Federal Food, Drug, and Cosmetic Act of 1938 explained

Shorttitle:Federal Food, Drug, and Cosmetic Act of 1938
Longtitle:To prohibit the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, and for other purposes.
Acronym:FFDCA, FD&C Act
Enacted By:75th
Public Law Url:https://research.archives.gov/description/299847
Cite Public Law:75-717
Acts Repealed:Pure Food and Drug Act
Title Amended:21 U.S.C.: Food and Drugs
Sections Created: § 301 et seq.
Introducedin:Senate
Introducedby:Royal Copeland (D–NY)
Introduceddate:January 6, 1937
Passedbody1:Senate
Passeddate1:March 9, 1937
Passedvote1:voice
Passedbody2:House with amendment
Passeddate2:June 1, 1938
Passedvote2:voice
Conferencedate:June 10, 1938
Passedbody3:Senate
Passeddate3:June 10, 1938
Passedvote3:voice
Passedbody4:House
Passeddate4:June 13, 1938
Passedvote4:voice
Signedpresident:Franklin D. Roosevelt
Signeddate:June 25, 1938
Amendments:

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford.[2] A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York.[3] 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 (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.[4] The act has been amended many times, most recently to add requirements about bioterrorism preparations.

The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was used to dissolve the drug and make a liquid form.[5] It replaced the earlier Pure Food and Drug Act of 1906.

Contents

The FDC Act has ten chapters:[6]

I. Short Title

II. Definitions

III. Prohibited Acts and Penalties

This section contains both civil law and criminal law 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, 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 due to the Dotterweich[7] and Park[8] Supreme Court 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"[9]

V. Drugs and Devices

VI. Cosmetics

VII. General Authority

VIII. Imports and Exports

IX. Tobacco Products

X. Miscellaneous

Food coloring

The FD&C Act is perhaps best known by the consumer because of its use in the naming of food coloring additives, such as "FD&C Yellow No. 6". The Act made the certification of some food color additives mandatory. 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.[10] Color additives derived from natural sources, such as vegetables, minerals or animals, and artificial counterparts of natural derivatives, are exempt from certification. Both artificial and naturally derived color additives are subject to rigorous standards of safety before their approval for use in foods.[11]

Certifiable colors

Name Common name Color Comment
FD&C Blue No. 1blue
FD&C Blue No. 2indigo
FD&C Green No. 3green
FD&C Red No. 3pink
FD&C Red No. 40red
FD&C Yellow No. 5yellow
FD&C Yellow No. 6orange
orange Restricted to specific uses[12]
red Restricted to specific uses[13]

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

A shortened definition of "food additive" is defined by the FDA as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958 or otherwise excluded from the definition of food additives."[14] The full definition can be found in Section 201(s) of the FD&C Act, which provides for any additional exclusions.[15]

Homeopathic medications

Homeopathic 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.[16]

However, under separate authority of FTC Act, the Federal Trade Commission declared in November 2016 that homeopathic products cannot include claims of effectiveness without "competent and reliable scientific evidence". If no such evidence exists, they must state this fact clearly on their labeling.[17]

Bottled water

Bottled water is regulated by the FDA as a food. The Agency has published identity standards for types of water (mineral water, spring water), and regulations covering water processing and bottling, water quality and product labeling.[18] [19] [20]

Cosmetics

This Act defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness, or altering the appearance." Under the Act, the FDA does not approve cosmetic products, but the Act prohibits the marketing of adulterated or misbranded cosmetics.[21] However, the FDA does not have the authority to order recalls of cosmetics.[22] [23] If a company is selling a product that is adulterated or misbranded, the FDA can ask the company to recall their product or sue them. The FDA can and does inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated.

