U.S. FDA 2016 Tobacco Deeming Regulation

As of 28 July 2017, enforcement delayed from 8.8.2018 to 8.8.2022

  • Recorded into the Federal Register on 10 May 2016 and became effective on 8 August 2016 as Federal Law, Code of Federal Regulations (CFR) TITLE 21 Parts 1100, 1140, and 1143.
  • Required by Federal Food, Drug, and Cosmetic Act (the FD&C Act passed in 1938), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act passed in 2009) gives the tobacco deeming mandate and authority to the U.S. FDA to regulate tobacco products.
  • Deems all e-Cigarettes and components regardless of nicotine content "Tobacco Products" including any whose "intended use" can be the delivery of nicotine.
  • Predicate date or grandfather date is 15 February 2007.
  • All products "on the market" before that date can be legally sold, all others are illegal/banned/prohibited until they pass SE, MRTA or PMTA compliance pathway.
  • Products that were "on the market" prior to 15 February 2007 are no longer manufactured.
  • Law allowed 2 years for products "on the market between 2.15.2007 and 8.8.2016" to be sold as long as they followed the prescribed pathway compliance dates/objectives and also prevents the sale of any "new" products on the market after 8.8.2016 - both provisions moot because enforcement delayed until 8.8.2022 at which time all must be removed from store shelves unless one of the pathways is completed and the FDA has granted permission.
  • No e-cigarette vendor or manufacturer can afford the millions of dollars necessary to follow the compliance pathways.
  • The law does not allow enough time to complete the testing required by the law - physically impossible - proves the tobacco deeming regulation is arbitrary and capricious.
  • Regardless, all law suits against the FDA have failed and all e-Cigarettes on the market today are deemed illegal by this federal law. It just isn't being enforced yet.
  • U.S. FDA has stated they will delay enforcement until 2022, assumed 8.8. This is just verbal, and can be changed at any time - nothing in the law allows or disallows enforcement delay.
  • Ingredient list submission delayed until 8.8.2018 (large business) and 11.8.2018 (small business) - as of Nov 2017. No other extension has been allowed. All original compliance dates had to be met.
  • Hazardous and Potential Hazardous Constituents (HPHC) declaration due 11.8.2019 - 93 on draft list and 20 of these require testing as of 2012 for tobacco.
  • The FDA has sent out 26 "CTP Letters to Industry" e-cigarette companies (retailers mostly) as of my read of the page on 28 Jan 2019.

    Asks these companies to supply a whole lot of incriminating evidence while stating "not intended to communicate that FDA is considering enforcement action".

    Not even a drop in the bucket as to what is out there today that is technically illegal by the deeming reg. Like 26 out of a million SKUs. The FDA knows it is overwhelmed and doesn't even try to cover them all. So why so few? It is my belief these are based on citizen filed complaints. Which is horrible if I am correct. Imagine...got a beef with a vape shop or a competitor, well then just report 'em. Can be used as retaliatory and worse yet even coercion. THIS IS VERY BAD Not only do I not agree with doing this, the FDA needs to stand this down immediately. This is a tool for bad people doing bad things and does not protect the public health, it guarantees evil and possibly criminal behavior. IMHO the FDA either should enforce the law as written or do nothing. Half measures like these entice bad, not good.

    Reading the letter to JUUL the FDA directly threatens to start enforcement on them immediately and therefore prior to 2022. SO like I say elsewhere on this site, the FDA can do whatever it wants, it can change the 2022 enforcement delay any time it wants to. And I believe later this year or early next it will for all vape products in FDA terminology "ENDS" products.

    Make no mistake, all e-cigarettes, e-liquid, vaping components and accessories on the market today are ILLEGAL by Federal Law.

SE

(Substantial Equivalency)

Not a pathway for e-Cigarettes because today's e-Cigarettes are SO MUCH different from those that existed prior to the predicate date and they aren't manufactured anymore. Today's e-Cigarettes have nearly a decades worth of improvements in safety and performance.

44 real, far more harmful than the e-Cigarettes, light 'em up and smoke em, kill you dead, causing cancer cigarettes were granted SE in 2016 by the U.S. FDA.

MRTA

(Modified Risk Tobacco Application)

Only one company that I am aware of has entered the MRTA pathway a decade ago and still had not been granted compliance - Swedish SNUS - and in their own words has cost them nearly a $100million in legal and laboratory costs. They were finally granted compliance under PMTA after nearly 12 years and untold millions spent.

I know of no-one else that has entered MRTA with an e-Cigarette or vaping product due entirely to the experience from Swedish SNUS.

PMTA

(Pre Market Tobacco Application)

Only one company that I know of entered PMTA - Swedish SNUS - and that was after entering MRTA and expending millions in legal and laboratory costs and still has not been granted compliance though it is expected this year was granted compliance on November 10, 2015. As of July 2018 396 applications were submitted and none others have been granted (1 out of 396 is 0.25%). All of the data needed and much of the legal work was already paid for under their MRTA process started many years prior. PMTA requires years and millions of dollars for just one product. U.S. FDA has stated "closed systems have a better chance of passing".

