Monday, July 27, 2009

Potent Carcinogens (Tobacco-Specific Nitrosamines) Found in Saliva of Nicotine Gum Users; When Will FDA Take Enforcement Action Against Nicorette?

An article in the journal Food and Chemical Toxicology has revealed that tobacco-specific nitrosamines are present in the saliva of nicotine gum users, indicating that actual exposure to carcinogens results from the use of Nicorette gum (see: Osterdahl BG. The migration of tobacco-specific nitrosamines into the saliva of chewers of nicotine-containing chewing gum. Food and Chemical Toxicology 1990; 28:619-622).

The article reported three major findings:

1. "All the saliva samples obtained during Nicorette chewing contained NNN and NAT/NAB at levels ranging from 0.42 to 19 ng/g and from 1.3 to 46 ng/g, respectively."

2. "All Nicorette samples contained NNN and NAT/NAB, at levels ranging from 38 to 180 ng/g
and from 29 to 260 ng/g, respectively, NNK was found in two samples at levels of up to 3.0 ng/g."

3. "The levels of TSNA found in the saliva of Nicorette chewers seem to be higher than the few values of TSNA reported in the saliva of smokers."

Thus, this study found that carcinogens were present in nicotine gum, that gum users are exposed to these carcinogens, that these carcinogens are present in the saliva of gum users, and that the level of these carcinogens in the saliva of Nicorette users is higher than in the saliva of cigarette smokers. The latter finding is not surprising since the gum is being chewed, while tobacco cigarette smoke is inhaled.

Where are the carcinogens coming from? The article hypothesized that "the presence of NAT/NAB could be due to contamination of the nicotine extracted from tobacco leaves."

The article concluded as follows: "The saliva of Nicorette chewers contains carcinogenic TSNA. It is not possible at present to estimate reliably the carcinogenic risk for man of exposure to such very small amounts of nitrosamines. It is, however, desirable to reduce the exposure to these compounds whenever possible. It should be possible to reduce the levels of TSNA in the nicotine-containing chewing gum to a minimum by using a more appropriate method to extract nicotine from tobacco leaves."

The Rest of the Story

This research demonstrates that a slanted presentation of laboratory data on the detection of carcinogens in nicotine delivering products can lead to completely erroneous public health conclusions.

In the case of nicotine gum, there are clearly detectable levels of carcinogens present in the product and users are exposed to these carcinogens, which are measurable in their saliva.

In the case of electronic cigarettes, there are also clearly detectable levels of carcinogens present in the product. Unlike with nicotine gum, it has yet to be determined the extent to which users are exposed to these carcinogens and whether they are detectable in body fluid samples of users.

The explanation for this finding of trace levels of carcinogens - in both cases - is that the nicotine is extracted from tobacco and there is contamination. It is difficult to extract the nicotine in a 100% pure form.

But unlike in this scientific article, the FDA failed to inform the public of exactly what was going on. The Agency withheld the truth from consumers. And it appears that this was done intentionally to try to scare electronic cigarette users into thinking that there are high levels of carcinogens in e-cigarettes and that they should therefore stop using them because of the high risk of cancer.

Of course, the FDA is not going to hold a similar press conference to announce that there are detectable levels of carcinogens in the saliva of nicotine gum users. Or that tobacco-specific nitrosamines have been identified in a wide variety of nicotine replacement products.

The Agency is apparently only going to present a slanted version of the facts when it fits its agenda.

If I really wanted to, I could scare nicotine gum users throughout the country by holding a press conference to announce that nicotine gum contains carcinogens, that we have detected these carcinogens in the saliva of gum users, and that the level of TSNA's in the saliva of nicotine gum users is higher than that in the saliva of cigarette smokers.

This would certainly scare many nicotine gum users, and many of them would probably be scared enough to lay off the gum and return to cigarette smoking.

If I did this, I would have to turn myself in for medical malpractice, because that's the label that I think fits. It would be criminal of me to use a misleading presentation of the scientific data to try to scare thousands of nicotine gum users into returning to cigarette smoking. Realistically, that is exactly what I would be doing.

Sadly, I believe that this is exactly what the FDA has done with respect to electronic cigarettes. I believe the Agency has used a misleading presentation of very similar scientific data to try to scare thousands of electronic cigarette users into returning to cigarette smoking.

And for the life of me, I just can't figure out why the FDA would want to do that. Why would they want perhaps hundreds of thousands of electronic cigarette users to return to cigarette smoking? It just baffles my mind and I can't figure out why they would want such a thing.

You can talk all day about how electronic cigarettes are a nicotine delivery device and they need to be regulated by the FDA and there's a risk that children might poison themselves and kids might be enticed to start smoking them, and on and on. But how does any of that justify taking the product off the market or scaring e-cigarette users into returning to conventional cigarette smoking?

It's not clear that tobacco control groups are capable of understanding a simple harm reduction argument. Or at least not when it comes to electronic cigarettes, a product that is not produced by either the tobacco or pharmaceutical industries.

However, when it comes to nicotine replacment therapy, anti-smoking groups seem to understand exactly what harm reduction means. For example, when it was reported that nicotine replacement products might pose some cancer risk to users, the UK anti-smoking group Action on Smoking and Health urged NRT users not to abandon these products and under no circumstances to return to cigarette smoking, stating: "It is important to keep a sense of proportion. Taking off the nicotine patches is much more likely to kill you than keeping them on."

But when it comes to electronic cigarettes, it seems that the same harm reduction argument no longer applies: Dr. Jonathan Samet, director of the University of Southern California's Institute for Global Health, was quoted in a Fort-Worth Star-Telegram article as stating: "I think the bottom line here is simple. These are devices of delivering nicotine through unknown magnitude into the body with no proven benefit for cessation and some indication that there may be risks."

There is certainly some indication that there may be risks of using NRT products. But Dr. Samet and other anti-smoking researchers are not calling for these products to be taken off the market until we know for sure what those risks are. Harm reduction, I guess, only applies to products made by corporations that funnel huge amounts of money into anti-smoking coffers.

Ironically, two individuals showing the greatest understanding of the issue are not from the tobacco control movement, FDA, or any public health group. They are members of the public - presumably electronic cigarette users - who truly appreciate exactly what is at stake here. On an electronic cigarette discussion forum, one individual commented:

"Pisses me off to no end that the FDA is now changing people's minds about how safe it is for the vaporer and for those around them. Many potential analog quitters will now not be making the switch to e-cigs....How sad and frustrating...."

To which another individual responded: "You know, this is a very good point. FDA has incredible power to disseminate information to the media. If they present skewed findings it is not the same as when a manufacturer does it -- the general public views FDA as "neutral" and will take FDA comments to be the independent truth. If FDA statements turn analog smokers away from PVs [electronic cigarettes], the FDA would be in a very difficult spot when the truth comes out."

These are insightful comments, and they are exactly on the mark.

Well the truth has now come out and the FDA is indeed in a very difficult spot. How can the Agency possibly explain its desire to have perhaps hundreds of thousands of electronic cigarette users returning to the most highly toxic consumer product out there -- conventional cigarettes? How can that possibly be a good thing for the public's health?

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