1.4 中国与美国对化妆品和药品法规管理
（1） 中国对化妆品及原料卫生监督规范概况4
（a）为了强化化妆品的卫生监督，保证化妆品的卫生质量和使用安全，保障消费者健康，在1989年9月26日国务院批准1989年11月13日卫生部第3号令，发布了化妆品的《卫生监督管理条例》。于2002年，卫生部又新修订了《化妆品卫生规范》，要求有关单位严格依照来规范进行化妆品审批和监督工作。使我国化妆品产业的发展，满足人民群众美化生活的要求，做出了法规保障。
在我国功能化妆品中，涉及育发、烫发、脱毛、美乳、健美、除臭、祛斑、防晒的这九类化妆品，又称为特殊用途化妆品3,7,8,9，必须经国务院卫生行政部门批准，即现在的中国食品与药品监督管理局（中国的FDA）批准，取得批准文号后，方可生产上市。中国的FDA骋请科研、医疗、生产、卫生管理等有关专家，组成化妆品安全性评审组，对进口化妆品，以上九类特殊用途化妆品，以及化妆品新原料进行安全性评审，对化妆品引起的重大事故进行技术鉴定。
（b）对生产人员健康的要求明确规定：直接从事化妆品生产的人员，必须每年进行健康检查，取得健康证后，方可从事化妆品的生产活动，凡患有手癣、指甲癣、手部湿疹，发生于手部的银屑病或者鳞屑，渗出性皮肤病，以及患有痢疾、伤寒、病毒性肝炎，活动性肺结核等传染病的人员不得直接从事化妆品生产活动。
（c）对化妆品原料的要求。禁止使用"《化妆品卫生规范》（中华人民共和国卫生部卫生法制与监督司1999年11月）第一部分总则表2（1）及（2）化妆品组分中禁用物质"中所列物质为化妆品组分。禁用物质多达数百种，这些物质有的是剧毒或有明显慢性毒性的物质，有的对皮肤或黏膜有刺激性。
凡以"《化妆品卫生规范》表3限用物质"中所列物质为化妆品组分的，必须符合规定的最大允许浓度，允许使用范围和限用条件，并规定了在标签上必须说明。
化妆品中所用防腐剂必须符合"《化妆品卫生规范》表4限用防腐剂"的规定。这些防腐均为微生物生长抑制剂，国家规定了防腐剂在化妆品中的最大允许浓度、限用范围、必备条件以及标签上的必要说明。
化妆品中所用紫外线吸收剂必须符合"《化妆品卫生规范》表5限用紫外线吸收剂"的规定。标准规定在避免毒、副作用的前提下使用这些物质滤除紫外线，以保护不受射线的危害。
化妆品所用着色剂必须符合"《化妆品卫生规范》表6限用着色剂"的规定。限用着色剂为4类：第一类为一般化妆品均可使用；第二类是不得用于口腔及唇部化妆品中的着色剂；第三类不得用于眼部化妆品中；第四类是不得用于眼部、口腔及唇部化妆品中的着色剂。
（d）对化妆品的包装材料的要求：即直接接触化妆品的容器和包装材料必须符合国家卫生标准。
（e）对化妆品内容物要求：在化妆品行业最为重视和最容易发生微生物污染现象，微生物对化妆品的不良影响，除了使产品的色、香和味发生变化，质量下降外，更主要的是致病微生物的污染，造成使用者人体健康的危害，如化脓性细菌污染，可引起皮肤和眼部的感染，产生过敏，红肿，既损害了消费者，又影响化妆品厂家的市场信誉。所以，对化妆品的微生物质量应符合下列规定：
化妆品的微生物学质量应符合下列规定：眼部、口唇等黏膜用化妆品以及婴儿和儿童用化妆品细菌总数不得大于500CFU、ml或500CFU/g;其他化妆品细菌总数不得大于1000CFU/mL或1000CFU/g;每g或每mL产品中不得查出粪大肠菌群、绿脓肝菌和金黄色葡萄球菌；化妆品中霉菌和酵母菌总数不得大于100
CFU/mL或100CFU/g。有害物质："汞"≤1mg/kg(含有机汞防腐剂的眼部化妆品除外)；"铅（以铅计）"≤40mg/kg(含乙酸铅的染发剂除外)；"砷（以砷计）"≤10mg/kg;甲醇≤2000mg/kg。
（2）中国新的《药品管理法》概括5
2001年2月28日，无疑是中国医药事业发展史上值得纪念的日子。就在这一天，第九届全国人大常委会第二十次会议审议通过了新修订的《药品管理法》，为我国进入新世纪和市场经济后更好地依法治药奠定了坚实的法律基础
药品管理法的宗旨是为了加强药品监督管理，保证药品质量，保障人体用药安全，维护人民身体健康和用药的合法权益。
《中华人民共和国药品管理法》（下称"现行药品管理法"）自1985年7月1日正式实施以来，在保证药品质量，打击制售假、劣药品的违法行为，保障人民用药安全等方面发挥了非常重要的作用。但是，随着我国改革开放的不断深入和社会主义市场经济的不断发展，药品研究、生产、流通、使用都出现了许多新情况和新问题，药品监督管理体制发生了重大变化。因此，对现行药品管理法进行修改、完善已经势在必行。修订的《中华人民共和国药品管理法》（下�"修订的药品管理法"）共十章，106条。
现将修订的主要内容概述如下：
（a）明确药品监督管理部门的执法主体地位，充分体现了政府机构改革的成果，在1998年国务院政府机构改革中，按照精简、统一、效能的原则，国务院决定将原国家医药管理局行使的药品生产流通监管职能、卫生部行使的药政管理和药检职能、国家中医药管理局行使的中药流通监管职能集中交由新组建的国家药品监管局行使。此后，党中央、国务院又作出了建立改革药品监督管理体制，对省以下药品监督管理部门实行垂直管理的重要决定。
为体现药品监督管理体制改革的精神，从法律上巩固改革成果，新修订的药品管理法明确了的药品监督管理部门（包括国家药品监督管理局、各省、自治区、直辖市药品监督管理局及其垂直管理的地、市、县药品监督管理部门）的执法主体地位。同时，新修订药品管理法还增加了与药品有关的监督管理的规定，以保护用药者的合法权益。
新修订的药品管理法规定："国务院药品监督管理部门主管全国药品监督管理工作。国务院有关部门在各自的职责范围内负责与药品有关的监督管理工作�""省、自治区、直辖市人民政府药品监督管理部门负责本行政区域内的药品监督管理工作。省、自治区、直辖市人民政府有关部门在各自的职责范围内负责与药品有关的监督管理工作。""国务院药品监督管理部门应当配合国务院经济综合主管部门，执行国家制定的药品行业发展规划和产业政策。"（第五条）
(b) 统一对新开办企业和药品的审批，减少审批环节，规范审批行为，提高行政效率
（b1）统一对新开办药品生产、经营企业的审批
按照现行药品管理法的规定和执行中的做法，开办药品生产企业、经营企业须经药品生产经营主管部门和卫生行政部门两道审查，分别取得药品生产企业合格证和许可证、药品经营企业合格证和许可证，凭两证办理工商登记、领取营业执照，有了"两证一照"方可开业；生产已有标准的药品须经卫生行政部门征求药品生产经营主管部门意见后审核批准。这种办法造成部门职权交叉，办事手续重复，行政效率低下，并加重了企业负担。长期以来，企业强烈呼吁减少审批环节、改革审批体制。
在本次政府机构改革中，党中央、国务院决定组建国家药品监督管理局，并建立新的药品监督管理体制，从管理体制上为统一对新开办药品生产、经营企业的审批创造了条件。
据此，新修订药品管理法简化了开办药品生产企业、经营企业的审批程序，将"两道审批、两证一照"改为"一道审批（药品监督管理部门审批）、一证（许可证）一照（营业执照）"。
（b2）统一药品审批，取消药品地方标准，将中药材、中药饮片逐步纳入标准化、规范化管理轨道
现行药品管理法规定，药品标准包括国家药品标准和省、自治区、直辖市药品标准；生产已有国家标准或者省、自治区、直辖市标准的药品，由省、自治区、直辖市卫生行政部门发给批准文号。这样的规定，导致同一药品品种在不同省、自治区、直辖市有不同的标准；有些地方为了保护地方利益，甚至降低地方标准审批药品。这是造成药品质量低下、低水平重复生产情况严重的重要原因之一。因此，新修订的药品管理法在取消地方对生产药品的审批权的同时，还取消了药品地方标准，规定："生产新药或者已有国家标准的药品的，须经国务院药品监督管理部门批准，并发给药品批准文号"（第三十一条），"药品必须符合国家药品标准"（第三十二条）。
按照现行药品管理法的规定，生产中药材、中药饮片不需要经审批并取得批准文号。由于对生产中药材、中药饮片缺乏科学、规范的管理，我国中药材、中药饮片质量不合格率长期居高不下，远远超过其他药品。中药材、中药饮片的质量问题制约了中成药质量的提高，导致了中药临床疗效的下降，损害了中医药事业的健康发展。因此，对那些需要并可能制定质量标准的中药材、中药饮片生产实行规范化、标准化管理是十分必要的。同时，考虑到中药材、中药饮片品种很多，规格不一，各地方用药习惯、炮制方法不统一，全部纳入规范化、标准化管理有现实困难，因此，新修订药品管理法原则规定�"实施批准文号管理的中药材、中药饮片品种目录由国务院药品监督管理部门会同国务院中医药管理部门制定"（第三十一条）。