I have heard conflicting rumors of e-Cigarettes submitting data for PMTA - assumed none until data is presented. However, there are far more than 396 e-cigarette products (SKUs) as of January 2019. No one knows the exact number, suspected at least 100X that number and rumored upwards of a million.

cGMP

(current Good Manufacturing Practices)

These requirements are beyond Quality Management systems like ISO 9001 and small and medium sized businesses. Think pharmaceutical grade laboratory here. Extremely expensive to start, operate and maintain. Beyond the capabilities of all current e-Liquid and most e-Cigarette manufacturers. Although a couple e-Cigarette manufacturers are trying to establish processes needed for e-Cigarettes through ISO committees.

delayed Enforcement

For two years, presumed 8.8.2018. Presumed due to FDA allowing 2 years to complete PMTA or at least make "substantial" progress. Verbally stated by the U.S. FDA. Delayed enforcement is not provided for in the law and can go away at any moment. Scott Gottlieb (FDA commissioner under Trump administration) announced an extension of enforcement until 2022 but the deadlines for submitting data have changed little and their is no further submittals past July 2018. I.E. the deadline for PMTA submittals remained 8.8.2018.

Registration

Record keeping, ingredients and components origin tracking, registration requiring onerous product details all required on 31 December 2016 and enforced on 1 April 2017 for all vendors and manufacturers.

Free Sample Ban

Applies to all deemed products, covered, finished and components including 0 nicotine.

Health Statement Ban

Manufacturers and Vendors cannot say nor imply e-Cigarettes are safe nor less harmful than cigarettes.

Labeling

Requires e-Cigarettes and components to be labeled "Tobacco Product" even if it contains no nicotine. Based on "intended use".

CvBA

(Cost versus Benefit Analysis)

Woefully inadequate but largely irrelevant. Underestimated the number of shops, employees and economic impact. Does not consider employee income tax lost nor income taxes from life extension of switching to vaping. Did not include taxes spent on Medicare and Medicaid for smoking related illnesses and diseases.

A CvBA is typically required for any regulation but all the Barney Fife U.S. Government organizations like the FDA whose sole product is verbiage that becmoes law, figured out how to blow off these CvBAs and get through this "wicket" easily. In other words, it's always ajoke, nothing more than lip service and as proven by history, the OMB is complicit with this tradition.

Definitions

Covered, Finished, Component – could contain tobacco or tobacco derived substances – nicotine addiction warning label by 2018 – changes to label do not constituent a new product therefore no PMTA required just to add warnings to labels.

Based on intended use - covered, includes 0 nicotine.

Finished as in ready for sale.

A component would be as simple but not limited to a drip tip for example. Possibly even an 18650 battery if it is labeled expressly for an e-cigarette. And yes components must also be labeled as a "Tobacco Product" and "Nicotine is an addictive chemical".

Customs

Import Product codes are already uploaded. Custom seizures happened before, expected to commence at FDA's discretion, maybe 2018, maybe sooner.

There is some thought that only a small percentage of large shipments will be confiscated. However, the import product codes make it easy to seize all shipments large or small and foreign vendors that do not comply with the import product codes that get caught, will pay fines, make it onto a watch list and can get permanently banned.

So they can get real nasty about this. Will they? Anybody's guess. Good luck.

Also includes no sale to minors but that is irrelevant as shops were self imposed not selling to minors and 48 states already had laws.

Child Nicotine Poisoning Prevention Act of 2015 signed into law on January 28, 2016 required compliance by 26 July 2016 and was not a part of the Deeming Regulation. This required all e-Liquid to be packaged in certified (by requirements in the law - Consumer Product Safety Commission [CPSC] standards) Child Resistant Packaging (CRP).


The deadlines for product SKU reporting and ingredients lists have passed, the next hurtle is Harmful and Potential Harmful Constituents (HPSC) testing. FDA regulatory guidance 904 under the food drug and cosmetics act serves as the basis for the requirement and the list of 93 HPHCs in tobacco smoke are established, but nothing yet for vapor. SO the vapor industry is looking at established protocols from non-FDA sources, for example Canada. IMHO, that is unlikely to succeed and likely will result wasted finite resources in the end.


Packaging Requirements

Don't blame vendors or manufacturers for warning labels.

