FDA Global by Dr. Cheng
¬ü°ê¥[¦{¤j¾Ç(UCSF)Ãľdzդh¾G¼z¤åªºFDA
global¡A
¬O¤@Ó´£¨Ñ«O°·¾i¥Í¸ê°Tªº¥þ²yºô¸ô³q°T¯¸¡A
¥]¬AÃÄ«~¡B°·±d¹«~¡B¤Æ§©«~¡BÁô§Î²´Ãè¡BÅ髱±¨îµ¥¥DÃD¡C
«e¨¥
°·±d¹«~¡AÄY®æ»¡À³¸ÓºÙ¬°¡u¨ã¦³«O°·¥\®Äªº¤fªAª««~¡v¡A¤@ª½
¬Oӻᦳª§Ä³ªº¸ÜÃD¡C¦Û¤é¥»¦b1991¦~ 9¤ë¤½§i¡u¯S©w«O°·¥Î¹«~¨î
«×¡v¥H¨Ó¡A¨ä¦b¥@¬É¦U°ê©Ò¤Þµoªº½Ä¬ð«ùÄò¤£Â_¡C¦Ó«á¬ü°ê©ó1994¦~
10¤ë³q¹L¡u DSHEA¡]¿¯¹¸É¥R«~ªº°·±d¸ê°T¤Î±Ð¨|ªk®×¡^¡v¡B¤j³°¤]
¦b1996¦~ 3¤ë¤½§G¡u«O°·¹«~ºÞ²z¿ìªk¡v¡A¥[®³¤j¡B¼ÚÅé¡BÁp¦X°ê§ó
¦b¤µ¦~«×´N°·±d¹«~ªºÄ³ÃD´£¥X°Q½×¡C
¥»¤å±N´N°·±d¹«~¦b¥@¬É¦U°êªº²{ªp§@¤@ºî¦X©Êªº¤ñ¸û¡A¥H¨ÑŪ
ªÌ¤F¸Ñ¦U°ê¬F©²¬O¦p¦ó©w¦ì°·±d¹«~¡C
ì¤å¥Z¸ü©óÂåÃÄ·s»D¡A²Ä2528´Á¡A1996.12.23¡C
°·±d¹«~¦b¥@¬É¦U°êªº¬ÛÃö¥Î¦r¤Î©w¸q
§@ªÌ¡G¬ü°ê¥[¦{¤j¾ÇÃľdzդh¾G¼z¤å
¸Ó¦p¦óºÙ©I¨ã¦³«O°·¥\®Äªº¤fªAª««~¡H¡u°·±d¹«~¡]Health Foods¡^
¡v¬O³Ì®e©öÅý¤H¥ß§YÁp·Qªº¦r²´¡C¾Ç³N¬É«h©w¸q¡u¾÷¯à©Ê¹«~
¡]Functional Foods¡^¡v¡B¡upµe©Ê¹«~¡]Designer Foods¡^¡vµ¥
¦rµü¡A¾¬±æºë·Ç¦a´yø¥X¤fªAª««~ªº«O°·¯S©Ê¡C´NÂå¾Ç¬Éªº¨¤«×¦Ó
¨¥¡A¦p¦ó½T«O¡u¯S§O¥Î³~¹«~¡]Foods for Special Dietary Use¡^
¡v¡B¡u¯f±w±M¥Î¹«~¡]Medical Foods¡^¡v¤£³QÀݥάO±M·~Â卯¤Hû
³ÌÃö¤ßªº«ÂI¡C¨Ï¥Î¸gÅç±y¤[ªº¡uÃįó¤ÎÃĥδӪ«¡]Herbs and
Botanicals¡^¡v¡Bµ´¤£³y¦¨¥ÍºAt¾áªº¡u¦³¾÷¹«~¡]Organic Foods¡^
¡v¡B»P¤G¤Q¥@¬ö¥Íª«¬ì§Þ²£ª«ªº¡u¬ì§Þ¹«~¡]Novel Foods¡^¡v¤]¦]
¬°¯à°÷´£¨Ñ«O°·¥\®Ä¤§¬G¦Ó³Q¦C¤J°Q½×¦W³æ¡C
©x¤è¦p¦ó¬Ý«Ý³o¤@Ãþ¨ã¦³«O°·¥\®Äªº¤fªAª««~©O¡H¤é¥»©ó1991¦~
©w¸q¡u¯S©w«O°·¥Î¹«~¡G¬°¤F¹F¦¨¯S©w«O°·¥Øªº¡B¦Ó©ó¤é±`¿¯¹¤¤©Ò
