Submit Comments to FDA on 2 Tobacco Issues.

The FDA is accepting comments from the public on two tobacco control issues:

• Nicotine Replacement Therapy (NRT): Two years ago, New York State Health Commissioner Richard Daines submitted a petition to the FDA to make nicotine replacement therapy more readily available and encourage more quit attempts. Two groups, the Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT), recently submitted a similar but more detailed petition. The ATTUD-SRNT petition seeks action on the following issues:

1) Comparison of Health Risks: The FDA must recognize and use as a guiding principle that tobacco dependence is a chronic disease, one that causes other grave illness and often death in smokers. The magnitude of the risk of continued smoking should be considered at all phases of review of NRT products. On NRT products approved as safe and effective, product labeling should reflect the potential health risks associated with use of NRT as compared to the significant negative health risks caused by smoking. This comparison is the appropriate measure, as it should be assumed that the consumer considering NRT is currently smoking and plans to reduce or quit smoking by using NRT.

2) Combined Use: Package labeling should allow for combined use of NRT products. Current labeling strongly warns against the combined use of NRT products yet sound research shows that combined use is safe and highly effective. Labeling should reflect that certain NRT products may be used safely and effectively in combination rather than that such use is prohibited or discouraged.

3) Term of Treatment: NRT users should not be discouraged from using the product beyond the currently recommended 10 to 12 weeks. Research supports that use well beyond 12 weeks is safe and may be more effective in achieving full and permanent smoking cessation for some individuals than the standard shorter course of treatment. Current labeling instructing that NRT
use stop at 10 or 12 weeks should be amended.

4) Package Size: To enhance accessibility, the FDA should permit the sale of NRT in one-day packages that can be priced affordably. Currently the FDA prohibits such packaging. The high price of NRT under current packaging standards, particularly as compared to the much lower price of a package of cigarettes, discourages quit attempts and smoking cessation.

5) Continued Smoking and NRT: Package labeling strongly warning against continued smoking and use of NRT should be amended such that consumers are encouraged to use NRT to treat the symptoms of nicotine withdrawal during temporary smoking abstinence or to assist consumers

The full ATTUD-SRNT petition is available here:
http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2010-P-0089.

To submit a comment to the FDA on this issue, go to
http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480aa6675.


 
• E-Cigarettes: Since last year, the FDA has sought to regulate e-cigarettes as drug delivery devices, citing the lack of published studies on product safety. However, a federal judge recently ruled that the FDA cannot regulate e-cigarettes as such. An appeal is expected. Click here to read more. The American Association of Public Health Physicians recently submitted a petition to request that the FDA classify and regulate e-cigarettes as tobacco products instead of drug delivery devices, noting the potential for harm reduction. The petition can be found at http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2010-P-0095.
To submit a comment on this petition, go to
http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480aa84a7. 
 


Labels: Citizens Petition, e-cigarette, FDA, jonathan foulds, NRT, tobacco

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The Future of the Tobacco Industry

The tobacco industry and its products (primarily cigarettes) has caused the premature deaths of over 13 million people in the United States since the 1964 Surgeon General’s Report which concluded that cigarette smoking causes lung cancer. Those health professionals, who are familiar with these statistics, and with the great lengths the industry has gone to to try to cover them up, have little sympathy for the industry’s current decline in the U.S. Many want nothing more than the annihilation of the tobacco industry. This is all the more understandable for those people who have seen patients and loved ones suffer and die from a smoking-caused illness. Some may feel that the tobacco industry and those in it do not deserve to continue to make money from such a deadly business.

It is quite appropriate that the emotions evoked by these aspects of the tobacco industry inspire many public health professionals to strive harder to oppose everything the tobacco industry does. However, these emotions may also cause some in public health to take their eye off the ultimate goal, which is the reduction of tobacco-caused harm. It is an unfortunate fact that the tobacco industry is not only a legal business; it is a very profitable one that has existed and gained in power and influence since the very birth of the United States.

Through that history and those massive financial resources the tobacco industry has been able to have enormous influence on elected and appointed public officials, continuing to this day. In addition, the dramatic increase in both federal and state cigarette taxes over the past 15 years has led to a situation in which the states have become dependent on those taxes as a source of revenue to balance their budgets. Recently total state revenues from tobacco taxes have been in the region of $20 billion per year.

Meanwhile, tobacco companies have a duty to maximize profits for shareholders. They are not going to stop selling cigarettes just because it would be good for public health.