The U.S. FDA Deeming Regulation signed into law and became effective 8.8.2016 as 21 CFR § 1143.3(a)(1), requires this labeling even on chunks of SS and glass that contain no nicotine because they are deemed "components" whose "intended use" is as a "tobacco product", vis-a-vis ENDS (Electronic Nicotine Delivery System == E-cigarette):

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

In addition, e-liquid with 0mg nicotine has to have the tobacco product label on it:

"This product is made from tobacco."

https://www.fda.gov/TobaccoProducts/Labeling/Labeling/ucm524470.htm

Oddly enough if you were not aware of this, then don't fret, most Americans aren't either. And yes many are trying to change this. Full enforcement has been delayed until 8.8.201822 though labeling has not been delayed. Some companies are going ahead and complying expressly so the items CAN be legally sold and will not be confiscated. Expect many other actions until then to occur like pulling products from the businesses that don't card well. Expect flavor bans. Expect location bans. I even expect the FDA to not wait until 2022 as they have said. Given comments that the current FDA commissioner has made, it is apparent the data received thus far as part of the PMTA process deadlines is ...less than impressive. To put it mildly. I really get the feeling he is miffed about it. I also get the feeling he is a good dude, not a shill and like us, was hoping the vaping industry would get it's crap together. Much to all our chagrins, it hasn't.

As far as U.S. Customs, I don't know how other countries do it, but here in the U.S. the package has outside markings that have to be followed according to U.S. Law, and if those markings are not followed, then the package gets confiscated. Note, there is not a push currently to verify proper markings nor confiscation but confiscation did happen back in 2009 for a little while, and it was not 100%, more like random inspections. The point is, it can happen again and be enforced at any time or come 8.8.201822 if not before.

Also, e-cigarette imports are being tracked by big brother uncle sam.

You may not be aware but the deeming regulation also provides for USER FEES, in other words "TAXES" or "TARIFFS" to "help pay for the FDA". Which is of course is a total lie as any monies go directly into the general fund at the U.S. Treasury and not direct to any organization, FDA or otherwise. Further, we didn't want to pay for this deeming reg in the first place. Though details are scarce, shipping codes for electronic cigarettes have already been uploaded by customs and the FDA in preparation for 8.8.201822 . All imports will have to follow the new codes. However, there are some existing HTS codes specific to electronic cigarettes already.

HTS Codes:

8543.70.99

Electronic Personal Vaporizer.

3824.90 (This was for Ruyan)

Cartridge for an electronic cigarette, consisting of a plastic mouthpiece and a plastic tube containing an absorbing material saturated with a solution consisting of propylene glycol, glycerol, tobacco volatile oil, vanilla, menthol, linalool, 2,5-dimethylpyrazine and 2-acetylpyrazine. The cartridge is used in an electronic cigarette which heats and vaporises the solution in the cartridge to produce a vapour mist which is inhaled by the user of the cigarette.

Cartridge for an electronic cigarette, consisting of a plastic mouthpiece and a plastic tube containing an absorbing material saturated with a solution consisting of propylene glycol, glycerol, nicotine and ethyl alcohol. The cartridge is used in an electronic cigarette which heats and vaporises the solution in the cartridge to produce a vapour mist which is inhaled by the user of the cigarette.

 


Older Stuff


It's done, it's over, we lost. Anyone who says anything deferent IS WRONG.

The FDA Deeming regulation is now law. It was posted into the Federal Registry on 10 May 2016.

This kills vaping.

READ THIS

8 August 2016 is the date the law went into effect.

Products developed after 2007 have to be pulled from shelves.

No new products.

Forget loopholes, Forget the Substantial Equivalency.

Gives small vendors up to a year to pull existing eLiquid inventory from shelves.

All products and processes are deemed tobacco products; mods, atomizers, coils, coil/wick build training and the producers of those are deemed tobacco product manufacturers.

You read that right, not just e-Liquid which incidentally is considered a tobacco product even if it has 0 nicotine. Hunks of metal, plastics, glass and electronics are considered tobacco products.

FDA has said they will not start enforcement until 2018.

There are only two potential Miracles left:

Legislation

We need relief in some form. Either move the predicate date to something recent or remove PMTA.

Litigation

Lawsuits against the US Government and the FDA


 

You have from now until maybe 8 August 2022 to prepare for Vaporgeddon.

Expect huge amounts of legislation at the state level before then, taxes and limitations.

 

I am prepared. Are you?


What follows are details of the above, the lengthy version of the above BLUF.

The FDA Deeming Regulation was published 10 May 2016 into the Federal Registry. It is written to take affect on 8 August 2016. All petitions, emails and letters and discussions with the FDA, OMB, Congress by any individual or group has been absolutely useless. All have been ignored. Our voice did not matter.

There are only two avenues left and while possible, I would call them improbable or MLE - Miracle Level Event. And those two avenues are Legislation and Litigation.

The Bishop Cole amendment is a bipartisan bill that comes up for vote in mid-June. It essentially boils down to this modification of the FDA deeming regulation:

Requires no sale under 18 unless state is requires older (some states like Hawaii and California are no sale under 21)

Moves predicate date to the date the law goes into effect - 8 August 2016.

Requires advertising to not be attractive to youth.

Requires Vapor Product Battery standard.

Advertising only in adult publication (defined in bill).

Must be sold in face to face exchange - except mail order - no vending machine (unless facility is guaranteed 18+).

Requires labeling - "Keep Out Of Reach Of Children", "Underage Sale Prohibited" and "accurate statement of nicotine content".

Retailer must register with Secretary of Health and Human Services.

