FDA sends warning letter to snus company in Sweden claiming website violates Section 911 of FSPTCA

[Bill Godshall]

FDA sends warning letter to http://www.mysnus.com in Sweden claiming company website violates MRTP provision in Section 911 of FSPTCA by truthfully stating "All products are pasteurized, with low levels of Nitrosamines," and by describing one brand of snus as "A mild snus."
Mysnus AB 3/12/12


If the FDA proposes/approves a "deeming" regulation to apply Chapter IX provisions of the FSPTCA to e-cigarettes, e-cigarette companies that make similar types of claims (i.e. the vast majority of e-cigarette companies) would likely receive similar letters from the FDA (assuming that the FDA doesn't interpret other Chapter IX provisions as banning sales of all e-cig products not on market in 2006 (Section 910), and doesn't issue a regulation banning internet sales [Section 906(d)(4)(A)]).

 

[TennDave]

Very interesting- they got rid of "lite" cigs in the U.S. too- now there are: Blue, Silver, and I suppose Red? I guess this is BT's way of getting around the FDA hounding of what's light, regular and full-strength. Maybe they should have SINUS Blue or SINUS Silver ??

 

[rothenbj]

Somehow these people need to be realed <sic> in.

 

[Vocalek]

I think I have an idea to fix the little red wagon of the FDA litig8rz.

Their hang-up appears to be descriptive words like "low" and "light". What could their objection be if the site displays a table showing the actual TSNA levels of a variety of products? This page contains a list of TSNA levels of smokeless products: For Smokers Only

"All analyses were performed at the Swedish National Food Administration."

This table is from a published article: PubMed Central, Table 1: Nicotine Tob Res. 2008 December; 10(12): 1773

Irina Stepanov, Ph.D. New and traditional smokeless tobacco: comparison of toxicant and carcinogen levels. Nicotine Tob Res. 2008 December; 10(12): 1773–1782.

The web site might not be able to get permission to reproduce the table from the journal, but nothing stops them from posting a link to the table.

Table 1, on page 312 of this article lists TSNA levels for a range of products from NRT products, through smokeless, to various brands of cigarettes. http://www.starscientific.com/404/stepanov tsna in.pdf

Irina Stepanov, Joni Jensen, Dorothy Hatsukami, Stephen S. Hecht. tobacco-specific nitrosamines in new tobacco products. Nicotine & Tobacco Research Volume 8, Number 2 (April 2006) 309–313.

 

[Vocalek]

For a real eye-opener, compare the values in the tables cited above with the values in this table, showing TSNAs in popular brands of cigarettes sold in 2010. Carcinogenic tobacco-specific N-nitrosamines in US cigarettes: three decades of remarkable neglect by the tobacco industry -- -- Tobacco Control

Stepanov I, Knezevich A, Zhang L, Watson CH, Hatsukami DK, Hecht SS. Carcinogenic tobacco-specific N-nitrosamines in US cigarettes: three decades of remarkable neglect by the tobacco industry. Tob Control 2012;21:44-48

Link to full text of article: Carcinogenic tobacco-specific N-nitrosamines in US cigarettes: three decades of remarkable neglect by the tobacco industry -- Stepanov et al. 21 (1): 44 -- Tobacco Control

Just noticed that the table for cigarettes is expressed as nanograms per cigarette, while the smokeless tables are expressed as micrograms per gram of product. To convert to micrograms per gram, you would need to divide the number shown in the table by 50. (Nanograms / 1000 equals Micrograms per cigarette * 20 = Micrograms per gram.)

 

[house mouse]

How do they get to reach into another country and tell them what to do?

 

[Vocalek]

They can set up an import alert that triggers a seizure of incoming orders by Customs agents.

 

[Stubby]

Brad Rodu did a blog about TSNA levels in US made smokeless tobacco and has shown very low levels in todays products.

http://rodutobaccotruth.blogspot.com/2011/12/low-nitrosamine-levels-in-altria-and.html

Compared to the levels in the past TSNA levels are significantly lower. Most of the studies done on US snuff that had shown a very slight increase oral cancers are getting rather dated. I have to wonder if there is any connection to any oral cancer with current products. The past studies that show a connection go back to the sixties.

 

[hittman]

What a bunch of crap. I saw where they pointed out the word "mild" in describing one of the snus brands on the site. What they don't realize is that it is most likely meant as a mild flavor and not mild amount of tobacco or whatever they think it means. They should try using that round thing on top of their neck for doing something besides cracking nuts.

 

[rothenbj]

But Hitt, they like cracking our nuts.

 

[TomCatt]

I think I have an idea to fix the little red wagon of the FDA litig8rz.

