FDA What about non-nicotine containing juices/products?

[akwit]

Forgive me for any ignorance I might display here as I am new to this space:

What about the disposable products and the juices (and I believe there are quite a few juices) that don't contain any nicotine?

Are they lumped in under the PMTA requirements and if so, do you think the FDA might ultimately be a bit more lenient with them?

Although not as desirable as nicotine containing products, some people just want something to puff on, that just has a nice flavor (like myself).

 

[retired1]

It's all covered under the deeming regulation, regardless of content.

 

[Verb]

Nicotine free Liquid can be considered a tobacco product if the FDA determines it is reasonable to believe the product will be mixed with nicotine by the end users. It the FDA approves the product through a PMTA (they won't), the product will have to be labelled "this product is made from tobacco."

Going after these products opens a judicial nightmare. Particularly if the manufacturing company is completely divorced from nicotine or tobacco products.

If the product is not labelled ejuice or eliquid, is not sold at a location that sells nicotine products or nicotine vaping equipment, and the manufacturer does not make anything containing nicotine, the product should be in the clear.

Still, there is uncertainty. Unfortunately, the Chicago tax which exempts nicotine free eliquid was a set up to create the data set showing all zero nicotine eLiquid is sold for nicotine to be added. And from what I read of the Vape shops in Chi-town, the data confirms the hypothesis.

 

[akwit]

Nicotine free Liquid can be considered a tobacco product if the FDA determines it is reasonable to believe the product will be mixed with nicotine by the end users. It the FDA approves the product through a PMTA (they won't), the product will have to be labelled "this product is made from tobacco."

Going after these products opens a judicial nightmare. Particularly if the manufacturing company is completely divorced from nicotine or tobacco products.

If the product is not labelled ejuice or eLiquid, is not sold at a location that sells nicotine products or nicotine vaping equipment, and the manufacturer does not make anything containing nicotine, the product should be in the clear.

Still, there is uncertainty. Unfortunately, the Chicago tax which exempts nicotine free eLiquid was a set up to create the data set showing all zero nicotine eLiquid is sold for nicotine to be added. And from what I read of the Vape shops in Chi-town, the data confirms the hypothesis.

Verb-thank you for this comprehensive response.

What about a disposable that has no nicotine?
Meaning, you cant add nicotine to it. (You could technically open the thing up but maybe the manufacturer could seal the device).

Also, I wonder if the FDA would even bother with these type sof companies (now)...as they will intially have their hands full with nicotine containing ones...

 

[Rewired5150]

Nicotine free Liquid can be considered a tobacco product if the FDA determines it is reasonable to believe the product will be mixed with nicotine by the end users. It the FDA approves the product through a PMTA (they won't), the product will have to be labelled "this product is made from tobacco."

I think its ridiculous that they can regulate something based on what someone may do with it. Its like making an age requirement for Coke because the end user may mix it with Jack Daniels, or Capitan Morgan. This country is getting to be ridiculous

 

[FishingBuffalo]

If a flavor profile includes nic choices including zero mg, the zero is considered a tobacco product. If FDA thinks a zero only profile (no nic choices) is intended for end user to add nic or mixed with other nic (aka tobacco products), it will be considered a tobacco product. The way it is written the toilet paper I use in the morning while sitting and taking a vape may arguably be a tobacco product.

 

[DC2]

What about the disposable products and the juices (and I believe there are quite a few juices) that don't contain any nicotine?

I think a zero nicotine disposable is quite possibly free and clear of the regulations.
If anything is, it would be a zero nicotine disposable.

But we aren't lawyers, so...

 

[Kent C]

Forgive me for any ignorance I might display here as I am new to this space:

What about the disposable products and the juices (and I believe there are quite a few juices) that don't contain any nicotine?

Are they lumped in under the PMTA requirements and if so, do you think the FDA might ultimately be a bit more lenient with them?

Although not as desirable as nicotine containing products, some people just want something to puff on, that just has a nice flavor (like myself).

