Q. What are some of the reasons the American Cancer Society, American Heart Association, American Lung Association and Campaign for Tobacco-Free Kids are supporting these bills?

These bills would give FDA the tools and resources it needs to protect public health.

* The bills would reinstate the FDA's marketing and youth access restrictions, as well as the rest of the 1996 FDA rule.

* The bills would give FDA broad authority over tobacco marketing based on considerations of public health - something that no agency currently has. At worst, FDA won't use it. At best, FDA will go after a broader category of marketing that encourages tobacco use or misleads consumers about the relative health effects of different products.

* The bills would do away with the current misleading FTC tar and nicotine reporting system. While we know that the current system misleads consumers, without new legislation the current broken system will continue to mislead. The bill gives FDA broad authority to come up with a new system for testing whatever components and smoke constituents FDA deems appropriate. Equally important, it stipulates that FDA should require the disclosure of this information on packs and ads if it can find a way to do so that won't mislead consumers about the health significance of the information - a vitally important step forward. * The bills would prevent the use of terms such as "light", "low tar", "mild" unless given specific authority by FDA. The bill would require tobacco companies to tell FDA what is in each brand - not just the ingredients but smoke constituents as well, and would give FDA the authority to tell the tobacco companies how to test for these substances. It would also require the tobacco companies to tell FDA when it changes the amount of any of these ingredients or smoke constituents. This information in the hands of government scientists could be very helpful in efforts to reduce the harm and addictiveness of tobacco products.

* The bills give FDA the authority to require the removal of ingredients and smoke constituents based on what will protect the public health. Will FDA use this authority? No one can be sure, but under the right FDA Commissioner, this authority represents a powerful new tool.

* The bill gives the government new and real authority over claims related to whether new tobacco products actually present less of a risk than other products on the market. No standards currently exist. The current unregulated environment only gives tobacco companies the incentive to create the impression that so-called product innovations make a difference - as happened with low tar products - without any real meaningful change and leaves consumers in the dark. Although no standards are immune from the potential for misuse, the standards in the new bill are tough. If implemented in good faith, they should make it very, very hard for tobacco companies to claim that any of their products are safer than other products. They should also encourage the development of science in this area - an important by-product.

* By imposing tough standards for reduced risk claims for tobacco products, it seems likely that the bill would give a boost to non-tobacco NRT's in the marketplace. The bill also encourages FDA to fast track NRT products to help with cessation. An effective FDA handle on tobacco products may be the best boost we can give to clean NRT.

Q. Why don't we wait for a time when the leadership of the House and Senate and the White House are more supportive and possibly seek even stronger FDA legislation?

We have concluded that this is a good bill from a public health perspective or else we would not be supporting it. If we can pass this bill in its present form, it would be a public health victory. No one can be certain that a better bill could be developed or passed no matter who is President. We have also concluded that it is important to take advantage of the current opportunity to move a bill. The absence of FDA jurisdiction is the status quo. We currently do not have a situation where the market place protects the public health or where we know for certain that tobacco companies will be held liable for the failure to adequately warn consumers. In the current environment, we have worthless health warnings, no control over what tobacco companies say about the relative health effects of their products, no authority for the states to curtail tobacco marketing beyond the MSA, no control over the products and no ability to find out what the industry is doing with the products. The new health warnings the legislation would mandate won't provide the tobacco industry more protection against lawsuits, they already have all the protection they will receive as the result of the existing health warnings.

Were this legislation to pass, enactment into law simply marks the beginning of the process to ensure effective regulation of tobacco products; all of us must face the challenge to aggressively push the tobacco control and public health community to work with FDA to constantly hold the agency's feet to the fire, and to use all of the tools that the legislation provides to it.

We will have the ability to actively participate in the regulatory process through public comments and actively advocate before the agency.

Q. What impact could this legislation have on DOJ and other lawsuits?

The bill will have no direct impact on the lawsuit brought by the Department of Justice. That lawsuit is scheduled for trial in September 2004 and it will proceed separately from the legislation. The one potential impact it may have relates to the remedy. The Department of Justice has indicated that if it proves its legal claims, it will ask the court to impose a range of remedies, including, for example, restrictions on youth advertising. To the extent that those restrictions are imposed by legislation enacted by Congress, then they would not be part of the Justice Department's request for relief, if it prevails in the case. The bill will not change the rules applicable to product liability litigation brought by citizens against the tobacco industry.

Q. What compromises were made?

Like any piece of legislation, this bill contains compromises, but even with these compromises, we believe that this is the strongest bipartisan bill ever introduced. We also believe that the compromises contained in the bill do not undermine FDA's ability to act.

What are the major compromises? Under these bills, while FDA can require many changes to tobacco products, Congress reserves the right to ban any broad class of products (all cigarettes, all smokeless tobacco) and to require the reduction of nicotine yields of a tobacco product to zero. This does not prohibit FDA from requiring major changes in tobacco products or requiring dramatic decreases in nicotine. We also preferred to expand states' rights to give them unfettered authority to regulate tobacco marketing. The bill expands states' current authority but not as broadly as we wished. We also sought broad provisions to govern exports. Instead, we were only able to achieve provisions requiring monitoring and reporting on exports. These are meaningful concessions, but do not impact the overall strength of the legislation.

Q. How can the legislation be good if Philip Morris supports it?

Philip Morris's support for legislation is always good reason for suspicion. This decision by Philip Morris reflects a change in their prior position on the kind of bill it is willing to support. Philip Morris may well believe that it will benefit at the expense of the other companies, which in the past have stated their opposition to FDA legislation. We believe Philip Morris has likely made a decision that regulation - even strict regulation - will give it a competitive advantage over the other tobacco companies and that it believes it will increase its share versus the other companies.

We believe the DeWine/Kennedy/Davis/Waxman bill is very strong legislation, indeed stronger in some critical areas than the FDA bills we have supported in the past. It is important that this legislation is being introduced by two longtime champions of public health, Representative Henry Waxman and Senator Edward Kennedy, as well as by Senator Mike DeWine who has been a stalwart supporter on this issue for years. We reached our opinion about the legislation on the merits of the legislation and independent of Philip Morris' position. We would have reached the same conclusion -- that this is strong FDA legislation that protects the public health and should be strongly supported - even if Philip Morris had not supported it.

Q. Does this mean FDA legislation will be passed this year?

Introduction of these bills by no means guarantees that they will be voted on or passed in this Congress. But the introduction of these bills significantly strengthens the position of the public health community as Congress considers what to do about both FDA tobacco regulation and a proposed quota buyout for tobacco farmers. The tobacco buyout has received significant media attention in tobacco states in recent weeks and pressure is growing on Members of Congress from tobacco-growing states to get something done before the election. Introduction of these identical and bipartisan FDA bills strengthens the position of the public health community in working to make sure that if a buyout bill begins to move, it is attached to strong FDA tobacco authority that benefits public health.