FDA to regulate e-cig as tobacco

[yvilla]

TennDave, you are forgetting a critical point.

Nicotine, per se, is not a "tobacco product". But when it is "derived from tobacco" (and it's intended use is NOT as a drug product), then it is a "tobacco product", pursuant to the new federal defintion of "tobacco product" found in the FSPTCA.

Here is the relevant part of the statutory definition of "tobacco product" found in the FSPTCA.

"(1) The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

(2) The term “tobacco product” does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 353 (g) of this title.

United States Code: Title 21,321. Definitions; generally | LII / Legal Information Institute

So no, nicotine derived from any other plant or vegetable would in no case be considered a "tobacco product". It would, however, be considered a "drug" if marketed for human consumption in such a way as to fall within the definition of a drug under the FDCA.

And here is the definition of a "drug" for purposes of the FDCA:

(g)
(1) The term “drug” means

(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and

(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

(D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343 (r)(1)(B) and 343 (r)(3) of this title or sections 343 (r)(1)(B) and 343 (r)(5)(D) of this title, is made in accordance with the requirements of section 343 (r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343 (r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

(Same url as above)

 

[TennDave]

I thank you for the education...I believe the key words here are "intended purpose." We are lucky that e-juice is going to be classified under tobacco! Now, to convince the public and legislators of "less harm," and to avoid classification to the degree that taxation occurs to pay for the sins of the tobacco industry.

 

[Thulium]

I believe the key words here are "intended purpose."

That is the conclusion drawn by the US Supreme Court in Brown & Williamson and cited by Judge Leon in the DC Circuit Court and affirmed by the Appellate. This overrides the FDA's previous policy of "whatever we say" which seemed to follow very closely with whatever would be in large Pharmaceutical and/or Tobacco corporations' financial interest.

 

[KDK]

1B: Prevention of disease in man or other animals? So the use of vitamin C to prevent disease makes vitamin C a drug instead of a natural substance? This makes no sense to me, as we would all be dead if we didn't get at least a certain amount of the needed substances to keep going. We would all be dead if we didn't get the natural substances we need to prevent disease! And vitamins are certainly recognised as able to prevent disease.

 

[jlarsen]

Wait a minute now...wouldn't this mean that they would have to ban everything that produces nicotine (even if eaten- that is still injestion...same as vaping in my opinion- we're not smoking it)? Tomatoes, bell peppers, potatoes, egg plant?...the list goes on....

The source of the nicotine for all tobacco products (including ecigs), unless the nic is synthesized which isn't economical, is tobacco. So no, vegetables that contain nicotine wouldn't be regulated by the FDA. Besides, the amount in vegetables is measured in nanograms, not milligrams. So the amount in vegetables is negligible. You'd need to eat something like 50 pounds of potatoes to get the nic in a cigarette.

 

[jlarsen]

1B: Prevention of disease in man or other animals? So the use of vitamin C to prevent disease makes vitamin C a drug instead of a natural substance? This makes no sense to me, as we would all be dead if we didn't get at least a certain amount of the needed substances to keep going. We would all be dead if we didn't get the natural substances we need to prevent disease! And vitamins are certainly recognised as able to prevent disease.

When it comes to the FDA, nothing has to make sense. They supposedly regulate the tobacco industry to for our health, so they regulate the tobacco, but not the other chemicals that are added to cigarettes that make them deadlier than tobacco alone. None of it makes sense to anyone but the FDA.

 

[CthulhuSaves]

On a related topic, I had a friend of mine stop by this evening after work (he works at CompleteTax, one of those big, nationwide "do your taxes" outfits). He told me that everyone got a new memo recently that specifically went out of its way to explain that the in-house smoking ban included e-cigs. If you wanna vape, you'e gotta go to a designated smoking area on your break. (Vomiting and passing gas are, apparently, still acceptable group activities...)

 

[KDK]

When it comes to the FDA, nothing has to make sense. They supposedly regulate the tobacco industry to for our health, so they regulate the tobacco, but not the other chemicals that are added to cigarettes that make them deadlier than tobacco alone. None of it makes sense to anyone but the FDA.

I'm sorry, I just think that it SHOULD be understandable to the average person because it pertains to them, but what do I know. After all, I'm just an average person (who takes vitamins, and vapes ALOT).

 

[yvilla]

1B: Prevention of disease in man or other animals? So the use of vitamin C to prevent disease makes vitamin C a drug instead of a natural substance? This makes no sense to me, as we would all be dead if we didn't get at least a certain amount of the needed substances to keep going. We would all be dead if we didn't get the natural substances we need to prevent disease! And vitamins are certainly recognised as able to prevent disease.

But KDK, classification as a "drug" under the FDCA (Food, Drug and Cosmetic Act) doesn't imply anything negative - other than that it puts whatever substance that is classified as a drug squarely under the FDA's regulatory authority of course.

Are you perhaps confusing the medicinal term "drug" with those illegal to sell or possess substances that are legally classified as "controlled substances", but commonly called drugs, or street drugs? That's an entirely different issue!

