Federal Food, Drug, and Cosmetic Act
Acronym FFDCA, "FD&C Act"
Enacted by the 75th United States Congress
Public Law 75-717
Stat. 52 US Stat. 1040
U.S.C. sections created 21 U.S.C. § 301 et seq
• Signed into law by President Franklin D. Roosevelt on June 25, 1938
18th & 19th Century:
• States in charge of domestic products & Federal authority limited to imports.
• Chemical preservatives, additives, and fraud became more common
• But-science’s ability to detect fraud was also advancing!
Harvey W. Wiley (1844-1930)
• Published his 1st
paper on how to detect if “pure cane sugar” had been diluted
with glucose (1881).
• 1883 – Wiley became chief chemist in U.S. Department of Agriculture &
began investigating adulteration and misbranding of food products.
• Wiley’s “Poison Squad”- Experiments to test for effects of chemicals, food
preservatives on human body.
1879 – 1906
Over 100 food and drug bills were put before Congress but none
of them passed.
1906 – Public Outrage!!!
• Upton Sinclair’s “THE JUNGLE” published
which Exposed horrors of meat packing
1906 – Pure Food and Drugs Act
• Prohibited the interstate transport of unlawful
(adulterated or misbranded) food and drugs
• Product labeling (not pre-market approval)
Labels on packaging could not be false or misleading
no requirement to disclose ingredient
11 “dangerous ingredients” could be used, but
had to be listed on label (e.g., alcohol, heroin, cocaine)
Harvey Wiley resigned & Created “Good Housekeeping Seal of Approval”
Bureau of Chemistry becomes the “Food, Drug, and Insecticide
Harvey Wiley died & Franklin Roosevelt elected president
“Food, Drug, and Insecticide Administration” became the Food and Drug
Consumer protection groups & journalists started pushing for a new and
The American Chamber of Horrors!!!
FDA assembled a traveling
road-show of horrible
products that were technically
“legal” under the old, 1906
1937 - Sulfanilamide crisis
Tennessee company marketed an “Elixir Sulfanilamide” a
wonder drug for children
Drug contains chemical analog of antifreeze, which contained
unlisted ingredient "diethylene glycol”
kills >100 children
Failure to test for safety or to list ingredients was not a violation
of 1906 Act
Drug labels must include directions for safe use
Required pre-market approval for new drugs to ensure safety
Prohibited false therapeutic claims for drugs
Authorized factory inspections
FDA also given regulatory authority over medical devices (and
cosmetics) for the first time
Devices treated very similarly to drugs, except no pre-market
approval for devices
And Cosmetic Act
Set of laws passed by Congress in 1938
Gave authority to the U.S. Food and Drug Administration (FDA) to
oversee the safety of food, drugs, and cosmetics
Principal author Royal S. Copeland, a three-term U.S. Senator from
Electronic Product Radiation Control provisions were added to the FD&C
Drug Efficacy Study Implementation (DESI) to incorporate into FD&C
regulations the recommendations from a National Academy of Sciences
investigation of effectiveness of previously marketed drugs
The act has been amended many times, most recently to add requirements
about bioterrorism preparations.
Chapter One Short title
Chapter Two Definitions and terms
Chapter Three Prohibited Acts and Penalties, adulteration and
misbranding, enforcement through Justice Department
Chapter Four Authorizes the regulation of foods, standards of
Chapter Five Drugs and Devices
Chapter Six Cosmetics
Chapter Seven Administrative provisions and tools, Inspections
Chapter Eight Imports and Exports
Chapter Nine Miscellaneous
201(f) is the definition for a food, which explicitly includes chewing gum
201(g) is the definition for a drug
Drug is any substance that, when absorbed into the body of a living organism,
alters normal bodily function.
201(h) is the definition for a medical device
Medical device is a product which is used for medical purposes in patients, in
diagnosis, therapy or surgery
201(s) is the definition of a food additive
201(ff) is the definition of a dietary supplement
Dietary 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 quantity in
a person's diet
This section contains both civil law and criminal law clauses.
