Federal Food, Drug, and Cosmetic Act

United States

The United States of America is a federal constitutional republic comprising fifty states and a federal district...

Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress

United States Congress

The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....

in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food

Food safety

Food safety is a scientific discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. This includes a number of routines that should be followed to avoid potentially severe health hazards....

, drugs, and cosmetics. A principal author of this law was Royal S. Copeland

Royal S. Copeland

Royal Samuel Copeland was an American academic, homeopathic physician, and politician who held elected offices in both Michigan and New York . He represented New York in the United States Senate from 1923 until 1938.-Early life and medical career:Born in Dexter, Michigan to parents Roscoe P....

, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation

Drug Efficacy Study Implementation

Drug Efficacy Study Implementation was a program begun by the Food and Drug Administration in the 1960s after the requirement that all drugs be efficacious as well as safe. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective,...

(DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences

United States National Academy of Sciences

The National Academy of Sciences is a corporation in the United States whose members serve pro bono as "advisers to the nation on science, engineering, and medicine." As a national academy, new members of the organization are elected annually by current members, based on their distinguished and...

investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism

Bioterrorism

Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents are bacteria, viruses, or toxins, and may be in a naturally occurring or a human-modified form. For the use of this method in warfare, see biological warfare.-Definition:According to the...

preparations.

The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol

Diethylene glycol

Diethylene glycol is an organic compound with the formula 2O. It is a colorless, practically odorless, poisonous, and hygroscopic liquid with a sweetish taste. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used solvent...

was used to dissolve the drug and make a liquid form. See Elixir Sulfanilamide disaster

Elixir Sulfanilamide disaster

Elixir sulfanilamide was an improperly prepared sulfanilamide medicine that caused mass poisoning in the United States in 1937. It caused the deaths of more than 100 people...

. It replaced the earlier Pure Food and Drug Act

Pure Food and Drug Act

The Pure Food and Drug Act of June 30, 1906, is a United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines...

of 1906.

The FD&C Act has twenty chapters:

I. Short Title

II. Definitions

201(f) is the definition for a food, which explicitly includes chewing gum
Chewing gum
Chewing gum is a type of gum traditionally made of chicle, a natural latex product, or synthetic rubber known as polyisobutylene. For economical and quality reasons, many modern chewing gums use rubber instead of chicle...
201(g) is the definition for a drug
Drug
A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
201(h) is the definition for a medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
201(s) is the definition of a food additive
201(ff) is the definition of a dietary supplement
Dietary supplement
A dietary supplement, also known as food supplement or nutritional supplement, is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet...

III. Prohibited Acts and Penalties

This section contains both civil law

Private law

Private law is that part of a civil law legal system which is part of the jus commune that involves relationships between individuals, such as the law of contracts or torts, as it is called in the common law, and the law of obligations as it is called in civilian legal systems...

and criminal law

Criminal law

Criminal law, is the body of law that relates to crime. It might be defined as the body of rules that defines conduct that is not allowed because it is held to threaten, harm or endanger the safety and welfare of people, and that sets out the punishment to be imposed on people who do not obey...

clauses. Most violations under the act are civil, though repeated, intentional, and fraudulent violations are covered as criminal law. All violations of the FD&C Act require interstate commerce because of the commerce clause

Commerce Clause

The Commerce Clause is an enumerated power listed in the United States Constitution . The clause states that the United States Congress shall have power "To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes." Courts and commentators have tended to...

, but this is often interpreted broadly and few products other than raw produce are considered outside of the scope of the act.

Notably, the FD&C Act uses strict liability

Strict liability

In law, strict liability is a standard for liability which may exist in either a criminal or civil context. A rule specifying strict liability makes a person legally responsible for the damage and loss caused by his or her acts and omissions regardless of culpability...

due to the Dotterweich and Park Supreme Court

Supreme Court of the United States

The Supreme Court of the United States is the highest court in the United States. It has ultimate appellate jurisdiction over all state and federal courts, and original jurisdiction over a small range of cases...

cases. It is one of a very small number of criminal statutes that does.

