FDA components and parts not derived from tobacco excluded from covered tobacco product

[tangerine3]

Just FYI. I had recently watched a video from the FDAs website regarding the requirements for asking for photo ids for ppl under age 18 and found this out it is confusing but clearly they are now saying that any parts and/or components that are NOT derived from nicotine do not fall under a "covered tobacco product" and therefore do not need photo identification to purchase. I can't find the video but here is a response they sent me when I specifically asked them about it.

"Dear Ms. Waters,
Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, “Deeming tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and tobacco Control Act” (Deeming rule).
The Deeming Rule amends the Code of Federal Regulations, 21 CFR part 1140, to prohibit the sale of covered tobacco products to persons under the age of 18 and requires retailers of covered tobacco products to verify the purchaser's birth date by reviewing the individual's photographic identification (§ 1140.14). The Deeming Rule defines “covered tobacco product” to include all tobacco products that are subject to the Deeming Rule, but “excludes any component or part that is not made or derived from tobacco” (§ 1140.3). Therefore, the definition of covered tobacco products includes all deemed tobacco products, including components and parts, made or derived from tobacco. Components or parts that are not made or derived from tobacco do not meet the definition of “covered tobacco product.”
For More Information
Not all legal requirements related to tobacco products are discussed in this response. Please remember that it is your responsibility to comply with all applicable provisions of the FD&C Act, and other federal, state, or local requirements that apply to you.
Final Rule and Accompanying Documents

• Final Rule: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
• Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
• Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS); Draft Guidance for Industry

To assist the newly-regulated tobacco industry in complying with the requirements, the FDA has also published several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products:
Resources for Additional Information
FDA continues to update its Deeming webpage to provide information designed to help industry understand the Deeming rule. We anticipate that many of your questions will be addressed by the resources available on this website. We have also created a chart that may help you determine which provisions apply to you and the timeframes for complying. In addition, FDA plans to post Tobacco Compliance Webinars to our website and updates will be provided as additional webinars are available.

We also encourage you to subscribe to FDA’s “This Week in CTP.” By subscribing, you’ll receive updates about regulatory activities, retailer notices, upcoming events, and public education campaigns.

Should you have further questions after reviewing this information, you may contact CTP using the following communication methods:

Email:
SmallBiz.Tobacco@fda.hhs.gov
Phone:
1-877-287-1373
Mail:
Food and Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993

 

[ENAUD]

This sounds very encouraging, and at the same time, the double speak confuses the heck out of me...

 

[choochoogranny]

Sounds like only nicotine for DYI and e-juice containing nicotine is a "tobacco product" and requires the photo ID. Would be good, since they should now be very familiar with all the bits and pieces of vaping, they post a list of products that DO require photo ID.

 

[Letitia]

Encouraging. Probably due to legal advice concerning all parts of our gear. The tobacco qualification would eliminate the many pending lawsuits filed that the FDA had no hope of winning. Now if all the states would just get on board...

 

[papergoblin]

All that means is the FDA isn't regulating it, look to the ATF. Mods and attys will be labeled as paraphernalia just like rolling machines, papers and such are with smokes. That or it will be vague so that each state can do as they please.

The only thing I can see, that won't be regulated is batteries and chargers on the mod side and PG/VG on the liquid side. The only way they aren't going to regulate something or tax it to death, is if it has a popular and valid use in some other market.

Then again anything being sold by a "tobacco" company my be taxed by intent to sale. They love to use the word "intent" a lot. Intent is a huge legal noose that is used a lot in an industry I used to work in. Intent leaves a lot of "gray" area, but guess who gets to determine what "your" intent is.

This is why all those 2nd Amendment people won't budge an inch, it's because if you give an inch people take a mile. Nothing is done with common sense or actual facts anymore (if it ever was). Heck look at NY, can't buy a soda of a certain size.

They need to get out there and find a way to effectively (and efficiently) enforce the laws/regulations we have, before piling on more. It might actually negate the need for some new laws and regulations

 

[sofarsogood]

The way I read the above is that mods, atomizers and electronics designed for vaping are NOT covered by the deeming. If that is correct then they are not subject to pre market approval regulations that might eventually take most products off the market. If that is right the only thing that needs to be stockpiled is nicotine?

I saw a recent interview with the Evolv owners where they talked about the significant money they've spent attempting to comply with the deeming rules. Are they now exempt because the FDA has decided vaping hardware is not derived from tobacco?

If the FDA has decided that hardware is not derived from tobacco and is not subject to deeming that should be very significant news that we should be hearing more about so what am I missing here?

 

[ENAUD]

If the FDA has decided that hardware is not derived from tobacco and is not subject to deeming that should be very significant news that we should be hearing more about so what am I missing here?

I thought the same thing. It would be nice to hear from folks who have done the deep dive into the Deeming regs or someone who is active in tobacco control or advocacy. I tried to research this and found the part about not covered in the definitions section, I am not versed enough to even know what that means regarding what that really means, and whether or not it influences these things regarding there status as a finished tobacco product in the eyes of the FDA.

 

[ENAUD]

Perhaps @Bill Godshall could offer some help here if he sees this tag?

 

[zoiDman]

The way I read the above is that mods, atomizers and electronics designed for vaping are NOT covered by the deeming. If that is correct then they are not subject to pre market approval regulations that might eventually take most products off the market. If that is right the only thing that needs to be stockpiled is nicotine?

