Food And Drug Administration

Food and Drug Administration (FDA) in the United States

Introduction to Food and Drug Administration

Food and Drug Administration (FDA), agency of the United States Department of Health and Human Services. Part of the Public Health Service, the FDA administers the federal Food, Drug, and Cosmetic Act of 1938 and related laws to ensure that foods are pure and wholesome and produced under sanitary conditions; that drugs and therapeutic devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that labels and packaging of products are truthful, informative, and not deceptive. The FDA also enforces the federal Hazardous Substances Act to ensure proper labeling and safety of chemical products, toys, and other articles used in the home. In 1969 the FDA became responsible for promoting sanitation in public eating places and interstate travel facilities and for federal-state programs to ensure safety of milk and shellfish.

In 1971 the FDA was given responsibility for enforcing the Radiation Control for Health and Safety Act of 1968. This law was designed to prevent unnecessary human exposure to radiation from electronic equipment ranging from television receivers to dental X-ray machines. In 1972 the agency was assigned to regulate biologic drugs, including vaccines, antitoxins, and serums.

The federal Food, Drug, and Cosmetic Act prohibits interstate traffic in adulterated or misbranded products. Defective products may be voluntarily destroyed or recalled from distribution by shippers, or seized by U.S. marshals on court orders obtained by the FDA. Persons responsible may be prosecuted in the federal district courts or enjoined from further violations. All court proceedings are introduced by U.S. attorneys based on evidence supplied by the FDA.

Field operations are carried out at regional and district offices and at about 135 resident inspection posts in the United States and Puerto Rico. FDA inspectors periodically visit facilities and warehouses, and agency chemists analyze the samples that inspectors collect. Facts so determined are the basis of regulatory decisions.

Specific products must be approved for safety prior to sale or use. Manufacturers submit samples of production batches of antibiotic drugs, insulin, or color additives to FDA laboratories for testing. The agency must certify their purity, potency, and safety before they may be shipped. New drugs and their labeling must be approved for safety and effectiveness. Food additives must be generally recognized as safe or proven safe by scientific tests. Residues of pesticide chemicals in food commodities must not exceed safe tolerances, which are established by the Environmental Protection Agency and enforced by the FDA. Such premarketing clearances are based on scientific data provided by manufacturers, subject to review and acceptance by FDA scientists.

The FDA maintains extensive educational programs in order to promote compliance by industry with its regulations and to enable consumers to benefit from its work.” (1)

Legal Materials

Basics on the FDA: The FDA is a U.S. government agency with authority to regulate food, drugs, medical devices, cosmetics, livestock feeds, pet foods, and tobacco products. The FDA web site is at www.fda.gov, and phone numbers are available through the Contact page.

FDA documents not available on the FDA website can often be purchased from FOI Services. These include:

  1. Petitions (Citizen Petitions, Food Additive Petitions, Color Additive Petitions);
  2. Drug Approval Letters, Package Inserts and Labeling, FDA Final Reviews and the Summary Basis of Approval (SBOA);
  3. Medical device documents including 510(k) Notifications, Pre-Market Approval Notifications (PMA Notifications), Medical Device / Adverse Reaction Notifications;
  4. Inspection Reports (EIRs, 483s, warning letters and related correspondence),
  5. Guidelines and Guidance Manuals, Advisory Committee Meeting minutes and transcripts, etc.

Drug Approvals: New drug approvals are posted on the New and Generic Drug Approvals page of the FDA website. They are also reported in Pharmaceuticals Approvals Monthly and Scrip Intelligence.

If you subscribe, the Mediregs Pharmaceutical Regulation Suite (information available here) has an extensive searchable collection of FDA materials including drug approvals (archived back to 1996, plus a list of older approvals with Submission Tracking Numbers or STNs).

Drug Approval Processes: The FDA generally will not disclose or even confirm the filing of an application for approval of a new drug until and unless the drug is approved. Once a drug is approved, the FDA posts selected materials from the approval process. To find that material:

  1. Look up the name of the drug in the Drugs@FDA database
  2. Click the link for
  3. Scroll down to the “Approval History” section
  4. The available materials will be linked from the line that says “Approval.”

The FDA generally does not disclose the original application or the scientific material filed support application. You may be able to get these materials or additional materials by filing a FOIA request.