IV. Food

There is a distinction in food adulteration between those that are added and those that are naturally present. Substances that are added are held to a stricter "may render (it) injurious to health" standard, whereas substances that are naturally present need only be at a level that "does not ordinarily render it injurious to health"

V. Drugs and Devices

505 is the description of the drug approval process
510(k) is the section that allows for clearance of class II medical devices
515 is the description of the (class III) device approval process

VI. Cosmetics

VII. General Authority

704 allows inspections of regulated entities. Inspection results are reported on Form 483.

VIII. Imports and Exports

IX. Miscellaneous

Food coloring

The FD&C is perhaps best known by the consumer because of its use in the naming of food coloring

Food coloring

Food coloring is a substance, liquid or powder, that is added to food or drink to change its color. Food coloring is used both in commercial food production and in domestic cooking...

additives

Food additive

Food additives are substances added to food to preserve flavor or enhance its taste and appearance.Some additives have been used for centuries; for example, preserving food by pickling , salting, as with bacon, preserving sweets or using sulfur dioxide as in some wines...

, such as "FD&C Yellow No. 6." The Act made the certification of some food color additives mandatory. Some food colorings are generally recognized as safe

Generally recognized as safe

Generally recognized as safe is an American Food and Drug Administration designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act food additive tolerance requirements.-History:On January 1, 1958,...

(GRAS) by the FDA and do not require certification.

The FDA lists nine FD&C (Food, Drugs & Cosmetics) certified color additives for use in foods in the United States, and numerous D&C (Drugs & Cosmetics) colorings allowed only in drugs for external application or cosmetics. Color additives derived from natural sources, such as vegetables, minerals or animals, and man-made counterparts of natural derivatives, are exempt from certification. Both artificial and natural color additives are subject to rigorous standards of safety before their approval for use in foods.

Certifiable colors

Name	Common name	Color	Comment
FD&C Blue No. 1	Brilliant Blue FCF Brilliant Blue FCF Brilliant Blue FCF , also known under commercial names, is a colorant for foods and other substances to induce a color change. It is denoted by E number E133 and has a color index of 42090. It has the appearance of a reddish-blue powder...	bright blue Blue Blue is a colour, the perception of which is evoked by light having a spectrum dominated by energy with a wavelength of roughly 440–490 nm. It is considered one of the additive primary colours. On the HSV Colour Wheel, the complement of blue is yellow; that is, a colour corresponding to an equal...
FD&C Blue No. 2	Indigotine	royal blue Royal blue Royal blue describes both a bright shade and a dark shade of azure blue. It is said to have been invented by millers in Rode, Somerset, a consortium of which won a competition to make a dress for the British queen, Charlotte of Mecklenburg-Strelitz....
FD&C Green No. 3	Fast Green FCF Fast Green FCF Fast Green FCF, also called Food green 3, FD&C Green No. 3, Green 1724, Solid Green FCF, and C.I. 42053, is a sea green triarylmethane food dye. Its E number is E143....	sea green
FD&C Red No. 3	Erythrosine Erythrosine Erythrosine, also known as Red No. 3, is an organoiodine compound, specifically a derivative of fluorone. It is cherry-pink synthetic, primarily used for food coloring. It is the disodium salt of 2,4,5,7-tetraiodofluorescein...	cherry Cherry The cherry is the fruit of many plants of the genus Prunus, and is a fleshy stone fruit. The cherry fruits of commerce are usually obtained from a limited number of species, including especially cultivars of the wild cherry, Prunus avium.... red Red Red is any of a number of similar colors evoked by light consisting predominantly of the longest wavelengths of light discernible by the human eye, in the wavelength range of roughly 630–740 nm. Longer wavelengths than this are called infrared , and cannot be seen by the naked eye...
FD&C Red No. 40	Allura Red AC Allura Red AC Allura Red AC is a red azo dye that goes by several names including: Allura Red, Food Red 17, C.I. 16035, FD&C Red 40, 2-naphthalenesulfonic acid, 6-hydroxy-5--, disodium salt, and disodium 6-hydroxy-5--2-naphthalenesulfonate. It is used as a food dye and has the E number E129...	orange Orange (colour) The colour orange occurs between red and yellow in the visible spectrum at a wavelength of about 585–620 nm, and has a hue of 30° in HSV colour space. It is numerically halfway between red and yellow in a gamma-compressed RGB colour space, the expression of which is the RGB colour wheel. The... -red Red Red is any of a number of similar colors evoked by light consisting predominantly of the longest wavelengths of light discernible by the human eye, in the wavelength range of roughly 630–740 nm. Longer wavelengths than this are called infrared , and cannot be seen by the naked eye...
FD&C Yellow No. 5	Tartrazine Tartrazine Tartrazine is a synthetic lemon yellow azo dye used as a food coloring...	lemon yellow Lemon (color) Lemon or lemon yellow is a color somewhat resembling yellow and named after the fruit. The color lemon is a representation of the color of the outer skin of a lemon.The first recorded use of lemon as a color name in English was in 1598....
FD&C Yellow No. 6	Sunset Yellow FCF Sunset Yellow FCF Sunset Yellow FCF is a synthetic yellow azo dye, manufactured from aromatic hydrocarbons from petroleum. When added to foods, it is denoted by E Number E110...	orange Orange (colour) The colour orange occurs between red and yellow in the visible spectrum at a wavelength of about 585–620 nm, and has a hue of 30° in HSV colour space. It is numerically halfway between red and yellow in a gamma-compressed RGB colour space, the expression of which is the RGB colour wheel. The...
Orange B Orange B Orange B is a food dye from the azo dye group. It is approved by Food and Drug Administration for use only in hot dog and sausage casings or surfaces, only up to 150 ppm of the finished food weight. It usually comes as disodium salt....			Restricted to specific uses
Citrus Red No.2			Restricted to specific uses