另外，有些中药饮片的炮制没有国家标准，生产这些中药饮片应当按省、自治区、直辖市药品监督管理局制定的炮制规范执行。因此，新修订的药品管理法规定：
"中药饮片必须按照国家药品标准炮制；国家药品标准没有规定的，必须按照省、自治区、直辖市人民政府药品监督管理部门制定的《炮制规范》炮制。省、自治区、
直辖市人民政府药品监督管理部门制定的《炮制规范》应当报国务院药品监督管理部门备案"（第十条）。
(c) 进一步规范和加强对进口药品的管理，保证进口药品安全有效，适应我国即将加入世界贸易组织（WTO）的新形势
（c1）确定进口药品审查注册制度
现行药品管理法仅对首次进口的药品提出了经国务院卫生行政部门批准的要求；对进口药品有效性、安全性的评价及对其质量标准和检验方法是否可以控制产品质量，亦未明确提出加以确认的要求。另外，现行药品管理法规定对进口药品经批准后方可签定进口合同，将药品监督与商业行为相混淆，已不适应市场经济发展的客观实际。
因此，新修订的药品管理法规定："药品进口，须经国务院药品监督管理部门组织审查，经审查确认符合质量标准、安全有效的，方可批准进口，并发给进口药品注册证�"（第三十九条）。
上述规定明确了进口药品审查、注册制度，即：对国外已上市的药品进入我国市场前由国家药品监督管理局进行审查、注册；国家药品监督管理局对申报的技术资料和有关的证明文件进行查验和审核，必要时要在我国进行临床试验；药品质量标准要进行实验室复核审查，并确认其可控制药品质量；在申报品种的质量复核和临床研究结束后，国家药品监督管理局对有关资料进行审查，符合要求的，核发《进口药品注册证》；《进口药品注册证》是国外药品进入中国市场合法销售的证明文件，没有《进口药品注册证》而在中国销售的国外药品将被作为假药论处。
（c2）确定进口药品在指定口岸的药品监督管理部门的审查备案制度
按照现行药品管理法的规定，进口药品进入中国市场销售前实行市场准入审批，每一批进口药品在进口入关前还要由口岸药检所检验合格方准进口。
为了达到既保证进口药品的质量，又与WTO国际贸易规则相衔接的目的，新修订药品管理法规定："药品必须从允许进口的口岸进口，并由进口药品的企业向口岸所在地药品监督管理部门登记备案。海关凭药品监督管理部门出具的《进口药品通关单》放行。无《进口药品通关单》的，海关不得放行。""口岸所在地药品监督管理部门应该通知药品检验机构按照国务院药品监督管理部门的规定对进口药品进行抽查检验，并依照本法第四十一条第二款的规定收取检验费。""允许药品进口的口岸由国务院药品监督管理部门会同海关总署提出，报国务院批准."（第四十条）
上述规定确定了实行进口药品在指定口岸的药品监督管理部门的审查备案制度的基本原则：
进口药品从指定的口岸进口。我国是一个发展中的大国，随着改革开放的不断深入，对外开放的口岸不断增多，据不完全统计，我国目前对外开放的口岸达三百多个。由于对进口药品的检验需要相当强的技术力量和设备，我国目前无法在每一个口岸均设置一个进口药品检验机构。新修订的药品管理法规定，允许药品进口的口岸由国务院药品监督管理部门会同海关总署提出，报国务院批准。
进口企业须向口岸所在地药品监督管理部门登记备案。进口药品进入中国市场销售必须首先取得国家药品监督管理部门颁发的《进口药品注册证》。但是，取得《进口药品注册证》只是获得了进入中国的市场准入许可，仍要在进口每批药品时接受中国药品监督管理部门的监督，监督的方式为登记备案。
口岸所在地的药品监督管理部门应当通知按照国务院药品监督管理部门的规定对进口药品进行抽查检验，并按照本法第四十一条第二款的规定收取检验费用。
(d) 增加药品监督管理执法行政强制措施，加大对制售假劣药品等违法行为的处罚、打击力度，完善法律责任制度和行政执法手段，为进一步整顿药品生产、流通秩序提供了强有力的法律手段，充分体现了对人民群众用药安全有效的高度负责
（d1）新增了药品监督管理部门对涉嫌生产、经营假药、劣药或发生严重不良反应的情况，可采取行政强制措施或紧急控制措施的规定
整顿药品生产、流通秩序，加快药品流通体制改革，严厉打击制售假劣药品的违法行为，是广大人民群众关注的热点问题。现行药品管理法规定的行政执法手段比较单一，强制措施不够完善、有力，针对生产、销售假劣药品违法行为处罚的规定过于原则，可操作性不强，在很大程度上给药品监督管理部门的执法带来困难。因此，新修订药品管理法增加规定�"药品监督管理部门对有证据证明可能危害人体健康的药品及其有关材料可以采取查封、扣押等行政强制措施，并在七日内作出行政处理决定；药品需要检验的，必须自检验报告书发出之日起十五日内作出行政处理决定"（第六十五条），"对已确认发生严重不良反应的药品，国务院或者省、自治区、直辖市人民政府药品监督管理部门可以采取停止生产、销售、使用的紧急控制措施，并应当在五日内组织鉴定，自鉴定结论作出之日起十五日内依法作出行政处理决定"（第七十一条）。
（d2）扩大了认定制售假劣药品的行为范围，规范认定依据
现行药品管理法规定的假药和按照假药论处的行为共有六种，确定为劣药的行为共有三种。总结近年来药品监督管理行政执法的经验，新修订的药品管理法将假药和按照假药论处的行为增加为八种，将劣药和按照劣药论处的行为增加为七种
："有下列情形之一的，为假药：（一）药品所含成份与国家药品标准规定的成份不符的；（二）以非药品冒充药品或者以他种药品冒充此种药品的。有下列情形之一的药品，按假药论处：（一）国务院药品监督管理部门规定禁止使用的；（二）依照本法必须批准而未经批准生产、进口或者配制，或者依照本法必须检验而未经检验即销售的；（三）变质的；（四）被污染的；（五）使用依照本法必须取得批准文号,而未取得批准文号的原料药生产的；（六）所标明的适应症或者功能主治超出规定范围的"（
第四十八条）。
药品成份的含量不符合国家药品标准的，为劣药。有下列情形之一的药品，按劣药论处：（一）未标明有效期或者更改有效期的；（二）不注明或者更改生产批号的；（三）超过有效期的；（四）直接接触药品的包装材料和容器未经批准的；（五）擅自添加着色剂、防腐剂、香料、矫味剂及辅料的；（六）其他不符合药品标准规定的"（
第四十九条）。
同时，为了切实体现行政监督以技术监督为依托的原则，新修订药品管理法增加规定："除本法明确排除的情形外，对假药、劣药的处罚通知，必须载明药检所的质量检验结果（第七十八条）"。
（d3）加大对生产、销售或者配制假药劣药行为的处罚力度
考虑到制售假药是一种故意侵犯公众健康权利的严重违法行为，社会危害性极大，不仅是应没收违法所得和罚款,情节严重的，还应当吊销许可证，使其丧失生产、经营药品资格。另外，针对实践中对制售假劣药品违法所得难以取证和计算的问题，参照刑法和产品质量法的规定，应明确将罚款以违法药品货值金额为处罚基数，增加行政处罚的可操作性，并加重处罚力度。
因此，新修订的药品管理法规定："生产、销售假药的，没收违法生产、销售的药品和违法所得，并处违法生产、销售药品货值金额二倍以上五倍以下的罚款；有药品批准证明文件的予以撤销，并责令停产、停业整顿；情节严重的，吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》；构成犯罪的，依法追究刑事责�"（第七十四条）。"生产、销售劣药的，没收违法生产、销售的药品和违法所得，并处违法生产、销售药品货值金额一倍以上三倍以下的罚款；情节严重的，责令停产、停业整顿或者撤销药品批准证明文件，可以吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》；构成犯罪的，依法追究刑事责任"（第七十五条）。此外，还针对为制售假劣药品提供便利条件的行为，增加规定："知道或者应当知道属假劣药品而为其提供运输、保管、仓储等便利条件的，没收全部门运输、保管、仓储的收入，并处违法收入百分之五十以上三倍以下的罚款；构成犯罪的，依法追究刑事责�"（第七十七条）。
（d4）扩大对违法行为的处罚范围并增加资格罚
从实际情况看，一些单位生产、销售和配制假劣药品往往同其主管人员和其他直接责任人员有密切关系。由于现行药品管理法没有设定对个人进行的处罚，因此，新修订的药品管理法增加规定："从事生产、销售假药以及生产、销售劣药情节严重的企业或者其他单位，其直接负责的主管人员和其他直接责任人员十年内不得从事药品生产、经营活动。""对生产者专门用于生产假药、劣药的原辅材料、包装材料、生产设备，予以没收"（第七十六条）。
