FDA rules that dissolvable tobacco lozenges are NOT currenty regulated tobacco products

[Bill Godshall]

Star Scientific claims the FDA has informed the company that Ariva BDL and Stonewall BDL dissolvable tobacco lozenges are NOT subject to existing FDA tobacco regulations, indicating that Star can market these tobacco products to smokers as less hazardous alternatives to cigarettes.
http://phx.corporate-ir.net/phoenix.zhtml?c=105863&p=irol-newsArticle&ID=1542053&highlight=


It appears the FDA has determined that Ariva BDL and Stonewall BDL are NOT smokeless tobacco per its definition in the FSPTCA Chapter IX Section 900(18) - The term "smokeless tobacco" means any tobacco product that consist of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity.
http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf

This may mean that some/most/all other dissolvable tobacco products are also NOT subject to existing FDA tobacco regulations. Please note that cigars, pipe tobacco (and e-cigarettes if federal court rulings in SE/NJOY v FDA are upheld) aren't currently subject to existing FDA tobacco regulations under Section 901(b) of the FSPTCA.

Per Star's 6/21/10 press release at:
http://phx.corporate-ir.net/phoenix.zhtml?c=105863&p=irol-newsArticle&ID=1440233&highlight=
"Stonewall-BDL(TM), like ARIVA-BDL(TM), is a dissolvable tobacco lozenge with wintergreen flavoring. The product is made with flue-cured tobacco that contains levels of tobacco-specific nitrosamines (TSNAs) that are below detectable limits ("BDL") by most current standards of measure."

 

[Vocalek]

I am really confused. I have just been searching around trying to figure out why the press release talks about Chapter IX of the Food, Drug, & Cosmetics Act, instead of the Family Smoking Prevention and Tobacco Control Act.

Chapter IX of the FDCA is "Miscellaneous". It doesn't mention tobacco. FD&C Act Chapter IX: Miscellaneous

But I found another page that reads "The Family Smoking Prevention and Tobacco Control Act adds a new Chapter IX to the Food, Drug, and Cosmetic Act, establishing and governing the regulation of tobacco products."

 

[yvilla]

Yes, Elaine, the FSPTCA itself declares that it is to be a new Chapter IX of the FDCA. The FDA is just late in updating its website. This provision is found in Title I, Section 101(b) of the FSPTCA, as follows:

SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
*****
(b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—The Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended—
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901 through 910 as sections
1001 through 1010; and
(3) by inserting after chapter VIII the following:
‘‘CHAPTER IX—TOBACCO PRODUCTS

 

[Bill Godshall]

The FSPTCA is at
http://frwebgate.access.gpo.gov/cgi...=111_cong_public_laws&docid=f:publ031.111.pdf

On page 9 of the printed version of FSPTCA is Title I - Authority of the Food and Drug Administration

Immediately below, Sec. 101(a) amends the FDCA to define "tobacco product" as

any product made or derived from tobacco that is intended for human consumption ...

This is the clause that Judge Richard Leon cited when stating that e-cigarettes meet the FSPTCA's definition of tobacco product. This clause also applies to all tobacco products, including cigars, pipe tobacco and dissolvable tobacco products.

On page 10 of the printed version of the FSPTCA is the beginning of Chapter IX - Tobacco Products

On page 11 of the printed version of the FSPTCA "smokeless tobacco" is defined as

any tobacco product that consist of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity.

On page 12 of the printed version of the FSPTCA is

Section 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.

So it appears that while all tobacco products (and e-cigarettes) are considered to be tobacco products under Section 101 (on page 9), cigars, pipe tobacco, e-cigarettes and apparently dissolvable tobacco products (which I previously presumed were smokeless tobacco products) are not currently regulated as tobacco products by the FDA.

But Section 901(b) authorizes the Secretary (i.e. FDA) to regulate any other tobacco product (that currently isn't regulated by the FDA).