Keller and Heckman Lawsuit R2B Smoke Free

THIS WAS LOST IN TOTAL

No details (won't show hand too early - wait for its release for details - standard litigation practices so don't be upset) but every vendor manufacturer or retailer of any product or service related to vaping better get on board and send money to these attorneys NOW. Even if its $20. The details are out and IMHO are spot on but you need to remember two things about litigation:

1. Lawsuits take years and decades to get resolved. In the meantime the full force of the deeming regulation is in effect meaning all vaping gear is banned ie illegal. Maybe someone will be taking odds in Vegas as to what happens first, litigation successfully getting the deeming regulation remanded or an ecig company successfully completing the PMTA process.

2. This is just the first shot over the bow. Many more steps to follow. Do not expect instant success. And anything can happen. The exiting tobacco act was the result of lawsuits and politics and is messed up beyond all recognition and is why we are where we are with the deeming regulation.

All vaping products manufactured after 2007 have to be removed from the marketplace.

Forget substantial equivalency or any other consideration for "loopholes". That is determined by the FDA, NOT YOU. At this point because it is law, they win all arguments regardless of content.

On Dec 31 2016 all vaping manufacturers or vendors of vaping product or process has to register annually (cost unknown), must provide product listing including container, tools, labeling, and advertising by brand sub-brand and all ingredients including origin of ingredients and how they were made AND undergo a PMTA process. Oh and the point of registering is so they can INSPECT you. And if you are thinking of selling and not registering, you just get to wear orange longer and pay even higher fines.

Large scale 90 day deadline for >150 employees or 5mil a year - Products before June 22nd 2009 have to submit all documents on health, clinical, toxicological, physiological, behavioral on all components of your product.

 Those that are not large scale have until 8 August 2017.

This provision is just added burden, in other words large scale out of business 1 April 2017, small scale out of business 8 August 2017.

Why do I say out of business? Because A) that data doesn't exist and would cost a fortune to develop and deliver and B) is added onto, not in lieu of the predicate date or PMTA thereafter.

All products "on the market" after February 2007 are outright banned until they go through PMTA. This is known as the predicate date, aka grandfather date.

Products made back then for vaping don't exist today.

So any product after that date is banned and will NOT pass substantial equivalency.

This predates the kayfun. This predates VW let alone TC.

It was an old Ruyan that they don't even make anymore.

Some claim was never marketed in the U.S. However my research has found they were by one company and Altria is trying to buy those rights.

PMTA is the pre market tobacco application process. Vendors have to provide testing and data. The Government doesn't do squat but stand in your way. It is interesting to note that cigarettes are substantially equivalent and only one tobacco company has gone through the PMTA and it took them 20 years and untold millions and in the end I cannot confirm if they were successful or not.

Today, if you go through the PMTA process YOU must prove No Danger to public health and Must prove not attractive to youth. This is impossible. Along with all the clinical, physiological, toxicological and other required medical testing. It will take decades and millions per product, counting every difference, flavors, nic strength ingredients, and creation of those, must have clinical data  and no set process check list gives the FDA discretionary power to add more steps as THEY see needed, not you, and can result in complete denial in the end after stringing you along for 20 years. Ask SNUS how it went for them.

Any alteration of vaping products and the FDA considers YOU a tobacco manufacturer, vendor this includes YOU if you give coil building classes, etc. I am not legally convinced this is limited to only those that profit monetarily from vaping products or services.

In advertising vaping gear, YOU cannot state less dangerous than smoking, YOU cannot state 0 nic, as 0 nic is by definition a tobacco product in the deeming regulation - so the label doesn't have to include "contains nicotine" but does have to say "tobacco product". Anything whose "intended use" is as an "alternative to smoking" covers everything. This language ensures everything is by legal definition a tobacco product. All the FDA needs is "reasonable doubt". NOT YOU, the FDA. This reasonable doubt language in the law closes all potential loopholes. If they believe it, your done. Doesn't matter what YOU can PROVE.

For us consumers, the worst case scenario has come to pass. Only a miracle at this point can save vaping.

I do not agree that federal regulation is good or needed. But it is here and it won't go away.

Yes the FDA and our own Government are aware that the World Health Organization has determined that 1 Billion people will die this century from smoking and that vaping could save the lives of those 1 Billion people but they didn't care. The deeming reg is now law and it will kill us, quite literally unless you prepare now.

Some say don't go out and hoard. Well I don't agree totally. No need to hoard, but for sure I would prepare by getting my lifetime supply of base nic for making my own e-Liquid. No need to hoard but you will want a lifetime supply. Anything other than that is VERY HIGH RISK. Why? because the occurrence of a Miracle Level Event has an extremely low probability. But we must still continue supporting the legislative bills and calls to action by mailing your congressmen.