This situation is part of the reason why I believe the best strategy for public health is one that forces/encourages the tobacco industry to morph from an industry that predominantly sells products that cause the premature deaths of half of its consumers (cigarettes), to one that sells products that do not cause lung cancer or respiratory diseases at all.

I believe the most practical way for this to happen is for tobacco companies to switch their focus away from cigarettes and towards other less harmful tobacco products such as smokeless snus tobacco. This is more realistic than total annihilation of the industry, partly because it would allow the companies to remain in business as tobacco companies, and for governments to continue to tax these products in order to balance their budgets.

For more details on the rationale for this, check out a presentation I gave to the Tobacco Merchants’ Association Annual Meeting in 2007:
http://www.tobaccoprogram.org/fouldstma.htm


For a summary of recent changes in tobacco taxes check out:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a2.htm

For an article on the implications of state tax revenues for policy, check:
http://www.medicalnewstoday.com/articles/120076.php

Labels: jonathan foulds, smokeless, tobacco, tobacco industry, tobacco tax

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Could FDA reduce nicotine levels in cigarettes?

In the previous posting I discussed the possibility of FDA requiring that no tobacco products be allowed to emit Carbon Monoxide. While appealing in its simplicity, such a strategy may have problems in that it could be interpreted as a ban on a whole class (or classes) of tobacco products, which the legislation does not allow.

Another strategy might be to reduce the harm from tobacco by lowering the nicotine content/delivery of cigarettes down to the level at which they are no longer addictive. A form of this strategy was proposed in the 1990’s by leading tobacco researchers Professor Neal Benowitz, and Professor Jack Henningfield. The FDA legislation singles out nicotine as the only chemical that cannot be reduced to zero, but this allows FDA the right to reduce the nicotine delivery of tobacco products down to a level just above zero at which they would no longer be addictive.

Although people could debate and study precisely what level of nicotine delivery is non-addictive, in reality it would not be at all difficult to define a level that would be so lacking in reinforcement as to be insufficient to perpetuate addictive use. For example, one could require that no cigarettes are capable of providing the user with a venous blood nicotine level higher than 4 ng/ml, whether from chain-smoking a number of cigarettes, or from smoking a whole pack throughout the day. For cigarettes to meet this criterion would not require them to be nicotine-free, but it would require them to deliver a per-cigarette boost in venous blood nicotine of less than 2 ng/ml (as compared to a typical boost of 10-20 ng/ml from a typical cigarette). This low level of nicotine delivery would not be sufficiently reinforcing for the vast majority of users. If alternative nicotine delivery products such as nicotine replacement therapy, smokeless tobacco products and possibly e-cigarettes were allowed to remain on the market with their normal (or possibly even increased) nicotine delivery then highly addicted smokers would transition onto these products as the nicotine delivery of their cigarettes is cut.

One of the primary aims of this strategy is to get to the point where young people will no longer become addicted to cigarettes.

So long as very low nicotine delivery cigarettes remain available, this strategy should be consistent with the legislation, and so long as plenty of smoke-free nicotine delivery products remain available it should not cause major problems of nicotine withdrawal, even if it is implemented relatively swiftly.

Of course, although in these days of FDA regulation there is talk that now tobacco policy can be driven by science rather than politics. While there is now a much more direct role for science than we had before the legislation, that does not mean that politics do not play a part. In the end, money counts, and right now the federal government and the states have become somewhat reliant on revenue from tobacco (primarily cigarette) taxes to come close to balancing budgets. If that revenue source was suddenly taken away (or even gradually) then there is a risk that the political world may interfere with the science-based public health strategy. For that reason I would recommend that the same nicotine reduction strategy not be applied to smokeless tobacco products. Rather, these should be regulated with a toxin reduction strategy to ensure they are minimally harmful, while maintaining the ability to deliver adequate amounts of nicotine to satisfy smokers’ addiction. These products would continue to be taxed at a relatively high rate and would take on the tax burden vacated by smoked products (which would no longer deliver adequate amounts of nicotine to be the lead product). In this way, the financial consequences for the states need not be so severe that the cigarette nicotine reduction strategy would be called to a halt. This dual track strategy also allows the tobacco industry to stay in business. There will be a greatly increased demand for low-toxin medium-high nicotine-delivery smokeless tobacco products, along with a greatly reduced demand for very-low-nicotine cigarettes and cigars. The companies will have to change fairly drastically to producing products that no longer cause hundreds of thousands of cases of lung cancer and COPD each year. But this is precisely the purpose of the FDA legislation: to regulate tobacco in a manner that prioritizes public health.

