Regulations & Regulatory Agencies
FDA regulates over $1 trillion worth of products, which account for 25 cents of every dollar spent annually by American consumers.
The Food and Drug Administration touches the lives of virtually every American every day. For it is FDA's job to see that the food we eat is safe and wholesome, the cosmetics we use won't hurt us, the medicines and medical devices we use are safe and effective, and that radiation-emitting products such as microwave ovens won't do us harm. Feed and drugs for pets and farm animals also come under FDA scrutiny. FDA also ensures that all of these products are labeled truthfully with the information that people need to use them properly.
FDA is one of our nation's oldest consumer protection agencies. Food and Drug regulation began in 1906 when congress enacted the Federal Food and Drugs Act. The act placed the power to regulate food and drugs in the hands of the Secretary of the Treasury, the Secretary of Agriculture, and the Secretary of Commerce and Labor. In 1953, President Eisenhower issued and Congress enacted a plan to reorganize food and drug regulation under the Department of Health, Education, and Welfare (now, Department of Health and Human Services, as education was reorganized under the Education Department when congress enacted the Department of Education Organization Act). Title 21, issued by the Department of Health and Human Services in the late 80s, established the Food & Drug Administration and redelegated certain powers vested in the Assistant Secretary for Health to the newly established FDA.
In 1997, Congress enacted the FDA Modernization Act, a major legislation focused on reforming the regulation of food, medical products, and cosmetics. The following are the most important provisions of the act affecting food safety:
- FDA Initiatives and Programs - The law enacts many FDA initiatives undertaken in recent years under Vice President Al Gore's Reinventing Government program. The codified initiatives include measures to modernize the regulation of biological products by bringing them in harmony with the regulations for drugs and eliminating the need for establishment license application; eliminate the batch certification and monograph requirements for insulin and antibiotics; streamline the approval processes for drug and biological manufacturing changes; and reduce the need for environmental assessment as part of a product application.
- Food Safety and Labeling - The act eliminates the requirement of FDA's premarket approval for most packaging and other substances that come in contact with food and may migrate into it. Instead, the law establishes a process whereby the manufacturer can notify the agency about its intent to use certain food contact substances and, unless FDA objects within 120 days, may proceed with the marketing of the new product. Implementation of the notification process is contingent on additional appropriations to cover its cost to the agency. The act also expands procedures under which FDA can authorize health claims and nutrient content claims without reducing the statutory standard.
Charged with enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws, FDA's approximately 9,000 employees monitor the manufacture, import, transport, storage and sale of about $1 trillion worth of products each year. FDA protects the nation's food supply in a number of ways. First, scientists test samples to see if any substances, such as pesticide residues, are present in unacceptable amounts. If contaminants are identified, FDA takes corrective action. Second, FDA sets labeling standards to help consumers know what is in the foods they buy. Third, FDA sees that medicated feeds and other drugs given to animals raised for food are not threatening to the consumer's health.
FDA has some 1,100 investigators and inspectors who cover the country's almost 95,000 FDA-regulated businesses. These employees are located in district and local offices in 157 cities across the country. These investigators and inspectors visit more than 15,000 facilities a year, seeing that products are made right and labeled truthfully. If a company is found violating any of the laws that FDA enforces, FDA can encourage the firm to voluntarily correct the problem or to recall a faulty product from the market. When a company can't or won't correct a public health problem with one of its products voluntarily, FDA has legal sanctions it can bring to bear. The agency can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties--including prison sentences--are sought against manufacturers and distributors.
About 3,000 products a year are found to be unfit for consumers and are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. In addition, about 30,000 import shipments a year are detained at the port of entry because the goods appear to be unacceptable.
From the suggestions of George Washington to Congress in 1766 that the nation should have a "National Board of Agriculture"...to the establishment of the U.S. Department of Agriculture (USDA) in 1862 (and its eventual rise to cabinet status in 1889)...to the myriad regulations to protect the nations food supply...our nation has a track record of developing programs and policies that ensure our agricultural products meet the strictest quality standards.
American consumers spend $120 billion, one third of their annual food dollars, on meat and poultry products. USDA's Food Safety and Inspection Service (FSIS) is the agency that protects American consumers by ensuring that the meat, poultry, and egg products they purchase are safe, wholesome, and accurately labeled. It also makes certain that U.S. products sold in foreign commerce are safe for export. Performing this enormous task are more than 7,500 veterinarians and food inspectors located in some 6,400 privately-owned plants nationwide that produce and sell meat, poultry, and egg products. Each year FSIS staff inspect more than 7 billion birds, 136 million head of livestock, and millions of pounds of processed products.