I saw a recent interview with the Evolv owners where they talked about the significant money they've spent attempting to comply with the deeming rules. Are they now exempt because the FDA has decided vaping hardware is not derived from tobacco?

If the FDA has decided that hardware is not derived from tobacco and is not subject to deeming that should be very significant news that we should be hearing more about so what am I missing here?

Just Curious...

But when did the FDA ever say that Hardware was "Derived from Tobacco" ?

And Isn't this the Difference of a "Tobacco Product" being either a Covered Product, a Component and or Part, or an Accessory?

 

[sofarsogood]

Just Curious...

But when did the FDA ever say that Hardware was "Derived from Tobacco" ?

And Isn't this the Difference of a "Tobacco Product" being either a Covered Product, a Component and or Part, or an Accessory?

My reasoning is that if hardware wasn't covered by deeming, as suggested above, it wouldn't be subject to the premarket approval process so Evolv wouldn't have spent 100's of thousands of dollars preparing documents to comply with FDA requirements.

During the Obama era the FDA was quite explicitly saying that all the hardware and componants intended for vaping met the definition of "derived from tobacco". Has the FDA now changed that? The people at Evolv would likely know the answer to that one.

 

[zoiDman]

My reasoning is that if hardware wasn't covered by deeming, as suggested above, it wouldn't be subject to the premarket approval process so Evolv wouldn't have spent 100's of thousands of dollars preparing documents to comply with FDA requirements.

During the Obama era the FDA was quite explicitly saying that all the hardware and componants intended for vaping met the definition of "derived from tobacco". Has the FDA now changed that? The people at Evolv would likely know the answer to that one.

I see No Suggestion that Hardware, under certain circumstances, is not subject to the Deeming Rule Set. What I do see is a Clarification as to what a "Covered Tobacco Product" is and Isn't.

One thing to Remember is Deeming hasn't really changed.

To do that, you would need the FDA to basically do the Deeming Process again. And or for Congress to Change current Legislation under which the Deeming was created.

 

[sofarsogood]

I see No Suggestion that Hardware, under certain circumstances, is not subject to the Deeming Rule Set. What I do see is a Clarification as to what a "Covered Tobacco Product" is and Isn't.

One thing to Remember is Deeming hasn't really changed.

To do that, you would need the FDA to basically do the Deeming Process again. And or for Congress to Change current Legislation under which the Deeming was created.

It seems the FDA has demonstrated broad disgression since the Trump administration. I re read the FDA "clarification" above. Your response doesn't settle the issue for me. It rambles into tortured bureaucratic mumbo jumbo that's expertly crafted by FDA lawyers to say anything they might later decide they want it to mean. I bet 2/3 of FDA employees are lawyers and the rest are their secretaries and paralegals.

 

[zoiDman]

I think where the Problem arises sometimes is when people take something that the FDA says, like Age Requirements for sales and then tries to Apply them to something that the FDA Didn't say. Like Component Tobacco Products not being subject to FDA Deeming.

 

[mcclintock]

I found this: "However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product," -- from Commonly Asked Questions: About the Center for Tobacco Products

Humm, synthetic might be allowed?!? Otherwise, I don't know where you're seeing a change, at least from those links, except some clarifications.

 

[zoiDman]

", if it is not intended or reasonably be expected to be used in such a fashion."

A Closed System 0mg e-Cig might stand a Good Chance of not falling under Deeming Regulation. Because the concept of "Unadulterated" is mentioned Many Times in the Deeming Rule Set.

It also Undermined the Portion of the NicoPure Lawsuit regarding Intended Use.

 

[Rossum]

Humm, synthetic might be allowed?!?

I think that's a dead horse. If synthetic becomes popular, the FDA will smack it down as an unapproved drug or drug delivery device, which is exactly what they did back in 2009 or thereabouts, until Judge Leon told 'em something to the effect of: "Nope, since the Nicotine is derived from tobacco, the most you can do is regulate this stuff as a tobacco product!" But of course, synthetic nic isn't derived from tobacco, so it doesn't qualify for exemption.

 

[ENAUD]

I think that's a dead horse. If synthetic becomes popular, the FDA will smack it down as an unapproved drug or drug delivery device, which is exactly what they did back in 2009 or thereabouts, until Judge Leon told 'em something to the effect of: "Nope, since the Nicotine is derived from tobacco, the most you can do is regulate this stuff as a tobacco product!" But of course, synthetic nic isn't derived from tobacco, so it doesn't qualify for exemption.

Yeah, that is the jist of it right there, the ball is clearly in their court, and the ONLY way we will ever be free and safe from whichever way the wind blows legislation, will be to remove vaping from tobacco control and the hands of the FDA, and placing it into a different type of regulation, that hopefully would only be concerned with mitigating any risky ingredients, components, and devices as the science and technology advances in this field. The FDA has repeatedly shown disdain towards vaping, and a conflicting viewpoint and stand on how they are going to regulate these things.
They could change direction and focus on a whim tommorrow if it pleases them.

 

[mcclintock]

And yet the bizarre thing about synthetic there is they (someone writing their site) mentioned it, I was only commenting -- and was really just looking for the statement that only closed system 0mg might be allowed as not containing nicotine or being made from tobacco.. I didn't quote "case by case basis" and some more, see link.