The National Academies Press

Currently Skimming:

Index
Pages 489-506

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.

From page 489... ... , Dietary Supplement Health and 272, 275, 279, 281, 300, 373, Education Act (DSHEA) , 135- 389, 402, 436 136, 301-303 vulnerable subpopulations, 112 epidemiological studies and, 129, 148, Advisory committees, external 149 conflicts of interest, 46, 59, 65, 270 evidence, value as, 104, 112, 126, 127- Framework review process, 8, 9, 10, 87, 136, 141, 152 91, 97-99, 123-124, 290, 296 glucosamine, 366 prototype safety monographs, 290 health care professionals, 16, 283, 303 Age factors, 248 historical use data and, 141 see also Fetal development in vitro assays and, 224-225 children, 48, 64, 248, 365, 369, 370, integration of data, 255-257 376 international perspectives, 131(n.3) Read the entire page →
From page 490... ... 470, 476-477 Allergic reactions, 69-70, 191, 201, 324, teratogenicity, 248-249 345, 350, 365, 388 veterinary medicine, 159-161, 164, 187American Botanical Council, 72 200 (passim) American Herbal Pharmacopoeia, 68-69 Assays, see In vitro assays American Herbal Products Association, 69- Attitudes and beliefs 70, 395 consumer beliefs, general, 22-23, 36 Botanical Safety Handbook, review consumer expectations about approach, 51-54, 272 supplement safety, 23-24 American Pharmaceutical Association's Recommended Dietary Allowance, 31 Practical Guide to Natural Medicines, 61-63, 76 Amino acids, 20, 34, 61, 76 B Androgens melatonin, 377 Behavioral toxicity, 484 animal studies, 158, 159, 166 saw palmetto ingestion by women, prototype monograph, 286, 450- melatonin, 369, 370 477 prototype monographs, 278, 279, 369, 370 Angiogenesis inhibitors, shark cartilage, 211, 281, 282, 381-384 Bioavailability, 114-115, 162, 285, 383 Animal studies, 156-173 Biological activity/mechanism of action see also Metabolism and metabolites; adverse event reporting and, 135, 163 164, 172 Pharmacokinetics and behavioral toxicity, 158, 159, 166 pharmacodynamics adverse event reporting, 132, 136 botanicals, 159-161, 390-391, 437-439, 453, 456, 457-458, 468-470, chemically and botanically related 476-477 substances, 176, 205 DSHEA review approaches, various, 17 carcinogenicity, 163, 164, 172, 368 chaparral, 390-391, 437-439 functional relatedness of chemicals and chemical components and botanicals, related botanicals, 92, 175, 208, 210-212, 279-280, 283, 299, taxonomic relatedness, 187-200 (passim) Read the entire page →
From page 491... ... shark cartilage, 381 animal studies, 187-200 (passim) , 210, supplements, various, 23, 75, 69, 290 211 Cardiovascular effects cultivation and other conditional factors, chemical components and botanicals, 201-202, 205 taxonomic relatedness, 187-199, endogenous substances, 108, 115, 175, 381 208-210, 214, 238, 363, 367, melatonin, 369, 379 372, 373 saw palmetto, 279, 377, 378, 379, 432 Framework review process, 11, 100, Cartilage, see Shark cartilage 106-108, 110-111, 377 Case reports and case series, 72 functional relatedness, 92, 175, 208, see also Adverse events; Prototype safety 210-212, 279-280, 283, 299, monographs 392, 453, 476-477 adverse event reporting and, 127, 128, general classes and specific constituents 135, 283 of concern, 180-181 Read the entire page →