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

From the deeming doc, page 164:

"In addition, nicotine-containing cartridges that include varying degrees of nicotine are
components or parts and subject to FDA's chapter IX authorities because they constitute an
assembly of materials intended or reasonably expected to be used with or for the human
consumption of a tobacco product and do not constitute a tobacco product accessory. Upon the
effective date of this final rule, FDA intends to regulate the entire line of cartridges (including
cartridges that include varying degrees of nicotine or those that do not contain nicotine, if they
meet the definition of component or part)."

There are other parts of the doc that deal with no nic stuff but mainly regarding labels and warnings. If you go to the link above and use a 'find'/search function and put in "does not contain nicotine" - you'll see the other references.

 

[DC2]

"In addition, nicotine-containing cartridges that include varying degrees of nicotine are
components or parts and subject to FDA's chapter IX authorities because they constitute an
assembly of materials intended or reasonably expected to be used with or for the human
consumption of a tobacco product and do not constitute a tobacco product accessory.

Please to be corrected if I am wrong...

I think if cartridges are sold seperately with zero nicotine they are considered tobacco products.
But it sold as a complete and unadulterated product ready for use, they are not.

This is how I've been interpreting things anyways.
But I haven't stayed at a Holiday Inn Express for a long time now.

 

[WillyZee]

my understanding is ... even zero nicotine eLiquid must have a label stating that it is a tobacco product

 

[sofarsogood]

Verb-thank you for this comprehensive response.

What about a disposable that has no nicotine?
Meaning, you cant add nicotine to it. (You could technically open the thing up but maybe the manufacturer could seal the device).

Also, I wonder if the FDA would even bother with these type sof companies (now)...as they will intially have their hands full with nicotine containing ones...

They are the Federal DRUG Administration. They control drugs for the government. The government gets most of the money from tobacco sales. They are moving agressively to protect their business. That's what drug dealers do. I think the smart thing for them to do is to hand out those little sample packs of cigarettes to the kids like they did when I was a kid to encourage them to smoke instead of vape. It worked with me. If the kids don't smoke a lot of government employees will be laid off. Isn't that a terrible thought?

 

[puffon]

FDA= Food and Drug Administration

 

[DC2]

my understanding is ... even zero nicotine eLiquid must have a label stating that it is a tobacco product

I see where you're going with this, but...
Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS)

Nicotine Warning Statement
The product packages and advertisements of all newly-regulated covered tobacco products must bear the following warning statement:

“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”

If the tobacco product manufacturer submits a self-certification statement to FDA that the newly-regulated tobacco product does not contain nicotine (and that the manufacturer has data to support this assertion), then an alternate statement must be used on product packages and advertisements:

“This product is made from tobacco.”

This only applies to a tobacco product manufacturer of a regulated tobacco product.

A closed-system disposable zero nicotine device would not be considered a tobacco product.
Well, as long as it is sold by Starbucks or Panera Bread.

 

[Kent C]

http://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm499354.pdf

3. What is a “covered tobacco product”? Covered tobacco product means any tobacco product deemed to be subject to the FD&C Act pursuant to § 1100.2 of this chapter (i.e., subchapter K), but excludes any component or part that is not made or derived from tobacco. Covered tobacco products include ENDS, cigars, pipes, waterpipe, dissolvable nicotine products, to name a few, as well as parts and components made or derived from tobacco, e.g., an e-cigarette cartridge containing e-liquid made or derived from tobacco.

For example:

• An e-liquid with nicotine is a covered tobacco product;
• An e-liquid without nicotine may be a component (and subject to FDA’s tobacco control authorities) if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product and does not constitute a tobacco product accessory (e.g., with liquid nicotine); but
• An e-liquid that does not contain nicotine or tobacco or a tobacco derivative is not a covered tobacco product as defined by the Deeming Rule (§ 1140.3; 1143.1).

And:

http://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm499352.pdf

E. E-liquids
For the purposes of this guidance document, liquid nicotine and nicotine-containing e-liquids (i.e., liquid nicotine combined with colorings, flavorings, and/or other ingredients) are generally referred to as e-liquids. Liquids that do not contain nicotine or other material made or derived from tobacco, but that are intended or reasonably expected to be used with or for the human consumption of a tobacco product, may be components or parts and, therefore, subject to FDA’s tobacco control authorities.

