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Food drug and cosmetic act 1938
 

Food drug and cosmetic act 1938

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    Food drug and cosmetic act 1938 Food drug and cosmetic act 1938 Presentation Transcript

    • 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 misleading no requirement to disclose ingredient 11 “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,_an d_Cosmetic_Act uwacadweb.uwyo.edu
    • QUESTIONS????QUESTIONS????