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Regulation of Tobacco Products: What FDA Legislation Would Do

On February 15, 2007, U.S. Senators Edward M. Kennedy (D-MA) and John Cornyn (R-TX) and U.S. Representatives Henry A. Waxman (D-CA) and Tom Davis (R-VA) introduced identical, bipartisan bills (S. 625/H.R. 1108) to grant the U.S. Food and Drug Administration authority to regulate tobacco products.

This legislation has been strongly endorsed by the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and numerous public health, faith and other organizations around the country.

This legislation would grant the FDA enormous authority to regulate both current and new tobacco products and restrict tobacco product marketing. The FDA would be empowered to take a broad range of actions that no federal or state agency currently can take that can significantly reduce the number of people who start to use tobacco and significantly increase the number of people who quit using tobacco, saving countless lives.

Reinstate the 1996 FDA Rule on youth access and marketing

This legislation would require that the FDA's 1996 Rule, which restricted tobacco marketing and sales to youth, be republished within one month and take effect within one year of enactment of the legislation. These rules:

• Ban all outdoor tobacco advertising within 1,000 feet of schools and playgrounds
• Ban all remaining tobacco brand sponsorships of sports and entertainment events
• Ban free giveaways of any non-tobacco items with the purchase of a tobacco product or in exchange for coupons or proof of purchase
• Ban free samples and the sale of cigarettes in packages that contain fewer than 20 cigarettes
• Limit any outdoor and all point-of-sale tobacco advertising to black-and-white text only
• Limit advertising in publications with significant teen readership to black-and-white text only
• Restrict vending machines and self-service displays to adult-only facilities
• Require retailers to verify age for all over-the-counter sales and provide for federal enforcement and penalties against retailers who sell to minors.

FDA's authority in these areas would not be limited to provisions of the 1996 Rule. The FDA could take additional regulatory steps to restrict tobacco marketing and to prevent tobacco sales to persons under 18. The legislation would codify the 1996 rule, which received very strong support from the tobacco control and public health communities at the time they were originally proposed and partially implemented.

Grant FDA specific authority to restrict tobacco marketing

The Secretary of Health and Human Services may by regulation impose restrictions on the advertising and promotion of a tobacco product consistent with and to the full extent permitted by the First Amendment to the Constitution. The finding as to whether such regulation would be appropriate for the protection of the public health shall be determined with respect to the population as a whole, including users and non-users of tobacco.

Require detailed disclosure of ingredients, nicotine and harmful smoke constituents. Tobacco companies must:

• Disclose to the FDA what is in each existing tobacco product by brand and by quantity in each brand, including all product constituents and smoke constituents. Information must be submitted at least 90 days prior to the introduction of new brands;
• Inform the FDA of any changes to the product;
• Submit to the FDA a description of the content, delivery and form of nicotine in each product, as well as all documents that relate to health, toxicological, behavioral or physiological effects of current or future tobacco products;
• FDA will publish a brand-specific list of harmful and potentially harmful constituents.

These disclosure requirements will give the FDA the information it needs to require changes to tobacco products to reduce the harm they cause and to better educate the public about the thousands of dangerous chemicals in tobacco products and health effects of tobacco use.

Empower FDA to establish a periodically re-evaluated content standard, and require changes in tobacco products to meet the standard

• Grants FDA authority to require changes in current and future tobacco products to protect public health, such as the reduction or elimination of harmful ingredients, additives and constituents, including smoke constituents.
• Empowers FDA to reduce nicotine yields to any level other than zero (reserved to Congress). This means FDA can reduce nicotine to minimal levels, including levels that do not lead to addiction.
• Authorizes FDA to require the reduction or removal of harmful or potentially harmful constituents to protect the public health.

Ban all cigarette flavorings other than menthol, that is a characterizing flavor of the product

• Bans fruit or candy-flavored cigarettes.

Ban the use on labels or in advertising of terms such as "light," "mild," or "low."

Strictly regulate "reduced harm" products

• Requires prior FDA approval before the introduction of any so-called "reduced harm" tobacco product.
• Prohibits tobacco companies from making any explicit or implicit health claims, such as reduced risk of disease or reduced exposure to specific toxins, without first proving to the FDA that the scientific evidence is adequate to conclude both, (1) that the product as actually used by consumers will significantly reduce the risk of disease to individual consumers AND, (2) that the product as marketed will benefit the health of the population as a whole.
• Requires the FDA to ensure that the marketing of any such products does not discourage current tobacco users from quitting or encourage new users to start. Throughout, the bill language stresses the importance of determining the effect of new products and advertising for new products on both smokers and nonsmokers (i.e. those who might be tempted to continue smoking or begin smoking by reduced harm claims). This gives important direction to courts deciding future challenges to regulatory decisions.
• Requires tobacco companies to conduct and report to FDA post-market surveillance of these products' actual usage.

Thus, the bill would prohibit claims of reduced risk in the absence of sound science, but would not serve as a bar where there is both good science AND adequate protection to prevent the marketing of these claims from interfering with prevention and cessation efforts.

Bigger, better health warnings

• The law requires adoption of stronger, more specific health warnings covering the top 30% of the front and rear panels of the package and bearing the word "WARNING" in 17 point type. The FDA is empowered to revise labeling requirements including text, format size and use of color graphics (i.e. Canadian-style warnings).
• The same warning labels are required in advertising and must comprise 20% of the area of the advertisement.

Establish a Tobacco Products Scientific Advisory Committee

To advise the FDA on nicotine and "other safety, dependence, or health issues," an 11 member advisory committee is established consisting of 7 scientists or health professionals, 1 government official, 1 representative of the general public, 1 representative of the tobacco industry and 1 representative of tobacco growers.

Fund FDA activity through a fee on tobacco product manufacturers, allocated by market share

Eliminate existing federal preemption of state laws restricting cigarette advertising

The bill would eliminate current federal law that restricts States from banning or restricting the time, place or manner of cigarette advertising under the Federal Cigarette Labeling and Advertising Act (FCLAA). It would allow states to address the location, color, size, number and placement of cigarette advertising.

Protect states' ability to pass other tobacco control laws

States are specifically NOT preempted from enacting other tobacco control laws and are completely free to:

• prohibit, restrict, or regulate the sale, distribution, and possession of tobacco products,
• pass smoke-free workplace laws,
• increase tobacco excise taxes,
• restrict youth access to tobacco products,
• restrict advertising and promotion of or use of tobacco products by individuals of any age,
• pass laws relating to information that is reported to the State, and
• pass measures relating to fire safety standards.