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Procedural Fairness FDA's ability to regulate tobacco products should not be subject to different
or more onerous standards or procedures than are applied to "drugs" or "devices".
The FDA should be empowered to "consider" all factors the Secretary deems relevant to the
rule's or standard's overall impact on the public health, including but not limited to technological
feasibility, the likely response of consumers to the proposal, and the likelihood that the change
will result in the creation of a substantial black market. But the Secretary should not have the
burden of making a formal determination with regard to any of these factors.
Procedurally, the Secretary should be entitled to establish "product performance standards"
through the use of "notice and comment rulemaking." Tobacco product performance standards
should be subject to the same level of Congressional and judicial review as is applied to other
products, but no greater. It shall not be a requirement that a tobacco product performance
standard, including a standard that requires the elimination of a harmful component of a tobacco
product, including nicotine, can take effect only upon an affirmative vote of Congress.
Authority Over Youth Access and Tobacco Advertising and Marketing FDA should be the
federal agency with primary rulemaking and enforcement authority over restrictions on a) youth
access to tobacco products, b) tobacco advertising and marketing that appeals to children.
Health Information Disclosure FDA should be entitled to receive from the tobacco industry all
documents and information in the tobacco industry's possession relevant to the health effects of
tobacco products, nicotine and its effect on the body, addiction, marketing to children and the
effect of marketing on children, and such other information that the Secretary deems necessary to
permit the FDA to protect the public health. FDA should have the authority to subpoena this
information when necessary. None of this information should be withheld from the FDA on the
ground that it is confidential, represents a trade secret, or is subject to a claim of lawyer client
privilege.
Respecting legitimate trade secrets and legitimate claims of lawyer client privilege, the FDA
should have the authority to make information and documents available to the public as the FDA
deems to be in the public's interest.
The authority to develop accurate measures and test for tar, nicotine, carbon monoxide yields, as
well as other components of tobacco products and tobacco smoke, should be transferred from the
FTC to the FDA.
Ingredients FDA should have the authority to require the tobacco industry to provide it with a
complete list of all tobacco ingredients and additives, by brand and by quantity, and should be
entitled to require that this information be disclosed to the public in a manner that does not
disclose legitimate trade secrets. It should be illegal for any tobacco manufacturer to use any
ingredient or additive that is harmful or which contributes to the harm of the product or which
boosts the impact of nicotine. The burden should be on the tobacco manufacturer to demonstrate
to the FDA that each ingredient and additive is safe in the quantity used under the conditions of
intended use.
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"ocrText": "Procedural Fairness FDA's ability to regulate tobacco products should not be subject to different\nor more onerous standards or procedures than are applied to \"drugs\" or \"devices\".\nThe FDA should be empowered to \"consider\" all factors the Secretary deems relevant to the\nrule's or standard's overall impact on the public health, including but not limited to technological\nfeasibility, the likely response of consumers to the proposal, and the likelihood that the change\nwill result in the creation of a substantial black market. But the Secretary should not have the\nburden of making a formal determination with regard to any of these factors.\nProcedurally, the Secretary should be entitled to establish \"product performance standards\"\nthrough the use of \"notice and comment rulemaking.\" Tobacco product performance standards\nshould be subject to the same level of Congressional and judicial review as is applied to other\nproducts, but no greater. It shall not be a requirement that a tobacco product performance\nstandard, including a standard that requires the elimination of a harmful component of a tobacco\nproduct, including nicotine, can take effect only upon an affirmative vote of Congress.\nAuthority Over Youth Access and Tobacco Advertising and Marketing FDA should be the\nfederal agency with primary rulemaking and enforcement authority over restrictions on a) youth\naccess to tobacco products, b) tobacco advertising and marketing that appeals to children.\nHealth Information Disclosure FDA should be entitled to receive from the tobacco industry all\ndocuments and information in the tobacco industry's possession relevant to the health effects of\ntobacco products, nicotine and its effect on the body, addiction, marketing to children and the\neffect of marketing on children, and such other information that the Secretary deems necessary to\npermit the FDA to protect the public health. FDA should have the authority to subpoena this\ninformation when necessary. None of this information should be withheld from the FDA on the\nground that it is confidential, represents a trade secret, or is subject to a claim of lawyer client\nprivilege.\nRespecting legitimate trade secrets and legitimate claims of lawyer client privilege, the FDA\nshould have the authority to make information and documents available to the public as the FDA\ndeems to be in the public's interest.\nThe authority to develop accurate measures and test for tar, nicotine, carbon monoxide yields, as\nwell as other components of tobacco products and tobacco smoke, should be transferred from the\nFTC to the FDA.\nIngredients FDA should have the authority to require the tobacco industry to provide it with a\ncomplete list of all tobacco ingredients and additives, by brand and by quantity, and should be\nentitled to require that this information be disclosed to the public in a manner that does not\ndisclose legitimate trade secrets. It should be illegal for any tobacco manufacturer to use any\ningredient or additive that is harmful or which contributes to the harm of the product or which\nboosts the impact of nicotine. The burden should be on the tobacco manufacturer to demonstrate\nto the FDA that each ingredient and additive is safe in the quantity used under the conditions of\nintended use."
}