Federal Food, Drug, and Cosmetic Act

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Federal Food, Drug, and Cosmetic Act
Great Seal of the United States.
Long title To prohibit the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics, and for other purposes.
Colloquial acronym(s) FFDCA, "FD&C Act"
Enacted by the  75th United States Congress
Citations
Public Law 75-717
Stat. 52 Stat. 1040
Codification
Act(s) repealed Pure Food and Drug Act
Title(s) 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 (DNY) on March 5, 1938
  • Committee consideration by: Committee on Interstate and Foreign Commerce
  • Passed the House on June 1, 1938 (amended and passed)
  • Passed the Senate on June 2, 1938 (disagreed)
  • Reported by the joint conference committee on June 11, 1938; agreed to by the House on June 15, 1938 (agreed) and by the Senate on June 15, 1938 (agreed)
  • 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 Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York.[2] 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.[3] 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 a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form.[4] See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act of 1906.

Contents[edit]

The FDC Act has ten chapters:[5]

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[6] and Park [7] 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"[8]
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[edit]

The FD&C 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. Some food colorings are generally recognized as safe (GRAS) by the FDA and do not require certification.[9]

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. 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.[10]

Certifiable colors[edit]

Name Common name Color Comment
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 sea green
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 Restricted to specific uses[11]
Citrus Red No. 2 Restricted to specific uses[12]

There are also "D&C" colors that are only approved for use in pharmaceuticals for external application and cosmetics.[13]

Food additives[edit]

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[edit]

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]

Genetically modified foods are regarded as containing food additives[edit]

These regulations apply to foods produced by genetic engineering and natural sources, if the protein added to the food by the genetic engineering process is not "generally recognized as safe" then genetically modified food is regarded as containing a "food additive" and is subject to pre-market approval by the FDA.[16] All genetically modified foods sold in the USA have been subject to this FDA pre-market approval process.

Homeopathic medications[edit]

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.

Bottled water[edit]

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.[17][18] [19]

Cosmetics[edit]

This Act defines cosmetics as products for "cleansing, beautifying, promoting attractiveness, or altering the appearance." In this sense the FDA can classify cosmetics without actually regulating them. This allows a manufacturer the ability to use ingredients or raw materials and market the final product without government approval.

Medical devices[edit]

On May 28, 1976, the FD&C Act was amended to include regulation for medical devices.[20] 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 amalgam alloys used to fill cavities 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.[21][22]

Premarket notification (510(k))[edit]

Section 510(k)[23] 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 - also called 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. This does not always happen.

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 Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. 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.[24] This may lead to a reevaluation of FDA procedures and better oversight.

Premarket approval (PMA)[edit]

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.[25]

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.[26] Because the PMA requires a clinical trial it is significantly more expensive than a 510(k).[27]:7

Related legislation[edit]

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[edit]

Descriptions of these can be found at the FDA's web site.[28]

Amendments:

Other laws:[31]

Comparison to state laws[edit]

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[edit]

References[edit]

  1. ^ "Food, Drug, and Cosmetic Law Research Guide," Georgetown Law Library
  2. ^ Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation
  3. ^ CDER - Time Line
  4. ^ ASHP Website : News Article
  5. ^ Federal Food, Drug, and Cosmetics Act Table of Contents
  6. ^ United States v. Dotterweich, 320 U.S. 277 (1943)
  7. ^ UNITED STATES V. PARK, 421 U. S. 658 (1975) - US Supreme Court Cases from Justia & Oyez
  8. ^ FD&C Act Chapter IV
  9. ^ US FDA/CFSAN: Color Additive Status List
  10. ^ "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. FDA. January 1997; Revised July 2009. Retrieved 22 Apr 2014. 
  11. ^ "Code of Federal Regulations: Title 21, Section 74.250". U.S. Food and Drug Administration. Retrieved 20 May 2014. 
  12. ^ "Code of Federal Regulations: Title 21, Section 74.302". U.S. Food and Drug Administration. Retrieved 20 May 2014. 
  13. ^ "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. 
  14. ^ [1] F.D.A. webpage "Food Ingredients and Packaging Terms" Page Last Updated: 02/28/2013
  15. ^ [2] 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. ^ FDA/USDA US Food Safety System Country Report Annex II: Precaution in US Food Safety Decisionmaking
  17. ^ Posnick, Lauren M. and Kim, Henry (2002). "Bottled Water Regulation and the FDA." Food Safety. August/September 2002. ISSN 1084-5984.
  18. ^ FDA. "21 CFR Part 129 - Processing and Bottling of Bottled Drinking Water." Code of Federal Regulations.
  19. ^ FDA. "21 CFR 165.110 - Requirements for Specific Standardized Beverages: Bottled Water." Code of Federal Regulations.
  20. ^ Staff, FDA. PMA Historical Background Last updated April 26, 2009
  21. ^ Duff Wilson for the New York Times. January 28, 2011 F.D.A. Panel Is Split on Electroshock Risks
  22. ^ "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)". United States Food and Drug Administration. Archived from the original on 2012-10-25. Retrieved 2012-10-25. 
  23. ^ US FDA/CDRH: Information on Releasable 510(k)s
  24. ^ Zuckerman, Diana (2011). "Medical Device Recalls and the FDA Approval Process". Archives of Internal Medicine. 
  25. ^ Staff, FDA Premarket Approval (PMA), last updated January 24, 2012
  26. ^ 21 U.S.C. §360e. Premarket approval
  27. ^ Josh Makower, Aabed Meer, lyn Denend. November 2010 FDA Impact on US Medical Device Innovation - A Survey of Over 200 Medical Technology Companies
  28. ^ Laws Enforced by the FDA and Related Statutes
  29. ^ http://www.fda.gov/AboutFDA/WhatWeDo/History/ThisWeek/ucm117726.htm
  30. ^ Staff, FDA. Updated April 18, 2013 Generic Drug User Fee Amendments of 2012
  31. ^ Food and Drug Administration Amendment Act of 2007

External links[edit]