Medical devices

On May 28, 1976, the FD&C Act was amended to include regulation for medical devices.[24] The amendment required that all medical devices be classified into one of three classes:

For devices that were marketed prior to the amendment (preamendment devices) and were classified as Class III, the amendment obligated the FDA to review the device to either reclassify it as a Class II device subject to premarket notification, or to require the device manufacturer to undergo the premarket authorization process and prove the safety and efficacy of the device in order to continue marketing it. Notable examples of such preamendment devices are those used for electroconvulsive therapy, which the FDA started reviewing in 2011.[25] [26]

Premarket notification (510(k), PMN)

Section 510(k)[27] 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.

This is known as premarket notification, 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, or PMA.

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.

A 2011 study by Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously cleared by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular issues.[28] This may lead to a reevaluation of FDA procedures and better oversight.

Premarket approval (PMA)

Premarket approval (PMA) is the most stringent type of device marketing application required by FDA. Unlike the 510(k) pathway, the maker of the medical device must submit an application to the FDA and must receive approval prior to marketing the device.[29]

The PMA application contains information about how the medical device was designed and how it is manufactured, as well as preclinical and clinical studies of the device, demonstrating that it is safe and effective for its intended use.[30] Because the PMA requires a clinical trial it is significantly more expensive than a 510(k).[31]

Automatic Class III designation (de novo classification)

The Food and Drug Administration Modernization Act of 1997 created section 513(f)(2) of the FD&C Act, which obligated the FDA to establish a risk-based regulatory system for medical devices. As a result, the FDA established a de novo pathway for devices that would automatically be classified as Class III because there was no already-existing device that could be used a predicate for a 510k submission, but for which general controls or general and special controls could provide a reasonable assurance of safety and effectiveness.[32] [33]

Related legislation

The Wheeler-Lea Act, passed in 1938, granted the Federal Trade Commission the authority to oversee advertising of all products regulated by FDA, other than prescription drugs.

Significant amendments and related laws

Descriptions of these can be found at the FDA's web site.[34]

Amendments:

Other laws:[42]

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.