Labels: cigarette, comprehensice tobacco control, FDA, Jack Henningfield, jonathan foulds, Neal Benowitz, nicotine addiction, nicotine reduction, nicotine regulation, smokeless

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Could FDA require tobacco companies to cease selling products emitting carbon monoxide?

Carbon monoxide (CO) is a clear, odorless gas that is produced by burning any carbon-based substance. So when tobacco is burned and inhaled, one of the 4,000 or more chemicals that enters the body is CO. When the smoke is inhaled into the lungs, CO is rapidly absorbed into the blood stream. CO binds to the hemoglobin in the red blood cells 200 times more effectively than oxygen does. The result is that many of these blood cells that were designed to carry oxygen to different parts of the body, instead bind to the CO, forming carboxyhemoglobin (COHb). This means that the heart has to do more work to supply the necessary amount of oxygen to the body. There is good evidence that high levels of carbon monoxide in the blood of smokers is one of the main factors causing smokers to have increased rates of cardiovascular diseases (such as angina and heart attacks). Other factors include platelet aggregation increasing the “stickiness” in the blood, stimulated by oxidant gases in cigarette smoke, and increased myocardial oxygen demand caused by nicotine. But it is clear that the reduced oxygen supply caused by carbon monoxide is a major factor. For example, increasing blood CO levels (either by smoking non-nicotine cigarettes or inhaling CO) has been shown to reduce the amount of exercize required to cause angina (chest pain) in patients with a history of angina.
(see: http://circ.ahajournals.org/cgi/content/abstract/61/2/262 )

Tobacco smoking is by far the largest determinant of CO levels in the blood, with smokers typically having blood COHb levels around ten times higher than non-smokers. So the idea that you might as well smoke because there is so much pollution in the air anyway is just nonsense. See this link for a study of this in a population sample:
http://www.biomedcentral.com/1471-2458/6/189

The legislation that was passed 8 months ago giving the US Food and Drug Administration the right to regulate tobacco products, allows FDA to require tobacco product manufacturers to take out any chemical (except nicotine) that appears to be harmful to public health. This can include not only chemicals IN the product, but also chemicals emitted by the product and absorbed by the user during normal use. Given the kind of evidence described above, it would seem highly likely that if it were to be reviewed by the FDA scientific advisory committee, it would conclude that CO is a chemical emitted by cigarettes that is harmful to the individual consumer, and also that limiting the industry to selling products that do not emit carbon-monoxide would be very likely to improve public health. I don’t believe there would be any controversy over the scientific evidence on CO from cigarettes and cigars, or the benefits of banning CO-emitting products.

However, the controversy would arise over whether or not the FDA legislation really empowers FDA to do this. It is highly likely that such a move would immediately result in tobacco company lawyers claiming that such a requirement is in effect a ban on at least 2 classes of products (cigarettes and cigars), and that the legislation does not give FDA the right to ban whole classes of products. This is something that would be decided by lawyers and possibly ultimately by politicians. But here is another view of the possibilities:

The legal definition of a cigarette in the United States is as follows:

“Any roll of tobacco wrapped in paper or in any substance not containing tobacco; and any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette.”

By this definition, electronic cigarettes (e-cigarettes) could be classified as cigarettes. In fact just last month a U.S. judge ruled that e-cigarettes were cigarettes and not drug delivery devices (actually over-ruling the claims of FDA). For more details on this, cut and paste the following link:

http://www.e-cig.org/2010/01/19/what-does-judge-leons-ruling-against-the-fda-mean-for-electronic-cigarettes/

So if e-cigarettes are judged to be cigarettes, and they don’t emit carbon-monoxide (which they don’t), then FDA requiring tobacco companies to cease selling CO-emitting products would NOT in fact be a ban on a class of products. It would simply be a sensible way of reducing the harm to health from certain tobacco products, just as the legislation was intended to do. Of the big smoked tobacco manufacturers want to stay in business they could (and should) switch to focus exclusively on making and selling products that deliver nicotine without simultaneously delivering carbon-monoxide, such as e-cigarettes and smokeless tobacco.