（d5）增加法律责任，体现对药品全过程的监督管理
为了充分体现对药品研制、生产、经营、使用的全过程监督管理，新修订药品管理法在法律责任一章增加了相应的条款，规定了对违反《药品生产质量管理规范》和《药品经营质量管理规范》、扰乱进口药品监控、骗取许可证或者药品批准证明文件、出具虚假检验报告等违法行为的处罚。
(e) 充分地吸纳了改革开放以来我国药品监督管理工作行之有效的规定和做法，规定了实行药品认证制度、药品分类管理制度和药品不良反应报告制度等
（e1）规定实行药品认证制度，对药品研究、生产、经营单位提出规范管理的要求，促进药品质量进一步提高现行药品管理法只要求药品生产企业必须按照《药品生产质量管理规范》的要求，制定和执行保证药品质量的规章制度和卫生要求。根据我国近年来制定和推行《药品生产质量管理规范》（GMP）、《药品经营质量管理规范》（GSP）的经验，新修订药品管理法明确规定："药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证，对认证合格的，发给认证证书"（第九条），"药品监督管理部门按照规定对药品经营企业是否符合《药品经营质量管理规范》的要求进行认证，对认证合格的，发给认证证书"（第十六条）。上述条款明确了GMP、GSP的法律地位，必将会有力促进药品生产、经营企业提高质量意识，加强质量管理，把企业工作的重点转移到加快技术进步和提高劳动者素质的正确轨道上来。
新修订药品管理法还增加规定："药物的非临床安全性评价研究机构和临床试验机构必须分别执行药物非临床研究质量管理规范、药物临床试验管理规范"（第三十条）。实施药物非临床研究质量管理规范（GLP）和药物临床试验管理规范（GCP），将促使药物研究更加严谨、科学、规范。
新修订药品管理法对药品认证制度的规定，包括GMP、GSP、GLP、GCP认证等，严格了药品研究、生产、经营的准入条件，提高了对质量的要求，把从源头克服低水平重复的根本措施以法律的形式固定下来，对促进我国医药事业健康发展意义重大。
（e2）规定实行处方药与非处方药分类管理制度，把党中央、国务院关于实施药品分类管理的决定纳入法制化轨道
处方药是必须凭医生处方购买，并在医生指导下使用的药品；非处方药是经过由专家遴选的经过长期临床实践后认为患者可以自行购买、使用并能保证安全的药品。处方药与非处方药分类管理，是国际上通行的药品管理模式。通过加强对处方药的监督管理，规范对非处方药的监督管理，规范药品生产、经营行为，引导公众科学合理用药，将对减少药物滥用和药品不良反应的发生，保护公众用药安全有效，起到十分重要的作用。
1997年1月，《中共中央、国务院关于卫生改革的决定》指出："国家建立并完善处方药与非处方药分类管理制度"。但是，由于现行药品管理法对此未作规定，因此，药品分类管理制度的建立和各项配套政策的制定，都缺乏必要的法律基础，实施药品分类管理制度存在较大困难。针对这种情况，考虑到药品分类管理制度的实施涉及相关的医疗体制改革等，还需要制定配套的行政法规和其他相关的政策，因此，新修订的药品管理法规定�"国家对药品实行处方药与非处方药分类管理制度。具体办法由国务院制定。"（第三十七条）
（e3）规定国家实行药品不良反应报告制度
药品不良反应直接关系人民生命健康。为了明确考察药品不良反应的主体、发现不良反应应报告的部门和药品监督管理部门可采取的紧急控制措施，新修订的药品管理法规定："国家实行药品不良反应制度"，"具体办法由国务院药品监督管理部门会同国务院卫生行政部门制定"。"对已确认发生严重不良反应的药品，国务院或者省、自治区、直辖市人民政府药品监督管理部门可以采取停止生产、销售、使用的紧急控制措施，并应当在五日内组织鉴定，自鉴定结论作出之日起十五日内依法作出行政处理决定"（第七十一条）。
(f) 明确药品检验机构的法律地位，改革药品抽验机制，保证药品监督检验的科学、准确、公正
（f1）明确药品检验机构的职责
药品检验机构是药品监督管理体系的重要组成部分，是政府对药品实施技术监督的法定检验机构。药品监督管理部门设置的药品检验机构依法承担药品检验工作；同时，为适应某些情况下监督检验工作的实际需要，也可以由药品监督管理部门确定的其他检验机构承担药品检验工作。因此，新修订药品管理法规定："
药品监督管理部门设置或者确定的药品检验机构，承担依法实施药品审批和药品质量监督检查所需的药品检验工作"（第六条）。
（f2）增加对药品监督检验收费管理的规定，从法律上提出改革药品抽验机制的要求，保护行政相对人的合法权益
加强对药品监督检验收费的管理，改革药品抽验机制，从法律上明确规定应当收费的检验项目，规定由国家支付抽验费用，是保证药品监督检验公正、公平的重要条件。因此，新修订的药品管理法规定："…药品的检验项目和收费标准由国务院财政部门会同国务院价格主管部门核定并公告。检验费收缴办法由国务院财政部门会同国务院药品监督管理部门制定"（第四十一条）。"药品监督管理部门根据监督检查的需要，可以对药品质量进行抽查检验。抽查检验应当按照规定抽样，并不得收取任何费用。所需费用按照国务院规定列支"（第六十五条）。
(g) 增加药品广告、药品价格、药品回扣等相关规定，依法解决人民群众和广大医药企业关注的热点问题
（g1）进一步加强对药品广告的管理，禁止处方药在大众传播媒介进行广告宣传
针对药品广告过多、过滥，对药品的功效作虚假宣传，误导消费者的现象，新修订的药品管理法加强了对药品广告的管理，进一步重申："药品广告必须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准，并发给药品广告批准文号"（第六十条），并强化了广告审批者对所批准的广告的监督检查的职责，规定："省、自治区、直辖市人民政府药品监督管理部门应当对其批准的药品广告进行检查，对于违反本法和《中华人民共和国广告法》的广告，应当向广告监督管理机关通报并提出处理建议，广告监督管理机关应当依法作出处理"（第六十二条）。
处方药是经医师开具处方才能使用的药品，只应针对医师等专业人员作适当的广告宣传。禁止处方药在大众媒体上作广告宣传的做法，已经为世界上大多数国家所接受。因此，新修订的药品管理法明确：
"处方药可以在国务院卫生行政部门和国务院药品监督管理部门共同指定的医学、药学专业刊物上介绍，但不得在大众传播媒介发布广告或者以其他方式进行以公众为对象的广告宣传"（第六十条）。
（g2）增加对药品价格、药品回扣的监督管理规定，防止虚高定价，保护人民用药的合法权益
目前，药品价格过高，不合理的虚高定价和大折扣、高回扣，大大加重了国家和患者个人的负担，也容易诱发腐败行为。对人民群众反映强烈的药品价格问题，新修订的药品管理法增加了必要内容，作出了针对性的规定�"依法实行政府定价、政府指导价的药品，政府价格主管理部门应当依照《中华人民共和国价格法》规定的定价原则，依据社会平均成本、市场供求状况和社会承受能力合理制定和调整价格，做到质价相符，消除虚高价格，保护用药者的正当利益。""药品的生产企业、经营企业和医疗机构必须执行政府定价、政府指导价，不得以任何形式擅自提高价格。""药品生产企业应当依法向政府主管部门如实提供药品的生产经营成本，不得拒报、虚报、瞒报"（第五十五条）。"依法实行市场调节价的药品，生产、经营企业和医疗机构应当按照公平、合理和诚实信用、质价相符的原则制定价格，为用药者提供价格合理的药品"。"药品生产、经营企业和医疗机构应当遵守国务院价格主管部门关于药价管理的规定，制定和标明药品零售价格，禁止暴利和损害用药者利益的价格欺诈行为"（第五十六条）。"药品的生产企业、经营企业、医疗机构应当依法向政府价格主管部门提供其药品的实际购销价格和购销数量等资料"（第五十七条）。"医疗机构应当按照患者的要求提供所用药品的价格清单；医疗保险定点医疗机构还应当按照规定如实公布其常用药品的采购价格和向患者出售的价格。具体办法由国务院卫生行政部门规定"（第五十八条）。"禁止药品的生产企业、经营企业和医疗机构在药品购销中帐外暗中给予、收受回扣或者其他利益。""禁止药品的生产企业、经营企业或者其代理人以任何名义给予使用其药品的医疗机构的负责人、药品采购人员、医师等有关人员以财物或者其他利益。禁止医疗机构的负责人、药品采购人员、医师等有关人员以任何名义收受药品的生产企业、经营企业或者其代理人给予的财物或者其他利益"（第五十九条）。
（g3）增加禁止设置障碍、实行地方保护的规定，促进建立统一、开放、竞争、有序市场，为医药企业的正当竞争创造公平环境