 

[Vocalek]

I think I just figured out the FDA's game plan.

FDA says Star Scientific smokeless products not covered under law | Richmond Times-Dispatch

The agency said it is "currently considering its legal and regulatory options regarding these products."

"FDA recognizes there are uncertainties regarding the regulatory status of a variety of nicotine-containing products derived from tobacco; more specifically, whether these products are regulated as drugs or tobacco products," the agency said in the statement.

So it appears that the FDA is not only trying to regulate e-cigarettes as a drug (i.e., ban them), it wants to drag the dissolvable tobacco prdoucts under that bus as well. That could backfire on the Agency.

 

[Vocalek]

And Matthew Myers of Campaign for Tobacco-free Kids is clearly not amused.

FDA Takes Troubling Step in Telling Star Scientific Two Smokeless Tobacco Products Are... -- WASHINGTON, March 23, 2011 /PRNewswire-USNewswire/ --

 

[rothenbj]

Let's face it, Star Scientific is NOT BP or BT it's almost as big an enemy to those giants as PVs. I would guess Myers would like to get them crushed to protect his cash flow from the real money. I don't really like where this could be going and if I were SS, I'd be more alert to the danger than ever before. The FDA may have lifted it's big foot off their heads temporarily with the full intent of stomping harder when it gets lowered again.

 

[JustJulie]

And Matthew Myers of Campaign for Tobacco-free Kids is clearly not amused.

FDA Takes Troubling Step in Telling Star Scientific Two Smokeless Tobacco Products Are... -- WASHINGTON, March 23, 2011 /PRNewswire-USNewswire/ --

How awful is it of me that I'm rather amused at the thought of Matthew Myers not being amused?

All joking aside, I've been racking my brains trying to figure out in which alternate universe this position by the FDA makes sense . . . the only conclusion I can reach is, as others have said, this might signal that the FDA is considering regulating these products as pharmaceuticals.

And if true, that isn't funny . . . that's horrifying.

 

[Paisley]

Dialectical progress:

“The Communist method of advance may be likened to the hammering of a nail. It is a very foolish person who brings the hammer down with a crashing, resounding blow and then keeps pushing. When the first blow has spent itself, back must go the hammer in preparation for the next blow. A person seeing the reverse movement of the hammer as an isolated act in time and not understanding the process of which this was a part, might find it difficult to believe that this hammer was driving in the nail. When he sees the backward swing as a portion of a complete process, he realizes that the withdrawal is as important as the downward thrust to the realization of the objective.”

Dr. Fred Schwartz, You Can Trust the Communists (to be Communists)

 

[Bill Godshall]

Today's Winston-Salem Journal article sheds more light on this sitution

Two tobacco products free of FDA oversight
Two tobacco products free of FDA oversight | JournalNow.com

I consider the FDA's decision as another victory for tobacco harm reduction. If Reynolds and Altria obtain similar nonregulatory decisions from FDA for Camel Orbs, Strips and Sticks, and Marlboro and Skoal Sticks, dissolvables could become another large growth segment (along with smokeless) for the tobacco inudstry (at the expense of cigarettes, nicotine lozenges and gum).

I suspect CTFK/ACS/AHA/ALA will respond by advocating more State sales bans on dissolvables, and continue pushing for very high state taxes on dissolvables (and all other smokeless products).

If the FDA determined that dissolvables don't meet the FSPTCA's definition of smokeless tobacco, its possilbe that dissolvables also don't meet other federal statutory definitions of smokeless tobacco (e.g. PACT Act, Federal Tobacco Tax, Synar amendment) and that of various State tobacco laws (e.g. tobacco taxes, sales to minors bans, underage usage/purchase/possession laws).