F. Finished Tobacco Product
The term finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use. For example, an e-liquid sealed in final packaging that is to be sold or distributed to a consumer for use is a finished tobacco product, but in contrast, an e-liquid that is sold or distributed for further manufacturing into a finished ENDS product is not itself a finished tobacco product. At this time, FDA does not intend to enforce the premarket authorization requirements against e-liquids or other components and parts of newly deemed products that are not finished tobacco products. Finished tobacco products that are not covered tobacco products are not subject to the health warning statement requirements (21 CFR part 1143), age and identification restrictions (21 CFR 1140.14), and vending machine restrictions (21 CFR 1140.14) (see definition of covered tobacco product).

 

[akwit]

http://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm499354.pdf

3. What is a “covered tobacco product”? Covered tobacco product means any tobacco product deemed to be subject to the FD&C Act pursuant to § 1100.2 of this chapter (i.e., subchapter K), but excludes any component or part that is not made or derived from tobacco. Covered tobacco products include ENDS, cigars, pipes, waterpipe, dissolvable nicotine products, to name a few, as well as parts and components made or derived from tobacco, e.g., an e-cigarette cartridge containing e-liquid made or derived from tobacco.

For example:

• An e-liquid with nicotine is a covered tobacco product;
• An e-liquid without nicotine may be a component (and subject to FDA’s tobacco control authorities) if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product and does not constitute a tobacco product accessory (e.g., with liquid nicotine); but
• An e-liquid that does not contain nicotine or tobacco or a tobacco derivative is not a covered tobacco product as defined by the Deeming Rule (§ 1140.3; 1143.1).

And:

http://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm499352.pdf

E. E-liquids
For the purposes of this guidance document, liquid nicotine and nicotine-containing e-liquids (i.e., liquid nicotine combined with colorings, flavorings, and/or other ingredients) are generally referred to as e-liquids. Liquids that do not contain nicotine or other material made or derived from tobacco, but that are intended or reasonably expected to be used with or for the human consumption of a tobacco product, may be components or parts and, therefore, subject to FDA’s tobacco control authorities.

F. Finished Tobacco Product
The term finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use. For example, an e-liquid sealed in final packaging that is to be sold or distributed to a consumer for use is a finished tobacco product, but in contrast, an e-liquid that is sold or distributed for further manufacturing into a finished ENDS product is not itself a finished tobacco product. At this time, FDA does not intend to enforce the premarket authorization requirements against e-liquids or other components and parts of newly deemed products that are not finished tobacco products. Finished tobacco products that are not covered tobacco products are not subject to the health warning statement requirements (21 CFR part 1143), age and identification restrictions (21 CFR 1140.14), and vending machine restrictions (21 CFR 1140.14) (see definition of covered tobacco product).

Kent-thank you for your thorough responses and links to pertinent information.
That said, you appear to be referring to E-Juices.
I am referring solely to a company that does not sell and E-Juice but rather only sells disposables, that have zero nicotine (and neither nicotine nor tobacco are not offered at all by this company).
Further, the disposable would be sealed and would not even allow for someone to add nicotine in/to it.

I wonder then if the above description classifies this disposable product as a finished tobacco product (simply because it would be a "cigalike" device)? Im guessing it does not...and therefore it would not require a PMTA (for now).
Would you agree this assumption is correct?

Im just trying to discern between "covered" and "finished" and whether or not a disposable company that has zero nicotine in any of its products or in its manufacturing facilities, would be responsible to submit a PMTA (or even an exemption).

 

[Kent C]

I wonder then if the above description classifies this disposable product as a finished tobacco product (simply because it would be a "cigalike" device)? Im guessing it does not...and therefore it would not require a PMTA (for now).
Would you agree this assumption is correct?

I just was copy/pasting the parts of the deeming and guidance docs that seem to apply to your question without taking an opinion on it. There is much 'talk' about "closed systems" in other commentary, but I see nothing in the docs that mention it specifically, although the 'sealed' wording tends to point to that.

Imo, and again, just opinion - from what is said above - it appears that it's just the opposite - an eliquid (vs. a cartridge with eliquid) that has no nicotine is neither a "finished tobacco product" or a "covered tobacco product".