On July 25, 1996, the Agency finalized the most significant changes in meat and poultry inspection rules since Congress enacted the Meat Inspection Act of 1906. These changes target microscopic pathogens, such as E. coli O157:H7 and Salmonella, and establish measures to prevent them from entering the food supply. It also strengthens industry responsibility to produce safe food.
An important part of the food safety chain is making sure consumers know how to handle the food once it’s in their hands. To help consumers, USDA requires safe-handling labels on all raw meat and poultry products. USDA also has a Meat and Poultry Hotline where home economists, dieticians, and food technologists provide accurate answers to safe food handling and preparation questions.
USDA has broad responsibility for assisting and protecting agriculture and our food supply. USDA safeguards our animals and crops from pests and diseases, monitors the agricultural marketing system, ensures fair trade practices, and assures value and quality in agricultural products that are bought and sold. Protecting our food supply includes keeping American agriculture free from foreign pests and diseases. Agricultural transportation issues, market regulatory laws, market news, and Federal grading and certification are other tools which help assure a steady supply of high-quality food on American tables.
The Grain Inspection, Packers, and Stockyards Administration (GIPSA) helps ensure a productive and competitive marketplace for U.S. agricultural products. GIPSA provides the U.S. grain market with Federal quality standards and a uniform system for applying them, and ensures open and competitive markets for livestock, meat, and poultry.
The Federal Register is a key source of information on what USDA and FDA are doing. Published daily, Monday through Friday, the Federal Register carries all proposed and finalized regulations and many significant legal notices issued by the various agencies, as well as presidential proclamations and executive orders.
The Federal Register provides information on the following USDA and FDA issues and activities:
- ADVANCE NOTICE - Often, USDA and FDA will publish "Notices of Intent" in the Federal Register to give you the earliest possible opportunity to participate in its decisions. These notices inform you that USDA and FDA are considering an issue and that your views are welcome before a formal proposal is made.
- PROPOSED REGULATIONS - When a formal proposal is developed, USDA and FDA publish a "Notice of Proposed Rulemaking" in the Federal Register. The notice also informs you how much time you have to submit written comments about the proposed action. If you do not feel you have enough time to study the proposal and comment on it, you can request, in writing, that Agency officials extend the comment period. If USDA or FDA extends the period, a notice of the extension will be published in the Federal Register. Occasionally, a second or third proposal is published in the Federal Register because of the nature of the comments received. Each time a proposal is substantively revised or amended, a notice is published in the Federal Register.
- FINAL REGULATIONS - Ultimately, a "Final Rule" is published, and the rule specifies the date when the new regulatory requirements or regulations become effective.
- REGULATORY AGENDA - Twice a year USDA and FDA publish an agenda in the Federal Register that summarizes policy-significant regulations, regulations that are likely to have a significant economic impact on small entities, and other actions under development. These agendas will help you identify actions of interest early to plan your participation. Each item listed includes the name, address and telephone number of an Agency official to contact if you need more information.
- MEETINGS AND HEARINGS - Notices are published in the Federal Register announcing all meetings of the Agency's advisory committees (see public hearings) and all public meetings that provide an information exchange between USDA, FDA, and industry, health professionals, consumers, and the scientific and medical communities. The notice contains the date, time and place of the meeting, as well as its agenda. The Federal Register also announces administrative hearings before the Agency and public hearings to gain citizen input into Agency activities (see citizen petition).
Outside sources used in producing this page:
- "The FDA Modernization Act of 1997," FDA Backgrounder # 97-13, November 21, 1997, http://www.fda.gov/opacom/backgrounders/modact.htm, Accessed: 6/15/2000.
- "The Federal Register - What It Is and How To Use It," Small Business Guide to FDA, Update: January 27, 2000, http://www.fda.gov/opacom/morechoices/smallbusiness/fulltext.html, Accessed: 6/15/2000.
- The Food and Drug Administration: An Overview, Publication No. BG99-2, January 11, 1999, http://www.fda.gov/opacom/hpview.html, Accessed: 6/15/2000.
- "The People's Department," A Poster About USDA, http://www.usda.gov/yourusda/layout.htm, Accessed: 6/16/2000.
- "Government Programs and Policy," A History of American Agriculture 1776-1990, http://www.usda.gov/history2/text11.htm, Accessed: 6/16/2000.
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