If you are thinking of buying or selling via loopholes or sub market, DON'T. The FDA has infiltrated every vaping organization and are completely aware. They are dying to find an example, a martyr. There will be witch hunts. There will be highly publicized examples of arrests, long prison sentences, stiff fines and people wearing orange. Think you are too small? Think again, the smaller you are the easier target you are. Over 150000 inspections were made on cigarette retailers last year. These same resources will be used for vaping shops. I will bet none of the vaping shops are prepared for what is about to happen to them. I would bet from the guy around the corner making e-Liquid and printing labels on his inkjet and selling out of a trailer to the company with 100 employees have no clue how to prepare let a lone handle an FDA inspector whether announced or un-announced. There are also nation wide associations with ignorant people bent on destroying vaping (becasue they think it is the same as smoking) at every level of society and they WILL report you.

There is no escape. Only legislation and litigation can save us.


Everything below is OBE - Overcome By Events. I leave it for now until I take this site down for historical reference and posterity sake.

 

Deeming Regulation

To a hammer, everything looks like a nail!

Hi, I'm from the Government and I'm here to help!

Now I know this chapter is going to be “vibrant” as I "bloviate". And my seething tone will shine through. But it is how I honestly feel. The following is a heavily modified excerpt from an FDA warning to an eCigarette company. The original can be found at Reference 17. I did edit it mostly to replace the companies name with the word “E-Cigarette” but also made modifications as it relates to nicotine. I did this editing to prove a point. To be fair, the particular company the warning was written to also marketed eCigs as a means for delivering other things like Cialis as well. Which is just goofy. But similar statements about health benefit can apply to eCigarettes with just nicotine. So I think this gives us an idea at how the U.S. FDA views e-Cigarette products:

E-Cigarette products are marketed and intended both to affect the structure or function of the body and to mitigate, treat, or prevent disease see 21 C.F.R. § 201.128 (describing the meaning of “intended use”). In particular, these statements suggest that these products are intended for use as smoking deterrents or to reduce dependence on traditional tobacco products, and are also capable of delivering nicotine.  The scientific and medical communities have determined that nicotine is a pharmacological agent, 1 that nicotine addiction is a disease, 2 and that nicotine withdrawal is itself a recognized medical condition. 3 It is well understood that people smoke for the pharmacologically rewarding effects of nicotine, such as alleviation of stress and negative mood, enhancement of thinking, and increased alertness. 4 For an addicted smoker, the body has adapted to nicotine, and abstinence produces withdrawal and craving. 5  As a result, people also smoke to avoid the negative effects of nicotine withdrawal, such as anxiety, difficulty concentrating, negative mood, increased appetite, insomnia, and irritability. 6  Therefore, the claims noted above demonstrate that E-Cigarette products are intended to affect the structure or function of the body and to mitigate, treat, or prevent disease.

Furthermore, E-Cigarette products and their components, are also intended both to affect the structure or function of the body (e.g., improving the overall health of the user) and to mitigate, treat, or prevent disease (e.g., mitigate, treat, or prevent <insert whatever word you would like here e.g. cancer>).

As described in 21 C.F.R. § 310.544, any product that bears labeling claims that it “helps stop or reduce the cigarette urge,” “helps stop or reduce smoking,” or similar claims is a smoking deterrent drug product. 7 Products that are labeled, represented, or promoted as smoking deterrents, such as the E-Cigarette, are regarded as “new drugs” under section 201(p) of the Act (21 U.S.C. § 321(p)) because there is a lack of adequate data establishing that they are generally recognized as safe and effective for such use. See 21 C.F.R. § 310.544. These products are also “new drugs” under the Act because we are not aware of any data establishing that these E-Cigarettes are generally recognized among scientific experts as safe and effective for the other drug uses described above and in the products’ labeling. “New drugs” require approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of the E-Cigarettes are so approved; therefore, marketing these products in the United States violates section 505 of the Act.

Basically what it means to me is that the U.S. FDA will view any e-Cigarette product as a new drug if any claim of health benefit whatsoever is used. Now I don’t know about you, but I find that particularly bureaucratic, unhelpful, moribund, and plain stupid.

Here is what I would like to see. I would like to see the U.S. FDA require eLiquid products to be properly labeled as to the ingredients actually used in them. I don’t think that is too much to ask as even the can of green beans in my pantry has that and some people have allergies to certain ingredients commonly used in eLiquid.

I would also like to see the U.S. FDA actually provide scientific data on the health effects to humans of actually using eCigarettes. Not studies on the contents of eCigarette vapor obtained by operating them incorrectly. Why is it that Dr. Farsalinos can do this correctly but the FDA cannot?

If the U.S. FDA can’t do either of those, then it is essentially useless to me. The eCigarette community is self-regulating by selling all eCigarette products to adults only, performing it’s own tests and studies.  And making it’s own eLiquid where it can control ingredients. One could make an argument that only the products that contain nicotine should be limited to adult only sale such as eLiquid, prefilled cartridges and disposables that actually do contain nicotine. Hint FDA, some don't. But the community also limits the sale of mods and attys that in of themselves contain no nicotine. We are doing better than what one would expect the Government to be doing. In fact, all I can see the FDA doing is harming not helping.

