Science & Research

Volume IV - 1.2 FDA Laws and Regulations

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Orientation and Training
Food and Drug Administration



Section 1 - Laboratory Orientation



The analyst will use methods from a number of sources to determine regulatory compliance. These include methods described in official compendia, in manuals relating to analytical categories, and in FDA compliance manuals.

1.3.1 Official Compendia

The FD&C Act and regulations cite publications that contain methods to determine if a product conforms to legal requirements. The compendia cited have gained official status within the Federal judicial system as methods of choice. Most commonly used in the laboratory are the United States Pharmacopeia (USP), National Formulary (NF) and Official Methods of Analysis of AOAC International (formerly the Association of Official Analytical Chemists). These books are referred to here as USP, NF, and AOAC. Note that the USP and NF are now combined into one publication, and that we use the acronym AOAC to refer to both the compendia and the professional organization.

Official methods are those in compendia specified in the Food, Drug & Cosmetic Act and prescribed in the Code of Federal Regulations. Official methods are used, whenever found, or unless otherwise specified, for either original or check analysis, when regulatory actions are based on analytical findings.

Four common sources of methodology, and their citation in the Act or CFR, are listed below. Review the citations for pertinent information.

The Federal Food, Drug, and Cosmetic (FD&C) Act, which is the reason for the existence of the Food and Drug Administration, provides legal authority for almost all FDA activities. This Act and some of its amendments as well as a number of other acts are enforced by FDA. The analyst is to be familiar with these and also familiar with two official government publications, the Code of Federal Regulations and the Federal Register.

1.2.1 FD&C Act and Amendments

The FD&C Act, as amended, with its general and enabling regulations, provides the basic authority for the majority of our regulatory operations. The Act is republished periodically in booklet form. The Act will be discussed with the analyst by their training supervisor and, later, in greater detail at FDA training sessions. It is important that the analyst acquire an understanding of its provisions because they will play a significant part in decisions the analyst will make during his or her career.

The Act, which was passed by Congress in 1938, replaced the Food and Drug Act passed in 1906. Since 1938, the Act has been amended a number of times. Among the amendments are the following:

INSULIN (1941) AND ANTIBIOTIC AMENDMENTS (1945 et seq.). Requires FDA to batch-certify insulin and antibiotic drugs before they are placed on the market.

MILLER AMENDMENT (1948). Gives FDA jurisdiction over products that become adulterated or misbranded after interstate shipment.

DURHAM-HUMPHREY AMENDMENT (1951). Makes it unlawful to dispense a drug bearing the Rx legend without a prescription or to refill a prescription without authorization from the prescriber.

FACTORY INSPECTION AMENDMENT (1953). Permits FDA inspection, after written notice, without a warrant and without permission of the owner.

PESTICIDE CHEMICAL AMENDMENT (1954). Requires the manufacturer of a pesticide chemical to obtain a tolerance from EPA for the chemical in or on specified raw agricultural products. The burden for proving that residue levels are safe is placed on the manufacturer. FDA is responsible for enforcing the tolerance established by EPA.

FOOD ADDITIVES AMENDMENT (1958). Requires premarketing clearance of food additives whose safety is not generally recognized. Burden for proving that a food additive is safe for its intended use is placed on the manufacturer.

COLOR ADDITIVES AMENDMENT (1960). Requires that conditions for safe use of a color additive be established by regulation. Burden for proving safety is placed on the manufacturer.

DRUG AMENDMENTS (1962). Requires, among other provisions, that manufacturers prove their new drugs to be effective as well as safe and gives FDA authority to regulate prescription drug advertising.

DRUG LISTING AMENDMENTS (1972). Requires manufacturers and processors of drugs to submit a list of all drugs manufactured or processed for commercial distribution. Among other provisions is the requirement that a copy of the labeling for each drug be submitted.

MEDICAL DEVICE AMENDMENTS (1976). Provides for the safety and effectiveness of medical devices intended for human use. Devices are to be classified and, depending on classification, may require a performance standard or premarket approval.

INFANT FORMULA AMENDMENT (1980). Establishes nutrient requirements for infant formulas and quality control requirements for their manufacturers.

1.2.2 Other Acts Enforced by FDA

TEA IMPORTATION ACT (1897, Repealed 1996 ). Provides for standards of purity, quality, and fitness for teas and requires the examination of each imported shipment.

FDA FEDERAL IMPORT MILK ACT (1923). Regulates importation of fluid milk products from foreign producers.

FILLED MILK ACT (1927). Prohibits shipment of filled milk in interstate or foreign commerce. Filled milk is defined as any milk, cream, or skimmed milk to which has been added fat or oil other than milk fat to produce a product in imitation of or in semblance of milk, cream or skimmed milk.

