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Getting Information from FDA

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?

What Does FDA Regulate?

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:

Biologics:

Cosmetics:

Drugs:

Electronic Products:

Foods:

Medical Devices:

Veterinary Products:

When Does FDA Get Involved?

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.

Public Affairs Specialists

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.

World Wide Web

The FDA Internet Website provides up-to-date, authoritative information on food, cosmetics, human and animal drugs, biologics, medical devices, and more.

The FDA Home Page is located on the Web at 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 Hot Lines for Consumers

Due to increased public interest, FDA has established a general toll-free number: 1-888-INFO-FDA (1-888-463-6332). In addition, there are toll-free hot lines on the following topics:

Freedom of Information Staff

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 $18, $36, or $64 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 $15 are filled without charge.

For additional information or to make an FOI request, contact the Freedom of Information Staff, FDA, 5600 Fishers Lane, Room 12A-30, 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.

Our Lips Are Sealed

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.


Agencies with Related Responsibilities

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.

Advertising

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 Federal Trade Commission, Consumer Response Center, Room 130, 600 Pennsylvania Ave., NW, Washington, DC 20580; telephone 1-877-382-4357.

Alcohol

The Treasury DepartmentĂ­s Alcohol and Tobacco Tax and Trade Bureau (TTB) (www.ttb.gov) regulates the labeling, quality, and taxation of alcoholic beverages. TTB is a new agency created when the Bureau of Alcohol, Tobacco and Firearms was split into two entities by the Homeland Security Act of 2002. TTBĂ­s address is Alcohol and Tobacco Tax and Trade Bureau, 650 Massachusetts Ave., N.W., Washington, DC 20226; telephone (202) 927-5000; e-mail ttbquestions@ttb.treas.gov.

Consumer Products

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 US Consumer Product Safety Commission, 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. CPSC also can be reached through e-mail at info@cpsc.gov.

Drugs of Abuse

Illegal drugs with no approved medical use--such as heroin, cocaine and marijuana--are under the jurisdiction of the Drug Enforcement Administration (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, 2401 Jefferson Davis Hwy., Alexandria, VA 22301; telephone (202) 307-1000.

Meat and Poultry

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 to the Food Safety and Inspection Service, United States Department of Agriculture, Washington, DC 20250-3700; telephone (800) 535-4555 or TDD/TTY (1-800) 256-7072, e-mail MPHotline.fsis@usda.gov.

Pesticides

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, Ariel Rios Building, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone (202)260-2090; e-mail public-access@epa.gov.

Restaurants and Grocery Stores

Inspections and licensing of restaurants and grocery stores are typically handled by local county health departments.

Securities

The primary mission of the Securities and Exchange Commission is to protect the investing public and maintain the integrity of the securities market. FDA assists SEC staff by assessing the accuracy of statements by FDA-regulated firms in SEC filings. FDA officials routinely provide technical and scientific information and expert advice to the SEC to assist in their investigations of possible violations of federal securities laws. SEC's address is 450 Fifth St., N.W., Washington, DC 20549; telephone (202) 942-7040; e-mail help@sec.gov.

Water

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.

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