But actually, vitamins are usually classified as "dietary supplements" under the food provisions of the FDCA.

 

[randyith]

I don't see how you can say it will put vendors out of business if it is taxed jlarson, we the consumer will be paying those taxes not the vendors, the vendors will be the ones collecting those taxes from us the consumers and handing it over to the Feds & State, in no way will it hurt the vendor financially the way I see this, it will ad another line on their spreadsheet and another check they will have to cut to uncle Sam, that's about it. Just about everything is taxed in the retail world and always will be.

Taxes will not put small suppliers out of business but the laboratory requirements mandated by the FDA for the manufacture of flavored or unflavored juices could. If they mandate a "clean room" and what status of clean room they require should be the most scariest concern for small companies. Google laboratory clean rooms and the different levels and cost. $10 k to $250 k depending on grade. It is more than wearing hair nets and lab gear.

Testing is not cheap ladies and gentlemen. I have imported 3 one liter pure nicotine juice from China ranging from 98.9% to 99.8 % pure. Average FOB cost $150 per liter plus $60 freight. Cost of a laboratory test per liter over $500 USD. Checking for impurities such as arsenic. The Feds already have maximum percentages for various impurities in pure nicotine liquid. Check out this math .... one of 3 Chinese vendors liter exceeded the maximum arsenic level. So the $210 per liter becomes $315 plus $500 lab test plus $250 for the liter that failed equaling $1,065 per liter instead of $210 which is a 507% increase. Clean room requirements at the lowest level could easily push the price per liter to over $3,000.

I only test 1 out of 3 shipments and I can tell my competitors are testing zero by their pricing structure. Point is taxes are the least of small companies worries. So if you smoke 24 mg juice just the 24% nicotine component would increase by 507%/4= roughly 125% meaning the juice mixer's cost for 24 mg juice would increase 125% divided by 4 or 31%. If you factor the lowest level clean room requirement into the equation you are talking roughly a 90% increase in 24 mg e-juice cost before adding taxes.

 

[kristin]

Taxes will not put small suppliers out of business but the laboratory requirements mandated by the FDA for the manufacture of flavored or unflavored juices could.

This is the reason we wanted classification as a tobacco product and not a drug. The requirements and standards for tobacco production are far less than for drugs. If they don't require snus or tobacco lozenges to meet those "clean room" and testing requirements, it could be argued that e-cigarette liquid, as a tobacco product, shouldn't be held to a higher standard than those other tobacco products. More than likely they will have to meet food prep standards and occassional spot testing - at least, that is what we would fight to limit it to, worst case. But I think most vapers would welcome knowing that their liquid is being made in reasonably sanitary conditions using basic safety and handling practices to avoid contamination.

A tobacco product doesn't have to prove it is safe. From my understanding, the onus is now on the FDA to try to prove it presents a danger to the public and that would require them to do the testing and it would only affect that particular vendor whom they tested. (Think of how they handled diet products with phen-phen or toothpaste with DEG - people got sick, the government investigated and pulled the offending brands off the market, not all diet pills or all toothpaste.)

Although, any NEW tobacco products (after Feb. 17, 2007) need to prove that they don't pose a GREATER danger to the public than similar tobacco products currently on the market. And the requirements would differ for companies seeking classification as smoking cessation devices or as a FDA-recognized/approved reduced harm product. But e-cigs intended as a "smoking alternative" would have different requirements, IMO.

Now, if the vaping public demands those standards (apart from any FDA requirements) from their vendors and "votes" with their dollars by only using the most stringently produced and tested liquids, those vendors who fail to meet those standards will find their sales dropping off and will most likely leave the market.

 

[Vocalek]

When it comes to the FDA, nothing has to make sense. They supposedly regulate the tobacco industry to for our health, so they regulate the tobacco, but not the other chemicals that are added to cigarettes that make them deadlier than tobacco alone. None of it makes sense to anyone but the FDA.

Actually, it isn't the chemicals that they add to cigarettes that makes them more deadly than tobacco alone. There has been in place, for several years now, limitations on the chemicals that can be added. The list of permitted chemicals are related to flavoring and to preserving the tobacco. The List of Additives in Cigarettes - Additives in Cigarettes

Tobacco companies are not permitted to add toxic or cancer-causing chemicals.

What makes cigarettes more deadly than tobacco alone is the fact that they are used by setting them on fire and creating smoke that is inhaled by the user. The process of combustion creates an estimated 4,000 new chemical compounds that don't exist in the unburned cigarette. Many of these new chemicals are toxic or carcinogenic.

And as far as tobacco alone is concerned, it's not quite as deadly as you might think. The tobacco companies have been working to reduce the quantity of Tobacco-Specific Nitrosamines in tobacco products. Smokers who switch to low-nitrosamine Swedish snus have the same life-expectancy as former smokers who stopped using all forms of tobacco.

 

[Bill Godshall]

Several threads back, someone inquired

All nicotine products ?
For example, could we see a tobacco gum ?