Äá¨úªº¯S§O¥Î³~¹«~¡v¡C1994¦~¬ü°ê«h©w¸q¡u¿¯¹¸É¥R«~¡]Dietary
Supplement¡^¡G¬Y¤@Ãþ¯S©wªº¤fªAª««~¡A¥i¥H§@¬°¤@¯ë¿¯¹ªº¸É¥R«~
¤§¥Î¡C¡v¤j³°«h¦b1996¦~©w¸q¡u«O°·¹«~¡G¨ã¦³¯S©w«O°·¥\¯àªº¹«~
¡C¾A©y¯S©w¤H¸s¹¥Î¡B¨ã¦³½Õ¸`¾÷Åé¥\¯à¡B¤£¥HªvÀø¯e¯f¬°¥Øªº¤§¹
«~¡C¡v
¤Wzªº¥Î¦r¦³¤@Ó¦@³qªº¯SÂI¡G¥ç§Y±N³o¤@Ãþ²£«~ÂkÃþ©ó¡u¹«~
¡v¤§¤U¡A¦ý¬O«o¨ü©ó¹«~¤£±o«ÅºÙÂåÀø®Ä¯àªºªk¥O³W©w¡B¨Ï±o²£«~
¶D¨D¦¨¤F¤@¤jÃøÃD¡CµM¦Ó¬ü°êªº¿¯¹¸É¥R«~Á×¶}¤F¦¹¤@µ~¹Ò¡A¥H¥t¦¨
¤@Ãþªº¤è¦¡¿W¥ß¦s¦b¡A¦Ó±o¥HÝÅU²£«~ªº«O°·¤ÎÀç¾i¶D¨D¡A¥i¿×¬O³Ð
«Ø¤§Á|¡Cµ§ªÌÓ¤H«h»{¬°¡A²æL©ónutrition¤Îpharmaceuticals¤G¦r
¦Ó¦¨ªº¡uÃþÃľ¯Àç¾i«~¡]Nutraceuticals¡^¡v¡A¨ä©w¸q¶Ç¯«¦aªí¹F¤F
¨ã¦³«O°·¥\®Äªº¤fªAª««~¤§¯S©Ê¡G¡u¨ä®ÄªG¬Û·í©óÃÄ«~¡A¦ý«o¥H¹«~
ªº§ÎºA¨ÑÀ³µ¹¤@¯ë¤j²³¨Ï¥Î¡C¡v
|
¥Î¦r¤Î©w¸q
|
¬ü°ê
|
¥[®³¤j
|
|
Health Foods
°·±d¹«~
|
* °Ó·~¥Îµü¡A«Dªk³W¥Î
µü
|
* ³Ì±`¨£ªº¥Î¦r¡C
* ¦X¥G F&D&Regs³W©w
¤§¹«~§Y¬°°·±d¹«~¡C
|
|
Functional Foods
¾÷¯à©Ê¹«~
|
* ¬ÛÃöªk³WµL¦¹¦r©w¸q
* Dr. Clare M. Haslery¦b
1995¦~©w¸q¤§¡C
* «D«O°·Ãþ¹«~¤§±`¥Î
¦r¡A¦ý¨ä©w¸q¼s¬°Àç¾i
®v©Ò±µ¨ü¡C
|
* F&D Act¤¤¹ï¦¹¥Î¦r
µL©w¸q¡C
* ¥«°â¥i¥H¤J¤fªº²£«~
¦U¥H¹«~©ÎÃÄ«~©w¸q¤§C
|
|
Nutraceuticals
ÃþÃľ¯Àç¾i«~
|
* 1989¦~ Dr. Stephen
DeFelice³Ð³y¤Î©w¸q¦¹
¦r¡A¥Ñnutrition©M
pharmaceuticals©Ò³Ð¤§
·s¦r¡A·N«ü®ÄªG¬Û·í©ó
ÃÄ«~¡B¦ý¥H¹«~§ÎºA¨Ñ
À³¤j²³¹¥Î¡C
* ¾Ç³N¬É¥Îµü¡C
* Food Technology¨ó·|
¥ç©w¸q¤§
|
* ¾Ç³N¬É¥Îµü¡C
|
|
Designer Foods
pµe©Ê¹«~
|
* 1989¦~National
Cancer InstituteªºDr.