At that point FDA could require the companies to minimize the amount of harmful chemicals being emitted by these products, even although over 90% of the harms from tobacco would already have been eliminated by taking out the burning part of the process. Some people reading this may think it sounds naïve or even crazy. But maybe its not. The federal government and the states would likely ramp up the taxes on e-cigarettes and smokeless tobacco to make sure their revenue is not affected too much, and cigarette and cigar manufacturers would focus on exports and on sales to sources they know will smuggle them back into the country. So in reality, traditional cigarettes would still exist, but they just wouldn’t be used nearly as widely in the United States, just as marijuana is still smoked, but not as regularly as cigarettes.

Labels: carbon monoxide, cigarette, e-cigarette, FDA, jonathan foulds

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Citizens’ Petition To FDA on Regulation of Tobacco Treatment Medicines.

On Friday February 12th 2010 two of the leading organizations concerned with reducing the harm to health from tobacco submitted a petition to the US Food and Drug Administration, requesting changes in the way tobacco treatment medicines are regulated. The Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT) were co-petitioners, with the final petition being reviewed and approved by the relevant committees within these organizations. At SRNT this included review by a sub-committee consisting entirely of members who have no links with pharmaceutical companies. The petition was accompanied and supported by a review paper, entitled “Barriers to Use of FDA-Approved Smoking Cessation Medications: Implications for Policy Action”, which was funded by the Robert Wood Johnson Foundation.

The review paper sought to identify barriers to consumer demand for effective FDA-approved tobacco treatment medications, and to suggest potential policy solutions. It identified widespread misconceptions about the harms and benefits of nicotine replacement therapy, characterized by an exaggerated concern about the safety of NRT and skepticism about the effectiveness of NRT. Many of the recommended solutions are consistent with those that have previously been recommended to reduce tobacco consumption generally. In addition, broadening indications and access conditions, and altering labeling on tobacco treatment products may enable these products to help more tobacco users to become tobacco-free. There is an urgent need for this policy action, because every additional year that hundreds of billions of cigarettes are smoked in this country results in hundreds of thousands of premature deaths and millions of cases of avoidable illness.

The mission statement of the FDA states that:
╥The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health╙.

The Citizens Petition from ATTUD and SRNT requests that FDA regulate tobacco treatment medicines in a manner that is consistent with this mission. Specifically, it requests that the following actions be taken. Support for these actions and further explanation is provided in the body of the Petition and in the Barriers Report.

1) Comparison of Health Risks: The FDA must recognize and use as a guiding principle that tobacco dependence is a chronic disease, one that causes other grave illness and often death in smokers. The magnitude of the risk of continued smoking should be considered at all phases of review of NRT products. On NRT products approved as safe and effective, product labeling should reflect the potential health risks associated with use of NRT as compared to the significant negative health risks caused by smoking. This comparison is the appropriate measure, as it should be assumed that the consumer considering NRT is currently smoking and plans to reduce or quit smoking by using NRT.

2) Combined Use: Package labeling should allow for combined use of NRT products. Current labeling strongly warns against the combined use of NRT products yet sound research shows that combined use is safe and highly effective. Labeling should reflect that certain NRT products may be used safely and effectively in combination rather than that such use is prohibited or discouraged.

3) Term of Treatment: NRT users should not be discouraged from using the product beyond the currently recommended 10 to 12 weeks. Research supports that use well beyond 12 weeks is safe and may be more effective in achieving full and permanent smoking cessation for some individuals than the standard shorter course of treatment. Current labeling instructing that NRT
use stop at 10 or 12 weeks should be amended.

4) Package Size: To enhance accessibility, the FDA should permit the sale of NRT in one-day packages that can be priced affordably. Currently the FDA prohibits such packaging. The high price of NRT under current packaging standards, particularly as compared to the much lower price of a package of cigarettes, discourages quit attempts and smoking cessation.

5) Continued Smoking and NRT: Package labeling strongly warning against continued smoking and use of NRT should be amended such that consumers are encouraged to use NRT to treat the symptoms of nicotine withdrawal during temporary smoking abstinence or to assist consumers

You can access the Citizens Petition and the report on barriers to the use of FDA-approved smoking cessation medicines on the ATTUD website at:
www.attud.org

and on the SRNT website at:
http://www.srnt.org/about/policies.html

I believe these documents will shortly be posted on the FDA website and at that point will be available for comment.

Labels: ATTUD, Citizens Petition, FDA, jonathan foulds, Nicotine Replacement, SRNT

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