The Protect Act, Civil Liability Provisions: Hearings Before the Committee on the Judiciary, United States Senate, One Hundred Fifth Congress, Second Session, on S. 1530 ... March 6 and 12, 1998, Volume 4

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Page 48 - Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals...
Page 143 - ... representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.
Page 48 - ... intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
Page 48 - drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and...
Page 48 - Pharmacopoeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which...
Page 57 - It includes virtually every user of tobacco products, literally tens of millions of people, all of whom can make some general allegation that their use of these products has jeopardized their health. At the same time, the principal issue in each case and the industry's principal defense—that the particular user was aware of the products' risks—can be fully assessed only through trial on an individual by individual basis.
Page 44 - Association joined other public health organizations to form the Advisory Committee on Tobacco Policy and Public Health, chaired by former surgeon general C. Everett Koop and former Food and Drug Administration head David Kessler. More than twenty other health organizations participated on the committee and unanimously endorsed the final report.
Page 127 - Director the Center for Tobacco Research and Intervention at the University of Wisconsin Medical School in Madison, Wisconsin.
Page 48 - ... articles (other than food) intended to affect the structure or any function of the body of man or other animals ; and (4) articles intended for use as a component of any articles specified in clause (1), (2), or (3) ; but does not include devices or their components, parts, or accessories.
Page 99 - I would like to ask that my statement be included in the record. [The prepared statement of Senator Kennedy follows:] PREPARED STATEMENT OF SENATOR EDWARD M. KENNEDY The Judiciary Committee meets today to consider the nomination of Mr.

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