以往一些地方采取违法进行强制检验、设置多重标准或发放"准销证"、"准入证"等做法，阻止、排斥外地合法药品进入本地市场，实行地方保护。针对这些完全违背社会主义市场经济规律，违背有关法律、法规的做法，新修订的药品管理法规定："地方人民政府和药品监督管理部门不得以要求实施药品检验、审批等手段排斥非本地区药品生产企业照本法规定生产的药品进入本地区"
（第六十九条）。
（g4）允许药品生产企业接受委托生产药品，减少重复建设
允许具备一定条件的药品生产企业接受委托生产药品，可以充分利用现有的生产条件，减少重复投资和重复建设，有利于资源的优化组合，有利于促进医药产业的结构调整。新修订的药品管理法规定："经国家药品监督管理部门或者经其授权的省、自治区、直辖市药品监督管理部门批准，药品生产可以接受委托生产药品（第十三条）"。
(h) 增加对药品监督管理部门和人员监督的规定，从法律上提出了建设勤政、廉洁、务实、高效药品监督工作队伍的要求
为了确保药品监督部门依法行政，公正执法，建立一支勤政、廉洁、务实、高效的药品监督工作队伍，新修订药品管理法在明确规定药品监督管理部门及其设置的药品检验机构的职责的同时，也针对不依法履行职责或滥用职权的行为规定了相应的法律责任。新修订药品管理法新增的有关规定主要有：
（h1）明确违法发给有关证书或者批准证明文件的法律责任
新修订药品管理法规定：药品监督管理部门违法发给《药品生产质量管理规范》、《药品经营质量管理规范》、《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》、进口药品注册证书或者批准进行临床试验、发给新药证书、发给药品批准文号的，"由其上级主管机关或者监察机关责令收回违法发给的证书或者撤销药品批准证明文件，对直接负责的主管人员和其他直接责任人员依法给予降级、撤职、开除的行政处分；构成犯罪的，依法追究刑事责任"（第九十四条）。
（h2）禁止药品监督管理部门、药品检验机构及其工作人员参与药品生产、经营活动
新修订药品管理法规定：药品监督管理部门、药品检验机构参与药品生产经营活动的，"由其上级机关或者监察机关责令改正，有违法收入的予以没收；情节严重的，对直接负责的主管人员和其他责任人员依法给予行政处分"；对参与药品生产经营活动的有关工作人员，"依法给予行政处分"（第九十五条）
(h3)禁止药品监督管理部门、药品检验机构违法收取检验费用
新修订的药品管理法规定：药品监督管理部门、药品检验机构违法收取检验费用的，"由政府有关部门责令退还，对直接负责的主管人员和其他直接责任人员依法给予行政处分"；对情节严重的药品检验机构，"撤销其检验资格"（第九十六条）。
（h4）明确与制售假劣药品有关的失职、渎职行为的法律责任
新修订的药品管理法规定："已取得《药品生产许可证》、《药品经营许可证》的企业生产、销售假药、劣药的，除依法追究该企业的法律责任外，对有失职、渎职行为的药品监督管理部门直接负责的主管人员和其他直接责任人员依法给予行政处分；构成犯罪的，依法追究刑事责�"（第九十七条）。
（h5）明确了药品监督系统内实行层级监督管理的规定
新修订的药品管理法规定："药品监督管理部门对下级药品监督管理部门违反本法的行政行为，责令限期改正；逾期不改正的，有权予以改变或者撤销"（第九十八条）。
（h6）明确药品监督管理人员违法行为应承担的法律责任
新修订的药品管理法规定："药品监督管理人员滥用职权、徇私舞弊、玩忽职守，构成犯罪的，依法追究刑事责任；尚不构成犯罪的，依法给予行政处�"（第九十九条）。
（h7）明确药品检验机构及有关人员玩忽职守应承担的法律责任
新修订的药品管理法规定："药品检验机构及其人员出具虚假检验报告，构成犯罪的，依法追究刑事责任；不构成犯罪的，责令改正，给予警告，对单位并处三万元以上五万元以下的罚款，对直接负责的主管人员和其他直接责任人员依法给予降级、撤职、开除的处分，并处三万元以下的罚款；有违法所得的，没收违法所得；情节严重的，撤销其检验资格。药品检验机构出具的检验结果不实，造成损失的，应当承担相应的赔偿责任"（第八十七条）。
功能化妆品是科学研究中，国际的热门课题。有关报道的文献资料已经迅速增加，展示很多特殊利益集团以及化妆品厂商的观点。他们已经利用自身许多资源，加入日益高涨的功能化妆品市场。
（3）美国对化妆品和药品法规管理
美国1938年联邦食品、药物与化妆品法案立法历史
FDA管制化妆品的权利，首次出现在FDCA（联邦食品、药物和化妆品法案）的化妆品政府法规中，它不包括在1906年食品和药物法案13，政府机构的官员在1917年注意到这个空白："尽管食品与药物法案的完成具有重大意义，但是必须承认，它有严重的局限性。特别显著的一个是…在定义上给术语'药物'的限制，致使难以控制有害化妆品…"14。纽约参议员Copeland在1933开始，被来自政府机构的化妆品损害报告所激发，这类损害是由例如"Koremlu面霜"这类产品所产生，"Koremlu面霜"是一种含有醋酸铊的脱毛霜，醋酸铊是一种非常有毒的化学品。该产品虽然正如FDA在1933年的年度报告，已经被描述成"对皮肤完全无害和实际上有益"，但是由于其普遍的流行，已经造成对许多例使用者的皮肤损害，这样迫使制造商做出巨大的赔偿，造成破产。联邦政府由于缺乏管制化妆品的立法权，不能给予消费者提供应有的保护15。于是Coneland在1933年6月6日提出S.1994，它是几个法案版本中的第一个版本。立法机构对化妆品安全性的关注，体现在该法案的第5章，禁止化妆品的掺假现象。按照该提议的法规，如果在通常或指定的使用条件下，化妆品对消费者造成伤害，或者如果化妆品含有任何被政府机构法规限制或禁止的"有毒的或有害的成分"，那么该化妆品将被认为是掺假的16。然而S.1994法案在美国的每个地区都遇到强烈的反对，17并且被S.2000版法案所代替，改变第5章的第一部分以将掺假化妆品定义为："具有或含有任一有毒或有害物质"，18在通常或指定的使用条件下，可能对消费者有害。这种定义在法案的后来版本中被充分保持着，从而将FDA法规集中在化妆品有害的组成物。
贯穿法规多个版本中的另一个转变，是出现在对术语"药物" 的定义方面。在最初的参议院法规中，正如目前在FDCA中所显示，食物被排除在"药物"定义的最后部分之外："意欲影响机体任何功能或结构的所有物质、制剂和器械（除了食物）"，在法案于1935年5月31日到达众议院州际和外贸委员会的时候，食品和化妆品都被排除在定义之外19。尽管这个版本法案在众议院没有被通过，但是当该法案作为S.5于1937年1月6日被重新提出时，化妆品的定义没有再出现20。结果，"药物"和"化妆品"的定义不会相互排斥，并且符合这两个定义的产品，必须遵守这两个法规21。
(4) FDCA中的化妆品与药品法规
FDCA中的化妆品法规与药品法规一个重大区别在于：化妆品制造商被免除产品上市前的检验。这就意味着具有潜在有害的化妆品，通常只能是在上市后，并对消费者产生显著伤害后，才会被发觉。
美国法典章节21的条款361至363， 详细记述了化妆品法规，其与条款331一起，禁止美国州际贸易中任何化妆品的掺假或贴假商标22,23。如果按照通常的使用方法，化妆品含有
"使其具有伤害性的有毒或有害物质" 24；如果它含有"不干净的、腐烂的或已分解的物质"25；或如果它在不卫生条件下被生产或包装26，那么该化妆品是不合法的。如果化妆品的标签或容器弄虚作假或使人误解，27
或者如果它不具有必要的信息28，那么它也可被认为是不合法的。因而FDCA授予FDA权力去管制市场上，那些被发现有害，或已经做出使人误解声称的产品。但是因为FDCA，不要求化妆品制造商向政府提交任何结果信息，必须完全以制造商自愿提供的信息为基础，29
或以上市后对消费者投诉的反应或其他警戒机制为基础，实施该法规。
相反，在许多致力于安全的法规子章节方面，药品法规相当详尽30。同化妆品一样，对于药品的掺假也是被禁止的。虽然FDCA进一步规定，如果药品不是按照"现行良好制造规�"制造，以确保安全、质量和纯度31，那么该药品可被认为是掺假的。药品，同化妆品一样，如果它贴上假商标，更确切地说，如果它的标签是虚假的、使人误解的，不能给予足够的使用说明，或相反不遵守法律32，或者如果当按照建议使用药物时，药物对健康是危险的33，那么该药物就算是违法。FDCA还进一步规定：所有药品制造商必须向美国卫生和人类服务部（DHHS）登记，并且提供所有生产药品的清单34。此外，如果新药没有向该机构申请并获其批准，那么不得上市。申请必须含有关于药物安全性和有效性进行研究的完整报告；药物成分的全部清单与其生产过程的描述；和药品计划采用的标签的样本35。一旦药物被批准，制造商必须向该机构提交：关于临床试验的资料；或者其他暗示该药物对公众健康有危险的信息36，并且该机构根据这些信息，进行重新审查，决定是否批准该新药上市37。