In the U.S. FDAs own words Reference 5:

E-cigarettes have not been fully studied, so consumers currently don’t know:

•the potential risks of e-cigarettes when used as intended,

•how much nicotine or other potentially harmful chemicals are being inhaled during use, or

•whether there are any benefits associated with using these products.

Additionally, it is not known whether e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.

So what does the U.S.FDA want to do? In their own words:

Only e-cigarettes that are marketed for therapeutic purposes are currently regulated by the FDA Center for Drug Evaluation and Research (CDER). Currently, the FDA Center for Tobacco Products (CTP) regulates

•cigarettes,

•cigarette tobacco,

•roll-your-own tobacco, and

•smokeless tobacco.

FDA has issued a proposed rule that would extend the agency’s tobacco authority to cover additional products that meet the legal definition of a tobacco product, such as e-cigarettes. FDA’s Extending Authorities to Additional Tobacco Products webpage offers more information on the proposed rule.

I want you to take a moment and think about the stupidity of all this. The U.S. FDA have no idea what eCigarettes do so they want to treat them like analog cigarettes. And woe to you if you claim a health benefit for using an eCigarette instead of an analog cigarette because they will treat the eCigarette like a new drug.

Oh that’s wonderful, more proof that no good deed goes unpunished. This mindset will have a negative impact on the vaping industry and user community by unnecessarily stifling innovation and unnecessarily raising costs of everything. It is one thing to be cautious and quite another to be strangling.

There are those that believe the U.S. FDA was created to help companies bring products to market. While part of that is true, the U.S. FDA was also created to help Congress determine laws and regulations for general public safety. The current FDA Deeming Regulation is in the Office of Management and Budget. From there it will proceed to Congress and become law.

I wish that the U.S. FDA would actually dedicate the necessary scientific resources to figuring out what eCigarettes actually do or at least use the considerable amount of research that has already been done to recommend regulation that supports what eCigarettes actually are doing and then keep it under surveillance and making course corrections later if needed instead of launching the only tool in their arsenal at the unknown. The U.S. FDAs current plan is akin to dropping a neutron bomb on a black hole. Except I actually think we know more about black holes than the U.S. FDA does about eCigarettes.

And while the reaction of the U.S. FDA being a bureaucratic Government organization is not surprising, it is disheartening. Electronic cigarettes are not even close to being a cigarette and numerous scientific studies and health statements show that eCigarettes have great potential for harm reduction to smoking. Let alone a rudimentary understanding of science and logical thought processes. I wish the eCigarette moniker had never been used. Even the Electronic Nicotine Delivery System (ENDS) moniker would have been better even though it is also susceptible to the same ignorance.

The U.S. FDA is no help to us and in fact is a hindrance. We the eCigarette users really do want to know what the health effects from using them are. What we don’t want is a bureaucracy levying strangling, disproportionate and inappropriate regulations that will unnecessarily raise vaping products costs which in itself could eliminate vaping altogether.

I give special thanks to folks like Dimitri Agrafiotis that has organized the Shenzhen China manufacturers into action giving all vapers badly needed help with the US FDA and Congress. Taken directly from the www.seviausa.org website:

On January 20th 2016 over 100 ecig manufacturers came together at a conference in Shenzhen China to commit their resources and financial support in the fight against unfair and burdensome FDA regulations. SEVIA USA was created and looking forward to assisting various advocacy and litigation groups in the US.

Mission Statement :

1) Congress SHOULD NOT regulate vapor products as tobacco products, considering these products DO NOT actually contain tobacco leaf.

2) The FDA should modify the grandfather date to allow products currently on the market in order to avoid the Pre Market Tobacco Application (PMTA) process.

3) The FDA should create a streamlined process that allows companies to submit more reasonable applications for the vapor market.

We have formed a coalition of responsible Chinese electronic cigarette manufacturers concentrating our financial efforts and resources to keep vapor products affordable, accessible and with the variety needed in order to help smokers transition to a less harmful alternative.

Moreover looking forward to a regulatory path we want to enforce industry standards to assure consumers safety and confidence in Chinese manufacturing.

At first blush this seems like nothing more than a bunch of people making money off the vaping industry doing nothing more than lobbying for their own interests. Well that is partly true in that it is their livelihood but we as vapers that need continued access to vaping products also need this.

If the FDA recommendation to Congress for a ‘Deeming Regulation’ on vaping products is passed, vaping will become more costly, options will be more limited, and our access to life saving products may well disappear. The deeming regulation literally deems vaping products as tobacco products. Which of course they are not.

The proposed deeming regulation says that tobacco products that were commercially marketed in the US prior to February 15, 2007 are allowed to stay on the market without taking any action. Since vaping is so new and technology has changed so much in the last few months let alone years, basically none of the products on the market today fall within that date. Not even by substantial equivalency. Substantial equivalency is a legal loophole that has been used by tobacco product manufacturers in the past so there is precedence. However, vaping technology has changed so much in the last few years that it can’t be used.

