..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 prevention, and fundamentally change the nature of a human or animal's body.
However, a product can function as both a cosmetic and a drug. For example, anti-dandruff shampoos contain a chemical with medicinal purposes that treat a medical condition. Toothpastes can whiten a consumer's smile but also contain fluoride, a chemical that promotes good oral hygiene (Is it, 2002, FDA). The purpose of the product -- whether drug, cosmetic, or both -- is conveyed through explicit product labeling and also the implications of the product's advertising.
Q4. Overall, there are structural similarities between the drug approval process for human and animal drugs. However, there is an important difference, particularly with respect to drugs for use in food-producing animals, resulting in differences in policy and approach to the drug approval process for animal drugs. What is that difference, and briefly how does it result in differences in the drug approval process between human and animal drugs?
When a drug for an animal that is consumed submits a product claim to the FDA, the drug's sponsors must list all adverse effects and the drug's intended use. Consistency must also be demonstrated in its composition and in the manufacturing of the drug. But "if the drug product is to be used in a food-producing animal, residues in food products...
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
S. Food and Drug Administration, because they were in wide use before the 1938 Act (grandfathered in, as it were). (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
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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