SUMMARY OF HOUSE AND SENATE FDA BILLS *
Youth Access and Marketing. R equires the FDA to restrict marketing that targets children and youth access to tobacco products, and requires 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.
Health Information Disclosure. Requires tobacco companies to submit within six months of the date of 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.
“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. Revises the health warning on both cigarettes and smokeless tobacco products and grants 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 bills would result in an immediate change in health warning to require them to cover at least 30 percent of the front and back of cigarette packs and strengthen the warning’s content.
Authority to Require Changes in Tobacco Products. Provides FDA with the authority to require changes to tobacco products to protect the public health, such as the reduction or elimination of ingredients, additives, and 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. The FDA could not ban cigarettes or nicotine.
Modified Risk Products. 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 bills 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 legislation.
State and Local Authority. Expands 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.
*parts excerpted from the Campaign for Tobacco Free Kids, http://www.tobaccofreekids.org/reports/fda/summary.shtml
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