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 - 471 pages 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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Page 17
... consensus within the biomedical community that it would be prudent for Americans to limit their intake of sodium . Finally , just a year ago , FDA published proposed regulations on fatty acid and cholesterol content labeling in response ...
... consensus within the biomedical community that it would be prudent for Americans to limit their intake of sodium . Finally , just a year ago , FDA published proposed regulations on fatty acid and cholesterol content labeling in response ...
Page 26
... consensus in the scientific community to allow disease specific claims ; the added information will confuse the consumer because too little information will be communicated ; and FDA may not have sufficient resources to vigorously ...
... consensus in the scientific community to allow disease specific claims ; the added information will confuse the consumer because too little information will be communicated ; and FDA may not have sufficient resources to vigorously ...
Page 28
... consensus of scientific evidence than mentioned in the proposal . Others stress that all evidence must be considered and advice given to consumers only when there is strong scientific consensus that public health benefits clearly will ...
... consensus of scientific evidence than mentioned in the proposal . Others stress that all evidence must be considered and advice given to consumers only when there is strong scientific consensus that public health benefits clearly will ...
Page 39
... consensus was that it was worth a try , but not with these words . I think Fred Degnan drafted something that we began to use in the agency as a working document . Mr. WEISS . It is fairly important because we often have difficulty ...
... consensus was that it was worth a try , but not with these words . I think Fred Degnan drafted something that we began to use in the agency as a working document . Mr. WEISS . It is fairly important because we often have difficulty ...
Page 40
... consensus . There are so many drafts that go in and out of any of the policy statements that it is difficult to keep a strict account . These drafts are kept in a variety of offices and with different indi- viduals . Once the final ...
... consensus . There are so many drafts that go in and out of any of the policy statements that it is difficult to keep a strict account . These drafts are kept in a variety of offices and with different indi- viduals . Once the final ...
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Expressions et termes fréquents
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
Fréquemment cités
Page 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...
Page 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.
Page 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...
Page 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.
Page 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
Page 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...
Page 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.
Page 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.
Page 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.
Page 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...