Summary of Key Provisions Below is a short summary of how the DeWine-Kennedy and Davis-Waxman bills deal with the issues that have been considered critical in any FDA bill.

Youth Access and Marketing. These bills would grant FDA the same broad authority regarding the sale and distribution of tobacco products, including access, advertising and promotion that FDA asserted in 1996. This would allow FDA to restrict advertising and promotion, including advertising that impacts children or misleads consumers, beyond the restrictions of the 1996 FDA Regulations, to the extent permitted under the First Amendment. The FDA could also take further action to ensure that tobacco products are not illegally sold to children.

Youth Access and Marketing Restrictions of the 1996 Rule to Help Reduce Youth Tobacco Use Reinstated. These bills require that one month after enactment, FDA republish the 1996 regulations, which restrict marketing that targets children and youth access to tobacco products, and require that these regulations shall become effective one year after enactment. These regulations include bans on outdoor advertising within one thousand feet of schools and limiting all remaining outdoor and point-of-sale tobacco advertising to black-and-white text only. The regulations, which will be identical to the regulations promulgated by the FDA in 1996, would become effective one year after enactment

After the regulations have gone into effect, the bills give the Secretary of the Department of Health and Human Services (HHS) the authority to amend these regulations through a standard rulemaking process, which will provide for public discussion about the necessity of any changes to the regulations.

Health Information Disclosure. These bills require the tobacco companies to submit within six months of the date of the bill's enactment a listing of all tobacco ingredients and additives to tobacco, paper and filters by brand and by quantity in each brand, a description of the content, delivery and form of nicotine in each product, as well as all documents developed after enactment that relate to health, toxicological, behavioral, or physiological effects of current or future tobacco products.

The Secretary of HHS may also require the tobacco companies to submit information on all research related to health, behavioral or physiologic effects of these products and their marketing, as well as information about whether technology exists to reduce the harm caused by their products.

"Public Health" Standard. The existing FDA standard for approving drugs and devices is whether there is a "reasonable assurance that a product is safe and effective." A different standard is necessary with tobacco products because there is no such thing as a safe cigarette. As the public health community has requested, under these bills the FDA would seek to determine whether an action regarding a tobacco product will "protect the public health." This standard would require consideration of whether a product change would reduce the overall harm caused by tobacco use, including the harm caused to individual tobacco users and the impact on the population as a whole.

Health Warnings. These bills would revise the health warning on both cigarettes and smokeless tobacco products and grant FDA the authority to further revise and add health warnings and to alter their format, including, but not limited to, changing their size, location and color. The bill would result in an immediate change in health warning to require them to cover at least 30% of the front and back of cigarette packs and strengthen the warning's content.

Authority to Establish Performance Standards. These bills provide FDA with the authority to require changes to tobacco products to protect the public health, such as the reduction or elimination of ingredients, additives, constituents, including smoke constituents or reduction in nicotine yields through the issuance of performance standards. A performance standard would be the primary way in which FDA would require tobacco products to be made less harmful.

While the bill allows FDA to require changes to the product, the bill reserves to Congress the narrow and specifically tailored authority to ban "all cigarettes", or "all smokeless tobacco products", or "all little cigars", or "all cigars other than little cigars". While FDA can require the reduction of nicotine on its own, even to very low levels, the bill also reserves to Congress the right to require the reduction of nicotine yields of a tobacco product to zero. The language related to the ban is straightforward language that ensures that only Congress can ban cigarettes but it does not prevent the FDA from requiring meaningful changes to tobacco products.

Modified Risk Products. FDA authority over new products that the tobacco industry wants to portray as less harmful is increasingly important as new products are marketed with such slogans as, "All of the taste...Less of the toxins" and "Reduced Carcinogens. Premium Taste." Under these bills, FDA would be able to prohibit these claims unless it had first determined that the manufacturer had proven that these claims have been scientifically proven.

The bill prohibits any person from labeling, advertising or taking any other action directed to consumers that states or implies that the product is less hazardous or risky than other tobacco products or reduces one's exposure to substances in tobacco products without first having sought and obtained FDA approval according to the standards set forth in the bill. The bill would also prohibit the use of descriptors, such as "light", "mild" and "low" to characterize the level of a substance in a product. Any product for which such a claim is sought to be made would have to meet the standards for a "modified risk product" under the bill.

Under the bills, the Secretary shall approve an application for a modified tobacco product only if the applicant demonstrates that the product, as actually used by consumers, will significantly reduce harm, and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole - taking into account both users of tobacco products and persons who do not currently use tobacco products.

The bill also sets out criteria for certain products where the manufacturer does not seek to make a claim for reduced risk, but seeks to assert that the product contains a reduced level of a substance, or presents a reduced exposure to a substance. The Secretary may only approve an application for a product for which the manufacturer wants to make this type of claim when a number of criteria have been met. They include a requirement that the manufacturer has demonstrated and the Secretary has found, that scientific evidence is not available, and using the best available scientific evidence, it cannot be demonstrated without conducting long term epidemiological studies to meet the strict standards to make a modified risk claim, but that the Secretary concludes that the evidence that is available demonstrates that a substantial reduction in morbidity or mortality among individual tobacco users is anticipated. Under this provision, a product can be approved for no more than five years at a time and the manufacturer must conduct and submit to the Secretary of HHS post-market surveillance and studies annually. This type of application may also be approved only if the Secretary also determines that the manufacturer has demonstrated that the product would be appropriate to promote the public health, is expected to benefit the public as a whole, and will not mislead customers into believing that the product is less harmful than other products.

State and Local Authority. The bills expand state authority over tobacco marketing. Today states have no right to regulate tobacco marketing. Under the bills, states and localities could impose bans or restrictions on the time, place and manner, but not content of the advertising or promotion of any cigarettes. Under these bills, state and local governments would be free to adopt measures related to the sale, distribution, possession, exposure to, access to, use of tobacco products, or fire safety standards for tobacco products.

FDA would maintain exclusive authority in such areas as tobacco product standards, pre-market approval, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk products. States could not establish requirements in these areas.

Adequate Funding. These bills include adequate funding for FDA to effectively carry out the requirements outlined. The funding is provided through a user fee on tobacco manufacturers.

FDA Authority over Tobacco Farms or Tobacco Growers. These bills do not give FDA authority over the growing of tobacco.