Health Hippo: FDA

• Medical Devices: FDA Review Time (Letter Report, 10/30/95, GAO/PEMD-96-2). Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) review of medical devices, focusing on how FDA review time has changed from fiscal year 1989 to May 18, 1995.
• FDA Drug Approval: Review Time Has Decreased in Recent Years (Letter Report, 10/20/95, GAO/PEMD-96-1). Pursuant to a congressional request, GAO provided data on the Food and Drug Administration's (FDA) new drug application (NDA) process.
• HHS: FDA Approvals in 1996 Set New Records
• Decision Analysis and FDA Drug Review The Food and Drug Administration (FDA) has long been in a crossfire between those who complain of overly strict standards for approving new drugs and those who charge the opposite.1 Who is correct? What should FDA's standards be? What are they now? Do they differ for different classes of drugs? Should they, and, if so, how much?

This page covers only FDA administrative issues and some food stuff. Go to the Health Hippo pages on BIOLOGICAL PRODUCTS, DRUGS and MEDICAL DEVICES for more information on FDA's regulatory activities.

Be sure to check your suspicious fish species (whole or fillet) against those found in Health Hippo's all-time favorite internet site, The Regulatory Fish Encyclopedia. Regulatory Fish ...what a concept! }+++;)

• 21 USC TITLE 21
• 21 USC Sec. 301. Short title
• 21 USC Sec. 321. Definitions; generally
• 21 USC Sec. 331. Prohibited acts
• 21 USC Sec. 332. Injunction proceedings
• 21 USC Sec. 333. Penalties
• 21 USC Sec. 334. Seizure
• 21 USC Sec. 335. Hearing before report of criminal violation
• 21 USC Sec. 336. Report of minor violations
• 21 USC Sec. 337. Proceedings in name of United States; provision as to subpoenas

• FDA MODERNIZATION ACT: TITLE III--IMPROVING REGULATION OF FOOD
  • SEC. 301. Flexibility for regulations regarding claims
  • SEC. 302. Petitions for claims
  • SEC. 303. Health claims for food products
  • SEC. 304. Nutrient content claims
  • SEC. 305. Referral statements
  • SEC. 306. Disclosure of irradiation
  • SEC. 307. Irradiation petition
  • SEC. 308. Glass and ceramic ware
  • SEC. 309. Food contact substances

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• Food Bills (105th Congress)
• 1997 Congressional Record: FDA

• Food Safety: Risk-Based Inspections and Microbial Monitoring Needed for Meat and Poultry (Testimony, 04/19/94, GAO/T-RCED-94-189). Because of outdated statutory requirements for visual inspection of meat and poultry, the federal Food Safety and Inspection Service is unable to target scarce resources to detect microbial contamination, a primary cause of foodborne disease.
• Food Safety: A Unified, Risk-Based Food Safety System Needed (Testimony, 05/25/94, GAO/T-RCED-94-223). The nation's food safety system hampers efforts to address public health concerns and is slow to respond to changing health risks. 
• Food Safety: Fundamental Changes Needed to Improve Monitoring of Unsafe Chemicals in Food (Testimony, 09/28/94, GAO/T-RCED-94-311). GAO identified five basic weaknesses in the overall federal structure and systems for monitoring chemicals in food.
• Meat and Poultry Inspection: Impact of USDA's Food Safety Proposal on State Agencies and Small Plants (Letter Report, 06/30/95, GAO/RCED-95-228). Pursuant to a congressional request, GAO reviewed state meat and poultry inspection programs, focusing on the possible effects of new food safety regulations on: (1) current state inspection programs; and (2) small meat processing plants.
• Fruit Juice Adulteration: Detection Is Difficult, and Enhanced Efforts Would Be Costly (Letter Report, 11/03/95, GAO/RCED-96-18). Pursuant to a legislative requirement, GAO reviewed the sale of adulterated fruit juice to school meal programs.
• Food Safety: Reducing the Threat of Foodborne Illnesses (Testimony, 05/23/96, GAO/T-RCED-96-185). Pursuant to a congressional request, GAO discussed foodborne pathogens and their impact on public health.
• Food Safety: Risk-Based Inspections and Microbial Monitoring Needed for Meat and Poultry (Letter Report, 05/19/94, GAO/RCED-94-110). The federal inspection system falls short in protecting the public from the most serious health risks caused by microbial contamination.
• Food Safety: Changes Needed to Minimize Unsafe Chemicals in Food (Chapter Report, 09/26/94, GAO/RCED-94-192). GAO identified five basic weaknesses in the overall federal structure and systems for monitoring chemicals in food. First, fragmentation of responsibility among multiple agencies results in inefficiencies and gaps in federal monitoring activities.
• Salvaged Food: Lessons Learned from the Americold Fire (Letter Report, 03/08/95, GAO/RCED-95-76). Pursuant to a congressional request, GAO provided information on the events surrounding a fire at a food storage warehouse in Kansas, focusing on the: (1) disposition of food salvaged from the facility; and (2) lessons learned from the incident that could be used to improve regulation of the food salvaging industry.
• FDA Laboratories: Magnitude of Benefits Associated With Consolidation Is Questionable (Letter Report, 03/19/96, GAO/HEHS-96-30). Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) plan to consolidate its Office of Regulatory Affairs' (ORA) 18 field laboratories for product testing.
• FDA Regulation: Compliance by Dietary Supplement and Conventional Food Establishments (Letter Report, 06/13/94, GAO/HEHS-94-134). The Food and Drug Administration (FDA) regulates dietary supplements, which include vitamins, proteins, herbs, and fish oils, on a case-by-case basis, generally responding to complaints or other information on health risks.
• Food and Drug Administration Nicotine Regulation Pages All collected in one place, for easy reference.
• Food and Drug Law Institute Annual Meeting Washington, D.C. December 10, 1996 (Dr. Kessler's Remarks) This is the seventh, and as most of you know, the last time that I will come before you as the Commissioner of Food and Drugs. There is a time to say goodbye and there is a time to thank all of you for your help during my time as commissioner.
• FDA: Regulatory Fish Encyclopedia The Regulatory Fish Encyclpedia (RFE) is a compilation of data in several formats that assists with the accurate identification of fish species.
  • Fish FAQ A private site devoted to our finned friends.
  • Fish Advisories: Useful or Difficult to Interpret? Fish advisories can be issued a variety of ways, e.g., sign postings at fishing sites, television and radio, or newspapers and magazines. In some instances, information is issued directly by the regulatory agency.
• FDA News The latest from the Food and Drug Administration.
• Introduction to Foodborne Pathogenic Microorganisms and Natural Toxins This handbook provides basic facts regarding foodborne pathogenic microorganisms and natural toxins. Some technical terms have been linked to the National Library of Medicine's Entrez glossary.
• Making Your Voice Heard at FDA As a regulatory agency, FDA publishes rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation- emitting electronic products, and medical devices-- commodities close to the daily lives of all Americans.
• ProVisions Online Links to companies in the food & beverage industry.
• UNSAFE HERBS The following is a list compiled by the FDA of some herbs that should NOT be used in FOODS, BEVERAGES, OR DRUGS.

Center for Food Safety and Applied Nutrition: Foodborne Illness ~ Consumer Information -Food & Nutrition ~ Food and Drug Administration ~ FoodLaw ~ Institute of Food Technologists ~ Most Recent Items on FDA's Web Site ~ Northwest Food Processors Association ~ The Food and Drug Law Institute