Regarding concerns that the FDA might try reclassifying dissolvables as smoking cessation drug devices (like the agency has tried to do with e-cigarettes), please note that a decade ago GSK and CTFK/ACS/AHA/ALA petitioned the FDA to declare Star's Ariva a drug device in an attempt to ban the product (and of course those groups called it "candy" that appealed to kids).
GSK's petition basically acknowledged that Star's Ariva was nearly identical to GSK's Commit nicotine lozenge, and claimed that FDA should regulate Ariva just like Commit.

But the FDA ruled that Star's Ariva was a tobacco product and not a drug device (it also helped that Star didn't make any smoking cessation claims about Ariva), and then the FDA stated that the agency didn't have the regulatory authority over any tobacco products citing the 2000 SCOTUS ruling on Brown and Williamson.

The only way the FDA can now regulate Star's Ariva BDL and Stonewall BDL is by proposing/promulgating new regulations for the products and perhaps for all dissolvable tobacco products (similar to what the FDA must do if it wants to regulate e-cigarettes, cigars and/or pipe tobacco).

Since dissolvables and e-cigarettes are both less hazardous than cigars and pipe tobacco, the FDA (if it were truly concerned about protecting public health) would propose regulations for cigars and pipe tobacco before it proposes regulations for less hazardous dissolvables and e-cigarettes.

 

[Bill Godshall]

Its possible that the FDA has finally come to its senses by realizing Star's Ariva BDL and Stonewall BDL:
- are at least 99% less hazardous than cigarettes,
- contain/emit even fewer carcinogens that nicotine gums and patches,
- contain/emit similar or lower levels of nicotine than nicotine gums and lozenges,
- have never been known to harm any user,
- are marketed to adult smokers, and
- are not used by youth.

If that's the case, the agency might soon come to its senses by realizing that e-cigarettes:
- are probably 99% less hazardous than cigarettes,
- emit no secondhand smoke,
- contain/emit similar levels of carcinogens as nicotine gums and patches,
- have never been known to harm any of the million plus users,
- are marketed to adult smokers, and
- are not used by youth.

If that occurs, the FDA may decide that e-cigarettes either don't need to be regulated by the agency, or are deserving of just a few modest and reasonable regulations.


Then again, I'm feeling optimistic today.

 

[DC2]

Then again, I'm feeling optimistic today.

Damn, you sure are!

 

[JustJulie]

Then again, I'm feeling optimistic today.

Well, optimism is never a bad thing. And frankly, I prefer your scenario to the one I'm worried about.

 

[Vicks Vap-oh-Yeah]

Its possible that the FDA has finally come to its senses by realizing Star's Ariva BDL and Stonewall BDL:

<snip>

Then again, I'm feeling optimistic today.

Why does the phrase 'when pigs fly' spring immediately to mind here? Sure, the FDA COULD come to it's senses, and resume it's place in today's world, but I'm not holding my breath on this one.

 

[JayTheVapingGuy]

what COULD happen and what will LIKELY happen are sadly two different things... i'm more inclined to agree with the hammer analogy than any other!

 

[DaveP]

It's a lot easier to take things away when a small percentage of people are involved. If growth continues along its current path, eventually Ecigs will be a large enough market to effect resistance in the form of political pressure. Political pressure, being the way things are accomplished in federal circles, our plight could take one of two paths, IMO. The FDA could act rather quickly and eliminate Ecigs before the numbers grow, or this could take years to accomplish, all the while seeing Ecig users' numbers growing exponentially. In the latter circumstance, regulation would occur in the face of significant resistance from the number of users, sellers, tax dollars, and public sentiment from those who realize finally that the Ecig is a lesser of the two evils between tobacco and the alternative.

OTOH, pharma and big tobacco both represent large players in terms of payments, tax dollars, and political clout. If you follow the money, strength is on their side.

On the light side, here's an article on a dental web site that is positive. It does, however, have a subliminal plug in the text for NuCig.

http://dentisteverett.com/electronic-cigarettes-a-poll-of-consumers

Electronic Cigarettes A Poll Of Consumers.
May 27, 2010 | Author admin

Little is known about users of electronic cigarettes , or their opinions , satisfaction or how and why they use such items .

