BY:

SWATI SARIN

Federal Food, Drug, and Cosmetic Act

Acronym FFDCA, "FD&C Act"

Enacted by the 75th United States Congress

Citations

Public Law 75-717

Stat. 52 US Stat. 1040

Codification

U.S.C. sections created 21 U.S.C. § 301 et seq

Legislative history 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 industry.

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 misleadingno requirement to disclose ingredient11 “dangerous ingredients” could be used, but had to be listed on label (e.g., alcohol, heroin, cocaine)

1912

Harvey Wiley resigned & Created “Good Housekeeping Seal of Approval” 1927

Bureau of Chemistry becomes the “Food, Drug, and Insecticide Administration”

1930 Harvey Wiley died & Franklin Roosevelt elected president “Food, Drug, and Insecticide Administration” became the Food and Drug

Administration Consumer protection groups & journalists started pushing for a new and

improved law

The American Chamber of Horrors!!!

FDA assembled a traveling road-show of horrible products that were technically “legal” under the old, 1906 law

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 Public outcry!!!

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

Federal Food,

Drug,

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 New York.

In 1968 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 Identity

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(21 U.S.C)

 Chapter III (U.S.C. Subchapter III)--Prohibited Acts and Penalties

   

Prohibited Acts 301 331

Penalties 303 333

Seizure 304 334

Hearing Before Report of Criminal Violation

305 335

Debarment, Temporary Denial of Approval, and Suspension

306 335a

Civil Penalties 307 335b

Authority to Withdraw Approval of Abbreviated Drug Applications

308 335c

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”

Chapter Four:Authorizes the regulation of foods, standards of Identity

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 certification. 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

Orange B

Citrus Red No.2

Food coloring & additives

 Chapter IV (U.S.C. Subchapter IV)--Food

FD&C Act Number U.S. Code Section Number(21 U.S.C)

Definitions and Standards for Food

401 341

Adulterated Food 402 342

Misbranded Food 403 343

Tolerances for Poisonous Ingredients in Food

406 346

Food Additives 409 348

Bottled Drinking Water Standards

410 349

Vitamins and Minerals 411 350

Requirements for Infant Formulas

412 350a

New Dietary Ingredients 413 350b

Maintenance and Inspection of Records

414 350c

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 approval.

 Chapter VI (U.S.C. Subchapter VI)—Cosmetics

FD&C Act Number

U.S. Code Section Number

(21 U.S.C)

Adulterated Cosmetics

601 361

Misbranded Cosmetics

602 362

Regulations Making Exemptions

603 363

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

Chapter Seven: Administrative provisions and tools, Inspections

 Chapter VI (U.S.C. Subchapter VI)—Cosmetics

FD&C Act Number U.S. Code Section Number

(21 U.S.C)

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. Subchapter VIII)—Imports and Exports

FD&C Act Number U.S. Code Section Number(21 U.S.C)

Imports and Exports 801 381

Exports of Certain Unapproved Products

802 382

Office of International Relations

803 383

Importation of Prescription Drugs

804 384

 Chapter IX (U.S.C. Subchapter IX)—Miscellaneous

FD&C Act Number U.S. Code Section Number(21 U.S.C)

Effective Date and Repeals

902 392

Food and Drug Administration

903 393

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 Imported Food

908 398

Grants to States for Inspections

909 399

1951 - Food, Drug, and Cosmetics Act Amendments PL 82–215, 65 Stat 648.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 780. 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

Agency.

1990 -Safe Medical Device Amendments, PL 101-629, 104 Stat 4511.

Food and Drug Administration Revitalization Act, PL 101-635, 104 Stat 4583.

1994 -Dietary Supplement Health and Education Act, PL 103-417, 108 Stat 4332

• 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 Stat 2296

• 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 April 1999

• 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 Stat 823• 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 product safety.”

• Clinical trials reporting- on the freely-accessible site ClinicalTrials.gov

http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact

http://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act

uwacadweb.uwyo.edu

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