Herbert Pierson³Ð³y¤Î
©w¸q¦¹¦r¡A·N«ü§t¦³¤Ñ
µM¨¾Àù§ÜÀù¦¨¥÷ªº¹«~
* NCI©ó1992¦~®i¶}ªø
¹F¤¦~ªº¬ã¨spµe¡C
* American Chemical
Society¤w¥Xª©¤T¥U½×¤å
|
* µL©w¸q¡C
|
|
Dietary Supplements
¿¯¹¸É¥R«~
|
* DSHEA¹ï¦¹¥Î¦r¥¿¦¡
©w¸q¡A·N«ü¬Y¤@Ãþ¯S©w
ªº¤fªA¹«~¡A¥i¥H§@¬°
¤@¯ë¿¯¹ªº¸É¥R«~¤§¥Î
* ¥H¿õ¾¯¡B½¦Ån¡B¯»¥½
ª¬¡B³n½¦Ån¡B½¦Ån¿õ¡B
¤fªA²Gµ¥§ÎºA¥X²{¡C¡.
* ¨äºØÃþ¥]¬Aºû¥L©R¡B
Äqª«½è¡B¯óÃĤΨä¥L´Ó
ª«Ãþ¡BÓi°ò»Ä¡B¥i§@¬°
¸É¥R¤é±`¿¯¹Äá¨úÁ`¶q
¤£¨¬¤§¥Îªº¥LÃþ¥i¨Ñ¿¯
¹¤§¥Îªºª«½è¡B¥ô¦ó«e
zªº¿@ÁY«~¡B¥NÁª«¡B
²Õ¦¨ª«¡BµÑ¨úª«¡B©Î¬O
²Õ¦X§¡¥iºÙ¤§¡C
|
* 1995¦~10¤ëCanada
Gazette Notices Part II
©w¸q¬°Nutritional
Supplement¡C
* ¿¯¹¤£§¡¿Å®É©Ò¹¥Î
ªº¤@ºØÀç¾i¸Éµ¹«~¡C
* ¥H³æ¤@¹«~©Î¿¯¹¸É
¥R«~ªº§ÎºA¥X°â¡C
* ¥²¶·»P¤é±`¿¯¹·f°t
¹¥Î¡A¦]¬°²£«~©Ò¯à¨Ñ
µ¹ªº¯à¶q¤ÎÀç¾i²Õ¦¨¦³
¤@©wªº¨î¡C
|
|
Foods for Special Dietary Use
¯S§O¥Î³~¹«~
|
* µL©w¸q¡C
|
* Division 24, Part B,
F&D&Regs¥[¥H°Ï¤À¦¨
11ºØ¡C
|
|
Foods for Specified Health Use
¯S©w«O°·¥Î¹«~
|
* µL©w¸q¡C
|
* ¬ÛÃöªk³W©w¸q¤£©ú¡C
* ³q±`·N«ü¸g¹L¯S®í¥[
¤uªº¹«~¡C
|
|
Medical Foods
¯f±w±M¥Î¹«~
|
* ¥ÑFDA¤U³]¤§Office of
Special NutritionalsºÞ²z¡C
* ¥HÓ®×°Q½×ªº¤è¦¡¡B±N
²£«~¤ÀÃþ¬°¤@¯ë¯f¤H±M
¥Î©Î¯fµ£±M¥Î¡C
* ®Ú¾ÚInfant Formula Act
of 1980¡]1986¦~¥Í®Ä¡^
©w¸qÀ¦¨à¹«~¡C
|
* 1995¦~4¤ëA Strategic
Direction for Change - A
