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The need for legislation to grant the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products is a direct result of the Supreme Court’s March 2000 decision that held that, under current law, the FDA does not have authority to regulate tobacco products. As a result of the Court’s ruling, it is now up to Congress to grant the FDA the authority it needs to regulate tobacco products and to protect consumers of all ages. Any bill that grants the FDA authority to regulate tobacco products must address the critical, core elements described below. While authority to
regulate tobacco products would be new for the FDA such authority would be comparable to the agency’s existing authority over other consumer products.
Youth Access and Marketing. Legislation should grant FDA 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. Legislation should incorporate the substance of the youth access and youth marketing restrictions adopted by the FDA so that the agency would not need to go through a new rulemaking process to implement them.
Health Information Disclosure. Legislation should entitle 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, legislation should create a new “protection of the public health” standard for all tobacco products that refers to reducing health risks to the American public. This standard would require 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. Legislation should grant 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. It should further provide FDA with authority to regulate the use of any ingredient or additive that is harmful or which contributes to the harmfulness of the product. Also, the burden should be placed on tobacco manufacturers to demonstrate that each ingredient and additive is safe in the quantity used under the conditions of intended use.
Health Warnings. Legislation should grant 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. Legislation should grant FDA 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 of all tobacco products in order to protect the public health.
Reduced Risk Health Claims. Legislation should grant FDA authority to review and approve or deny reduced risk health claims related to specific tobacco products. Such authority should allow FDA 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 authority should pre-empt state and local authority over tobacco products only to the extent that FDA authority with regard to other products it regulates is preemptive.
FDA Authority over Tobacco Farms or Tobacco Growers. Legislation should make clear that FDA would not have authority over tobacco farms or tobacco growing.
Routine Regulatory and Procedural Fairness. Legislation should subject tobacco products to the same standards or procedures that are applied to other FDA-regulated drugs or devices.
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