From page 492... ... , 130, 297 393 glucosamine, 264 taxonomic relatedness, 92, 175, 178, saw palmetto, 377 182-201, 213-214, 299, 322-351, shark cartilage, 380, 382 378, 381, 391 supplement review approaches, various, teratogenicity, 187-195 (passim) , 44, 70, 78 199, 200, 207 Cosmetic, Toiletry, and Fragrance Children, 48, 64, 248, 365, 369, 370, 376 Association, 310-311 Chromium picolinate Cosmetics, FDA review approach, 310-312 adverse events, 275, 373 Cost-effectiveness animal studies, 373, 374 adverse event reporting, 129 clinical research, 373-374 Framework approach, 301 diabetics, 275-276, 373 in vitro studies, 218 dosage and administration, 276, 372- regulatory environment and, 1, 21 373, 374 Court decisions, See Litigation in vitro assays, 283, 373 international perspectives, 373 prototype monograph, 275-276, 372- D 375 Clinical studies and trials, 141-145, 151- Definitional issues 156 additives, 2, 29, 31, 36, 307 adverse event, 126(n.1) Read the entire page →
From page 493... ... , 51, 279, 282, 357, 363, 364-365, 70-71, 119, 254, 372 368, 369, 370, 372-373, 374, Dietary Supplement Health and Education 377, 387-388, 451-452 Act (DSHEA) , 1, 6, 19, 24, 30, glucosamine, 363, 364, 365 36-39, 78 historical use of supplements, value as additives, 4-5, 32-33, 80 evidence, 138-140 adverse event reporting, 135-136, 301- melatonin, 279, 368, 369, 370 303 non-oral exposure routes, 47, 50, 53, barriers to FDA regulation, 18, 21, 297, 56, 58, 60, 62, 64, 456 299, 300 review approaches, various, 47, 50, 52 committee recommendations, 15-16, 53, 55-56, 58, 60, 62, 64, 66, 67, 297, 300-301, 321 72 current status of foods, additives, drugs, saw palmetto, 377, 451-452, 456, 457 and supplements regulated, 4-5, 458 32-33 shark cartilage, 282 definition of supplements, 2, 6, 20, 36, vitamins and minerals, 118-121 85 weighing inconsistent evidence, 263, 267 Framework approach, 6, 86, 91, 95, 253, 294, 295, 299, 300-301 funding, 301 E history of use, 299 labeling, 22, 35, 38 Economic factors litigation, 7, 25 see also Cost-effectiveness; Funding review approaches, various, 81 monitoring, 300-301 Read the entire page →
From page 494... ... , weaknesses, 129 199, 200, 207 European Scientific Cooperative on new drug applications, 312 Phytotherapy, 73 plant family information, 336, 337, Evidence-based Practice Centers, 66-67 340, 348-349 Expertise Food Additives Amendment, 2, 29-31, 307 see also Advisory committees, external; Food and Drug Administration Monographs see Framework for dietary supplements, Framework review process, 319, 320- general; Legislation; Monitoring; 321 Notification requirements; committee members/consultants, 481- Regulatory issues 487 additives, 4-5, 32-33, 80, 307-309, 311 cosmetics ingredients evaluation, 311 adverse event reporting, 16, 127-131 FDA, 2, 3, 15, 21, 29, 295-296, 310 (passim) , 133, 294, 301-303 generally recognized as safe (GRAS) Read the entire page →
From page 495... ... , 6, 86, industry resistance to regulation, 2 91, 95, 253, 294, 295, 299, 300 labeling, 28-29, 31-35, 38 301 monitoring, 300-301 dosage and administration National Center for Toxicological considerations, 95, 96, 98, 114 Research, 17, 305 115, 118-119 new drug applications (NDAs) , 23, 27 science-based principles applied, 318 over-the-counter drugs, 23, 24, 313-314 319 premarket approval, 3, 16, 32-33, 36, prototype safety monographs, 276, 79-80, 295, 299, 307-309 279, 282, 357, 363, 364-365, Dietary Supplement Health and 368, 369, 370, 372-373, 374, Education Act (DSHEA) Read the entire page →
