FDA Papers, Volume 3U.S. Food and Drug Administration, 1969 - Consumer protection |
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Results 1-5 of 38
Page 11
... capsules of carmine red color . These capsules , commonly used in hospitals for the investiga- tion of gastrointestinal functions , were found to be contaminated with S. cubana . An outbreak of Klebsiella pneu- moniae septicemia in ...
... capsules of carmine red color . These capsules , commonly used in hospitals for the investiga- tion of gastrointestinal functions , were found to be contaminated with S. cubana . An outbreak of Klebsiella pneu- moniae septicemia in ...
Page 35
... capsules , Cal- cium Viosterol capsules , Viasol vitamin A , Camtocol vitamin E capsules , Geria- tric Formula capsules / Huntington Park , Calif . 10/25/68 * * Economic Violations The Chicago Dietetic Supply House / La Grange , III ...
... capsules , Cal- cium Viosterol capsules , Viasol vitamin A , Camtocol vitamin E capsules , Geria- tric Formula capsules / Huntington Park , Calif . 10/25/68 * * Economic Violations The Chicago Dietetic Supply House / La Grange , III ...
Page 36
... capsules . December 16 , 1968 : Fraud Order issued against Dr. Hall Cutler , Nu- Life Supplements , Odessa , Tex . Solicitations of orders and sale through the mails of a product to restore grey hair to natural color through use of food ...
... capsules . December 16 , 1968 : Fraud Order issued against Dr. Hall Cutler , Nu- Life Supplements , Odessa , Tex . Solicitations of orders and sale through the mails of a product to restore grey hair to natural color through use of food ...
Page 39
... capsules , at Nashville , M. Dist . Tenn . Charged 9-18-67 : while held by Rex Laboratory , Inc. , Nashville , Tenn . , after having repacked and labeled the article , the labeling lacked adequate directions and did not comply with the ...
... capsules , at Nashville , M. Dist . Tenn . Charged 9-18-67 : while held by Rex Laboratory , Inc. , Nashville , Tenn . , after having repacked and labeled the article , the labeling lacked adequate directions and did not comply with the ...
Page 40
... capsules , at Carolina , Dist . P. R. Charged 8-31-67 and amended 11-3-67 : when shipped by Davis - Edwards Pharmacal Corp. , New York , N.Y. , the article , labeled in part " Iron Hy - Dex caps ( con Vitamina C ) . Distribuido y ...
... capsules , at Carolina , Dist . P. R. Charged 8-31-67 and amended 11-3-67 : when shipped by Davis - Edwards Pharmacal Corp. , New York , N.Y. , the article , labeled in part " Iron Hy - Dex caps ( con Vitamina C ) . Distribuido y ...
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Common terms and phrases
aflatoxin agencies Amphetamine Angeles antibiotics Ariz article contained insect article's barbiturate Bureau Calif capsules chemical coagulase compliance Consent decree authorized consumer protection contained insect filth contraceptives cyclamates decree authorized release decree ordered destruction Default decree ordered Director Dist Drug Administration Drug Application enterotoxin false and misleading FDA District FDA PAPERS FDA's Federal feed firm flammable Food and Drug frozen Guilty plea held for sale held under insanitary hormonal contraceptives industry insanitary conditions inspection Inspector interstate commerce Kansas City label statements labeling contained false labeling lacked adequate laboratory lacked adequate directions manufacturing practice ment milk misleading claims N.Y. Charged Nolo contendere Notices of Judgment Ohio packed under insanitary percent pesticide plant poisoning prepared and packed problems Public Health reports residues rodent Salmonella salvaging samples Sanitation seizure actions shellfish shipped shipper standards staphylococci studies sumer tablets tion U.S. Customhouse vitamin York
Popular passages
Page 6 - As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and wellcontrolled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved...
Page 15 - food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food...
Page 20 - new drug" means — (1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug...
Page 9 - There is reason to fear that some chemicals may constitute as important a risk as radiation, possibly a more serious one. Although knowledge of chemical mutagenesis in man is much less certain than that of radiation, a number of chemicals— some with widespread use— are known to induce genetic damage in some organisms. To consider only radiation hazards is to ignore what may be the submerged part of the iceberg.
Page 6 - Administration with respect to such drug, there is lack of substantial 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, or suggested...
Page 35 - The Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this Act, including the nature of the charge and the disposition thereof. (b) The Secretary may also cause to be disseminated information regarding food, drugs, devices, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health, or gross deception of the consumer. Nothing in this section shall be construed to...
Page 15 - The identity of categories of household products which may present an unreasonable hazard to the health and safety of the consuming public; "2.
Page 12 - Amendments of 1962 indicate that the term safe has reference to health of man, nowhere do they define safety. Discussing this subject before the Subcommittee of the Committee on Government Operations of the House of Representatives, the Commissioner of FDA pointed out that no effective drug can be absolutely safe.
Page 19 - The Food and Agriculture Organization (FAO), and the World Health Organization ( WHO ) of the United Nations...
Page 20 - new animal drug" means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed — (1) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of...