At the Senate HELP Committee mark-up of the FDA tobacco bill - currently scheduled for this coming Wednesday - a number of amendments will be offered that would substantially strengthen the legislation. In this post, I will summarize these amendments.
But first, it is important to note that the health groups supporting this legislation, including the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, and American Lung Association, oppose each and every one of these improvements to the bill.
Why would these health groups oppose amendments that will strengthen the legislation and take out some of the loopholes that protect Big Tobacco profits at the expense of the protection of the public's health?
To me, the reason appears to be simple. The Campaign for Tobacco-Free Kids essentially struck a deal with Philip Morris at the Congressional negotiating table two years ago. The two major parties to that negotiation process basically struck a deal, and it appears that the Campaign for Tobacco-Free Kids wants to preserve the terms of that deal because if the deal is broken, it will lose the support of Philip Morris and the whole thing may crumble. This would be a devastating blow to the Campaign, which has put so much on the line (using all kinds of deceptive and unethical tactics to try to even get to this point).
Two things, then, are clear:
First, the Campaign for Tobacco-Free Kids and the other health groups which appear to be taking marching orders from the Campaign apparently have no sincere interest in developing legislation that will be as effective as possible in protecting the public's health from the hazards of tobacco. They have no desire for input from other public health experts, they are not willing to consider criticism of the legislation, they are not willing to consider any changes that would strengthen the bill. There is no opportunity for a dialogue or discourse about what would represent effective regulation of tobacco products or what strategy would be most effective in reducing tobacco use or potentially creating safer cigarettes. All decisions have already been made. It is either this deal with Philip Morris, or no legislation at all. That's the only choice that the health groups are offering to the American people.
Frankly, that's a travesty, because the responsibility of public health is to protect public health, not to sell out the public's health to Big Tobacco merely to enact some legislation and be able to stick a feather in our cap.
Second, it's clear that the propaganda being put out by the Campaign is merely rhetoric. There is little sincerity in their proclamations that their desire is to end special protection for Big Tobacco and save countless lives. If the true desire were to end special protection for Big Tobacco, then the Campaign and its fellow health groups would have no choice but to support these amendments which would, indeed, get rid of special protections for Big Tobacco that Philip Morris has apparently required in order to support the bill. If the true desire were to save countless lives, then there would be no choice but to support amendments which would put the only teeth into the entire bill, which in its present form is devoid of anything that would actually put a dent in tobacco use or create a safer cigarette.
The Campaign for Tobacco-Free Kids told its constituents that it opposed Senator Kennedy's insertion of a last-minute change in the bill which allows tobacco companies to market clove cigarettes. However, the Campaign is not particularly sincere in that opposition, since it now opposes an amendment that would do nothing more than remove that special protection for Big Tobacco.
The Campaign also claims that it opposes this amendment because it would eliminate the bill's chances of passage through Congress. However, a majority of legislators in the Senate have already sponsored the bill with the clove ban in the bill. It would be politically untenable for them to oppose a bill with the exact language that was in the bill which they sponsored, solely because it is now apparent that Philip Morris is actually marketing clove cigarettes in Indonesia!
With those critical observations made, here then is a brief summary of the most important amendments that would strengthen the bill. Note that this is not a comprehensive list, but an attempt to inform the public of some of the most important amendments.
Enzi Amendment #1: This amendment would eliminate the loophole which precludes the FDA from banning any particular class of tobacco product. This would allow the FDA to mandate changes to improve the safety of cigarettes even if those changes required a major re-design of the cigarette. In its present form, this loophole allows the tobacco companies to challenge such a regulation on the grounds that it represents a de facto ban on a class of tobacco products. In addition, the amendment would allow the FDA to ban cigarettes at some point in the future if it becomes economically and socially feasible. A clause would probably need to be added by a further amendment to make it clear that the FDA can consider non-health factors, such as the social and economic feasibility of banning a class of tobacco products in any such deliberation.
Enzi Amendment #2: This amendment would eliminate the loophole which precludes the FDA from getting rid of nicotine in cigarettes. This would allow the FDA to get rid of the nicotine and thus require a cigarette that is greatly reduced in addictive potential. Under the current bill, the FDA cannot get rid of the nicotine, but can only reduce the nicotine yields. This would be a disaster, as smokers would smoke more to compensate for the reduced nicotine. In addition, if the FDA did try to reduce nicotine to extremely low levels, the tobacco companies would be able to tie such a rule up in courts for years, since it is clearly the intent of Congress to reserve to itself any decision regarding making cigarettes non-addictive. There is absolutely no reason for health groups to oppose this amendment, since if it is the intent of Congress to allow the FDA to make cigarettes non-addictive, then there will be no harm in explicitly stating that the FDA can do that. Short of this amendment, it will be clear that Congress' intent is not to allow the elimination or near elimination of nicotine, and any such attempt by the FDA will most certainly be overturned by Congress, using its veto power provided elsewhere in the bill (via yet another loophole).
Enzi Amendment #4: This amendment strengthens the required warning labels on cigarettes by increasing the size of warning labels from 30% to 50% of the pack and adding color graphics that depict the negative health consequences of smoking. This is similar to warning labels that have been used with some success in Canada. Again, there is absolutely no reason for health groups to oppose this amendment since it merely improves the warning labels.