Section Title FD&C Act Number U.S. Code Section Number
Chapter III (U.S.C. Subchapter
III)--Prohibited Acts and
Prohibited Acts 301 331
Penalties 303 333
Seizure 304 334
Hearing Before Report of
Debarment, Temporary Denial of
Approval, and Suspension
Civil Penalties 307 335b
Authority to Withdraw Approval
of Abbreviated Drug
Report of Minor Violations 309 336
There is a distinction in food adulteration between "good and
bad" 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”
Authorizes the regulation of foods, standards of
The Act made the certification of some food color additives mandatory.
Some food colorings are generally recognized as safe (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 U.S, plus 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
Both artificial and natural color additives are subject to rigorous standards of safety
before their approval for use in foods
Name Common name Color
FD&C Blue No. 1 Brilliant Blue FCF bright blue
FD&C Blue No. 2 Indigotine royal blue
FD&C Green No. 3 Fast Green FCF Seagreen
FD&C Red No. 3 Erythrosine cherry red
FD&C Red No. 40 Allura Red AC orange-red
FD&C Yellow No. 5 Tartrazine lemon yellow
FD&C Yellow No. 6 Sunset Yellow FCF Orange
Citrus Red No.2
Food coloring & additives
Chapter IV (U.S.C. Subchapter
FD&C Act Number U.S. Code Section Number
Definitions and Standards for
Adulterated Food 402 342
Misbranded Food 403 343
Tolerances for Poisonous
Ingredients in Food
Food Additives 409 348
Bottled Drinking Water
Vitamins and Minerals 411 350
Requirements for Infant
New Dietary Ingredients 413 350b
Maintenance and Inspection of
Registration of Food Facilities 415 350d
Sanitary transportation practices 416 350e
505 is the description of the drug approval process
Class I: Devices that do not require premarket approval or clearance but
must follow general controls Eg; Dental floss
510(k) is the section that allows for clearance of class II medical devices
known as Premarket Notification(PMN)
device manufacturers must register to notify FDA, at least 90 days in
advance, of their intent to market a medical device
Eg; Diagnostic tests, cardiac catheters, and amalgam alloys used to fill
cavities, hearing aids
515 is the description of the class III device approval process.
Devices that are approved by the Premarket Approval (PMA) process.
These tend to be devices that are permanently implanted into a human body
or may be necessary to sustain life. Eg; artificial heart
Cosmetics are products for "cleansing, beautifying, promoting
attractiveness, or altering the appearance."
FD & C allows a manufacturer the ability to use ingredients or
raw materials and market the final product without government
Chapter VI (U.S.C.
FD&C Act Number U.S. Code Section
Adulterated Cosmetics 601 361
Misbranded Cosmetics 602 362
704 allows inspections of regulated entities.
Inspection results are reported on Form 483
Chapter Seven: Administrative provisions and tools,
Chapter VI (U.S.C. Subchapter
FD&C Act Number U.S. Code Section Number
Regulations and Hearings 701 371
Examinations and Investigations 702 372
Records of Interstate Shipment 703 373
Factory Inspection 704 374
Publicity 705 375
Seafood Inspection 706 376
Part 2 (U.S.C. Subpart 2)—Fees
Relating to Drugs
Part 3 (U.S.C. Subpart 3)—Fees
Relating to Devices
Part 4 (U.S.C. Subpart 4)—Fees
Relating to Animal Drugs
Chapter VIII (U.S.C.
Imports and Exports
FD&C Act Number U.S. Code Section Number
Imports and Exports 801 381
Exports of Certain
Office of International
Importation of Prescription
Chapter IX (U.S.C.