Yes, Judge Leon's ruling (that FDA conceded to) now allows anyone to market e-cigarettes, e-liquid, nicotine gums, lozenges, patches, skin creams, nasal inhalers, and some/many/most/all dissolvables (along with cigars and pipe tobacco) as totally unregulated tobacco products (as long as the manufacturer/importer doesn't make therapuetic claims).

Vocalek wrote:

Don't forget the date specified. Any product that did not already exist before February 15, 2007 must go through an approval process. Since there was no tobacco gum before that date (that I ever heard of) it would be considered a new nicotine product.

No. That section (and alll other sections in Chapter IX of the FSPTCA) ONLY applies to cigarettes, RYO and smokeless tobacco, but does NOT apply to e-cigarettes or ANY other unregulated tobacco product.

Once again, everyone who is interested in understanding the impact of Judge Leon's ruling must very carefully read the FSPTCA, as the overwhelming majority of statements posted on the ECF (regarding the impact of FDA's announcement on Monday) are incorrect.

 

[tybin]

thanks bill

 

[mirinuh]

Bill Godshall is absolutely on point with respect to Title IX of the FSPTCA!! E-cigs and new tobacco products that fall outside of Title IX will not have the hurdle of being "grandfathered."

 

[Jacinda222]

Thanks for all the info Bill! Although I was wondering if you could clear something up for me? From this statement made by the FDA:

The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

I get the idea that they are going to try to amend the FD&C Act so that the pre-market requirements will apply to e-cigs and other tobacco products. Am I misunderstanding this? Do you think that they won't be able to change it, or are you just saying that currently it doesn't apply to e-cigs? I'm sorry if I'm missing something...

 

[yvilla]

No. That section (and alll other sections in Chapter IX of the FSPTCA) ONLY applies to cigarettes, RYO and smokeless tobacco, but does NOT apply to e-cigarettes or ANY other unregulated tobacco product.

Bill, I hate to be the bearer of bad news, as of course I've been right here with you trying to debunk the overly negative and uninformed reactions to Monday's announcement, but on this question specifically I have to qualify and question what you are saying.

As I read the FSPTCA, these sections of the new Chapter of the FDCA created by it WILL be applicable to e-cigs and other currently unregulated tobacco products, just as soon as the FDA, by properly promulgated regulation, deems them to be "tobacco products" subject to the chapter and to its regulatory authority.

Here is the provision I'm referring to:

‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
‘‘(a) IN GENERAL.—Tobacco products, including modified risk
tobacco products for which an order has been issued in accordance
with section 911, shall be regulated by the Secretary under this
chapter and shall not be subject to the provisions of chapter V.

‘‘(b) APPLICABILITY.—This chapter shall apply to all cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and
to any other tobacco products that the Secretary by regulation
deems to be subject to this chapter.

http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf (at page 12 of the pdf)

 

[yvilla]

I get the idea that they are going to try to amend the FD&C Act so that the pre-market requirements will apply to e-cigs and other tobacco products. Am I misunderstanding this? Do you think that they won't be able to change it, or are you just saying that currently it doesn't apply to e-cigs? I'm sorry if I'm missing something...

Jacinda, no they are not talking about nor do they need any amendment to the FDCA in order to assert regulatory authority. As I posted just above, the FSPTCA, now Chapter IX of the FDCA, was made to be applicable to any "tobacco product", both the traditional products such as cigarettes and smokeless specifically mentioned in Section 901(b), and to "any other tobacco products" that the FDA properly deems to be subject to the law.

So Monday's announcement, albeit worded as such in a way to save face in light of its loss in court, was the FDA's signaling that it will begin the process of proposing the regulations that will subject e-cigs to its regulatory authority, and to the provisions of Chapter IX.

 

[greenie]

Thank you Maxwell Edison, yvilla, Bill Godshall and et al

 

[Bill Godshall]

Yvilla wrote:

Bill, I hate to be the bearer of bad news, as of course I've been right here with you trying to debunk the overly negative and uninformed reactions to Monday's announcement, but on this question specifically I have to qualify and question what you are saying.

As I read the FSPTCA, these sections of the new Chapter of the FDCA created by it WILL be applicable to e-cigs and other currently unregulated tobacco products, just as soon as the FDA, by properly promulgated regulation, deems them to be "tobacco products" subject to the chapter and to its regulatory authority.

We completely agree. But unless/until new regulations are given final approval by the Secretary of HHS to apply Chapter IX provisions to currently unregulated tobacco products, they will remain unregulated tobacco products.

The rulemaking process (i.e. from the time of proposal to time of final approval) is likely to take several years, and must clear many hurdles and challenges.

I think it will be very difficult for the TPSAC and the Secretary of HHS to determine (based upon scientific evidence) that imposing all Chapter IX provisions on all unregulated smokefree tobacco alternatives "would be appropriate for the protection of the public health."

It should be much easier for the FDA to justify applying Chapter IX to cigars and pipe tobacco than for smokefree products (as there is no evidence that the latter products have harmed users).