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Monograph Regulation of Weight Control Products for Over-The-Counter (OTC) Use

Monograph Regulation of Weight Control Products for Over-The-Counter (OTC) Use. Joint Nonprescription Drugs Advisory Committee and Endocrine and Metabolic Drugs Advisory Committee Meeting Arlene Solbeck, M.S. Senior Regulatory Review Scientist

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Monograph Regulation of Weight Control Products for Over-The-Counter (OTC) Use

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  1. Monograph Regulation of Weight Control Products for Over-The-Counter (OTC) Use Joint Nonprescription Drugs Advisory Committee and Endocrine and Metabolic Drugs Advisory Committee Meeting Arlene Solbeck, M.S. Senior Regulatory Review Scientist Division of Nonprescription Regulation Development Center for Drug Evaluation and Research

  2. Overview • What is an OTC monograph? • What is the current status of the monograph for OTC weight control ingredients/products established in 1982?

  3. OTC Monographs • OTC Drug Review initiated in 1972 • > 100,000 OTC drug products that contained > 700 active ingredients • Active ingredients reviewed by therapeutic categories

  4. Advisory Review Panel OTC Monographs • Category I: GRASE (Generally Recognized as Safe and Effective) • Category II: not GRASE • Category III: data insufficient to determine if safe and effective; more data needed

  5. ANPR OTC Monographs • Category I: GRASE • Category II: not GRASE • Category III: cannot determine if safe and effective

  6. ANPR TFM OTC Monographs Comments

  7. TFM FM OTC Monographs Comments Data

  8. OTC MonographsSummary • Regulatory pathway for marketing of GRAS/GRAE OTC ingredients and drug products • Public process • Active ingredient specific • Pre-approval not required

  9. Weight Control Products For Over-The Counter UsePanel’s Report (ANPR) • January 26, 1982 • Advisory Review Panel on OTC Miscellaneous Internal Drug Products

  10. Weight Control Drug Products – Definition and Use • Definition of weight control drug product (January 26, 1982) • An agent which reduces appetite • Indication statements • Helps control appetite • Helps curb appetite • For appetite control to aid weight reduction • An aid for effective appetite control to assist weight reduction • Helps you eat less, weigh less • Appetite depressant in the treatment of obesity (excess weight) • An aid in the control of appetite • An aid to diet control in conjunction with a physician’s recommended diet • For use as an aid to diet control

  11. 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”

  12. Duration of Use • Duration of use • Temporary (3 months) • In conjunction with a diet • 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.”

  13. Efficacy Criteria • Efficacy Studies • 12 week treatment period • Average weight loss: • PLACEBO TEST 1 lb / week 12 lbs / treatment period 1.5 lbs / week 18 lbs / treatment period

  14. Ingredients • 113 reviewed • 2 recommended for Category I • Phenyl propanolamine hydrochloride (PPA) • Benzocaine • 111 ingredients recommended for Categories II and III by Panel • 111 ingredients classified as “not generally recognized as safe and effective” (nonmonograph) • TFM: 1990 • FM: 1991

  15. Current Status of Category I Ingredients • Phenylpropanolamine hydrochloride (PPA): • FDA published a proposed rule to reclassify PPA from Category I to Category II (nonmonograph) based on safety concerns (2005) • Benzocaine: • Final rulemaking in progress that will address the adequacy of available efficacy data for benzocaine for weight reduction

  16. Panel’s Report - Summary • Panel’s recommendations: • OTC weight control drug products reasonable • for temporary use (3 months) • for assistance in weight reduction • in “obese” population • in conjunction with a diet • Panel recognized that a diet and other behavioral changes are integral components of weight control • Uncertain whether there will continue to be any active ingredients in the weight control monograph recognized as safe and effective for that intended use.

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