There are also "D&C" colors that are only approved for use in pharmaceuticals for external application and cosmetics.

Food additives

The FFDCA requires producers of food additives to demonstrate to a reasonable certainty that no harm will result from the intended use of an additive. If the FDA finds an additive to be safe the agency issues a regulation specifying the conditions under which the additive may be safely used.

Definition of food additive

The definition of "food additive" is "any substance, the intended use of which results directly or indirectly, in its becoming a component or otherwise affecting the characteristics of food". A food additive requires a premarket approval by the FDA unless excluded from this requirement as a substance that is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food before January 1, 1958, through either scientific procedures or through experience based on common use in food) to be safe under the conditions of its intended use. This is the so called generally recognized as safe

Generally recognized as safe

(GRAS) exemption.

Genetically modified foods are regarded as containing food additives

These regulations apply to foods produced by genetic engineering and natural sources, if the protein added to the food by the genetic engineering

Genetic engineering

Genetic engineering, also called genetic modification, is the direct human manipulation of an organism's genome using modern DNA technology. It involves the introduction of foreign DNA or synthetic genes into the organism of interest...

process is not "generally recognized as safe" then genetically modified food

Genetically modified food

Genetically modified foods are foods derived from genetically modified organisms . Genetically modified organisms have had specific changes introduced into their DNA by genetic engineering techniques...

is regarded as containing a "food additive" and is subject to pre-market approval by the FDA. All genetically modified foods sold in the USA have been subject to this FDA pre-market approval process.

Homeopathic medications

Homeopathic

Homeopathy

Homeopathy is a form of alternative medicine in which practitioners claim to treat patients using highly diluted preparations that are believed to cause healthy people to exhibit symptoms that are similar to those exhibited by the patient...

preparations are regulated and protected under Sections 201(g) and 201(j), provided that such medications are formulated from substances listed in the Homeopathic Pharmacopoeia of the United States, which the Act recognizes as an official drug compendium.

Bottled water

Bottled water is drinking water packaged in plastic or glass water bottles. Bottled water may be carbonated or not...

is regulated by FDA as a food. The Agency has published identity standards for types of water (mineral water

Mineral water

Mineral water is water containing minerals or other dissolved substances that alter its taste or give it therapeutic value, generally obtained from a naturally occurring mineral spring or source. Dissolved substances in the water may include various salts and sulfur compounds...

, spring water), and regulations covering water processing and bottling, water quality and product labeling.

Cosmetics

This Act defines cosmetics

Cosmetics

Cosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, towelettes, permanent waves, colored contact lenses, hair colors, hair sprays and...

as products for "cleansing, beautifying, promoting attractiveness, or altering the appearance." In this sense the FDA can classify cosmetics without actually regulating them. This allows a manufacturer the ability to use ingredients or raw materials and market the final product without government approval.

Section 510(k) and the device approval process

Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device

Medical device

A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...

.

