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This article originally appeared in the December 1990
The version below is from a reprint of the original article
and contains revisions made in March 1995, December 1996, and September 1998.
by Dori Stehlin
Each year, thousands of people contact FDA to request information on a gamut of FDA-regulated items, from video display terminals, pet food, and tanning booths to infant formula, the blood supply, and newly approved medical devices, drugs, and biological products.
Exactly what information does FDA have for consumers, and how can they obtain it?
FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. (For information on what FDA does not regulate, see accompanying article.)
Some of the agency's specific responsibilities include:
FDA has legal jurisdiction over products shipped in interstate commerce. A product that is manufactured, shipped and marketed within a state is not, in most cases, subject to FDA regulation. Often, states will adopt guidelines, and they are responsible for ensuring compliance. Consumers with questions or complaints about products that are not involved in interstate commerce should contact their state governments.
Individual states are also responsible for licensing and monitoring the conduct of physicians, pharmacists, and other health-care professionals. State and local governments are also responsible for the inspection and regulation of establishments such as restaurants and health spas.
FDA public affairs specialists (PAS's) are located throughout the country and are able to respond to questions about FDA's programs, policies and procedures. PAS's provide consumers with information that has been prepared for public distribution.
PAS's provide reprints of articles from FDA Consumer magazine, brochures, posters, teacher kits, press releases, and background papers on FDA-related topics.
Consumers interested in obtaining audiovisuals can borrow or purchase agency-produced slide shows, videotapes and films. PAS's have information on the available materials, prices, and ordering instructions.
PAS's also speak publicly on topics such as food labeling, health fraud, or AIDS awareness.
To contact the public affairs specialist in your area, look for the Food and Drug Administration entry under the Department of Health and Human Services in the U.S. Government section of your local telephone directory.
FDA's Consumer Inquiries Staff, located in the agency headquarters offices, is devoted solely to answering consumers' questions. The staff often consult various other FDA offices to find the appropriate answers to consumer inquiries.
Consumers may request information by writing to the Consumer Inquiries Staff (HFE-88), FDA, 5600 Fishers Lane, Rockville, MD 20857, or may telephone (1-800) 532-4440.
FDA on the Internet--the FDA Internet Home Page provides up-to-date, authoritative information on food, cosmetics, human and animal drugs, biologics, medical devices, and more.
To access the FDA Home Page, use this URL (uniform resource locator): www.fda.gov. From there, you can easily locate consumer education materials, press releases, industry guidance, bulletins for health professionals, and a wealth of other useful documents and data from FDA's centers and offices.
FDA's Internet site replaces the agency's electronic bulletin board, which had provided on-line information for more than a decade. The Internet site offers far more material, in a more user-friendly form, including easy-to-use full-text searches and hot-links to other FDA documents and other government Internet sites.
Due to increased public interest, FDA has established toll-free hot lines on the following topics:
Occasionally, consumers seek information that has not been prepared for public dissemination. The Freedom of Information Act ensures public access to most agency documents, including:
The Freedom of Information Act pertains only to existing records and is not a research service that compiles information not already available and identifiable. An FOI request for agency records can be denied only under set guidelines. Documents that may be exempt from the Freedom of Information Act include:
All FOI requests must be made in writing and must include the requestor's name, address, and telephone number, as well as a specific statement of the records being sought. Consumers are charged for search time and duplication (with no charge for the first two hours of search time and the first 100 pages of duplication). Search and review time charges range from $13, $26, or $46 per hour, depending on the level of FDA employee filling the request. The photocopying rate is 10 cents per page for standard-size paper or the actual cost per page for odd-size paper. Requests incurring charges of less than $10 are filled without charge.
For additional information or to make an FOI request, contact the Freedom of Information Staff (HFI-35), FDA, 5600 Fishers Lane, Rockville, MD 20857, or send requests via facsimile to (301) 443-1726. Additional information is also available from FDA's Electronic Freedom of Information Reading Room.
Many information requests to FDA must be denied due to the confidential nature of the data. FDA employees are prohibited by law from divulging information considered either proprietary or confidential. For example, FDA employees cannot release any information on unapproved drugs unless the manufacturer has given the agency permission or has already released the information to the public.
Dori Stehlin is a member of FDA's public affairs staff.
FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following contact information is for government agencies that have functions related to that of FDA. (Contact information is given for agency headquarters offices, which are located in the Washington, D.C., area. Local offices, listed in the phone book under U.S. Government, may be available to provide assistance as well.)
The Federal Trade Commission is the federal agency which regulates all advertising, excluding prescription drugs and medical devices. FTC ensures that advertisements are truthful and not misleading for consumers. Consumers may write to FTC at 6th St. and Pennsylvania Ave., N.W., Washington, DC 20580; telephone (202) 326-2222.
The labeling and quality of alcoholic beverages are regulated by the Treasury Department's Bureau of Alcohol, Tobacco, and Firearms. ATF's address is 650 Massachusetts Ave., N.W., Washington, DC 20226; telephone (202) 927-7777.
While FDA regulates a large portion of the products that consumers purchase, the agency has no jurisdiction over many household goods. The Consumer Product Safety Commission (CPSC) is responsible for ensuring the safety of consumer goods such as household appliances (excluding those that emit radiation), paint, child-resistant packages, and baby toys. Consumers may send written inquiries to CPSC, Washington, DC 20207. CPSC operates a toll-free hot line at (800) 638-2772 or TTY (800) 638-8270 for consumers to report unsafe products or to obtain information regarding products and recalls.
Illegal drugs with no approved medical use--such as heroin, cocaine and marijuana--are under the jurisdiction of the Drug Enforcement Agency (DEA). FDA assists DEA in deciding how stringent DEA controls should be on drugs that are medically accepted but that have a strong potential for abuse. DEA establishes limits on the amount of these prescription drugs that are permitted to be manufactured each year. Inquiries regarding DEA activities may be sent to the Drug Enforcement Administration, U.S. Department of Justice, Washington, DC 20537; telephone (202) 307-1000.
The U.S. Department of Agriculture's Food Safety and Inspection Service is responsible for the safety and labeling of traditional meats and poultry. (FDA regulates game meats, such as venison, ostrich and snake.) Consumers with questions regarding meat or poultry, including safe handling and storage practices, should write or call the Food Safety Inspection Service's Meat and Poultry Hotline, Room 2925S, Washington, DC 20250; telephone (800) 535-4555.
FDA, USDA, and the Environmental Protection Agency share the responsibility for regulating pesticides. EPA determines the safety and effectiveness of the chemicals and establishes tolerance levels for residues on feed crops, as well as for raw and processed foods. These tolerance levels (the amount of pesticide allowed to be present in a food product) are normally set 100 times below the level that might cause harm to people or the environment. FDA and USDA are responsible for monitoring the food supply to ensure that pesticide residues do not exceed the allowable levels in the products under their jurisdiction. Public inquiries regarding EPA should be mailed to U.S. Environmental Protection Agency, Office of Pesticide Programs Public Docket (7502C), 401 M St., Washington, DC 20460; telephone (703) 305-5805.
Inspections and licensing of restaurants and grocery stores are typically handled by local county health departments.
The regulation of water is divided between EPA and FDA. EPA has the responsibility for developing national standards for drinking water from municipal water supplies. FDA regulates the labeling and safety of bottled water.
Publication No. (FDA) 98-1167
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