liquid nicotine or tobacco product nor even resemble cig-a-like devices. For example batteries, battery tubes, mods, etc... and tanks (Pro tanks, EVODs, CEx, RBA, RDA) plus other common components such as wicks, kanthal, etc.

While today these items are prevalently marketed as e-cigarette components have multiple usage applications that may or may not involve nicotine or other substances. Where would these devices fall within the proposed FDA deeming regulations, if at all?

Liquid Nicotine... Given the prevalence and availability within the current market. I can only assume this product has minimal regulation and is FDA approved for unlicensed sale just as vegetable glycerin and propylene glycol are today. The same with food grade flavorings. While these products are widely sold within the e-cigarette retail business... they are also sold through common chemical retail channels as well. Are there specific proposals in the FDA Tobacco regulations that would restrict legal sales of liquid nicotine outside of the e-cigarette retail market?

 

[etherealink]

OK, I'm late on the bandwagon and haven't read everything yet for quite a few reasons but I'm getting there.

Info read and a good long vape to clear my head so here we go.

Excerpts from the info Bill cited:

"...Tobacco Control Act gave the FDA the authority to review applications and determine which new tobacco products may be sold and distributed under the law in order to protect public health..."

This was granted by the group concerned with family health and safety (don't recall the exact name of the group) and *I* assume was done so that the FDA had more authority to regulate anything that could have an impact on that health and safety. Part of this makes sense as I would think that none of us wants underage kids to get ahold of a nicotine delivery device (NDD, my term lol), yet this is not what's being referred to in this specific part of the FDA. If I understand right, the concern is that NDD's have not been proven to be substantially equivalent (similar enough) in terms of safety (as of yet, at least) for the FDA to allow their sale in the US.

*I have not checked, but I would guess that the bidi's that were banned are new variations as bidi's were sold for years before 2007 and that not all bidi's were banned across the board.*

The ruling on SE goes a bit further on new products while still allowing an avenue for manufacturers to prove that they meet guidelines (more on that in a bit). It basically states that products must meet SE, basically saying they must be at least as safe as those manufactured, approved and sold in Feb. 2007 - that is not saying that those products caused no harm, just that they were within acceptable limits. More or less, manufacturers would be compelled to prove that they are as safe or safer than those products from 2007, which I assume is why Bill is looking for one.

The SE basically boils down to makers of ecigarettes having to prove that they are safe, the catch is going to be what is required to do so and how deeply the FDA will get into the juices, devices, batteries, wicks and wires and the like. Take a look at the guidelines for SE to manufacturers and you can see that most rebuilding and diy could be ready to be illegal.

"...new products had the same characteristics as a predicate product, or had different characteristics but did not raise different questions of public health, the basis used by the FDA..."

"...FDA has issued draft guidance containing more information on the agency’s enforcement policy for certain tobacco products that the FDA finds not substantially equivalent..."

Regarding the bidi's specifically, the FDA has guidelines in place that would make things very interesting if ecigarettes were banned the same way.

"... inventory may be subject to enforcement action, including seizure, without further notice..."

Looking at the guidelines for substantive equivalence to manufacturers (905j), a few things stick out. Material characteristics of composition, ingredients and heating source as well as a listing of any harmful ingredients. Of course this must all be tested and proven, but that's a bit obvious.

Simply put, every component of an ecigarette that has anything to do with the delivery of nicotine through the device; including all components of juice, anything used in diy and anything used in the components of all parts of the device (including the battery, and coil/wick assembly) would be called into question. It is possible that rebuilding and diy could be ruled as not meeting SE unless the components used meet SE individually and cannot create a situation that would be outside of SE specs once combined (ie: sub-ohming on a battery not safe for that purpose) and would therefore be illegal.

What this is going to come down to is that if the FDA rules that ecigarettes do not meet SE, we will lose ecigarettes. Bidi's are a very small section of the tobacco market and have very little impact on Big Tobacco, whereas ecigarettes have a large impact on sales of traditional cigarettes.

That said, skipping the lobbying and greed, just the SE specs alone could put ecigarettes out of commission for health and safety concerns no matter how unfounded we may think (or know) they are.

I have a feeling that we are only scratching the surface of this disaster and would like to know where to go from here to keep my very much loved mods and devices.

All comments welcome.

 

[2coils]

This FDA direction is quite concerning and certainly something we should all be vocal in expressing our opposition to.

I spent a few hours searching and reading material on the FDA Tobacco Products website. I was wondering if someone can point me to information on proposed regulation in two specific areas?

Hardware... this is a rapidly growing segment of the e-cigarette market. But specifically the components that are made and sold but contain no pre-filled liquid nicotine or tobacco product nor even resemble cig-a-like devices. For example batteries, battery tubes, mods, etc... and tanks (Pro tanks, EVODs, CEx, RBA, RDA) plus other common components such as wicks, kanthal, etc.

While today these items are prevalently marketed as e-cigarette components have multiple usage applications that may or may not involve nicotine or other substances. Where would these devices fall within the proposed FDA deeming regulations, if at all?

Liquid Nicotine... Given the prevalence and availability within the current market. I can only assume this product has minimal regulation and is FDA approved for unlicensed sale just as vegetable glycerin and propylene glycol are today. The same with food grade flavorings. While these products are widely sold within the e-cigarette retail business... they are also sold through common chemical retail channels as well. Are there specific proposals in the FDA Tobacco regulations that would restrict legal sales of liquid nicotine outside of the e-cigarette retail market?

There has been a big debate about these items within our community. It really depends on how the TCA is interpreted. Some folks think hardware will not be touched while others believe it will. I believe these items can be regulated in some way. Nobody really knows how the FDA will apply the rule or what e-cig specific regulation will be proposed except the FDA.
Two good interviews to listen to::
https://soundcloud.com/vp-live/bill-godshall-returns start at 59 mins
VPLive Vape Team Episode #85: Inside FDA Regulation - YouTube
Two interesting takes on FDA regs