Enzi Amendment #5: This amendment increases the federal cigarette excise tax by 39 cents per pack and allocates the revenues to support cancer research at the National Cancer Institute. This is a far better use of the revenues from a large cigarette tax increase than supporting children's health insurance - the last thing in the world that we want to become dependent upon continued cigarette consumption.
Enzi Amendment #6: This amendment would add menthol and clove to the list of flavorings that cannot be used as a primary flavor in cigarettes. This is a critical improvement, since it affects flavors that Big Tobacco actually does use to recruit smokers. Currently, the legislation bans plenty of flavors, but few, if any of them are actually being used to market cigarettes (when was the last time you saw a cherry cigarette?).
Enzi Amendment #7: This amendment increases the federal cigarette excise tax by 39 cents per pack and allocates 50% of the revenues to Medicare, 25% to Medicaid, and 25% to state tobacco education and cessation programs. This amendment alone would do more to reduce smoking than everything else in the FDA bill combined.
Enzi Amendment #8: This amendment increases the federal cigarette excise tax by 39 cents per pack and allocates the revenues to the FDA to allow it to increase the number of its inspectors. The amendment highlights the fact that FDA's ability to safeguard the public from food and drug threats is so impaired that it seems crazy to be considering adding tobacco products to its jurisdiction.
Enzi Amendment #11: This amendment would remove the exemption for menthol as one of only two flavorings allowable (along with clove). If Enzi Amendment #6 passes, then this amendment is not necessary.
Enzi Amendment #12: This amendment would remove the exemption for clove as one of only two flavorings allowable (along with menthol). This simply returns the bill to its form prior to Senator Kennedy's addition of the clove exemption in order to protect the financial interests of Philip Morris, which recently began marketing clove cigarettes in Indonesia. There is absolutely no reason for any of the health groups to fail to support this amendment, since it simply removes a special protection for Philip Morris which has no place in the legislation, and which wasn't even in the legislation to begin with. The explanation that this clause is necessary to avoid violating trade treaties is completely bogus. Besides, if that were true, then it would violate trade treaties for the FDA to require any changes in cigarette ingredients, since imported cigarettes wouldn't meet such requirements.
Burr Amendment #8: This amendment would strengthen the requirements for making a reduced exposure claim for a tobacco product and ease the requirements for making a reduced risk claim for a tobacco product. The problems with the current modified risk section of the bill are that it (1) makes it virtually impossible for a reduced risk claim to be approved, thus taking away any incentive for a tobacco company to research, develop, and seek to market what might be a truly reduced risk product; and (2) makes it too easy for a reduced exposure claim to be made, thus institutionalizing the fraud which tobacco companies were found guilty of committing in implying that low-tar and low-nicotine cigarettes are safer.
This amendment addresses, to some extent, these problems. First, it makes it at least possible for a reduced risk claim to be made (and thus restores the incentive for companies to develop a truly safer cigarette). Instead of having to conduct long-term epidemiologic studies to prove that a product reduces long-term risks, a company could instead demonstrate that the cigarette reduces actual human exposure to various constituents and that reduction in such constituents results in decreased disease as measured by some clinical marker of disease risk (but short of having to demonstrate reduced risk in a long-term epidemiologic study).
Second, this amendment makes it more difficult to make an undocumented reduced risk claim that might wrongly imply reduced disease risk. Under the current bill, a company merely needs to show that the yield of a certain constituent is reduced and that a reduction in disease risk is "anticipated." This amendment requires the demonstration of reduction in actual human exposure (not just in machine-measured yields). It also requires scientific documentation to back up that a reduction in disease risk is anticipated. The anticipation alone is not enough.
Finally, this amendment would allow the FDA to establish rankings which compare the risks of different classes of tobacco products. Communications of differences in risks between various classes of products is not allowed under the current bill.
Burr Amendment #10: This amendment would require states to spend Master Settlement Agreement funds on tobacco control programs at the amount recommended by the Centers for Disease Control and Prevention, or else they would face a reduction in their mental health and substance abuse block grants. This is a good idea and it would, if effective, actually make a dent in smoking, unlike the FDA bill itself. However, it's not clear to me that the financial penalties for not allocating the required amount of money to tobacco control programs are severe enough. I'm not aware of the amounts that states receive from substance abuse and mental health block grant funding to determine whether this provision would be effective. But clearly, the idea itself is an excellent one.
The Rest of the Story
I must emphasize that even with these amendments, I oppose the FDA legislation and I think it would be a public health disaster. The point is not that these amendments fix the legislation and address the concerns that I have expressed. The point is that they represent a significant strengthening of the legislation, and that it is telling that the health groups which supposedly want to end special protection for Big Tobacco and save countless lives are opposing each and every one of them.
Frankly, I would like to see a few of the amendments enacted into law as a stand-alone bill, while scrapping the rest of the FDA legislation. Some of these amendments demonstrate an appreciation of the types of actions that Congress could take to make a serious dent in smoking, rather than a bill which may appear great on the surface, but which is actually designed to institutionalize tobacco use, protect Big Tobacco at the expense of public health protection, and preserve and protect the profits of the nation's largest tobacco company.
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