Statements on Introduced Bills and Joint Resolutions

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

By Mr. DEWINE (for himself and Mr. KENNEDY):

S. 2461. A bill to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products; to the Committee on Health, Education, Labor, and Pensions.

Mr. DEWINE. Mr. President, today I join our colleague from Massachusetts, Senator Kennedy, to introduce a bill designed to help protect consumers-especially children-from the dangers of tobacco. Simply, our bill would finally give the Food and Drug Administration (FDA) the authority it needs to effectively regulate the manufacture and sale of tobacco products.

I say finally, because there are some tobacco proponents who would have you believe that the Master Settlement Agreement, which was signed in 1998 by 46 States, resolved the issue of youth tobacco use by imposing advertising restrictions.

I say finally, because my colleagues-first Senator McCain, then Senator Frist, then Senator Gregg, and then Senator Kennedy and I-have been seeking FDA regulation of tobacco products since the mid to late 1990's.

And, I say finally, because the bill that we are introducing today is the product of long and hard discussions and negotiations that I have had with Senator Kennedy and public interest groups and industry. Our bill has the support of Campaign for Tobacco Free Kids. Our bill has the support of Philip Morris. Our bill has the support of the American Heart Association, the American Lung Association, and the American Cancer Association. It is a bill that I am proud of, that is worthy of the Senate's consideration, and that will provide the FDA-finally-with strong and effective authority over the regulation of tobacco products.

I realize full well that tobacco users and non-users, alike, recognize and understand that tobacco products are hazardous to their health. We all know that smoking is not a healthy habit. But, that's an obvious point in comparison to the fact that right now, many consumers, including smokers, are surprised to learn that no Federal agency has the authority to require tobacco companies to list the ingredients that are in their products-things like trace amounts of arsenic, formaldehyde, and ammonia. And, no Federal agency has the authority to inspect tobacco manufacturers-how the cigarette and smokeless tobacco products are made, whether the manufacturers' machines and equipment are clean, etc.

While simply listing the ingredients, toxic as they may be, might not seem like much to some, think of it this way: Current law makes sure we know what's in products designed to help people quit smoking, like "the patch" or Nicorette gum, but not the very products that get people addicted in the first place-the cigarettes. That is absolutely absurd!

Think about this: Right now, the Food and Drug Administration (FDA) requires Philip Morris/Altria to print the ingredients in its Kraft "Macaroni and Cheese," but not the ingredients in its cigarettes-a product that contributes to the deaths of more than 440,000 people a year.

Right now, the FDA requires Philip Morris-owned Nabisco to print the ingredients contained in "Oreo Cookies" and "Ritz Crackers," but not the ingredients in its cigarettes-even though cigarettes cause one-third of all cancer deaths and 90 percent of lung cancer deaths. It is unfathomable to me that we would require the listing of ingredients on these products, yet not require the listing of ingredients for one of the leading causes of death and disease.

Right now, the FDA requires the printed ingredients for chewing gum, lipstick, bottled water, and ice cream, but not for cigarettes-a product that causes 20% of all heart disease deaths and is the leading cause of preventable death in the United States.

Think about this: If a company wants to market a food product as "fat-free" or "reduced-fat" or "lite," that company is required to meet certain standards regarding the number of calories or the amount of fat grams in that product. Yet, cigarette companies can call a cigarette a "light" or "mild" and not reveal a thing about the amount of tar or nicotine or arsenic in that supposedly "light" cigarette.

Not having access to all the information about this deadly product just makes no sense, and it is something that needs to change. By introducing this bill, we are finally saying that we are not going to let tobacco manufacturers have free reign over their markets and consumers any more.

Today, we are taking a step toward making sure the public gets adequate information about whether to continue to smoke or even to start smoking in the first place. With this bill, we are not just saying "buyer beware." We are saying "tobacco companies be honest." We are saying "tobacco companies stop marketing to innocent children." We are saying "tobacco companies tell consumers about what they are really buying."

The legislation that Senator Kennedy and I are introducing would do just that.

One of the most dramatic changes our bill makes is that tobacco products will now have to be approved before they reach consumer hands. It just makes sense that tobacco products should not be able to imply that they may be safer or less harmful to consumers because they use descriptors such as "light" or "mild" or "low" to characterize the level of a substance in a product. The National Cancer Institute has found that many smokers mistakenly believe that "low tar" and "light" cigarettes cause fewer health problems than other cigarettes. Our bill would require specific approval by the FDA to use those words, so that consumers could be informed.

For the first time ever, all new tobacco products entering the market would have to be approved by the FDA. Obviously, we already know that smoking is a health risk. But, what we don't know about is the harm caused by or what adverse health effects are created by the other ingredients in tobacco products or by how the tobacco is burned. There are tobacco products on the market that are not conventional cigarettes. They have carbon filters running down the center of them. They are sophisticated products that burn tobacco differently, that affect the body differently, and that may cause people to smoke them differently.

According to the Department of Health and Human Services, in an October article of the Journal of the National Cancer Institute, "the only proven method to reduce tobacco-related cancer risk is to stop smoking." Yet, often times, people cannot quit. It is very difficult to quit ingesting an addictive product. People are addicted to the nicotine in the tobacco product and are just simply unable to quit using it. So, tobacco companies have responded by developing and marketing tobacco products that purport to be "reduced-risk" or "safer."

Take, for example, a person who smokes Marlboro cigarettes-just plain Marlboro cigarettes, the ones in the red package. Let's say that person would like to quit smoking, has tried to quit smoking a number of times, but just hasn't been successful. So instead of quitting outright, that person figures they will switch the type of cigarette they smoke to a cigarette that has the implied claim of being "safer"-like a "light" cigarette or a "mild" cigarette or a "low tar" cigarette. Those cigarettes have not been found to be any safer? In fact, just the opposite has been discovered.