"an e-liquid that is sold or distributed for further manufacturing into a finished ENDS product is not itself a finished tobacco product."

• An e-liquid that does not contain nicotine or tobacco or a tobacco derivative is not a covered tobacco product as defined by the Deeming Rule (§ 1140.3; 1143.1).

However, it appears that a cartridge that contains no nic is both:

An e-liquid without nicotine may be a component (and subject to FDA’s tobacco control authorities) if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product and does not constitute a tobacco product accessory.

Here the mention of 'accessory' refers to the fact the distinction that the FDA makes wrt 'components' (covered by the deeming) and 'accessories' (not covered by the deeming). So an eliquid without nicotine MAY be a "component" - if intended or reasonably expected to be vaped, as would be assumed if it were part of a sealed system for human consumption. AND is 'not an accessory' - which means it doesn't have the exemption regular accessories would have - ashtrays, PV holders, cases, etc.

And this is the closest I've seen that would refer to a 'closed system' - ie 'sealed':

The term finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use. For example, an e-liquid sealed in final packaging that is to be sold or distributed to a consumer for use is a finished tobacco product.

Now that part doesn't mention no nicotine eliquid but the part just prior to that does:

Liquids that do not contain nicotine or other material made or derived from tobacco, but that are intended or reasonably expected to be used with or for the human consumption of a tobacco product, may be components or parts and, therefore, subject to FDA’s tobacco control authorities.

And it says that it is 'therefore subject to FDA's TC authorities - which I interpret as part of the deeming. I could be wrong, of course, and the best path for some manufacturer, who intends to build and sell 'closed systems' with no nic, would be to contact the FDA directly :- )

There are other sources - non-FDA - that may speak of this. And it's obvious not everyone reads the docs the same, but my aim was to report what the docs say and let people figure it out.

 

[Endor]

The long and short of this is....

There are contradictions and creative wording throughout this hot mess that is the deeming documents. Until there is legal precedent established, who knows if it is or not allowed. For example, Kent's great work at pulling together some tidbits that are relevant seem to contradict themselves quite a bit in this area.

Here's what I think happened here. Before the deeming came out, we all pontificated on how we could work around the system by buying unflavored nicotine in various strengths (which would be FDA-approved via a PMTA) and add purchased "flavor packs" (which would be zero-nic and hence not applicable to a PMTA).

As we found out later, the FDA had been monitoring these discussions. They added this whole "reasonable expected to be used as a tobacco product" language to cover zero-nic and to close this loophole. In the process, it became a messy area.

And yes, as was posted earlier, it is ridiculous and analogous to age-restricting Coke because an underage person might add rum to it.

But so is having to mark zero-nic with "This product is made from tobacco", when it contains PG (not made from tobacco), VG (not this, either) and water-based flavorings (clearly not tobacco-based). That would force a manufacturer to outright lie... a zero-nic product is as much a tobacco product as the aforementioned can of Coke. I can't see how that could be constitutionally legal.

 

[DC2]

As we found out later, the FDA had been monitoring these discussions. They added this whole "reasonable expected to be used as a tobacco product" language to cover zero-nic and to close this loophole. In the process, it became a messy area.

That's one of the main reasons I see a HUGE smackdown coming for the FDA.
But it's not even the only reason.

If this "hot mess" gets through court system unscathed...
There really is no hope for humanity...

But it won't.

The question now is how much "scathing" is going to happen.
Not sure if that's a word or not.

 

[Endor]

That's one of the main reasons I see a HUGE smackdown coming for the FDA.
But it's not even the only reason.

If this "hot mess" gets through court system unscathed...
There really is no hope for humanity...

But it won't.

The question now is how much "scathing" is going to happen.
Not sure if that's a word or not.

Deep down, I tend to agree with you that there will be some level of success with these lawsuits. I believe that there are First Amendment issues.

At a minimum, it violates my constitutional right to "pursuit of happiness".

 

[Kent C]

At a minimum, it violates my constitutional right to "pursuit of happiness".

And your right to freedom.... to (in their view) harm yourself as long as no harm comes to others.

And when in fact, we have stopped harming ourselves (and in their view - others) by quitting smoking.