FD&C Act Number U.S. Code Section Number
Effective Date and Repeals 902 392
Food and Drug
Scientific Review Groups 904 394
Loan Repayment Program 905 395
Practice of Medicine 906 396
Contracts for Expert Review 907 396
Notices to States Regarding
Grants to States for
1951 - Food, Drug, and Cosmetics Act Amendments PL 82–215, 65 Stat
o The Durham-Humphrey Amendment explicitly defined two specific categories
for medications, legend (prescription) and over-the-counter(OTC).
1962 -Food, Drug, and Cosmetics Act Amendments, PL 87–781, 76 Stat
Kefauver Harris Amendment or "Drug Efficacy Amendment“
In response to Thalidomide tragedy
Introduced a requirement for drug manufacturers to provide proof of the
effectiveness and safety of their drugs before approval
required drug advertising to disclose accurate information about side effects
stopped cheap generic drugs being marketed as expensive drugs under new trade
names as new "breakthrough" medications.
Fair Packaging and Labeling Act, PL 89–755, 80 Stat 1296.
It requires the label to state: identity of the product; name and place of business of
the manufacturer, packer, or distributor; and net quantity of contents in both metric
and U.S. customary units.
Medical Device Regulation Act, PL 94–295, 90 Stat 539,.
Radiation Control for Safety and Health Act, PL 90-602, 82 Stat 1173.
(Jan. 4, 1983) - Orphan Drug Act, PL 97-414.
• Companies that develop such a drug (a drug for a disorder affecting fewer than
200,000 people in the United States) may sell it without competition for seven
years, and may get clinical trial tax incentives
1984 -Drug Price Competition and Patent Term Restoration Act , PL 98-
471, 98 Stat 1585.
known as the "Hatch-Waxman Act"
established the modern system of generic drugs.
amended the Federal FD & C Act Section 505(j) 21 U.S.C. 355(j) sets forth the
process by which would-be marketers of generic drugs can file Abbreviated New
Drug Applications (ANDAs) to seek FDA approval of the generic.
1990 -Nutrition Labelling and Education Act, PL 101-535, 104 Stat 2353
• Gives the FDA authority to require nutrition labeling of most foods regulated by the
1990 -Safe Medical Device Amendments, PL 101-629, 104 Stat 4511.
Food and Drug Administration Revitalization Act, PL 101-635, 104 Stat
1994 -Dietary Supplement Health and Education Act, PL 103-417, 108 Stat
• defined a product that is intended to supplement the diet and contains any of the
following dietary ingredients: a vitamin; a mineral; an herb or other
botanical(excluding tobacco); an amino acid; a concentrate, metabolite, constituent,
extract, or combination of any of the above to be labelled as “dietary supplement”.
1997 -Food and Drug Administration Modernization Act, PL 105-115, 111
• Amended FFDCA relating to the regulation of food, drugs, devices, and biological
products by the FDA.
• It was signed by Bill Clinton on 21 November 1997, and was fully enacted by 1
• One result of the passing of the act was a reduction in the time for the approval of
new pharmaceutical drugs
2007 -Food and Drug Administration Amendments Act, PL 110-85, 121
• Signed on September 27, 2007 by President George W. Bush
• This new law is an important step for the FDA.
• It reviewed, expanded, and reaffirmed several existing pieces of legislation
regulating the FDA
• Prescription Drug User Fee Act- was first enacted in 1992 to allow the FDA to
collect “user fees” from biotechnology and pharmaceutical companies.
• It has been reauthorized three times; first in 1997, then 2002, and most recently with
the passage of the FDAAA in 2007.
• Medical Device User Fee and Modernization Act (MDUFMA)
• Best Pharmaceuticals for Children Act (BPCA)
• Pediatric Research Equity Act (PREA)
• Priority Review to Encourage Treatments for Tropical Diseases
• Reagan-Udall foundation- created to “modernize medical, veterinary, food, food
ingredient, and cosmetic product development, accelerate innovation, and enhance
• Clinical trials reporting- on the freely-accessible site ClinicalTrials.gov