Review of the Regulation
under the Food and Drug
Act - Vol. 3 ©w¸q¬°
Foods for Special Medical
Purpose¡A¨Ã¹ï¾A¥Î¯f±w
¥[¥H³W½d¡C
|
|
Herbs & Botanicals
Ãįó¤ÎÃĥδӪ«
|
* Amerrican Herbal
Pharmacopoeia©w¸q¤¤¡C
|
* 1984¦~°_§Y¶i¦æ³W½d
¡A¹w©w©ó1996¦~¦³¬ÛÃö
ªk³W¡C
* ¤£¯S§O«ü©ú®É¡A¦³50
ºØ«~¶µ¥H¹«~Ãþ¦CºÞ¡A
¦ý¨ã¦³ÃĥΩΪvÀø¥\®Ä
|
|
Novel Foods
¬ì§Þ¹«~
|
* µL©w¸q¡C
|
* Federal Regulatory Plan
¦b1994¦~¡B1995¦~§Y©w
¸q¦¹¥Î¦r¡A½Ã¥Í¥DºÞ¾÷
Ãö¹w©w¦b1996¦~§¹¦¨¥ß
ªk¯ó®×¡C
* §Q¥Î¥Íª«¬ì§Þ©Î°ò¦]
¤uµ{¬ãµo¦Ó±o¹«~¡C
|
|
Organic Foods
¦³¾÷¹«~
|
* ¥t¦³ªk¥O©w¸q¤ÎºÞ²z
³W½d¤§¡C
|
* ¥t¦³ªk¥O©w¸q¤ÎºÞ²z
³W½d¤§¡C
|
|
¥Î¦r¤Î©w¸q
|
¼ÚÅé
|
Áp¦X°ê
|
|
Health Foods
°·±d¹«~
|
* °Ó·~¥Îµü¡A«Dªk³W¥Îµü
* ²£«~³q±`©ó±M½æ©±¥X°â
|
* °Ó·~¥Îµü¡A«Dªk³W¥Îµü
|
|
Functional Foods
¾÷¯à©Ê¹«~
|
* ¦¹¥Î¦r¦b¬ÛÃöªk³W©|µL
©w¸q¡A¦ý¼s¬°²£·~¬É¤Î®ø
¶OªÌ©Ò±µ¨ü¡C
* 1994¦~6¤ë^°êÀç¾i°ò
ª÷·|British Nutrition
Foundation¡B1995¦~^°ê
¹«~¬ì§Þ¬ã¨s¾÷ºc
Institute of Food
Science & Technology
(UK)¡B¤Î1995¦~8¤ë^°ê
MAFF¹A·~º®ªª¤Î¹«~³¡
¹ï¦¹¦r¤À§O©w¸q
|
* µL©w¸q¡C
|
|
Nutraceuticals
ÃþÃľ¯Àç¾i«~
|
* ¦¹¦r¹ï¨ä¥L·|û°ê¨Ó»¡
¬°±Ôz©Ê¥Î»y¡A¦]¦¹±µ¨ü
«×¬Æ§C¡C
|
* µL©w¸q¡C
|
|
Designer Foods
pµe©Ê¹«~
|
* ¾Ç³N¬É¥Îµü¡C
|
* µL©w¸q¡C
|
|
Dietary Supplements
¿¯¹¸É¥R«~
|
* ¼ÚÅé·|û°ê»{¦P¬ü°ê©w
¸q¡A¥¼¥tq¨ä¥L©w¸q¡C
