A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments, Volume 23Department of Health, Education and Welfare, Public Health Service, Food and Drug Administration, 1979 |
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Common terms and phrases
87th Congress adequate amended by adding amended to read antibiotic antibiotic drug Antitrust ask unanimous consent authority bacitracin basis Chairman clause clinical testing conference substitute Congress CONGRESSIONAL RECORD contained Cosmetic Act 21 date of enactment doctors Drug Administration drug advertising drug application effective date end thereof evaluated exemption facturer Federal Food filed Food Additives Food and Drug further amended gentleman HARRIS hearing House amendment interest investigation issued July 19 KEFAUVER legislation Madam President ment metic mittee official name paragraph patent person physicians prescribed prescription drugs process drugs public health read as follows records and reports regulations request respect safety Secretary finds Secretary of Health section 505 Senate bill September 27 side effects Speaker stilbestrol Subcommittee subparagraph subsection thalidomide thereof the following tion tive transitional provisions United States Code United States Pharmacopeia Welfare words yield
Popular passages
Page 22 - I. If it is not subject to the provisions of Paragraph G of this section unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient...
Page 358 - ... generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use...
Page 283 - ... (5) The judgment of the court affirming or setting aside, in whole or in part, any order under this section shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28 of the United States Code.
Page 183 - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
Page 283 - ... (D) a description of practicable methods for determining the quantity of such additive in or on food, and any substance formed in or on food, because of its use...
Page 48 - ... to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein.
Page 358 - CHANGES IN EXISTING LAW In compliance with subsection (4) of rule XXIX of the Standing Rules of the Senate, changes in existing law made by the bill, as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed is shown in roman...
Page 283 - That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
Page 213 - House with such amendments as may have been adopted, and the previous question shall be considered as ordered on the bill and amendments thereto to final passage without intervening motion except one motion to recommit with or without instructions.
Page 191 - Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and...