Federal Food, Drug, and Cosmetic Act of 1938

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Federal Food, Drug, and Cosmetic Act of 1938
Great Seal of the United States (obverse).svg
Long titleTo prohibit the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, and for other purposes.
Acronyms (colloquial)FFDCA, FD&C Act
Enacted bythe 75th United States Congress
Citations
Public law 75-717
Statutes at Large 52  Stat.   1040
Codification
Acts repealed Pure Food and Drug Act
Titles amended 21 U.S.C.: Food and Drugs
U.S.C. sections created 21 U.S.C. ch. 9 § 301 et seq.
Legislative history
  • Introduced in the Senate as S. 5 by Royal Copeland (D–NY) on January 6, 1937
  • Passed the Senate on March 9, 1937 (voice)
  • Passed the House with amendment on June 1, 1938 (voice)
  • Reported by the joint conference committee on June 10, 1938; agreed to by the Senate on June 10, 1938 (voice) and by the House on June 13, 1938 (voice)
  • Signed into law by President Franklin D. Roosevelt on June 25, 1938
Major 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.

Contents

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
  • 201(f) is the definition for a food, which explicitly includes chewing gum
  • 201(g) is the definition for a drug
  • 201(h) is the definition for a medical device
  • 201(s) is the definition of a food additive
  • 201(ff) is the definition of a dietary supplement
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
  • 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. 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

NameCommon nameColorComment
FD&C Blue No. 1 Brilliant blue FCF blue
FD&C Blue No. 2 Indigo carmine indigo
FD&C Green No. 3 Fast Green FCF green
FD&C Red No. 3 Erythrosine pink
FD&C Red No. 40 Allura Red AC red
FD&C Yellow No. 5 Tartrazine yellow
FD&C Yellow No. 6 Sunset Yellow FCF orange
Orange B orangeRestricted to specific uses [12]
Citrus Red No. 2 redRestricted 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.[ citation needed ]

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. [21] The FDA can and does inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated. [21]

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.[ citation needed ]

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.[ citation needed ]

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] : 7 

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]

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.

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.[ citation needed ]

See also

Related Research Articles

<span class="mw-page-title-main">Food and Drug Administration</span> United States federal agency

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

<span class="mw-page-title-main">Food coloring</span> Substance used to color food or drink

Food coloring, color additive or colorant is any dye, pigment, or substance that imparts color when it is added to food or beverages. Colorants can be supplied as liquids, powders, gels, or pastes. Food coloring is commonly used in commercial products and in domestic cooking.

<span class="mw-page-title-main">Generally recognized as safe</span> United States government designation for food additives

Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards. The FDA list of GRAS notices is updated approximately each month, as of 2021.

<span class="mw-page-title-main">Food Additives Amendment of 1958</span>

The Food Additives Amendment of 1958 is a 1958 amendment to the United States' Food, Drugs, and Cosmetic Act of 1938. It was a response to concerns about the safety of new food additives. The amendment established an exemption from the "food additive" definition and requirements for substances "generally recognized as safe" by scientific experts in the field, based on long history of use before 1958 or based on scientific studies. New food additives would be subject to testing including by the "Delaney clause". The Delaney clause was a provision in the amendment which said that if a substance were found to cause cancer in man or animal, then it could not be used as a food additive.

<span class="mw-page-title-main">Medical device</span> Device to be used for medical purposes

A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

An investigational device exemption (IDE) allows an investigational device to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

The Center for Food Safety and Applied Nutrition is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA.

<span class="mw-page-title-main">FDA Center for Devices and Radiological Health</span>

The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of electromagnetic radiation, such as cellular phones and microwave ovens.

<span class="mw-page-title-main">Medical food</span>

Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States they were defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act. In Europe the European Food Safety Authority established definitions for "foods for special medical purposes" (FSMPs) in 2015.

<span class="mw-page-title-main">Food and Drug Administration Amendments Act of 2007</span> US law

President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.

The following outline is provided as an overview of and topical guide to clinical research:

<span class="mw-page-title-main">Regulation of food and dietary supplements by the U.S. Food and Drug Administration</span> Governmental regulation of food quality

The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

<span class="mw-page-title-main">Food and Drug Administration Modernization Act of 1997</span> US law

The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century. The main focus of this is the acknowledgment in the advancement of technological, trade, and public health complexities.

A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness. The FDA calls a device approved in this manner a "Humanitarian Use Device" (HUD).

The Food and Drug Administration is a federal agency of the United States, formed in 1930.

<span class="mw-page-title-main">Medical Device Regulation Act</span>

The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the 94th Congress of the United States. Congressman Paul G. Rogers and Senator Edward M. Kennedy were the chairperson sponsors of the medical device amendments. The Title 21 amendments were signed into law on May 28, 1976, by the 38th President of the United States Gerald R. Ford.

<span class="mw-page-title-main">Safe Medical Device Amendments of 1990</span>

Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act. The Act mandates reporting requirements by medical device manufacturers regarding adverse safety events and product effectiveness of devices classified as substantially equivalent to Class III medical devices. The United States Statute established the Health and Human Services Office of International Relations and a U.S. Food and Drug Administration office for regulatory activities concerning healthcare products which are considered a combinational biological, device, or drug product. The Act of Congress transferred the electronic product radiation control provisions established by the Radiation Control for Health and Safety Act.

Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.

Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.

References

  1. ↑ "Food, Drug, and Cosmetic Law Research Guide," Georgetown Law Library
  2. ↑ "Charles Crawford". Food & Drug Administration. Archived from the original on November 15, 2017. Retrieved September 26, 2017.{{cite web}}: CS1 maint: unfit URL (link)
  3. ↑ Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation
  4. ↑ CDER – Time Line
  5. ↑ ASHP Website : News Article Archived 2007-09-27 at the Wayback Machine
  6. ↑ "Federal Food, Drug, and Cosmetic Act (FD&C Act)". U.S. Department of Health and Human Services. 3 November 2018. Retrieved 8 January 2019.
  7. ↑ United States v. Dotterweich, 320 U.S. 277 (1943)
  8. ↑ UNITED STATES V. PARK, 421 U. S. 658 (1975) – US Supreme Court Cases from Justia & Oyez
  9. ↑ FD&C Act Chapter IV
  10. ↑ "Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices". U.S. Food and Drug Administration. Retrieved 20 May 2014.
  11. ↑ "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. July 2009 [January 1997]. Retrieved 22 Apr 2014.
  12. ↑ "Code of Federal Regulations: Title 21, Section 74.250". U.S. Food and Drug Administration. Retrieved 20 May 2014.
  13. ↑ "Code of Federal Regulations: Title 21, Section 74.302". U.S. Food and Drug Administration. Retrieved 20 May 2014.
  14. ↑ F.D.A. webpage "Food Ingredients and Packaging Terms" Page Last Updated: 02/28/2013
  15. ↑ F.D.A. Regulatory Information webpage "FD&C Act Table of Contents and Chapters I and II: Short Title and Definitions" Page Last Updated: 01/19/2012
  16. ↑ "21 USC Ch. 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT". United States Code . Section 321, subsection (g), paragraph (1), subparagraph (A) thereof.
  17. ↑ Press Release (15 November 2016). "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". FTC. Retrieved 17 November 2016.
  18. ↑ Posnick, Lauren M. and Kim, Henry (2002). "Bottled Water Regulation and the FDA." Food Safety. August/September 2002. ISSN   1084-5984.
  19. ↑ FDA. "21 CFR Part 129 – Processing and Bottling of Bottled Drinking Water." Archived 2009-09-26 at the Wayback Machine Code of Federal Regulations.
  20. ↑ FDA. "21 CFR 165.110 – Requirements for Specific Standardized Beverages: Bottled Water." Archived 2009-09-07 at the Wayback Machine Code of Federal Regulations.
  21. 1 2 3 "FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated". FDA. 2022-03-02.
  22. ↑ Cep, Casey (2022-09-12). "Johnson & Johnson and a New War on Consumer Protection". The New Yorker. Retrieved 2022-10-17.
  23. ↑ "FDA Recall Policy for Cosmetics". FDA. 2022-03-03.
  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. ↑ "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)" (PDF). United States Food and Drug Administration. Archived from the original (PDF) on 2013-10-19. Retrieved 2012-10-25.
  27. ↑ US FDA/CDRH: Information on Releasable 510(k)s
  28. ↑ Zuckerman, Diana (2011). "Medical Device Recalls and the FDA Approval Process". Archives of Internal Medicine. 171 (11): 1006–11. doi:10.1001/archinternmed.2011.30. PMID   21321283.
  29. ↑ Staff, FDA Premarket Approval (PMA), last updated January 24, 2012
  30. ↑ 21 U.S.C. § 360e. Premarket approval
  31. ↑ Josh Makower, Aabed Meer, lyn Denend. November 2010 FDA Impact on US Medical Device Innovation – A Survey of Over 200 Medical Technology Companies
  32. ↑ "De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff" (PDF). FDA. October 30, 2017.
  33. ↑ Drues, Michael (February 5, 2014). "Secrets Of The De Novo Pathway, Part 1: Why Aren't More Device Makers Using It?". Meddevice Online.Drues, Michael (February 18, 2014). "Secrets Of The De Novo Pathway Part 2 Is De Novo Right For Your Device". www.meddeviceonline.com.
  34. ↑ "Laws Enforced by FDA". U.S. Food and Drug Administration. 19 April 2021.
  35. ↑ "This Week In FDA History - April 22, 1976". U.S. Food and Drug Administration. May 20, 2009. Archived from the original on October 23, 2016. Retrieved June 13, 2014.
  36. ↑ "S.741 - 108th Congress (2003–2004): Minor Use and Minor Species Animal Health Act of 2003". Library of Congress. 2 August 2004. Retrieved 2018-03-17.
  37. ↑ Staff, FDA. Updated April 18, 2013 Generic Drug User Fee Amendments of 2012
  38. ↑ "Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway". U.S. Food and Drug Administration (FDA). 13 December 2016. Retrieved 13 March 2020.
  39. ↑ "21st Century Cures Act". U.S. Food and Drug Administration (FDA). 13 December 2016. Retrieved 13 March 2020.
  40. ↑ "21st Century Cures Act" (PDF). Public Law 114–255.
  41. ↑ "FDA Reauthorization Act of 2017" (PDF). Public Law 115–52.
  42. ↑ "Other Laws Affecting FDA". U.S. Food and Drug Administration. 3 November 2018.
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