The information that can be disclosed for “Investigative New Drugs” (INDs) is governed by 21 CFR 312.130. Subsection (b) cross references 21 CFR 314.430 for the specifics of what information can be disclosed for drugs.

Form 483s: After the FDA inspects a facility, the inspector fills out a Form 483 listing his or her “observations.” This can give you an idea of what FDA inspectors are looking for. For more about 483s, see the FDA’s 483 FAQ. A list of 483s back to 2000 is posted on FDAzilla’s FDA Inspections/483s Dashboard

A few 483s are posted free in the ORA FOIA Electronic Reading Room. Otherwise, you can get 483s by filing a FOIA request with the FDA (free but slow), or you can purchase them from FOI Services, 483sOnline.com (by FDANews) or the 483 Store.

Orange Book: For information about the list of Approved Drug Products With Therapeutic Equivalence Evaluations, see the Orange Book section on the “Books” entry in this legal Encyclopedia.

Warning Letters: The FDA posts “general” Warning Letters on their Inspections, Compliance, Enforcement, and Criminal Investigations page (1996-present). The FDA also posts Tobacco Retailer Warning Letters (from the last 45 days) and Untitled and Warning Letters to Pharmaceutical Companies sent to pharmaceutical companies (1997 to present). For searching, you can use:

  1. the FDA’s Warning Letters Advanced Search
  2. the Food, Drugs and Devices library on CCH Intelliconnect for general Warning Letters (1996 to present) but not the Untitled and Warning Letters to Pharmaceutical Companies (subscription only)
  3. the Pharmaceutical Suite MediRegs, which has general Warning Letters (1990-present), “Cyber” Letters (2000-present) and Untitled and Warning Letters to Pharmaceutical Companies (1997-present) (subscription only)
  4. Thompson’s online FDA Enforcement Manual [which may now be part of their Compliance Expert product] (subscription required).

Warning letters are summarized in the Warning Letter Bulletin.

Food and Drug Administration, Sexual Behaviour and the Law

Resources

Notes and References

See Also

Food
Medical Devices
Medical Materials
Pharmaceuticals
Legal Medicine

Further Reading

Food and Drug Administration (fda) in the International Business Landscape

Definition of Food and Drug Administration (fda) in the context of U.S. international business and public trade policy: The federal agency that aims to protect the health of U.S. citizens against impure and unsafe foods, drugs, and cosmetics.

Food And Drug Administration: Open and Free Legal Research of US Law

Federal Primary Materials

The U.S. federal government system consists of executive, legislative, and judicial branches, each of which creates information that can be the subject of legal research about Food And Drug Administration. This part provides references, in relation to Food And Drug Administration, to the legislative process, the federal judiciary, and the primary sources of federal law (cases, statutes, and regulations).

Federal primary materials about Food And Drug Administration by content types:

Laws and Regulations

US Constitution
Federal Statutory Codes and Legislation

Federal Case Law and Court Materials

U.S. Courts of Appeals
United States courts of appeals, inclouding bankruptcy courts and bankcruptcy appellate panels:

Federal Administrative Materials and Resources

Presidential Materials

Materials that emanate from the President’s lawmaking function include executive orders for officers in departments and agencies and proclamations for announcing ceremonial or commemorative policies. Presidential materials available include:

Executive Materials

Federal Legislative History Materials

Legislative history traces the legislative process of a particular bill (about Food And Drug Administration and other subjects) for the main purpose of determining the legislators’ intent behind the enactment of a law to explain or clarify ambiguities in the language or the perceived meaning of that law (about Food And Drug Administration or other topics), or locating the current status of a bill and monitoring its progress.

State Administrative Materials and Resources

State regulations are rules and procedures promulgated by state agencies (which may apply to Food And Drug Administration and other topics); they are a binding source of law. In addition to promulgating regulations, state administrative boards and agencies often have judicial or quasi-judicial authority and may issue administrative decisions affecting Food And Drug Administration. Finding these decisions can be challenging. In many cases, researchers about Food And Drug Administration should check state agency web sites for their regulations, decisions, forms, and other information of interest.

State rules and regulations are found in codes of regulations and administrative codes (official compilation of all rules and regulations, organized by subject matter). Search here:

State opinions of the Attorney General (official written advisory opinions on issues of state law related to Food And Drug Administration when formerly requested by a designated government officer):

Tools and Forms

Law in Other Regions

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