总之，FDCA对新药规定了相当多上市前的评估，特别是关于药物的安全性和有效性。对于新上市的化妆品没有这类评估，也不要求化妆品制造商向FDA注册，这种使国会关切的状况，足以发起听证会和立法38，但是还不足以修正FDCA39。
当然，如何管制某种产品，完全依赖于如何定义它；FDCA将"化妆品"定义为：
（1.1）意欲用来涂擦、倾注、喷撒或喷雾、引入或涂敷于人体或者人体的任何部位，以清洁、美化、增加魅力或改变容貌的商品；并且（2.2）打算作为任何这类物品的一种成分而使用的商品；只是这种定义不应包括肥皂；40并且将"药物"定义为"（B）意欲供诊断、治疗缓解、治疗或预防人类或其他动物疾病使用的商品，并且（C）意欲影响人类或其他动物机体任何功能或结构的商品（除了食物）…"。41最高法院趋向于广义地理解这个定义，并且这样就不会将它自己限制于"药物"这个词的严格医学定义42，国会完全想要"1969年注释的法律，其包括的范围，如其字面语言所显示的那样广泛和同样地清楚，另外，比严格医学定义更广泛的定义，也是可能允许的"43。这样，给许多化妆品的制造商产生了相当多的难题，因为几乎任何化妆品，都能有对机体的结构产生影响，那怕是微小的44。实际上，两者本质的区别是：化妆品是产生暂时的、表面作用的物质，该作用与一个人的容貌紧密联系，而药物是对一个人的健康产生更持久的、结构变化的物质。然而，对于被认为是药物的产品，不要求产品作为化学或代谢作用的结果而发挥影响，政府机构将"药物"的法定定义简单地解释为："液体、糊剂、粉末或其他药物制剂形式的化学药品或化学药品的组合物，口服、注射或灌输入人体内，以获得其想要达到的医疗目的"45。至今，FDA拒绝制定指导方针，以阐明化妆品与药物的区别，仅阐明厂家每个主张内容要经得起检验46。
然而，两个定义的关键是"意欲"这个词，一个产品被分类为药物还是化妆品？那就看它意欲当作何用途。因此，这两个定义不是由产品的化学成分所决定，而相反由制造商对该产品上市的目标意图47所决定。直到最近，不管制造商将产品宣传为治疗作用，还是只有表面作用，48，正如第二巡回审判庭在1969年所提到的，"不管一个产品的真实物理作用，根据法案的规定，如果标签上宣传主张显示：将其确定在药物定义范围内的指定用途，那么它将被认为是药物�"49这个焦点已经导致站不住脚体系的产生，因为产品的状况可以按照制造商一时的兴致而改变，也可以由制造商已经发布的广告主张、标签、宣传材料和"任何其他有关原始资料"50来确定。精明能干的制造商，不管产品的安全性，会阻止其产品进行详尽的管制和上市前试验，只是以不明确的、不能证实的语言来表达任何广告主张51。而且，不管产品实际上对机体结构或功能，是否有作用。如果制造商声称它有疗效作用，那么它被认为是药物；如果它不声称疗效作用，那么它就被认为是化妆品。对于声称为化妆品，但实际上是由危险化学药物制备的产品，也可以避免上市前的管制，然而声称完全由水52组成的能"使皮肤细胞变丰满"的产品，也会造成该产品作为药物来管制53。
20世纪60年代末和20世纪70年代初的三个案例，最好地阐明了这类法规体制的不合理性，在那个时代，在考虑"皱纹消除剂"应该被认为是化妆品还是药物54的时候，法庭抓住化妆品与药物的区别。尽管在每一个案例中由不同公司并且以不同名称上市，该产品同样是小牛血清和水的组合物，当该产品被用于面部的时候，它形成能暂时消除皱纹的膜。两个法庭认为该产品是药物；其他一个法庭认为该产品是化妆品。第二巡回审判庭坚持因为制造商声称该产品提供"无需手术的面部整容"，并且能"消除肿块"，它应该被认为是药物55。相似地，第三巡回审判庭坚持因为制造商在其广告中包含类似如"非常有效"和"使皮肤变紧"的短语，它暗示实际上该产品是治疗剂胜于化妆品，所以应该作为药物进行管制56。相反，马里兰州的联邦地区法庭坚持该产品是化妆品，认为在考虑中的产品所作的声称（其包括声称该产品是"纯的蛋白质"能造成"收缩感"），没有接近其他两个产品所作的声称的水平57。
由于联邦地方法庭在北卡罗来纳州裁决，这个相对已处理过的事件和产品声称，已经产生了问题，该裁决批准FDA具有管制烟草的权力58。工业界认为：指定用途的产品，只有根据制造商的声称来确定，并且因为烟草制造商，没有进行关于尼古丁影响机体结构或功能的广告宣传，所以尼古丁不能作为药物管制59。法庭拒绝这种立场，并认为在FDCA中，"意欲"的"通常意义""没有表明必须通过任何特殊证据来证明该意图"60。而且，地方法庭指出：尽管没有法庭在没有制造商的声称而发现产品的意图，"没有法庭已经认为指定用途，只是通过推广宣传代表来确定"61。结果，它认为，FDA对以证实意图的产品，可预测用途和实际用途（换句话说，因为尼古丁对机体的影响，消费者将被期望使用，并且的确使用尼古丁）的信任，是FDCA的合理解释，所以享有遵从权利62。
如果提出上诉63，这个裁决是否将影响FDA对化妆品的管制，是不清楚的。化妆品工业的神秘感，完全取决于广告，所以制造商不太可能停止宣传其化妆品的功效。如果这是真实的话，对化妆品法规，就不会有很大的影响，并且事态如以前那样继续。然而，在没有这类声称和很差的AHA名声情况下，法庭的裁决就会给严格的FDA法规，网开一面。
有迹象表明，在化妆品宣传方面，FDA可能寻求这类广泛定义，其包含将产品的配方，作为其指定用途的证据。"如果活性成分达到治疗浓度，那么，该产品就是药物，即使该产品没有声称会产生疗效性作�"，FDA化妆品和颜料办公室的主任
，John Bailey1996年如是说。"该活性成分的出现，即使没有达到治疗量，但当决定其管制状况时，也必须被考虑。因此，只要该活性成分出现，该产品就是药物，而不管标签上所做的是什么声称"64。例如，如果某产品在其标签上或成分名单中包括"荷尔蒙"这个词，那么它将被认为表达了暗指的药物声称，即使在产品的容器上没有出现其他宣传，也将作为药物来管制65。因此，FDA将如何管理AHA，将部分地依赖于：政府根据关于化妆品的管理目标，如何选择去定义"意欲"。
在1938年，美国国会通过食品、药物和化妆品法案，该法令在详细条款中确定化妆品和药物的法定定义，为将产品归类为药物或化妆品，提供了官方正式的标准。它承认只有两种性质相反的类群：药物和化妆品。没有中间类别的存在，尽管意识到：外用制剂既是化妆品，同时又是药物。
值得注意的是，1938年法案的产生，是针对许多可笑的灵丹妙药和秘方药、或是一些危险的、许诺能包医人类百病药物的正面反应。
根据这个1938年的定义，化妆品部分恰当地是"意欲美化和提升吸引力的物品"。
相反，药物被定义为在诊断、治疗、处理或预防疾病中使用，能够影响机体结构和功能的物品。这个结论性的条款，在法律上，决定某个制剂是药物还是化妆品。这也促使我们介绍功能化妆品。
那将我们带到这个重点：不是通过产品的成分，而是通过标签上或广告中的宣传，来决定该物品，将被归类为化妆品，还是药品。同样注意到，美国国会宣称将"意欲"使用，作为决定区分产品类型的标准。因此，如果声称涉及疾病的诊断和治疗，那么该物品就是药物。如果在广告中描述的指定用途，是为了提高吸引力，那么该物品是化妆品。
功能化妆品作为中间地带的产品
新生物现实：当1938年法令被起草的时候，美容科学还是很简单、很粗糙；充满民间色彩和缺乏支持论据的宣传。从现在看来，1938年的药物定义完全过时了，并且实际上是相互矛盾的。随着皮肤生理学的巨大进步，我们理解到：一种单一的物质在某些情况下，是不可能改变皮肤的结构和功能的。
最引人注目的例子是水，它是所有生命存在的基础。在公众心目中，水是最无害的重要象征。然而，将带水的棉花贴在人皮肤上，贴上两天的时间，发炎前的物质例如白细胞介素，就会从死亡的角质层释放出来；产生一系列活表皮细胞毒性变化。再过几天，在真皮层也会引起炎症反应。这就是长期与水接触，引起不良临床反应的例子。例如在日常家务或酒吧招待、罐头制造和其他等职业中，常见到这样的不良反应事件。因此，乳剂中水在给干燥皮肤补水时，水是有益的；同样大量与接触水，它又是有害的。
