FEBRUARY 21, 2001


  1. Provide FDA with Authority over Manufactured Tobacco Products
  2. FDA oversight authority over the manufacture, sale, marketing, labeling, and distribution of manufactured tobacco products comparable to its existing authority over other non-tobacco products.

    USDA retains responsibility over the farming of tobacco.

    FDA seeks to maximize the protection of the public health, but not through banning cigarettes.

  3. Fill in Gaps in Tobacco State Programs to Prevent Smoking and Other Forms of
  4. Tobacco Consumption

    Special emphasis on reducing youth smoking.

    Special emphasis on directing assistance to areas with highest smoking rates and highest levels of smoking-caused illness, harms, and costs (including many tobacco-farming communities).

  5. Include Cessation Assistance in Basic Medicaid and Medicare Coverage
  6. Such coverage provides lower-income persons with more equal access to desired or medically necessary assistance to help them stop smoking or consuming other tobacco products.

    Medicaid coverage is an especially effective way to reduce smoking among young pregnant women and new mothers, thereby avoiding related smoking-caused costs.

    Studies indicate that providing comprehensive cessation assistance via Medicaid would not only reduce overall state health costs but reduce state Medicaid costs, as well.

    At least 24 states have already elected to provide at least some cessation assistance through their Medicaid programs. Of the top six tobacco states, only North Carolina provides any cessation coverage under Medicaid.




Providing the U.S. Food and Drug Agency (FDA) with the authority described here would fill the gap created by the Supreme Court’s decision that the FDA does not have authority over tobacco products. The Supreme Court explicitly said that it is up to Congress to provide FDA with this authority. This proposal would establish the authority of the FDA to regulate manufactured tobacco products comparable to its authority over other products. It does not treat tobacco products as "drugs." It would not give FDA authority over tobacco farms. It would be designed to promote the public health and reduce tobacco-caused harms, but would not seek to prohibit tobacco use.

Youth Access and Marketing. Provides FDA with authority regarding the sale and distribution of tobacco products, including access, advertising, and promotion.

Adoption of Youth Access and Marketing Restrictions of the 1996 Rule to Help Reduce Youth Tobacco Use. The legislation incorporates the substance of the youth access and youth marketing restrictions adopted by the FDA so that the agency will not need to go through a new rulemaking process to implement them.

Health Information Disclosure. Entitles FDA to receive all documents and information in the tobacco industry’s possession relating to health effects of all tobacco products, nicotine and its effects on the body, addiction, marketing to children and its effects, and such other information that the HHS Secretary deems necessary to enable the FDA to protect the public health.

"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." Because there is no such thing as a safe cigarette, the proposal creates a new "protection of the public health" standard for all tobacco products that refers to reducing health risks to the American public. Also requires consideration of whether a product change or new rule will reduce or increase tobacco use, including increasing the number of new users or decreasing the number who quit.

Disclosure of Ingredients. Provides FDA authority to require the tobacco industry to provide a complete list of all tobacco ingredients and additives, by brand and by quantity, and the authority to require that this information be given to the public in a manner that does not disclose legitimate trade secrets. Provides FDA with authority to regulate the use of any ingredient or additive that is harmful or which contributes to the harmfulness of the product. Places the burden on tobacco manufacturers to demonstrate that each ingredient and additive is safe in the quantity used under the conditions of intended use.

Health Warnings. Provides FDA authority over health warnings on tobacco product packages and advertisements, including the power to revise and add health warnings and to alter their format, including, but not limited to changing their size, location, and color.

Authority to Reduce or Eliminate Harmful Components. Provides FDA with the authority to evaluate scientifically, and then through a rulemaking process, to decide whether to reduce or, where appropriate, eliminate the harmful and addictive components in any manufactured tobacco products or found in tobacco smoke in order to protect the public health. Provides Congress with an expanded opportunity to review any decision to eliminate nicotine.

Health Claims and "Reduced Risk" Products. Provides FDA authority to encourage the development of products that reduce consumer health risks or serve as less harmful alternatives and the authority to evaluate scientifically whether new products are actually "less harmful." Provides FDA authority to prohibit or restrict directly or indirectly made: (1) unsubstantiated health claims; and (2) health claims that discourage people from quitting or encourage them to start using tobacco.

Preemption. FDA would pre-empt state and local authority over tobacco products, but only to the extent that FDA authority with regard to other products it regulates is preemptive.

No FDA Authority over Tobacco Farms or Tobacco Growers. Explicitly prohibits FDA from exercising authority over tobacco farms or tobacco growing.

Routine Regulatory and Procedural Fairness. Provides that FDA tobacco regulations should not subject tobacco products to different or more onerous standards or procedures than are applied to other FDA-regulated "drugs" or "devices."