Filed by: American Lung Association, American Association for Respiratory Care, American Medical Women's Association, American Public Health Association, Americans for Nonsmokers Rights, Tobacco Products Liability Project, Interreligious Coalition on Smoking OR Health.  January 1998

  Petitioners have established legally and factually that FDA has jurisdiction over tobacco products and there is an urgent public health need for the agency to establish comparable regulatory standards for tobacco products as are applied to other drugs and devices Petitioner's have shown that by failing to apply similar standards over tobacco products the public health has been adversely affected and that the agency is acting in an arbitrary and capricious manner and in violation of its statutory obligations to protect public health.

  Petitioners therefore request that the FDA move expeditiously in correcting these discrepancies and by taking the following actions:

—  There should be established a Tobacco and Health Advisory Committee to the Commissioner of the FDA to provide expertise, guidance and assistance in developing, mapping out and implementing a process and a plan that will result in comprehensive and consistent regulations for tobacco products. This Advisory Committee should be composed of outside as well as FDA experts knowledgeable in issues related to the manufacturing, sales and distribution, labeling, advertising and marketing of tobacco products as well as other drugs and devices. FDA should provide the necessary staff in order to accomplish its committees goals.

—  There should be established a permanent Tobacco and Health/Drugs and Devices Advisory Panel (similar and comparable to advisory panels established by the FDA for other drugs and devices) charged with reviewing and considering on-going issues and products related to the manufacture, sales and distribution, labeling, advertising and marketing of tobacco products including assisting in the establishment of any performance standards.

  As part of the responsibilities and activities of the proposed advisory panels or using existing authorities the FDA should move to consider that:

—  All tobacco products presently on the market should be required to meet comparable labeling, advertising, and performance standard requirements established for other drugs and or devices by a specified date, including such things as full and complete disclosure of chemical additives in tobacco, information on addication, warnings on contraindications and adverse effects for people with pre-existing medical conditions, elimination of advertising and promotion practices which are misleading.

—  Any tobacco company making any new product or a derivation of any product presently on the market should be required to submit (comparable to the requirements for new drugs applications or abbreviated new drugs applications, or requirements for devices) all health and safety data about the product, a list of all components of such drug, a description of the methods used in, and the facilities and controls used for the manufacture, processing and packaging of such drugs, specimens of labeling proposed to be used for such drug, and advertising information as well as any other information required for ensuring adequate protection of the public. No new tobacco product should be allowed on the market until such time as the FDA has carefully reviewed the product, given its approval and prescribed the labeling and marketing conditions under which such product may be distributed and sold.

—  All tobacco companies should be held to all of the good manufacturing practices (GMP) required by the FDA for other drug and device manufacturers.

—  Any person, or company who engages in the manufacture, preparation, propagation, compounding or processing of a tobacco should be required to register with the Secretary of HHS.

—  Treatments to reduce the death and disease caused by tobacco use should be given priority standing in the FDA's review process.

—  All tobacco companies should provide the FDA with any and all relevant research, marketing data, scientific, and medical data allowable by law to ensure protection of the public health.

—  Staffing responsibilities for undertaking the necessary regulatory activities requested in this petition be assigned to the Center for Drug Evaluation and Research and the Center for Devices.

—  A process should be established by which all additives used in tobacco products are reviewed, certified and generally recognised as safe (GRAS) when used as intended, or removed from the market. All new additives used in the manufacture of tobacco products should be required to have FDA approval before being used in any product.

—  Scientifically based testing and rating requirements for nicotine, tar, carbon monoxide and other constituents are established and that there are scientifically based methods for disseminating such information to the public through labeling and advertising.

—  Investigation and appropriate action be taken to deal with the use of pesticides and other chemicals used on foreign tobacco leaf which is imported into the United States and used in the manufacture of cigarettes sold in the US or manufactured for export.

—  Existing import and export requirements for drugs and devices should be applied to tobacco products and that where additional authorities are needed, the FDA should seek such authorities in order to protect the public health of both US citizens as well as the citizens of foreign nations.

—  Tobacco product manufactureres should be required to pay "drug user" fees similar to requirements and fees by other drug manufacturers.

—  FDA should seek and request any necessary clarifying statutory language for tobacco products if applications of existing statutory authorities might lead to a ban or prohibition on the manufacture, sale and distribution of tobacco merely because such products cause disease and death from their intended use. However, nothing should prevent the FDA from carrying out its responsibilities for protecting public health should Congress fail to act.