However a recent survey of 81 respondents to an online survey in 2010 showed that all respondents, enjoyed the flavour and enjoyed the inhalation experience . However a few did report a dryness in the mouth but all that reported this said it passed quickly.

All respondents were from France, Canada, Belgium or Switzerland and 77% were men. They used an electronic cigarette for 100 days on average and drew on average 150 puffs a day.

One of the disappointments of the technology seemed to be regular technical failures of certain cheap brands but for the more advanced e-cigarettes like NUCIG , 97% of participants were overly satisfied with the technology.

Some positive effects were reported with electronic cigarettes included their usefulness to quit smoking, and the benefits of abstinence from smoking (i.e. less coughing ).

In conclusion – E-Cigarettes were used mainly to quit smoking, and, once approved, may be helpful for this purpose, but several respondents were worried about potential toxicity . There are very few official published studies on electronic cigarettes but other studies have achieved positive results and whilst further research is needed , particularly on the efficacy and toxicity of these devices, they certainly are fighting back very well against critics.

According to a recent medical study in South Africa, 45% of smokers using an e-cigarette were able tocompletely quit tobacco within two months of switching to the innovative new product, compared to 5% of Nicorette Gum consumers .

Of course, what counts is whether smokers can quit smoking for the long term. However, the results remain very positive .

The survey results found:
• 6% of smokers quit tobacco within two weeks
• 45% of smokers quit tobacco within two months
• more than half reported improved energy levels and an improvement in their overall appearance.

All of the doctors involved in the study felt that the e-cigarette could be an aid to overcoming all physical and psychological effects of smoking, with one doctor adding that:

“an e-cigarette is the most effective treatment method on the market for quitting tobacco smoking”.

If these little wonders reach the mainstream it may well be very soon that we all see little blue lights in our pubs and clubs .

 

[rothenbj]

Found this interesting article on Star Scientific-

Star Scientific Develops Ultra-Low Carcinogen Moist Snuff | CSP Daily News / Magazine | Tobacco - CSP Information Group, Inc. - news for convenience & petroleum retailing.

Interesting in that nobody seems to know that modified risk has been defined by the FDA.

 

[Vocalek]

Found this interesting article on Star Scientific-

Star Scientific Develops Ultra-Low Carcinogen Moist Snuff | CSP Daily News / Magazine | Tobacco - CSP Information Group, Inc. - news for convenience & petroleum retailing.

Interesting in that nobody seems to know that modified risk has been defined by the FDA.

Yup. And the definition is "There ain't no such animal."

 

[sqirl1]

**disclaimer: in no way am I advocating for violence against the FDA, any of it's members, or any individual or group. All references in this post are strictly metaphorical and should only be interpreted as such.**

if the FDA wants to strike again, they better send the hammer crashing down quick or they just left a big enough opening for us to strike back at them. here's another good analogy for you: watch saving private ryan or any WWII movie. when do you usually see the americans run past the nazi machine gun fire and advance to the next area? when the nazis are reloading, of course! it's the same principal here, if they think we're not going to use this opportunity to coordinate an effective political resistance movement, they just got sloppy. we gotta snipe 'em out when they're reloading!

 

[DC2]

[Bif the FDA wants to strike again, they better send the hammer crashing down quick or they just left a big enough opening for us to strike back at them. here's another good analogy for you: watch saving private ryan or any WWII movie. when do you usually see the americans run past the nazi machine gun fire and advance to the next area? when the nazis are reloading, of course! it's the same principal here, if they think we're not going to use this opportunity to coordinate an effective political resistance movement, they just got sloppy. we gotta snipe 'em out when they're reloading!

The main problem is that the vast majority of this community does not realize they are in a war.
And I personally have yet to discover any method to inform them of this fact that has made any difference.