From page 496... ... 44-45, 95, 97, 100-116, 293 advisory committees, external, 318- chromium picolinate, 373 319 in vitro studies, 218, 221, 225-231 new drug applications, 312 methodology for study, 318-319 prototype safety monographs, 283- Glucosamine 291 adverse events, 366 animal data, 276-277, 283, 364, 365 signal detection, 6-9, 86-89 signal review, 9, 87, 89-91 clinical research, 277, 363-366 (passim) toxicology, general, 11, 17, 100, 103, diabetics, 276-278, 365 dosage and administration 104, 106-108, 110-111, 299 unreasonable risk determination, 10, 13, considerations, 363, 364, 365 14, 15, 18, 85, 86, 93, 95, 99, elderly persons, 277 in vitro data, 276-277 100, 101, 103, 115, 298 utilization of the Framework, 14, 117, prototype safety monograph, 276-278, 292-296, 301 363-366 Good manufacturing practices, 17, 30, 39, vitamins and minerals, 118-121 vulnerable groups, 109, 112-113, 118- 78(n.7) Read the entire page →
From page 497... ... , 124 consumption of supplements, 19, 22 interactions, supplement-induced, 241 FDA regulation, 2-3, 22-39 242 labeling, 22, 28, 31-35, 78-79, 223 prototype monographs, 285, 287, 358, litigation, 28, 31 363-368 (passim) number/sales of dietary supplements, 1, chromium picolinate, 373-374 19 glucosamine, 277, 363-364, 365 vitamin and minerals, regulatory history, melatonin, 368, 369, 370 28, 31, 34, 36 review approaches, various, 45, 49, 266 Historical use of supplements, 22, 299 botanicals, 61, 137-141 chemical components and related I botanicals, 203-204, 205, 376, 377, 386 Immunotoxicity allergic reactions, 69-70, 191, 201, 324, dosage and administration considerations, evidence value, 345, 350, 365, 388 138-140 animal studies, 159 chaparral, 388, 394, 395 evidence value, general, 61, 126, 127, 136-141, 152, 299 chemical components and related FDA policy, general, 136, 152 botanicals, 191, 199, 200, 201, 324, 331, 345 Framework review process, acceptable evidence, 102, 103, 104 interactions with other substances, 236, science-based principles applied, 318- 239, 240, 241 melatonin, 369 319 specific supplements, 93, 101-104 saw palmetto, 455, 465, 471 (passim) Read the entire page →
From page 498... ... 498 INDEX animal studies and, 224 science-based principles for, 253-268, cell studies, 106, 112, 151, 219-220, 285-291 223, 225, 229 causal models, 256-262 chaparral, 287, 391, 440 proof of harm, 267-268 chromium picolinate, 283, 373 weighing inconsistent evidence, 262 cost of, 218 267, 319 enzymes, 106, 158, 211, 218, 220-221 Interactions, 235-244 FDA policy, general, 223, 230-231 see also Side effects Framework for dietary supplements, 11, biological activity/mechanism of action, 94, 100, 101, 102, 108-109, 127, 236-244 293 Framework review process, 11, 100, prototype safety monographs, 283, 109, 113, 294-295 287, 373, 378, 381, 382, 384, prototype safety monographs, 279 391, 440 280, 281, 359-360, 368, 369, functionally related substances, 370, 379, 400 210, 211 immunotoxicity, 236, 239, 240, 241 genetic toxicology, 218, 221, 225-231 metabolic, 238-239, 360 glucosamine, 276-277 other formal review approaches, 48, 51, historical use data on supplements and 53, 56, 58, 62, 63, 69, 72, 76 137 other xenobiotics and supplements, 11, integration of data, 258-259, 267 100, 109, 145, 221, 236-237, interactions, supplement-induced, 240- 238-240, 241-243, 249, 279-280, 241 281, 359-360, 400 review approaches, various, 45, 49, 57, pharmacokinetics and 59, 61, 299 pharmacodynamics, 236-243, 244 saw palmetto, 378, 471-475 types of, 236-238 serious adverse effects, 224-225 International perspectives, 157 shark cartilage, 381, 382, 384 adverse event reporting, European Union types of, by effect observed, 219-221, regulation, 131(n.3) 240-243 chaparral, 276, 396 types of, by experimental system, 221- chromium picolinate, 373 222 European Scientific Cooperative on validated studies, 222-224 