In a 2001 National Cancer Institute publication, they wrote the following:

The tobacco companies set out to develop cigarette designs that markedly lowered the tar and nicotine yield results as measured by the Federal Trade Commission (FTC) testing method. Yet, these cigarettes can be manipulated by the smoker to increase the intake of tar and nicotine. The use of these "decreased risk" cigarettes have not significantly decreased the disease risk. In fact, the use of these cigarettes may be partly responsible for the increase in lung cancer for long-term smokers who have switched to the low-tar/low-nicotine brands. Finally, switching to these cigarettes may provide smokers with a false sense of reduced risk, when the actual amount of tar and nicotine consumed may be the same as, or more than, the previously used higher yield brand.

So the products that tobacco companies develop and market as being "safer" are not safer. Rather than people quitting smoking entirely, they are often misled into thinking that the "light" or "mild" cigarettes that they switch to are better for them. In addition, people may begin to start smoking because they think some of these products aren't so bad for them-that the products have been made safer or better for them somehow and are okay to smoke.

Tobacco companies are able to make these implied health claims about their products because they are not regulated. Consumers have no choice but to trust the tobacco companies to reveal the ingredients and marketing claims about their products. That is just absurd to me. These are all things that should be examined, reviewed, and commented on by the Food and Drug Administration to determine whether it is appropriate for these products to be marketed as "reduced-risk" products, so the public knows what they are choosing to consume.

Tobacco advertising is in magazines and on billboards along the highway. Tobacco advertising is in convenience stores, along the aisles and at the checkout counter right beside the candy where children are likely to see it. Tobacco advertising is at sporting events, part of promotional items, where consumers can "buy 1 get 1 free." Tobacco advertising is on the Internet and in the daily delivery of mail.

Our bill would make changes regarding tobacco advertising. It would give the FDA authority to restrict tobacco industry marketing-consistent with the First Amendment-that targets our children. Our bill would require advertisements to be in black and white text only and would define adult publication in terms of readership.

An issue that is related to advertising and marketing of tobacco products has to do with the flavored tobacco products, which clearly target our children. We have probably all seen the flavored cigarettes-flavors like strawberry, chocolate, and wild rum. The scent of strawberry filters through the unopened pack of cigarettes. And guess what, the cigarettes smell like candy. A recent New York Times article described the scent of chocolate flavored cigarettes as if "someone had lifted the lid on a Whitman Sampler."

I can't speak for every parent, but I know my 8 grandchildren like candy, and they like the smell of chocolate, and they would be curious to try something that smells or tastes like candy. Cigarettes shouldn't be flavored and marketed in such a way to attract children and to encourage children to smoke. Our bill bans the use of flavors such as strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, coffee and other flavorings that would attract children to the product.

Despite the fact that 40 million Americans use tobacco products, many of them do not know what is inside the cigarette or the tobacco product they ingest. They do not know the ingredients or the constituents, like tar or nicotine, that are in the products they use. Consumers do not know what additives are included in the product. Additives like ammonia or urea, both of which may make the tobacco product more addictive because they increase the delivery of nicotine. Tobacco companies do not disclose the specific ingredients in their products because they don't have to. Tobacco products are unregulated.

Our legislation would give consumers more information about what's in tobacco products. Specifically, the bill would provide the FDA with the ability to publish the ingredients of tobacco products.

It would require a listing of all ingredients, substances, and compounds added by the manufacturer to the tobacco, paper, or filter.

It would require a description of the content, delivery, and form of nicotine in each tobacco product.
It would require information on the health, behavioral, or physiologic effects of the tobacco products.

I think it is equally important that I mention what our bill does not do. Here are some of the areas where authority is not conferred to FDA: Our bill does not allow FDA to ban tobacco products or to eliminate nicotine from a tobacco product. The bill ensures that FDA will not have the power to use its "performance standard" authority to ban cigarettes, smokeless tobacco or any other category of tobacco products, or to reduce their nicotine yields to zero.

Our bill does not allow FDA to establish a minimum smoking age higher than 18. The bill explicitly forbids FDA from establishing a minimum age higher than 18 years of age to purchase tobacco products.

Our bill treats all tobacco retailers equally. Our bill specifically provides that FDA can't prohibit the sale of tobacco products in any particular category of retail outlet. Our bill forbids FDA from creating a more permissive set of advertising rules for adult-only establishments. This provision protects retailers and convenience store owners.

Finally, I would like to make a comment about the tobacco farmers. There has been a lot of talk recently about the need for a buyout for our Nation's tobacco farmers. My colleagues, Senator McConnell and Senator Dole, have been working tirelessly to craft a buyout bill for tobacco farmers. They need a buyout-and the Congress should give them one. The Senate needs to pass the buyout, but the buyout needs to be passed along with this FDA bill. I look forward to working with my colleagues from the tobacco-growing states to make this happen.

The bill that Senator Kennedy and I introduce today gives the FDA the authority to regulate a product that has gone unregulated for far too long-a product that for the past century has not revealed its ingredients to the consumer-a product whose manufacturing facilities are not inspected or accountable for following good manufacturing practices-a product that is never reviewed or approved before reaching the hands of 40 million consumers, many of whom are just children. Congress needs to put an end to this. Congress should put an end to the marketing of tobacco products to our children. Congress should put an end to the ability of tobacco companies to make claims, whether they are implied claims or direct claims, about their products. Congress should put an end to tobacco companies putting any ingredient they want into their products without disclosing it to the consumer. It is time Congress give the FDA authority to it needs to fix these problems.

Mr. President, I ask unanimous consent that the text of the bill be printed in the RECORD.