This is known as Premarket Notification - also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

Any device that reaches market via a 510(k) notification must be "substantially equivalent" to a device on the market prior to May 28, 1976 (a "predicate device"). If a device being submitted is significantly different, relative to a pre-1976 device, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, the device nominally must go through a premarket approval

Premarket approval

Premarket approval is the U.S. Food and Drug Administration process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices and is significantly different from the Premarket Notification process known as 510...

, or PMA. This does not always happen.

As of 2007, this has been implemented by splitting devices into three classes:

Class I: Devices that do not require premarket approval or clearance but must follow general controls. Dental floss
Dental floss
Dental floss is made of either a bundle of thin nylon filaments or a plastic ribbon used to remove food and dental plaque from teeth. The floss is gently inserted between the teeth and scraped along the teeth sides, especially close to the gums. Dental floss may be flavored or unflavored, and...

is a class I device.
Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, and amalgam alloys used to fill cavities are all class II devices. The "predicate device" in question is often quite different, and this process is largely used to clear devices for marketing which do not meet the criteria to be considered class III. Hearing aids are class II devices.
Class III: Devices that are approved by the Premarket Approval (PMA) process, analogous to a New Drug Application
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...

. These tend to be devices that are permanently implanted into a human body or may be necessary to sustain life. An artificial heart
Artificial heart
An artificial heart is a mechanical device that replaces the heart. Artificial hearts are typically used in order to bridge the time to heart transplantation, or to permanently replace the heart in case transplantation is impossible...

meets both criteria. The most commonly recognized class III device is an Automated External Defibrillator
Automated external defibrillator
An automated external defibrillator or AED is a portable electronic device that automatically diagnoses the potentially life threatening cardiac arrhythmias of ventricular fibrillation and ventricular tachycardia in a patient, and is able to treat them through defibrillation, the application of...

. Devices that do not meet either criterion are generally cleared as class II devices.

A device that reaches market via the 510(k) process is not considered to be "approved" by the FDA. Nevertheless, it can be marketed and sold in the United States. They are generally referred to as "cleared" or "510(k) cleared" devices.

Some economists support pre-market approval of drugs and devices mainly based on the belief that imperfect information exists in the market.

Related legislation

The Wheeler-Lea Act

Wheeler-Lea Act

The Wheeler–Lea Act of 1938 is a United States federal law that amended Section 5 the Federal Trade Commission Act to proscribe “unfair or deceptive acts or practices” as well as “unfair methods of competition.” . It provided civil penalties for violations of Section 5 orders...

, passed in 1938, granted the Federal Trade Commission

Federal Trade Commission

The Federal Trade Commission is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act...

the authority to oversee advertising

Advertising

Advertising is a form of communication used to persuade an audience to take some action with respect to products, ideas, or services. Most commonly, the desired result is to drive consumer behavior with respect to a commercial offering, although political and ideological advertising is also common...

of all products regulated by FDA, other than prescription drugs.

Significant amendments and related laws

Descriptions of these can be found at the FDCA's web site.

Amendments:

Infant Formula Act of 1980, Public Law (PL) 96-359 (Oct. 26, 1980)
Orphan Drug Act, PL 97-414 (Jan. 4, 1983)
Drug Price Competition and Patent Term Restoration Act of 1984, PL 98-417 (Sept. 24, 1984)
Prescription Drug Marketing Act of 1987, PL 100-293 (Aug. 18, 1988)
Generic Animal Drug and Patent Term Restoration Act of 1988, PL 100-670 (Nov. 16, 1988)
Nutrition Labeling and Education Act of 1990, PL 101-535 (Nov. 8, 1990)
Safe Medical Devices Act of 1990, PL 101-629 (Nov. 28, 1990)
Medical Device Amendments of 1992, PL 102-300 (June 16, 1992)
Prescription Drug User Fee Act
Prescription Drug User Fee Act
The Prescription Drug User Fee Act was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration to collect fees from drug manufacturers to fund the new drug approval process...