另一个传统的物质是凡士林，每个人都承认它是非常稳定安全的。然而，许多研究表明：凡士林能促进伤口的康复；即使它不是遮光剂，但还能预防紫外线诱发的肿瘤。这些都说明凡士林，具有改变皮肤结构和功能的明显医疗作用。
一个有理性的人，不会把凡士林或水当作药物。如果我们按照1938年法案"结构和功能"限制性条款的严格解释，那么这些和许多其他例子都清楚地表明：几乎所有化妆品将会被重新归类为药物。
大多数的皮肤护理产品，几乎都处于药物和化妆品之间。它们包括国会定义的两种相反性质类别之间的、范围连续广泛的中间产品。某些传统的化妆品有药样的有益作用；而某些药物主要是影响于外表。就是这种居中的、范围广泛的物质，同时作为药物和化妆品发挥作用，这证明联合术语功能化妆品（Cosmetics
的字头 Cosme 加上Pharmaceuticals 的字尾 ceuticals 构成 Cosmeceuticals
功能化妆品 ）是合理的。这只是承认皮肤护理产品新现实的生物学概念。
法规的现实：这个新生物现实的接受，不意味着我们需要新的法律，来定义功能化妆品类别的法定术语。美国食品与药物管理局，一直有权从广告声称和标签来决定，作为化妆品宣传的产品，是否已经超越界限，将其重新归类为药物。
功能化妆品是一个很重实效的术语，它使我们不必虚伪地声明产品的益处。它不是成为通过新法律的借口。1938年法令的严格法律条文解释，将使得无数有活性化妆品转变成为药物。这将成为大灾难。它将直接地阻碍制造商的创新和创造力；并且通常需要药效和安全性证据，使药物的发展缓慢。在另一个方面，假如声称不是非常令人误解的，那么，化妆品就不需要上市前的官方许可，并且能被迅速地商业化。
有人赞扬FDA在过去几年中，尽管某些产品声称有些夸张，但在审查产品声称方面，表现出一定的灵活性和宽容性。当某些化妆品制造商，被鼓励对其产品进行坦诚的药物声称时，问题就来了。对此，FDA发出警告信：要求对产品进行重新标签，而不必改变原有任何成分。如果在发布α-羟基酸突出的防衰老的"声称"中，他们不做出诱人的声称，那么，谨慎和诚实的竞争者，就会处于不利境地。
总之，功能化妆品使化妆品科学家，能够相互交换关于标准的看法，该标准必须能够证明其功能声称，是有道理的，而不是借助于引人上当的广告宣传或欺骗。
1.5 功能化妆品在发达国家法规管理比较
国际法规政策
有3个主要的国际商业区：美国、欧洲和日本。明显地，如果每个地区对皮肤护理产品实行不同的分类和管制，那么作为完整自由贸易网络的全球化是不能起作用。遗憾的是，目前不存在一致的国际共识，对某些产品出现辩论和贸易摩擦，在所难免。
我们将简要地谈谈欧洲和日本的法规政策。即使是匆匆地看看法规差异，也会显示出，因没有建立一致的、国际的标准，而产生极度麻烦的、不稳定的影响。这些例子将展示目前盛行的、混乱的和不合理的现状。希望一些一致的意见会很快出现，以避免明显的严重争论。
欧洲：在1993年的欧洲经济共同体（European Economic Community; EEC）化妆品指令中，对化妆品标签的要求，是难以应付的和使人畏缩的66。必须提供给官员的产品信息包含以下内容：
产品的定性和定量组成；
原材料的规范；
制造方法；
安全性评；
有效性证据。
（在美国，化妆品在上市之前，不要求化妆品制造商像对药物要求那样，证明安全性或有效性。）所有这些该被结束了，因为EEC警告化妆品的实验动物，在1998年1月后将被禁止，后来延期到2000年6月。在我们看来，这些是不切实际和不负责任的。
日本：日本当局已经建立他们自己的法律，以对付这个问题，即许多皮肤护理产品在传统意义上，既不是纯粹的药物，也不是纯粹的化妆品，但是他们是这两种的混合物或杂合物。我们所称之为功能化妆品的东西，在日本被称�"类药物"
67。他们允许化妆品包括有药理活性的成分，假如该产品的医疗作用是温和的，并且已经被证明是安全的。该法律为不确定性和某些作为贸易限制的广告解释，留下了很大的模糊空间。
美国：在美国，下列药剂：止汗剂，去头屑香波的成分和防晒剂，作为药物被管制，而在欧洲，根据EEC标准，它们是化妆品。在欧洲防晒剂更先进、更有效，那是因为EEC允许化妆品制造商对防晒剂，有更多的选择空间。
似非而是的论点在美国大量存在。例如，视黄醇（维生素A）可作为化妆品出售，但是其氧化产物视黄酸，是作为药物被管制，而且，FDA最近批准视黄酸作为只涉及改善外表的纯化妆品声称的化妆品。然而，该产品只是作为药物才可以得到；它需要医生开处方！另一方面，米诺地尔（minoxidil）没有处方也可以得到，该药物声称可以生发，并且提高吸引力，因而满足化妆品的基本定义。
有时候，许多法令的例外和漏洞，也会导致危险。例如，茶碱（Theophyllin）是治疗哮喘的有效药物，其治疗指数小，而被建议做常规血液检查。然而，当它混合入局部制剂，用以治疗脂肪团（减肥）的时候，就可以作为非管制的化妆品，在保健食品店出售。为什么这样呢？
建议：建议所有利益团体应该读一读：由Vermier and Gilchrest撰写的切合实际和精深的论文。他们认为功能化妆品已经存在；实事上，他们希望：将功能化妆品作为化妆品和药物之间的中间产品；并且应该继续被认为是化妆品。目前的法律定义是过时的，和不切实可行的。作者接近欧洲的立场，建议证明活性化妆品的功效，是制造商的利益所在。
1.6 西欧美国和日本对功能化妆品的不同见解
尽管缺乏对功能化妆品的正式认可，术语功能化妆品如今流传甚广，成为国际化，并且对于在化妆品和药物之间存在第三类产品产生的争论正在加强。关于这个主题的著述是吸引人的，并且覆盖了一个相当大的范围，在该范围内，充满着来自全球各地有分歧的，混乱的、冲突的见解66。新近的论文强烈表达了：该领域中大多数参与者的感受和意见。
英国：Dweck的论文表达了英国人的观点。他表达如下："究竟什么是功能化妆品？是试图使消费者相信：他们的皮肤护理品，的确是不用正当许可的局部药物，或它是名副其实的类别，与普通皮肤护理产品相比，以试图提供温和的、更需要进行严格试验的产品吗？"68。他建议阅读官方医药宣传品作为指南，以决定什么是医药产品。他的结论是：未来的有关讨论会将充满着争论。充其量，英国人已经加深了该产品分类的相互争论。
欧洲大陆：Wittern从欧洲的观点开始谈这个问题。他明确表示不倾向功能化妆品，这个术语69。他认为"现有的法规是准确的，并且化妆品和药物功效之间的区分是清楚的"。他们不允许引入新类别产品例如功能化妆品。他认为引入该术语，但是不必对它进行定义。他写到，"很明显，Kligman不知道着手干什么。"我感到内疚：不知道这个新概念会带来什么争论的风暴。
德国：功能化妆品错综复杂局面的主要事件是标题为"功能化妆品：化妆品的未来" 的文章，由德国杜塞尔多夫（DUSSELDORF）的Umbach撰写70。他说："此刻，在化妆品工业几乎没有主题象功能化妆品那样，引起这么多的争论。"
Umbach认为，与美国成问题的法规现状相比较，欧洲的法规现状较有远见，因为美国法规各部分不协调，主要是旧法律造成的后果。
Umbach认为功能化妆品满足了，消费者对高功效的需求。但是根据Umbach所说，从消费者和法规观点来看，对功能化妆品进行单独分类，既不是有益的、科学上适合的，在法律上也不是有必要的。他写到：功能化妆品这个概念是多余的。我们能为消费者提供的最明智的和最有用的服务，建议立法者和制造商，在将来不使用这个术语！
美国：Steinberg在他的一篇文章："功能化妆品"中展现了美国人的观点71。他赞同功能化妆品这个术语,
他还认为： 该术语的引入，需要认可药物和化妆品的法规定义，而且他还呼吁，制定一个可以实施的这类产品的法规，得到国际社会的共认。
日本：在日本，Takamatsu在其标题为"我们该如何定义功能化妆品"的专题论文中67，叙述了相当不同的状况。它透露日本政府在早期认识到这些问题，这些问题是因为化妆品工业有能力，制造出不仅仅具有美化作用的"功效"产品，而涌现出来。
1.4 Regulatory policies for cosmetics
and drug between China and USA.
中国与美国对化妆品和药品法规管理
(1) Outline of China supervising and standardizing the
cosmetics and raw materials hygiene4
(a ) In order to strengthen the hygiene supervision