So that will force all vaping products, estimated by the FDA 1,600 vaping products, I think more like 1,600 companies and many thousands of products, to undergo an expensive Pre-Market Tobacco Application (PMTA) process. The big companies can probably survive that. The smaller companies that comprise e-Liquid products cannot. And the e-Liquids nor the hardware contain any tobacco.

Read this letter and this link provided in that letter.

The proposed deeming regulations include warning labels on vaping devices, prohibiting sales to minors, and banning free sampling. Ok fine, no problem. What are the labels going to say? That vaping is bad for your health? Well no credible study has proven that yet so it’s an outright lie. Will they say smoking is bad for your health? Well no kidding we know that and oh you dumbasses this is vaping not smoking. Sales to minors is already prohibited by the vendors voluntarily. Works well with alcohol and cigarettes now doesn’t it? You want to ban free samples. Uh ok, I guess so it hurts advertisement and or minors can’t get it that way. As stated vendors are already prohibiting sale and free samples to minors. What it means is if I want to try a new flavor I can’t try a couple of puffs, I have to buy a whole bottle. Brilliant. But ok go ahead with stupid labels, minor laws won’t matter and take away my taste testing. It is the rest of the regulation that will kill vaping.

Sure we’ll still have our gear, and maybe there could be some success with deeming the eLiquid versus the gear. But even at that without the eLiquid, being the most vulnerable segment due to its small company nature, the gear is useless.

Also let me point out something in case the “China” aspect of this bothers you. Our own elected US Government officials opened the door to trade with China many years ago and has been sustained by political activity or inactivity ever since. This has resulted in the outsourcing of manufacturing and production rendering our economy to more service based as predicted by the Japanese and now even services have been outsourced. Whether liked, disliked, right or wrong, it is reality. This is where we find ourselves by our own doing or not doing. I do not like it. I also strongly believe that the only way we will maintain our world dominance and correct our fiscal deficit is by regaining our production capabilities. But until that happens, and it is very unlikely for multiple reasons, the reality we live in is that China is the world production leader and those products are not only welcomed across the US border but necessary. Therefore I find this organization both apropos and ironic but most importantly, badly needed.

Even if nicotine, which exists in many nightshade family plants other than tobacco, is indeed extracted from tobacco as the most concentrated natural source of nicotine, it does not necessarily have to be deemed a 'tobacco product'. Both smoking and chewing tobacco are deemed 'tobacco products' which has particular legal meaning. There are generally accepted and legal precedents for a nicotine extract not to be deemed a tobacco product by the US FDA. For example patches and gum as Nicotine Replacement Therapies (NRTs) are US FDA approved but are not specifically deemed tobacco products by the US FDA. Therefore I do not support any claim that deems vaping as a tobacco product and the US FDA should add Open Vaping to the list of approved NRTs. There is also a paper from the Texas A&M University on NRTs. As the US FDA denotation of a tobacco product exists, a connotation also exists. Pipe, cigar, cigarette and chewing tobaccos are considered tobacco products where by action and/or inaction of the US FDA and the US Congress, NRTs are not.

It is interesting to note that we can vape with zero nicotine. Therefore, considering vaping gear as an NRT or tobacco product in of itself must be thought through carefully. Logically only the liquid vaped could have any such moniker attached to it. Not a hunk of stainless steel, glass, plastic, wires, batteries and electronics. Such kit is a vapor delivery system only. The actual vapor an Advanced Personal Vaporizer delivers, depends on the liquid being vaporized and that liquid could be or contain many things. However, taken holistically as a system including the gear and the liquid as a combined product may be considered an NRT. Meaning that a system with zero nicotine could not be considered an NRT but a system with nicotine could be. This seems to support an additional denotation beyond 'tobacco products', NRTs, or Electronic Nicotine Delivery Systems (ENDS) if there is no nicotine.

As a 100VG usually without flavorings and temperature protection technology user, the only remaining unknown at this point is flavorings. I look forward to all additional, credible research that properly implements, maintains and uses advanced personal vaporizer kit and especially look forward to research in flavorings. E-Liquid manufacturers should consider either joining SEVIA USA or organizing themselves and self-regulate by listing ingredients on their product labels and support chemical analysis and health effect research before it is inevitably mandated. And that should be obvious as many other precedents exist in this country and the deeming regulation is imminent. For example food labeling. No one company can do this alone but united you can. Waiting until it is mandated is a huge mistake. By taking action now you can have a voice. After it is done, it is far more difficult to manage. Opportunities are lost and doors are closed. And it is the lack of a body of knowledge on flavorings that prevent my continued use no matter how much I like vanilla, chocolate, bubble gum, apple pie, pumpkin pie and cotton candy flavorings and I do prefer them greatly.

As we all know but must be repeated as a prelude, Vaping is a harm reduction alternative to smoking especially where patches, gum and pills do not work. And given pills are associated with suicide and death, I am not sure they can be included in the 'harm reduction' category even if they are US FDA approved and not deemed a tobacco product.