Their hang-up appears to be descriptive words like "low" and "light". What could their objection be if the site displays a table showing the actual TSNA levels of a variety of products? This page contains a list of TSNA levels of smokeless products: For Smokers Only

"All analyses were performed at the Swedish National Food Administration."

This table is from a published article: PubMed Central, Table 1: Nicotine Tob Res. 2008 December; 10(12): 1773

Irina Stepanov, Ph.D. New and traditional smokeless tobacco: comparison of toxicant and carcinogen levels. Nicotine Tob Res. 2008 December; 10(12): 1773–1782.

The web site might not be able to get permission to reproduce the table from the journal, but nothing stops them from posting a link to the table.

Table 1, on page 312 of this article lists TSNA levels for a range of products from NRT products, through smokeless, to various brands of cigarettes. http://www.starscientific.com/404/stepanov tsna in.pdf

Irina Stepanov, Joni Jensen, Dorothy Hatsukami, Stephen S. Hecht. Tobacco-specific nitrosamines in new tobacco products. Nicotine & Tobacco Research Volume 8, Number 2 (April 2006) 309–313.

Just an FYI: The PubMed table units μg/g = ppm, parts per million and mg/g = parts per thousand (do not refer to parts per thousand as ppt as this is commonly used to indicate parts per trillion)

 

[Vocalek]

Just an FYI: The PubMed table units μg/g = ppm, parts per million and mg/g = parts per thousand (do not refer to parts per thousand as ppt as this is commonly used to indicate parts per trillion)

None of the tables expressed the value for TSNAs as milligrams per gram.

All three of the tables in the links listed in response #4 show the TSNA values expressed as micrograms per gram.

The table with the TSNAs for cigarettes (Carcinogenic tobacco-specific N-nitrosamines in US cigarettes: three decades of remarkable neglect by the tobacco industry -- -- Tobacco Control) expressed TSNA values as nanograms per cigarette.

I gave the formula for converting nanograms to micrograms (divide nanograms by 1000), and then to get to the same comparison as the other three tables (miocrograms per gram), multiply by 20 which would then give you the value for 1 gram of cigarettes.

Example: The table from the Tobacco Control article shows that Marlboro Full contains 397.7 nanograms per cigarette of TSNAs. Converting this to micrograms per gram we get 397.7 / 1000 = 0.3977 * 20 = 7.954 micrograms / gram.

In the Stepanov article, Table 1 shows a value of 6.3 micrograms / gram for Marlboro Full, which is in the ball park. Table 2 in that article shows a range of values from 2001 to 2005 for Marlboro full that goes from 8.9 down to 4.0.

Stepanov's article was published in 2006, and the Tobacco Control article was published this year (2012).

 

[Stop Smoking]

If anyone is familiar with, "Stranger in a Strange Land", a science fiction masterpiece written by Robert A. Heinlein. It tells the story of Valentine Michael Smith, a human who comes to Earth in early adulthood after being born on the planet Mars and raised by Martians. The entire idea that a group of individuals in their bureaucratic Orwellian holds placing ownership on the words, safety and acting in such ways would be uninterpretable. One would need to grok with them.

(The Oxford English Dictionary defines grok as "to understand intuitively or by empathy; to establish rapport with" and "to empathise or communicate sympathetically (with); also, to experience enjoyment)".

We must grok with the FDA, for to grok is to mutually understand the philosophical beliefs, the true nature and to become free of conflict as all points are correct, just not accurate.

GROK THE FDA

It won't happen because there is too much money and too many people who profit from the maintenance of rivalry and hate.

 

[Vocalek]

Let me put it this way: It is difficult to become water brothers with the FDA.

 

[VapApe]

They need to be turned 90 degrees from ever thing if you ask me

 

[JD4x4]

<snip>.. They should try using that round thing on top of their neck for doing something besides cracking nuts.

Oh, you mean like this?

 

[TennDave]

Gosh, they are really busting nuts! Gee OMG!!

 

[oldsoldier]

Lets stick to the subject at hand. We are not going to tolerate off topic political trolling on this thread, the next one will get a vacation.

 

[Vocalek]

Oh, you mean like this?

Additionally, your walnut products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.

I had no idea that there was a way to use walnuts unsafely. Perhaps directions would be needed to instruct laypersons to refrain from throwing unshelled walnuts at others?

These enforcement folks at FDA have entirely too much time on their hands. Maybe it is time to trim the government budget by laying off some of these jokers.

 

[Vocalek]

Can anyone explain to me why our tax dollars are being spent to send out warning letters to General Mills about Cheerios and to Diamond about their walnuts--two products that have never, to my knowledge harmed anyone--to "protect public health" and yet companies like this one, which took out a full page ad on the back of today's edition of Parade Magazine go unremarked and untouched by FDA enforcers?

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