of the cosmetics, and guarantee hygiene quality of the
cosmetics and security of using, and ensure consumer's
health, on September 26 1989 the State Council approved
the third order of Health Ministry of issuing the cosmetics"
the hygiene supervision and the management rule "
on November 13 1989. In 2002, Health Ministry revised
" hygiene standard of the cosmetics" newly,
Standard carry on the cosmetics and examine and approve
and supervise work according to coming to ask the unit
concerned strictly. To make cosmetics of our country
industry development, and satisfy the people and beauty
the request for life, have made regulations to ensure.
In the cosmeceuticals in our country, involve breed
hair, hair-perming, hair-peeling, hair dye, enlarging
breast, anticellulite, deodorant cosmetics, dispelling
spot, and sunscreen, these nine kinds of cosmetics,
is called functional cosmetics,3,7,8,9 Necessary with
the approval of hygiene administrative department of
the State Council, namely present Chinese Food and Drug
Bureau of Supervision and Administration (FDA. of China
), it will be approved after making approving the gentle
number, then, produced and marketed. China FDA invites
scientific research, medical, manufacture, the hygiene,
and the relevant expert, in order to evaluate the safety
property of the cosmeceuticals. Make up and sample the
kind special use more for cosmetics of importing, the
above: the new raw materials of and the cosmetics carry
on the safety property to evaluate, the great accident
caused to the cosmetics carries on the technical appraisement.
(b) The request that the personnel is healthy stipulates
clearly for production: The personnel engaged in the
cosmetics and produced directly, must carry on health
examination every year. After making the health card,
engaged in the activity in production of the cosmetics.
Any personnel suffering from tinea manus, nail tinea,
eczema of hand part, psoriasis in hand part, oozing
out nature skin complaints, and suffering from dysentery,
typhoid fever, and the of infectious diseases such as
viral hepatitis, active pulmonary tuberculosis, etc.
does not have engaged in the activity in production
of the cosmetics directly.
(c) Requisition on cosmetics raw materials. "Cosmetics
Hygiene Regulation Standard (CHRS) presents to forbid
using (The hygiene legal supervising department of Ministry
of Health of the People's Republic of China in November
of 1999) one part Tab.2 of the general rule (1) and
(2) in the group of the cosmetics gives forbidding material"
the materials listed. The forbidding materials reach
several hundred kinds, the materials have hypertoxicity
or obviously have materials of chronic toxicity, and
some have irritating to the skin or the mucous membrane.
In all " limited using material in Tab.3"
of CHRS, the ones that must be accorded with and stipulated
allow the density greatest, allow the scope of application
and limit to use the condition. Combine have stipulated
the mandatory declaration in the label.
The antiseptics must accord with "Tab. 4 of CHRS"
that are inhibitors of the microorganism growing, the
Nation claims antiseptic allowing density, greatest
in the cosmetics, and the limit uses range. The antiseptics
must prepare against the essential explanation on the
condition and label.
In the "Tab.5 of CHRS", cosmetics ultraviolet
absorbent must accord with "Tab.5 of CHRS".
The standard stipulates that is avoiding poison, use
the material of these under the prerequisite of side
effect and strain divided by the ultraviolet ray, by
protecting the danger not receiving ray.
