FDA Proposals to Permit the Use of Disease-specific Health Claims on Food Labels: Hearing Before a Subcommittee of the Committee on Government Operations, House of Representatives, One Hundredth Congress, First Session, December 10, 1987U.S. Government Printing Office, 1988 - Всего страниц: 471 Abstract: This hearing discusses proposals made FDA to permit disease-specific health claims on food labels. Statements from medical associations and government agencies examine the effect and legality of allowing disease-specific health claims on food labels. |
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adequate advertising agency agency's All-Bran American appropriate bran cereals CFSAN Chairman cholesterol claims on food Commissioner Committee concerning consensus consumers Cosmetic Act criteria cure develop diet and health dietary fiber Dietary Guidelines dietary supplements discuss Dockets document draft Drug Administration drug provisions effective enforcement evaluate FDA's Federal Food Federal Register Federal Trade Commission fiber Food and Drug food labeling food products Food Safety health claims health information health-related claims health-related information HUMAN SERVICES information on food intake issue Kellogg Kellogg Company manufacturers memorandum messages on food misbranded misleading mitigation National Cancer Institute nonmisleading notice nutrients nutrition labeling prevention promotional proposed rule public health messages Public Health Service recommendations relationship between diet requirements risk saturated fat SCARLETT scientific evidence sodium specific foods statement Subcommittee substantial Ted Weiss therapeutic total diet total dietary pattern vitamins WEISS YOUNG
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Стр. 348 - As used in this subsection . . ., 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, or suggested...
Стр. 346 - 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, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
Стр. 5 - 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...
Стр. 333 - ... 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.
Стр. 343 - drug," as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals. The term
Стр. 333 - false advertisement" means an advertisement, other than labeling, which is misleading in a material respect; and in determining whether any advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound, or any combination thereof, but also the extent to which the advertisement...
Стр. 153 - Its labeling represents, suggests, or implies: (1) That the food because of the presence or absence of certain dietary properties, is adequate or effective in the prevention, cure, mitigation, or treatment of any disease or symptom.
Стр. 333 - ... not only representations made or suggested by statement, word, design, device, sound or any combination thereof, but also the extent to which the advertisement 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 commodity to which the advertisement relates under the conditions prescribed in said advertisement, or under such conditions as are customary or usual.
Стр. 337 - If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the board determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses.
Стр. 346 - New drug" means: (a) 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...