Phytotherapy, 57-61, 73 Infants, 248-249, 311, 326, 368, 472 German Commission E, 54-57, 71-73, see also Lactating women 396, 456 Integration of data, 9-10 melatonin, 283 see also Advisory committees, external review approaches, various, 49, 52, 68 biological activity/mechanism of action, saw palmetto, 279-280, 283, 456 256-259 unreasonable risk determination, 15, cross-design synthesis, 262-265 298 focused integrative evaluation, 9, 10, 11, World Health Organization, 63-64, 70, 86 77 Framework definition, 3, 8 Internet Framework process, 3, 8, 9, 11, 91-100, chaparral marketing, 394-395 102, 120-121, 293, 319 Framework integrative evaluation focused vs broad-based, 10, 14, 92, results, 10 93, 98, 117, 123, 264, 269, 279, monographs, various review approaches, 273, 277, 278, 279, 282, 285- 59 286 MedWatch, 39 glucosamine, 278 Natural Medicines Comprehensive inconsistent data, 262-267, 287-290 Database, 74-75 Read the entire page →
From page 499... ... , 17, 57-63 (passim) , 67, 68-69, 72, 74 304 Litigation FDA policies, general, 28-29, 31-35, 38 botanicals regulated, 2, 31 good manufacturing practices, 130 DSHEA safety standards, legislative text, historical perspectives, 22, 28, 31-35, 7, 25 78-79, 223 historical perspectives, 28, 31 Labeling of Hazardous Materials Act, vitamins and minerals, 31 223 Liver, see Hepatic system Nutrition Labeling and Education Act, L-tryptophan, 34-35 31-35 resources on dietary supplements, various, 44 M risks, general, 16, 264 Mechanism of action, see Biological activity/ saw palmetto, safety monograph, 454 mechanism of action 455 MedWatch, 16, 39, 129, 302-303, 313, 484 Labeling of Hazardous Materials Act, 223 Melatonin Lactating women adverse events, 368, 370 prototype safety monographs, 314, 347, androgens, 377 364, 365, 368, 369, 454 animal studies, 368 supplement review approaches, various, behavioral toxicity, 369, 370 56, 58, 60, 62, 64, 68-69, 70, 75 carcinogenicity, 368, 370 Legislation clinical trials, 368, 369, 370 see also Dietary Supplement Health and dosage and administration Education Act; Regulatory issues considerations, 279, 368, 369, committee recommendations, 15-16, 370 297, 300-301, 321 international perspectives, 283 Constitutional law, 29 prototype safety monograph, 278-279, Federal Food and Drugs Act, 26 284-285, 290, 367-371 Federal Food, Drug, and Cosmetic Act, Men, see Gender factors 2, 26-27, 78, 96, 307 Mental health, see Behavioral toxicity Food Additives Amendment, 2, 29 31, 307 Read the entire page →
From page 500... ... , 2, 436 5, 29-30, 32-33, 80, 307-308, Special Nutritional Event Monitoring 309-310 System (SN/AEMS) , general, 300 intent to market, 3, 16, 38, 303 Monographs, various new chemicals, 314-315 see also Prototype monographs new drugs, 311-314 botanicals, 54, 55, 57, 59, 63-64, 68-69, Nutrition Labeling and Education Act, 31 71-78 35 Internet review approaches, 59 O N Office of Dietary Supplements, 99-100 National Center for Complementary and Over-the-counter drugs, 23, 302(n.2) Read the entire page →
From page 501... ... 