See also

External links

Notes and References

  1. "Food, Drug, and Cosmetic Law Research Guide," Georgetown Law Library
  2. Web site: Charles Crawford . Food & Drug Administration. September 26, 2017. unfit. https://web.archive.org/web/20171115153304/https://www.fda.gov/AboutFDA/WhatWeDo/History/Leaders/Commissioners/ucm093757.htm. November 15, 2017.
  3. http://www.homeowatch.org/history/reghx.html Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation
  4. https://www.fda.gov/cder/about/history/time1.htm CDER – Time Line
  5. http://www.ashp.org/s_ashp/article_news.asp?CID=167&DID=2024&id=3659 ASHP Website : News Article
  6. Web site: Federal Food, Drug, and Cosmetic Act (FD&C Act) . 3 November 2018 . U.S. Department of Health and Human Services . 8 January 2019.
  7. http://wings.buffalo.edu/law/bclc/web/dotterweich.htm United States v. Dotterweich, 320 U.S. 277 (1943)
  8. http://supreme.justia.com/us/421/658/index.html UNITED STATES V. PARK, 421 U. S. 658 (1975) – US Supreme Court Cases from Justia & Oyez
  9. https://www.fda.gov/opacom/laws/fdcact/fdcact4.htm FD&C Act Chapter IV
  10. Web site: Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices. U.S. Food and Drug Administration. 20 May 2014.
  11. Web site: Guidance for Industry: Color Additive Petitions – FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices . Laws, Regulations, and Guidance . Food and Drug Administration. January 1997. July 2009 . 22 Apr 2014.
  12. Web site: Code of Federal Regulations: Title 21, Section 74.250. U.S. Food and Drug Administration. 20 May 2014.
  13. Web site: Code of Federal Regulations: Title 21, Section 74.302. U.S. Food and Drug Administration. 20 May 2014.
  14. https://www.fda.gov/food/ingredientspackaginglabeling/definitions/default.htm
  15. https://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/default.htm
  16. Web site: 21 USC Ch. 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT . . Section 321, subsection (g), paragraph (1), subparagraph (A) thereof..
  17. Web site: FTC Issues Enforcement Policy Statement Regarding Marketing Claims for Over-the-Counter Homeopathic Drugs: Efficacy and Safety Claims Are Held to Same Standard as Other OTC Drug Claims. Press Release. FTC. 15 November 2016. 17 November 2016.
  18. Posnick, Lauren M. and Kim, Henry (2002). "Bottled Water Regulation and the FDA." Food Safety. August/September 2002. .
  19. FDA. "21 CFR Part 129 – Processing and Bottling of Bottled Drinking Water." Code of Federal Regulations.
  20. FDA. "21 CFR 165.110 – Requirements for Specific Standardized Beverages: Bottled Water." Code of Federal Regulations.
  21. 2022-03-02 . FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated . FDA . en.
  22. Cep . Casey . 2022-09-12 . Johnson & Johnson and a New War on Consumer Protection . 2022-10-17 . The New Yorker . en-US.
  23. 2022-03-03 . FDA Recall Policy for Cosmetics . FDA . en.
  24. Staff, FDA. PMA Historical Background Last updated April 26, 2009
  25. Duff Wilson for the New York Times. January 28, 2011 F.D.A. Panel Is Split on Electroshock Risks
  26. Web site: https://web.archive.org/web/20131019153738/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevicesAdvisoryCommittee/neurologicalDevicesPanel/UCM240933.pdf . 2013-10-19 . FDA Executive Summary Prepared for the January 27-28, 2011 meeting of the Neurological Devices Panel Meeting to Discuss the Classification of Electroconvulsive Therapy Devices (ECT) . . 2012-10-25 . dead .
  27. https://www.fda.gov/cdrh/510khome.html US FDA/CDRH: Information on Releasable 510(k)s
  28. Zuckerman. Diana. Medical Device Recalls and the FDA Approval Process. Archives of Internal Medicine. 2011. 10.1001/archinternmed.2011.30. 21321283. 171. 11. 1006–11.
  29. Staff, FDA Premarket Approval (PMA), last updated January 24, 2012
  30. http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec360e.htm 21 U.S.C. § 360e. Premarket approval
  31. [Josh Makower]
  32. Web site: De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff. FDA. October 30, 2017.
  33. News: Drues. Michael. Secrets Of The De Novo Pathway, Part 1: Why Aren't More Device Makers Using It?. Meddevice Online. February 5, 2014. en. News: Drues. Michael. Secrets Of The De Novo Pathway Part 2 Is De Novo Right For Your Device. www.meddeviceonline.com. February 18, 2014. en.
  34. Web site: Laws Enforced by FDA . 19 April 2021. U.S. Food and Drug Administration.
  35. Web site: This Week In FDA History - April 22, 1976. U.S. Food and Drug Administration. May 20, 2009. dead. https://wayback.archive-it.org/7993/20161023232851/https://www.fda.gov/AboutFDA/WhatWeDo/History/ThisWeek/ucm117726.htm. October 23, 2016. June 13, 2014.
  36. Web site: S.741 - 108th Congress (2003–2004): Minor Use and Minor Species Animal Health Act of 2003. Library of Congress. 2018-03-17. 2 August 2004.
  37. Staff, FDA. Updated April 18, 2013 Generic Drug User Fee Amendments of 2012
  38. Web site: Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway . U.S. Food and Drug Administration (FDA) . 13 December 2016 . 13 March 2020.
  39. Web site: 21st Century Cures Act . U.S. Food and Drug Administration (FDA) . 13 December 2016 . 13 March 2020.
  40. Web site: 21st Century Cures Act . Public Law 114–255 .
  41. Web site: FDA Reauthorization Act of 2017 . Public Law 115–52 .
  42. Web site: Other Laws Affecting FDA. 3 November 2018. U.S. Food and Drug Administration.

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