(PDUFA) of 1992, PL 102-571 (Oct. 29, 1992)
Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, PL 103-396 (Oct. 22, 1994)
Dietary Supplement Health and Education Act of 1994, PL 103-417 (Oct. 25, 1994)
Food Quality Protection Act of 1996, PL 104-170 (Aug. 3, 1996)
Animal Drug Availability Act of 1996, PL 104-250 (Oct. 9, 1996)
Food and Drug Administration Modernization Act (FDAMA) of 1997, PL 105-115 (Nov. 21, 1997)
Best Pharmaceuticals for Children Act, PL 107-109 (Jan. 4, 2002)
Medical Device User Fee and Modernization Act (MDUFMA) of 2002, PL 107-250 (Oct. 26, 2002)
Animal Drug User Fee Act of 2003, PL 108-130 (Feb. 20, 2003)
Pediatric Research Equity Act of 2003, PL 108-155 (Dec. 3, 2003)
Minor Use and Minor Species Animal Health Act of 2004
Food Allergen Labeling and Consumer Protection Act of 2004, PL 108-282 (Aug. 2, 2004)
Drug Efficacy Amendment ("Kefauver Harris Amendment
Kefauver Harris Amendment
The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval...

") of 1962

Other laws:

Federal Food and Drugs Act of 1906 (repealed; for historical reference)
Federal Meat Inspection Act (March 4, 1907)
Federal Trade Commission Act
Federal Trade Commission Act
The Federal Trade Commission Act of 1914 started the Federal Trade Commission , a bipartisan body of five members appointed by the president of the United States for seven-year terms. This commission was authorized to issue “cease and desist” orders to large corporations to curb unfair trade...

(Sept. 26, 1914)
Filled Milk Act (March 4, 1923)
Import Milk Act (Feb. 15, 1927)
Public Health Service Act
Public Health Service Act
The Public Health Service Act is a United States federal law enacted in 1944. The full act is captured under Title 42 of the United States Code "The Public Health and Welfare", Chapter 6A "Public Health Service"....

(July 1, 1944)
Trademark Act of 1946 (July 5, 1946)
Reorganization Plan 1 of 1953 (March 12, 1953)
Poultry Products Inspection Act (Aug. 28, 1957)
Fair Packaging and Labeling Act
Fair Packaging and Labeling Act
The Fair Packaging and Labeling Act is a US law that applies to labels on many consumer products. It requires the label to state:*The identity of the product;*The name and place of business of the manufacturer, packer, or distributor; and...

(Nov. 3, 1966)
The National Environmental Policy Act of 1969 (Jan. 1, 1970)
Controlled Substances Act
Controlled Substances Act
The Controlled Substances Act was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain...

(Oct. 27, 1970)
Controlled Substances Import and Export Act (Oct. 27, 1970)
Egg Products Inspection Act (Dec. 29, 1970)
Lead-Based Paint Poisoning Prevention Act (Jan. 13, 1971)
Federal Advisory Committee Act
Federal Advisory Committee Act
The Federal Advisory Committee Act is a United States federal law , which governs the behavior of federal advisory committees. There are now approximately 1,000 such committees...

(Oct. 6, 1972)
Government in the Sunshine Act
Government in the Sunshine Act
The Government in the Sunshine Act is a US law passed in 1976 which affects the operations of the federal government, Congress, Federal Commissions, and other legally constituted federal bodies...

(Sept. 13, 1976)
Government Patent Policy Act of 1980 (Dec. 12, 1980)
Federal Anti-Tampering Act (Oct. 13, 1983)
Sanitary Food Transportation Act (Nov. 3, 1990)
Mammography Quality Standards Act (MQSA) (Oct. 27, 1992)
Bioterrorism Act of 2002 (June 12, 2002)
Project BioShield Act of 2004 (July 21, 2004)
Food and Drug Administration Amendments Act of 2007
Food and Drug Administration Amendments Act of 2007
On September 27, 2007, President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 into law. This new law is an important step for the Food and Drug Administration . It reviewed, expanded, and reaffirmed several existing pieces of legislation...

Comparison to state laws

Some US states have adopted the FD&C Act as an equivalent state law and will by default adopt any changes to the Federal law as changes to the state law as well.

External links

The source of this article is wikipedia, the free encyclopedia. The text of this article is licensed under the GFDL.

Contents

Food coloring

Certifiable colors

Food additives

Definition of food additive

Genetically modified foods are regarded as containing food additives

Homeopathic medications

Bottled water

Cosmetics

Section 510(k) and the device approval process

Related legislation

Significant amendments and related laws

Comparison to state laws

See also

External links