* E. C. Directive
89/398/EEC ¼ÚÅé·|û°ê
¥tq©w¸q¤E¤jÃþFoods
for Particular
Nutritional Uses¡C
|
* ¹ï¤HÅé¥Í²z¾÷¯à¦³©Ò¼v
ÅTªºª««~¬°ÃÄ«~¡A¦Ó«D¹
«~©Î¿¯¹¸É¥R«~¡C
* ¨ã¦³¨C¤é«ØÄ³¥Î¶qRDA
ªº²£«~¡A¤~¬O¿¯¹¸É¥R«~
¨Ò¦pºû¥L©R©MÄqª«½è¡C
|
|
Foods for Special Dietary Use
¯S§O¥Î³~¹«~
|
* µL©w¸q¡C
|
* ©w¸qNutrition and
Foods for Special
dietary Use.
|
|
Foods for Specified Health Use
¯S©w«O°·¥Î¹«~
|
* µL©w¸q¡C
|
* µL©w¸q¡C
|
|
Medical Foods
¯f±w±M¥Î¹«~
|
* ©w¸q¤¤¡C
|
* µL©w¸q¡C
|
|
Herbs & Botanicals
Ãįó¤ÎÃĥδӪ«
|
* °Ó·~¥Îµü¡A«Dªk³W¥Îµü
* ²£«~³q±`©ó±M½æ©±¥X°â
|
* ©w¸q¤¤¡C
|
|
Novel Foods
¬ì§Þ¹«~
|
* 1995¦~10¤ë23¤éE. U.
Ministers©w¸q¬°§Q¥Î¥Í
ª«¬ì§Þ©Î°ò¦]¤uµ{¬ãµo¦Ó
±oªº¹«~¡C¦ý¤Ö¼Æ·|û°ê
©Úµ´±µ¨ü¦¹©w¸q¡C
|
* µL©w¸q¡C
|
|
Organic Foods
¦³¾÷¹«~
|
* ¥t¦³ªk¥O©w¸q¤ÎºÞ²z
³W½d¤§ ¡C
|
* ¥t¦³ªk¥O©w¸q¤ÎºÞ²z
³W½d¤§¡C
|
|
¥Î¦r¤Î©w¸q
|
¤é¥»
|
¤j³°
|
|
Health Foods
°·±d¹«~
|
* ®ø¶OªÌ¤Î²£·~¬ÉªººD
¥Î¦rµü¡C
|
* ¤@¯ë¥Î»y¡C
|
|
Functional Foods
¾÷¯à©Ê¹«~
|
* ¹«~ªº¾÷¯à©Ê¦¨¥÷¦@
¦³12ºØ¡C
* 1991¦~°_¥H¡u¯S©w«O
°·¥Î¹«~¡v¤@µü¥N´À¾÷
¯à©Ê¹«~¡C
|
* µL©w¸q¡C
|
|
Nutraceuticals
ÃþÃľ¯Àç¾i«~
|
* µL©w¸q¡C
|
* µL©w¸q¡C
|
|
Designer Foods
pµe©Ê¹«~
|
* ¾Ç³N¬É¥Îµü¡C
|
* µL©w¸q¡C
|
|
Dietary Supplements
¿¯¹¸É¥R«~
|
* µL©w¸q¡C
|
* µL©w¸q¡C
|
|