I smoked and chewed tobacco. I do not vape tobacco. Vaping is all I want now and it satisfies both the nicotine chemical and behavioral psychological additions (habit - hand to mouth inhale/exhale). Ever hear an ex-smoker say I don't know what to do with my hands? No other harm reduction to smoking alternative does that. Vaping satisfies BOTH the nicotine delivery and the hand-to-mouth inhale action that smokers crave. And Open Vaping is the only alternative that allows infinite control from zero to cigarette-strength or chew-strength of total nicotine delivered to the body making it one of if not THE best alternative supporting nicotine reduction and cessation goals. And where is the U.S. FDA? Trying to take that away from us due to their own ignorance and negligence. And if the U.S. Congress passes it, that could make for some very interesting legal cases. The chemical composition and health effects associated with properly implemented and maintained vaping kit have been properly performed, analyzed and studied and found to be far safer than smoking but not risk free.

I actively support CASAA and their endeavors as well as writing and mailing my state and federal representatives and comments to the U.S. FDA as many other vapers do and all should do. I do not receive any monetary benefit from any company for any product or service whatsoever, I am retired. I am just another average human being on this third rock from the sun. Therefore my comments are driven by the satisfaction and health benefit I receive personally from vaping only, I have no other reason, impetus or agenda. And for me to say I support this organization is saying something important. I am an American, I am proud to be one, a faithful servant, citizen, patriot, parent, grandparent and great-grandparent. I rue this day we need this help to overcome popular, grievous and predominate ignorance and insanity. And make no mistake, we need this help.

Vaping has saved years of my life. There is no credible scientific or logical reason for the US FDA and the US Congress to limit nor destroy our access to this cost effective and lifesaving solution. As a US Citizen, I am appalled at our representatives and employees taking any action that would limit, degrade or destroy our health or access to health improvement. And likewise appalled that organizations such as SEVIA USA are even needed. But alas, they are, and badly.

We can also expect significant taxes levied at all levels in the Government. And while I am not advocating defeatism and will continue to fight by doing my part in writing our elected officials, taxation is inevitable. I hate to say it but there it is. The Government needs money and anytime it can prey on the minority they will as they know they have the support of the majority as the majority is happy to let the minority pay the bills. As elected officials only care about votes and the majority of voters only care what the elected officials can do for them.

I only wish the taxes we will pay would go to the scientific research we need but unfortunately the truth is all taxes go into the general fund and pay for everything and the Government is not and will not conduct the scientific research we need.

And on top of that are reams of erroneous “polls” indicating vaping is a gateway for or attracts more teenagers or even younger children to smoking and worse. Erroneously claiming that candy flavors are aimed at addicting our youth. Hmm gee, I guess the candy flavors I like weren’t because an adult also likes them huh? The truth is children naturally explore their boundaries and while we would rather they didn’t and even teach them to just say no, and prevent them when we can, we all were children once and should know when we aren’t there, they will explore boundaries, some more than others. While we might not want that exploration we can at least laugh if they explore vaping because we know it is far better than smoking. Personally if a compromise with my child had to be made, I would rather make that at vaping than something more serious than nicotine.

There is a thought that Big Tobacco (BT) and Pharmaceuticals (Pharma) are trying to kill vaping and e-Cigarettes as BT stands to lose even more money as smokers switch over to vaping and Pharma stands to lose money as pill, patch and inhaler users switch over to vaping. There are also thoughts that BT and Pharma is lobbying Congress and corrupting U.S. Government officials with their significant monetary resources to stifle, strangle and potentially eliminate the vaping industry. There is no proof that this is the case. While I am not predisposed to conspiracy theories, it is plausible and stands reasoning. There is significant motive and means as those companies have huge resources under singular command unlike the collage of small businesses that make up the vaping industry. I would hope that these immoral and illegal activities are not taking place. There is an unspoken rule in Washington DC, don’t put any collusion in writing just wait until you leave office and they will take care of you. Whether that is with million dollar consultations, speeches, dinners, etc. And it’s not limited to companies. Countries do this as well. Now I know what you are thinking, that I am a conspiracy nut. I do not believe I am. I truly hope it is not happening, but the unspoken rule has happened with other topics. We all have seen it as it has been illuminated by the world press. I’m not talking about UFOs and Bigfoot. I’m talking about money talks and Bovine Stool (BS) walks, a.k.a. Politics a.k.a. Poly Ticks - many bloodsuckers.

So we the vaping community will have to do a few things. First we must remain ever vigilant and be prepared to write our elected officials as forces in play whether innocuous as ignorance or evil as corruption are actively trying their level best to destroy our freedoms and the vaping industry. And we will have to look elsewhere for our e-Cigarette scientific study answers as our own Government is at best useless and at worst obfuscating, erroneous and damaging.

Towards that end, we need to keep an eye out for CASAA calls to action and e-Cigarette health statements and studies from around the globe. And take action now for the inevitable Vaporpocalypse.

   

 

 

All the information contained in these pages are only the opinions of the author and the author is not an expert at anything.