Monograph Regulation of Weight Monograph Regulation of Weight Control Products for Over-The- Control Products for Over-The- Counter (OTC) Use Counter (OTC) Use Joint Nonprescription Drugs Advisory Joint Nonprescription Drugs Advisory Committee and Committee and Endocrine and Metabolic Drugs Advisory Endocrine and Metabolic Drugs Advisory Committee Committee Meeting Meeting Arlene Solbeck, M.S. Arlene Solbeck, M.S. Senior Regulatory Review Scientist Senior Regulatory Review Scientist Division of Nonprescription Regulation Development Division of Nonprescription Regulation Development Center for Drug Evaluation and Research Center for Drug Evaluation and Research
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Monograph Regulation of Weight Control Products for Over-The-Counter (OTC) Use Joint Nonprescription Drugs Advisory Committee and Endocrine and Metabolic.
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Monograph Regulation of Weight Control Monograph Regulation of Weight Control Products for Over-The-Counter (OTC) UseProducts for Over-The-Counter (OTC) Use
Panel’s Definition of “Obesity”Panel’s Definition of “Obesity”
• Target population– Adult “obese” persons free of known underlying organic
diseases
• Panel’s definition of obesity (1982)
“An increase in body weight beyond the limitation of skeletal and physical requirements as the result of an excessive accumulation of fat in the body; that physical state in which body weight in relation to height and body build is more than 10 percent above the ideal weight determined from the Metropolitan Life Insurance Company table of desirable weights”
– 3 months enough time to establish new eating habits
– Labeling to state: “This product’s effectiveness is directly related to the degree to which you reduce your usual daily food intake. Attempts at weight reduction which involve the use of this product should be limited to periods not exceeding three months, because that should be enough time to establish new eating habits.”