Foods for Special Dietary Use
¯S§O¥Î³~¹«~
|
* ©w¸q¬°¯f±w±M¥Î¹«~
¡B¥¥°ü©Î±Â¨Å°ü¤H¹«~
¡BÀ¦¨à½Õ°t¥¤¯»¡B°ªÄÖ
ªÌ±M¥Î¹«~¡B¤Î¯S©w«O
°·¥Î¹«~¡C
|
* µL©w¸q¡C
|
|
Foods for Specified Health Use
¯S©w«O°·¥Î¹«~
|
* ®Ú¾ÚÀç¾i§ïµ½ªk¡A¯S
©w«O°·¥Î¹«~¬°¯S©w¥Î
³~¹«~¤§¤@Ãþ¡C
* ·N«ü¦b¤é±`¥Í¬¡¤¤¡A
¬°¤F¯S©w«O°·¥Øªº©ÒÄá
¨úªº¶¼¹¡C
|
* ®Ú¾Ú¹«~½Ã¥Íªk¡A«O
°·¹«~«Y«ü¨ã¦³¯S©w«O
°·¥\¯àªº¹«~¡C
|
|
Medical Foods
¯f±w±M¥Î¹«~
|
* ¡u¯fªÌ¥Î¹«~¡vÂkÃþ
©ó¯S§O¥Î³~¹«~¤§¤U¡A
¤À¦¨³æ¤@¹«~©M²Õ¦X¹
«~¨âÓ¶µ¥Ø¡C
|
* µL©w¸q¡C
|
|
Herbs & Botanicals
Ãįó¤ÎÃĥδӪ«
|
* ¹ï¦¹¥Î¦rµL©w¸q¡C
* º~¤è¥ÍÃĨ㦳ªvÀø©M
«O¾iªº¥\®Ä¡C
|
* ¦³ªvÀø¥\®ÄªºÃįó¤Î
ÃĥδӪ«µø¬°¤¤Â夤ÃÄ¡C
|
|
Novel Foods
¬ì§Þ¹«~
|
* µL©w¸q¡C
|
* µL©w¸q¡C
|
|
Organic Foods
¦³¾÷¹«~
|
* ¥t¦³ªk¥O©w¸q¤ÎºÞ²z
³W½d¤§
|
* µL©w¸q¡C
|
¡i ¦^
" °·±d¹«~ªk³W " ¡j ¡i ¦^
" FDA global " ¡j
¥»¯¸ªºÂåÃÄ«O°·¸ê°T¶È¨Ñ°Ñ¦Ò¡CŪªÌY¦³¨Å餣¾A¤§²{¶H¡A½Ð¾¨³t´NÂå¶Eªv¡C
©Ò¦³¤º®e§¡ÅwªïÂsÄý³sµ²¡C±ýÂà¶K©ÎÂà¸ü¤§WWW¤ÎBBS¡A½Ð¥ý¨Ó«H¨ú±o¦Xªk
±ÂÅv¡A¥B»Ý«O«ù¤º®e§¹¾ã¡A¤£±o«þ¨©×§ï¡C
½Ð´L«´¼¼z°]²£Åv¡A¤Þ¥Î¥»¯¸¸ê®Æ®É¡A½Ð°È¥²µù©ú§@ªÌ¤Î¥X³B¡CÁÂÁ±zªº¦X§@¡C
¥»¯¸¯S§O·PÁ¤U¦C¼ö¤ß¤H¤hªº¤ä«ù»P¹ªÀy¡G
¤¤¤s¤j¾Ç¡B«n¤èªÀ°Ï¤å¤Æºô¸ô¡B°·±d¤Ñ¦a¡B¾Gºû²zÂå®v¡B¤Î
½Ã¥Í¸p¹«~³B°Æ³Bªø³¯³°§»³Õ¤h¡C
¥»¯¸«Øºc¤é´Á¡G1997.01.15¡C¥»¶§ó·s¤é´Á¡G1997.02.11.
¥»¯¸¥H Netscape Navigator Gold 3.01
«Øºc¡C