69 see also Over-the-counter drugs Pharmacoepidemiology adverse event reports and, 130 Framework review process, 484 consumer expectations, 23 Pharmacokinetics and pharmacodynamics, Framework, application of, 118 312 in vitro data and, 231 animal studies, 159, 161-162, 163, 172, PDR for Herbal Medicines, 75-76 241-242 saw palmetto, 280, 379, 455, 456 chemical components and related Prevalence of use, 250-251 botanicals, 179, 204, 396 FDA authority to undertake civil Framework review process, 109, 113, proceedings, 7, 25, 251 364 Framework review process, 109, 112, glucosamine, 364 114, 318-319 integration of data, 267 glucosamine, 277 interactions, supplement-induced, 236- prototype safety monographs, 243, 244 chaparral, 284, 395 Plant-based supplements, see Botanicals chromium pincolate, 275 Poison Control Centers, 16 glucosamine, 363 Postmarket surveillance, 79-80, 309 saw palmetto, 280, 283, 284 Pregnancy and lactation, 48, 50, 53, 56, 58, shark cartilage, 284 60, 62, 64, 248-249, 365, 369, Processing of supplements 458, 476 alcohol extraction, 139, 202, 203, 205, see also Fetal development 207, 393 abortifacients, 189, 193, 197, 199 good manufacturing practices, 17, 30, botanicals, various review approaches, 39, 78(n.7) , 130, 303-304 53, 56, 60, 64, 68-69 manufacturers, Framework review fetus, impacts on, 48, 50, 53, 56, 58, 60, approach, 295 62, 64, 68-69, 112, 230, 248- preparation methods, individuals, 202, 249, 259, 274, 337, 360, 378, 205, 451-452 383, 452, 453, 457, 476 Professional education, 302 lactation, 314, 347 see also Monographs glucosamine, prototype monograph, adverse event reporting, 16 364, 365 Framework review process, 16, 98, 99 melatonin, prototype monograph, Proof of risk/harm, 5, 295 368, 369 committee's summary findings and saw palmetto, prototype monograph, recommendations, 297-299 454 categories of scientific evidence, supplement review approaches, animal data, 156-157, 161, 172 various, 56, 58, 60, 62, 64, 68- human information and data, 127, 69, 70, 75 134, 136, 141, 142, 151 review approaches, various, 48, 50, 53, in vitro data, 218, 222-224, 229 56, 58, 60, 62, 64, 68-69, 112, integrating and evaluation data, 230, 248-249, 259, 274, 337, scientific principles, 253, 264, 360, 378, 383, 452, 453, 457, 266, 267-268 476 Dietary Supplement Health and Premarket approval, 3, 16, 32-33, 36, 79- Education Act (DSHEA) Read the entire page →
From page 502... ... , 428-431, 446 toxicity chromium picolinate, 372 Public education glucosamine, 365 see also Internet; Labeling and melatonin, 369 packaging shark cartilage, 281, 381 adverse event reporting, 16 human studies, 285, 287, 358, 363-368 FDA, committee recommendations, 302 (passim) 303 chromium picolinate, 373-374 Framework review process, 14, 16, glucosamine, 277, 363-364, 365 98-99, 123, 269, 293, 394, 455 melatonin, 368, 369, 370 Pure Food and Drug Act, 26 initial reviews, 54, 272-278 (passim) Read the entire page →
From page 503... ... , 314- advisory committees, external, 318 315 319 over-the-counter drugs, 23, 302(n.2) , causal models, 256-262, 288 313-314, 456 chemical components and related safety monographs, 94 botanicals, 176-177, 182, 205, vitamin and minerals, regulatory history, 208, 210 28, 31, 34, 36 integration of data, 253-268, 285Renal system, 130, 133, 163, 200, 238, 291, 319 239, 240, 248, 249 vulnerable subpopulations, 247 chaparral, 274-275, 356, 358, 360 Research recommendations, 15-18, 304-305 chromium picolinate, 275-276 chaparral, 361-362, 401 melatonin, 369 chromium picolinate, 375 Report of the Commission on Dietary glucosamine, 365-366 Supplement Labels, 38 melatonin, 370 Reporting requirements, see Adverse events; shark cartilage, 384 Premarket approval Respiratory effects Reproductive toxicity, 159, 166, 169, 200 chemical components and botanicals, see also Gender factors; Pregnancy and taxonomic relatedness, 187-199 lactation Risk assessment strategies, 3, 11-13 Framework review process, 106, 274, see Animal studies; Epidemiological 275, 279, 280, 281, 287, 312 studies; Expertise; Framework for prototype monographs