FDA's Continuing Failure to Regulate Health Claims for Foods: Hearings Before the Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations, House of Representatives, One Hundred First Congress, First Session, October 31 and November 9, 1989

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Page 347 - ... because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use...
Page 288 - In pursuing this responsibility, the following general policy applies where agency employees are invited by persons outside the Federal Government to attend or participate in meetings outside agency offices as representatives of the agency. (1) A person outside the executive branch may invite an agency representative to attend or participate in a meeting outside agency offices. The agency representative is not obligated to attend or participate, but may do so where it is in the public interest and...
Page 264 - Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document.
Page 286 - ... agency action" includes the whole or a part of an agency rule, order, license, sanction, relief, or the equivalent or denial thereof, or failure to act; and (14) "ex parte communication" means an oral or written communication not on the public record with respect to which reasonable prior notice to all parties is not given, but it shall not include requests for status reports on any matter or proceeding covered by this subchapter.
Page 286 - Administrative action includes every act, including the refusal or failure to act, involved in the administration of any law by the Commissioner, except that it does not include the referral of apparent violations to US attorneys for the institution of civil or criminal proceedings or an act in preparation of a referral. Administrative file means the file or files containing all documents pertaining to a particular administrative action, including internal working memoranda, and recommendations....
Page 388 - ... (B) the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet; and (C) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.
Page 251 - Federal agency in implementation of these regulations ( 1507.3) and for which, therefore, neither an environmental assessment nor an environmental impact statement is required.
Page 440 - Society32 have an urged the public to eat less fat in order to reduce their risks of heart disease or cancer. FDA surveys...
Page 286 - Dockets Management Branch" means the Dockets Management Branch, Office of Management and Operations of the Food and Drug Administration, US Department of Health and Human Services, Room 462, 5600 Fishers Lane. Rockville, MD 20857. "Ex parte communication...
Page 288 - Government on any matter concerning the laws administered by the Commissioner. (DA meeting initiated by FDA representatives which involves a small number of interested persons, for example, a meeting with a petitioner or with two manufacturers of a particular product which requires additional testing or with a trade association employee to discuss an industry labeling problem, may be a private meeting. A meeting initiated by FDA representatives which involves a large number of interested persons,...

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