FEDERAL CAUSTIC POISON ACT (1927). Specifies warnings and precautionary statements on labeling of certain household caustic preparations. Primarily a labeling act.

FAIR PACKAGING AND LABELING ACT (1966). Prohibits the use of unfair or deceptive methods of packaging or labeling of certain consumer commodities.

RADIATION CONTROL FOR HEALTH AND SAFETY ACT (1968). Protects the public from unwanted exposure to radiation from electronic products, e.g., color TV sets, microwave ovens, and X-ray machines.

PUBLIC HEALTH SERVICE ACT (1944). Areas of this act enforced by FDA are:

  • Regulation of interstate sales of biologics, such as vaccines, serums, and blood, to assure purity, safety, and potency.
  • Regulation of pasteurized milk and shellfish handling.
  • Regulation of food service sanitation and food, water, and sanitary facilities used by interstate travelers on common carriers.

FEDERAL ANTI-TAMPERING ACT (1983). Establishes criminal penalties for involvement in tampering with a consumer product.

ORPHAN DRUG ACT (1983). Encourages development and marketing of drugs for rare diseases by offering incentives to manufacturers.

DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT (1984). Establishes criteria for extending patents on drug products, methods of use, and methods of manufacturing.

THE PRESCRIPTION DRUG MARKETING ACT (1988).Bans the diversion of prescription drugs from legitimate commercial channels. Congress finds that the resale of such drugs leads to the distribution of mislabeled, adulterated, subpotent, and counterfeit drugs to the public. The new law requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons.

NUTRITIONAL LABELING AND EDUCATION ACT (1990). Requires all packaged foods to bear nutrition labeling and all health claims for foods to be consistent with terms defined by the Secretary of Health and Human Services. The law preempts state requirements about food standards, nutrition labeling, and health claims and, for the first time, authorizes some health claims for foods. The food ingredient panel, serving sizes, and terms such as "low fat" and "light" are standardized.

SAFE MEDICAL DEVICES ACT (1990). Requires nursing homes, hospitals, and other facilities that use medical devices to report to FDA incidents that suggest that a medical device probably caused or contributed to the death, serious illness, or serious injury of a patient. Manufacturers are required to conduct post-market surveillance on permanently implanted devices whose failure might cause serious harm or death, and to establish methods for tracing and locating patients depending on such devices. The act authorizes FDA to order device product recalls and other actions.

MAMMOGRAPHY QUALITY STANDARDS ACT (1992; in 1998 was reauthorized until 2002). Requires all mammography facilities in the United States to be accredited and federally certified as meeting quality standards effective Oct. 1, 1994. After initial certification, facilities must pass annual inspections by federal or state inspectors.

DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT (1994). Establishes labeling requirements, provides a regulatory framework, and authorizes FDA to promulgate good manufacturing practice regulations for dietary supplements. This act defines "dietary supplements" and "dietary ingredients" and classifies them as food. The act also establishes a commission to recommend how to regulate claims.

FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT (1997). Reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.

FOOD AND DRUG ADMINISTRATION ACT (1998). Officially establishes FDA as an agency of the Department of Health and Human Services, with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate, and broadly spells out the responsibilities of the Secretary of DHHS and the Commissioner for research, enforcement, education, and information.

FDA has some enforcement or regulatory authority under a number of other statutes:

  • Comprehensive Drug Abuse Prevention and Control Act
  • Controlled Substances Act
  • Federal Meat Inspection Act
  • Poultry Products Inspection Act
  • Egg Products Inspection Act

1.2.3 Code of Federal Regulations

The Code of Federal Regulations (CFR) is an official government publication that codifies the general and permanent rules (regulations) issued by the Executive Branch and its agencies to implement the laws they enforce. It is revised annually. FDA regulations are coded under Title 21 as "21 Food and Drugs." References to the CFR are written as "21 CFR" with part, section, and paragraph numbers following, e.g., "21 CFR 121.3(d)." Criminal penalties may also fall under Title 18.

FDA personnel responsible for pesticide analyses also consult Title 40, "Protection of the Environment." Part 180 of 40 CFR includes the pesticide residue tolerances for foods and feeds established by the Environmental Protection Agency and enforced by FDA.

1.2.4 Federal Register

The Federal Register (FR), an official government publication, is issued daily Monday through Friday. It makes known to the public the regulations and legal notices issued by Federal agencies, as well as other Federal issuances prescribed to be published in the FR. The FR is the source for the regulations published annually in theCode of Federal Regulations. Regulations published in the FR are effective on the date stated in the FR unless "stayed," i.e., not to be put into effect for some reason. If a regulation is "stayed," the FR publishes that notice.

Page Last Updated: 07/14/2015
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