dietary supplements, general; chaparral, 280, 284, 358, 360 Human studies and data; In vitro saw palmetto, 280, 284, 376, assays; Integration of data; 378, 451, 452, 453, 455, 457 Monographs; Proof of risk/harm; plant family information, 338 Prototype monographs; Safety Research methodology monographs see also Adverse events; Animal studies; cosmetics, FDA review approach, 310 Chemical components and related 312 botanicals; Clinical studies and current status of foods, additives, drugs, trials; Definitional issues; and supplements regulated, 4-5, 6, 32-33 Read the entire page →
From page 504... ... , 67, 68-69, 72, 74 gender factors, 280, 284, 376, 378, 451, 452, 453, 455, 457, 458, 468 peer review, 44, 46, 50, 52, 55-66 (passim) , 69 470 proof of risk/harm, 48, 75, 76 immunotoxicity, 455, 465, 471 in vitro data, 378, 471-475 science-based principles applied, 126, 156, 217, 235 individual components, 451, 463 adverse events, 104, 112, 126, 127- international perspectives, 279-280, 283, 456 136, 141, 152 advisory committees, external, 318- prescription drug status, 280, 379, 455, 319 456 prototype monographs, 95, 279-281, causal models, 256-262, 288 chemical components and related 286, 376-379, 450-477 botanicals, 176-177, 182, 205, Shark cartilage, 176(n.2) Read the entire page →
From page 505... ... , Toxicological Principles for Safety of Food 272, 275, 279, 281, 300, 373, Ingredients, see Redbook 389, 402, 436 Toxicology Stevia, 30, 34 see also Animal studies; Behavioral Surveys toxicity; Chemical components consumer beliefs, 22-24, 36 and related botanicals; Clinical consumption of supplements, 22 studies and trials; Genetic National Health and Nutrition toxicology; Immunotoxicity; Examination Survey, 22 Reproductive toxicity National Health Interview Surveys, 22 alcohol use and abuse, 23, 129, 358, prevalence of use, 250-251 359, 399 botanicals, various review approaches, 68-69, 72 T committee recommendations, 17 cosmetics ingredients evaluation, 311Telephone 312 adverse events reporting, 16, 303 Framework review process, 11, 17, 100, consumer surveys, 24 103, 104, 106-108, 110-111, 299 MedWatch, 303 Teratogenicity, 69, 166, 230, 248, 259, 267, 282, 309, 312, 382, 383, U 458, 477 animal studies, 248-249 Unreasonable risk determination, 2, 3, 24, chemical components and related 30, 32, 118, 119, 121, 131 botanicals, 187-195 (passim) , Framework review process, 10, 13, 14, 199, 200, 207 15, 18, 85, 86, 93, 95, 99, 100, new drug applications, 312 101, 103, 115, 298 plant family information, 336, 340, 348- other review approaches, 48 349 U.S. Read the entire page →
From page 506... ... infants, 248-249, 311, 326, 368, 472 Framework review process, 11, 100, interactions, supplement-induced, 242 109, 359-360, 400 other supplement reviews, 48, 64, 70, 163-164 Read the entire page →

From page 489...

... , Dietary Supplement Health and 272, 275, 279, 281, 300, 373, Education Act (DSHEA) , 135- 389, 402, 436 136, 301-303 vulnerable subpopulations, 112 epidemiological studies and, 129, 148, Advisory committees, external 149 conflicts of interest, 46, 59, 65, 270 evidence, value as, 104, 112, 126, 127- Framework review process, 8, 9, 10, 87, 136, 141, 152 91, 97-99, 123-124, 290, 296 glucosamine, 366 prototype safety monographs, 290 health care professionals, 16, 283, 303 Age factors, 248 historical use data and, 141 see also Fetal development in vitro assays and, 224-225 children, 48, 64, 248, 365, 369, 370, integration of data, 255-257 376 international perspectives, 131(n.3)

Index Pages 489-506

Index
Pages 489-506