510(k)

Federal Food, Drug, and Cosmetic Act

Federal Food, Drug, and Cosmetic Act

Acts of the United States Congress

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.

Quick Facts Long title, Acronyms (colloquial) ...

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

More information Name, Common name ...

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

Further information: Medical device § United States

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:

  • Class I: Devices that do not require premarket approval or clearance but must follow general controls. Dental floss is a class I device.
  • Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, hearing aids, and dental amalgams are examples of class II devices.
  • Class III: Devices that are approved by the premarket approval (PMA) process, analogous to a New Drug Application. These tend to be devices that are permanently implanted into a human body or may be necessary to sustain life. An artificial heart meets both criteria. The most commonly recognized class III device is an automated external defibrillator. Devices that do not meet either criterion are generally cleared as class II devices.

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

References

  1. [1]
    "Food, Drug, and Cosmetic Law Research Guide," Georgetown Law Library
  2. [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. [3]
    Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation
  4. [4]
    CDER – Time Line
  5. [5]
    ASHP Website : News Article Archived 2007-09-27 at the Wayback Machine
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    "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. [7]
    United States v. Dotterweich, 320 U.S. 277 (1943)
  8. [8]
    UNITED STATES V. PARK, 421 U. S. 658 (1975) – US Supreme Court Cases from Justia & Oyez
  9. [9]
    FD&C Act Chapter IV
  10. [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. [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.
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    "Code of Federal Regulations: Title 21, Section 74.250". U.S. Food and Drug Administration. Retrieved 20 May 2014.
  13. [13]
    "Code of Federal Regulations: Title 21, Section 74.302". U.S. Food and Drug Administration. Retrieved 20 May 2014.
  14. [14]
    F.D.A. webpage "Food Ingredients and Packaging Terms" Page Last Updated: 02/28/2013
  15. [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. [16]
    "21 USC Ch. 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT". United States Code. Section 321, subsection (g), paragraph (1), subparagraph (A) thereof.
  17. [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. [18]
    Posnick, Lauren M. and Kim, Henry (2002). "Bottled Water Regulation and the FDA." Food Safety. August/September 2002. ISSN 1084-5984.
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    "FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated". FDA. 2022-03-02.
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    "FDA Recall Policy for Cosmetics". FDA. 2022-03-03.
  24. [24]
    Staff, FDA. PMA Historical Background Last updated April 26, 2009
  25. [25]
    Duff Wilson for the New York Times. January 28, 2011 F.D.A. Panel Is Split on Electroshock Risks
  26. [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. [27]
    US FDA/CDRH: Information on Releasable 510(k)s
  28. [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. [29]
    Staff, FDA Premarket Approval (PMA), last updated January 24, 2012
  30. [30]
    21 U.S.C. § 360e. Premarket approval
  31. [31]
    Josh Makower, Aabed Meer, lyn Denend. November 2010 FDA Impact on US Medical Device Innovation – A Survey of Over 200 Medical Technology Companies
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    "De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff" (PDF). FDA. October 30, 2017.
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    "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.
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    Staff, FDA. Updated April 18, 2013 Generic Drug User Fee Amendments of 2012
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    "21st Century Cures Act" (PDF). Public Law 114–255.
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    "FDA Reauthorization Act of 2017" (PDF). Public Law 115–52.
  42. [42]
    "Other Laws Affecting FDA". U.S. Food and Drug Administration. 3 November 2018.
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