(Dunn 1938)
The problem was that Act contained a definition for a "new drug" (one in need of prior approval to market), as any drug "the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." FDCA § 201(p) (1). The manufacturers set out to establish then, that anything GRAS/GRAE therefore was not a new drug, and needed no FDA blessing.
Many medicines are ancient, and the active ingredients of many drugs on were first introduced before 1938. To make matters worse, between 1938 and 1962, the FDA considered drugs that were identical, related, or similar (IRS) to any approved drug to be covered by that approval, permitting IRS drugs to be marketed without independent approval.
Naturally, some companies brought drugs onto the market between 1938 and 1962 based on their own conclusion that the products were generally recognized as safe and effective (GRAS/GRAE), or based on an opinion letter from FDA that they were not new drugs. Conversely, a medicine would not be considered a new drug if it is generally recognized as safe and effective (GRAS/GRAE) and has been used to a material extent and for a material time. See 21 U.S.C. 321(p) (1) and (2).
The impact on the over-the-counter market (drugs that are available to consumers without a prescription) was as expected. As with prescription drugs, the FDA oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks. The basis for FDA oversight is similar to the...
Q3: Compare FDA Form 483 to an FDA "warning letter." The intention of a Form 483 is to teach, not to punish, according to the FDA. After it conducts an inspection, the FDA prepares an internal briefing. However, it also presents a Form 483 in private to the establishment which lists all of the institution's violations of FDA regulations (Gyi et al. 2001). This is to better enable the facility to
..for cleansing, beautifying, promoting attractiveness, or altering the appearance" while a drug is "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "intended to affect the structure or any function of the body of man or other animals" (Is it, 2002, FDA). Cosmetics thus alter the appearance of the individual and are aesthetic or hygienic in nature, while drugs promote health through wellness and disease
Drug Laws: The Impact of Changing Social Norms and Shifting Morality There is a veritable universal consensus that the federal government’s half century-long “war on drugs” has been a dismal failure, and there has been a corresponding sea change in public opinion concerning the use of cannabis and other formerly illicit drugs in recent years. Indeed, two-thirds of the states in America have already legalized marijuana in some fashion, and many
The web site gives kids a definition of drugs and then goes on to discuss the difference between legal and illegal drugs. Written in a way that children can understand, this web site makes it easy for children to gain a positive attitude toward taking the legal, prescribed drugs that a doctor has given them while still understanding the danger of taking illegal drugs. Because it is geared toward
14). Soon, Congress passed the Marijuana Tax Act, which was signed into law in 1937. Like the Harrison Act, the Marijuana Tax Act placed marijuana into the same category as the cocaine and opium drugs. It was now illegal to import marijuana into the United States (McWilliams, 1991). However, this law was ineffective in curbing marijuana use (Brecher, 1986, p. 14). By the early 1940s narcotic addiction had significantly reduced
The specifications about label placement were "to reduce consumer confusion about food labels, to aid them in making healthy food choices" and the act as a whole was supposed to encourage manufactures to engage in healthy product innovation by giving manufacturers an incentive to improve the quality of the food and make more healthy food choices available (Wilkening 1993:1). However, no label can be comprehensive and the 1993 legislation reflects
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