The United StatesFederal Food, Drug, and Cosmetic Act (abbreviated asFFDCA,FDCA, orFD&C) is a set of laws passed by theUnited States Congress in 1938 giving authority to the U.S.Food and Drug Administration (FDA) to oversee thesafety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting wasCharles W. Crawford.[2] A principal author of this law wasRoyal 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 theDrug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from aNational Academy of Sciences investigation of effectiveness of previously marketed drugs.[4] The act has been amended many times, most recently to add requirements aboutbioterrorism preparations.
This section contains bothcivil law andcriminal 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 thecommerce clause, but this is often interpreted broadly and few products other than raw produce are considered outside of the scope of the act.
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 IImedical 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 onForm 483.
The FD&C Act is perhaps best known to consumers because of its use in the naming offood coloring additives, such as "FD&C Yellow No. 6". The Act made the certification of some food coloradditives 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]
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]
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."[15] The full definition can be found inSection 201(s) of the FD&C Act, which provides for any additional exclusions.[16]
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.[17]
However, under separate authority ofFTC Act, theFederal 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.[18]
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.[19][20][21]
This Act definescosmetics 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.[22] However, the FDA does not have the authority to order recalls of cosmetics.[23][24] 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.[22] The FDA can and does inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated.[22]
On May 28, 1976, the FD&C Act was amended to include regulation formedical devices.[25] Theamendment 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, anddental amalgams are examples of class II devices.
Class III: Devices that are approved by the premarket approval (PMA) process, analogous to aNew Drug Application. These tend to be devices that are permanently implanted into a human body or may be necessary to sustain life. Anartificial heart meets both criteria. The most commonly recognized class III device is anautomated 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 forelectroconvulsive therapy, which the FDA started reviewing in 2011.[26][27]
Section 510(k)[28] 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 amedical 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 byDiana Zuckerman and Paul Brown of theNational 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.[29] This may lead to a reevaluation of FDA procedures and better oversight.[citation needed]
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.[30]
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.[31] Because the PMA requires aclinical trial it is significantly more expensive than a 510(k).[32]: 7
Automatic Class III designation (de novo classification)
TheFood 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 ade 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.[33][34]
Vitamin-Mineral Amendment ("Proxmire Amendment") (April 22, 1976) prohibited the FDA from establishing standards to limit the potency of vitamins and minerals infood supplements or regulating them as drugs based solely on their potency.[36]
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]
^[1] F.D.A. webpage "Food Ingredients and Packaging Terms" Page Last Updated: 02/28/2013
^[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
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