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..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...
The drug must be safe and effective for animal use, but the producer or sponsor of the animal drug must also provide the FDA "with the scientific information and experimental data that demonstrate that the presence of residues of the animal drug in the edible food products of the animal are safe for the consumer of the food product….To assure that human food of animal origin can be monitored for the presence of drug residues, FDA requires sponsors of drugs for food animal use to provide acceptable analytical methods capable of determining and confirming the animal drug or its metabolites in the animal tissue" (a brief overview, 2010, FDA).
References
A brief overview of CMV's drug approval process. (2010). FDA. Retrieved April 22, 2010
http://www.fda.gov/AnimalVeterinary/ResourcesforYou/FDAandtheVeterinarian/ucm077383.htm
Can you explain the approval process for animal drugs? (2010). FDA. Retrieved April 22, 2010
at http://www.fda.gov/AboutFDA/Basics/ucm193855.htm
Dietary supplements. (2010). FDA. Retrieved April 22, 2010 at http://www.fda.gov/food/dietarysupplements/default.htm
How to find a predicative device. (2009, June 18). FDA. Retrieved April 22, 2010 at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134571.htm
Is it a cosmetic, drug, or both (or is it soap?). (2002). FDA. Retrieved April 22, 2010 at http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm
Nutrilab Inc. v. Schweiker. Alt Law. Retrieved April 22, 2010 at http://www.altlaw.org/v1/cases/480567
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