The cosmetic dyestuff must accord with "Tab.6 of
CHRS". Cosmetic dyestuff of limited use is 4 kinds:
The first kind can be used for general cosmetics. The
second kind is coloring agent that can't be used in
the oral cavity and lip part cosmetics. The third kind
can't be used in the eyes parts cosmetics. The fourth
kind can't be used in the oral cavity, eye and lip cosmetics.
(d) The packing request for the cosmetics: namely keeping
in touching the container and wrappings of the cosmetics
directly must accord with the national sanitary standard.
(e) The content thing is demanded to the cosmetics:
cosmetic manufacturer pay attention to and take place
the little biological pollution phenomenon easily most
conduct industry. The harmful effects to the cosmetics
of microbial, make product color, fragrant and smell
change, and quality drops. Microorganism's pollution
cause a diseasing mainly that, Cause user's health danger.
If the quality bacterium pollutes, can cause the consumer's
the infection of skin that is allergic, red to emerge
swollen, and influence the market prestige of the producer
of the cosmetics again. So, microorganism quality to
the cosmetics should accord with stipulate following:
The quality of microorganism in the cosmetics should
accord with the following regulation: the bacterium's
total amount in eyes, lip and baby cosmetics can't be
greater than 500 CFU/ml Or 500 CFU/g. The bacterium's
total amount of other cosmetics can't be greater than
1000 CFU/mL or 1000 CFU/g. Or can't find the excrement
coliform groups, pseudomonas pyocyanea and saccharomycete
aureus of every mL of or g of product. Total amount
of mould and yeast can't be greater than 100 CFU / mL,
or 100 CFU / g in the cosmetics. The harmful substance:
" Mercury"≤1 mg / kg (Include the except eyes
parts cosmetics of organic mercury antiseptic ); Lead,
(Count with the lead )≤ 40 mg / kg (Include CH3COOPb
except hair dye ); Arsenic, (Count with the arsenic
)≤10 mg / kg), 2000 mg / kg of ≤ of methyl alcohol .
(2) Overview of Chinese New Drug Regulation Act 5 (CNDRA)
On February 28, 2001, it is undoubtedly memorable day
on China's medicinal history of development. At this
day, revised and passed " CNDRA " by Standing
Committee of the National People's Congress a time of
meetings. In accordance with ruling by law better, and
in order to enter new century and market economy in
our country, our country has established the solid legal
foundation.
The aim of managing law of drugs is in order to strengthen
drugs supervision and management, guaranteeing drugs
quality, it is safe to ensure the human body to use
the drugs, and safeguard the in good health and legitimate
right and interest of the people using drugs.
Since implement officially on the 1 of July of 1985,
" current drug regulation act of the People's Republic
of China " (the following called as " CDRA
" ). Guarantee drugs quality, attack and make and
sell false, bad drugs illegal activities finish ensures
the civil drugs of people to be safe. It is important
in our country. However, with the deepening with constant
development of socialist market economy of reform and
opening up to the outside world of our country, study
drugs, production, circulation, and use appear the a
lot of new problems: The drugs supervision and management
system emerge great change. So, manage the law and revise
to the current drugs, it is imperative to improve it
already. " CNDRA " revised. Amounting to ten
chapters and clause106. The main content summary revised
now is as follows:
(a ) Make the drugs clear and supervise the enforcing
the law in the subject position of the administrative
department, have embodied the achievement of reform
in government organization fully. During the State Council
reform in government organization of 1998, According
to principle of efficiency, retrenching and unifying,
the State Council determined to produce the drugs which
original State Pharmaceutical Administration exercises
and circulates to supervise function, drugs policy management
and drug test function which the National Health Ministry
exercised, National Traditional Chinese medical bureau
exercised. Traditional Chinese drugs that the bureau
of administration exercises circulates and supervises
the function to concentrate on being handed in and supervise
the office of managing to exercise by national drugs
setting up newly. After this, the State Council has
made reform drugs of setting up and supervision management
system again, Supervise the administrative department
and implement perpendicular management important decision
to the under drugs of province. Supervise the spirit
of managing system reform in order to embody the drugs,
legally consolidate the reform achievement, manage by
what has been revised supervise the administrative department
drugs with clear law newly drugs (Supervise bureau of
administration including the national drugs, every province,
autonomous region, the municipality directly under the
Central Government drugs supervise ground for the bureau
of administration and perpendicular management, city,
the county drugs supervise the administrative department
) enforce the law subject status. At the same time,
revised the drugs and managed the law and still increased
the management regulation of supervision related to
drugs, by protecting the legitimate right and interest
of the person who uses drugs.
The new drugs regulation revised newly claims: "
the State Council drugs supervision administrative department
and in charge of the national drugs and supervise the
management ". The department concerned of the State
Council is responsible for the relevant supervision
management with the drugs in the each duty range. Province,
autonomous region, the municipality directly under the
Central Government people civil administration office
drugs supervise the administrative department and responsible
for supervising the management drugs the area of a administration.
Province, autonomous region, the people's civil administration
office department concerned of the municipality directly
under the Central Government is responsible for the
relevant supervision management with the drugs in the
each duty range. Last administrative department the
State Council drugs and cooperate economy in charge
of department of syntheticallier the State Council,
Carry out drugs trade development plan and industrial
policy that the country makes. " (Clause 5 )
(b) Unify to the examination and approval of running
the enterprise and drugs newly, reduce examining and
approve the link, the standard examines and approve
the behavior, and improve administration efficiency.
(b1) Unify to running drugs production newly, manage
the examination and approval of enterprise according
to the method while managing the regulation of law and
carried out of current drugs. Run drugs manufacturing
enterprise, managing the enterprise must pass the drugs
raw produce and manage responsible institution and two
examinations of the hygiene administration department,
and get the certificate of quality of drugs manufacturing
enterprise and license separately, the drugs are managed
enterprise certificate of quality and license. Handle
the industry and commerce according to two register
certifications, get the business license and have "
take by two cards and one" open. The drugs that
production has there is standard already need be verified
and approve after being solicited the drugs production
and management and been in charge of the department
suggestion by the hygiene administrative department.
This kind of method causes department functions and
powers to cross. The formality is repeated to handle
affairs, administration efficiency is low, and aggravated
the enterprise to bear. For a long time, the enterprise
appeals for reducing examining and approve link strongly,
the reform examines and approve the system.
During this reform in government organization, The Party
Central Committee, the State Council determines to set
up the national bureau of drugs supervision and administration,
and set up new drugs and supervising management system.
In order to unify correctly from management system run
drugs production newly, the examination and approval
of managing the enterprise creates the condition. In
view of the above, revised the new drugs regulation
simplified drugs manufacturing enterprise of running
newly, managing the examination and approval procedure
of the enterprise," two will examine and approve
", one is taken and" change into" examining
and approve together in two cards (The drugs supervise
the administrative department to examine and approve).
And one License (Business License )" .
(b2) Unify the drugs to examine and approve, and cancel
the drugs place standard. At traditional Chinese drugs
material, the traditional Chinese drugs sliced medicinal
herbs is brought into and standardized gauge. Current
drugs manage the regulation to fix in the standardize
management track, The drugs standard includes the national
drugs standard and province, autonomous region, the
municipality directly under the Central Government drugs
standard. Already there is national standard or province
in production, autonomous region, the drugs of municipality
directly under the Central Government standard, from
province, autonomous region, the municipality directly
under the Central Government hygiene administrative
department approves gentle number. Such a regulation,
cause the same drugs variety in different province,
autonomous region, there are different standards in
the municipality directly under the Central Government.
Some localities are in order to protect place interests.
Even reduce local standards and examine and approve
the drugs. This causes drugs quality to drop, one of
the serious important reasons that the low level repeats
the production situation. However, manage the law in
canceling the locality to while producing the examination
and approval authority of the drugs that revise newly,
have still cancelled the drugs place standard. The new
regulation: "The new drugs of production or already
had drugs of national standard, Must be approved by
the drugs supervision administrative department of the
State Council, and approve gentle number for the new
drugs " (The clause 31 )," the drugs must
accord with the national drugs standard " (The
clause 32 ).
According to the current new drugs regulation: Traditional
Chinese drugs of production material, the traditional
Chinese drugs sliced medicinal herbs does not need through
examining and approve and make and approve gentle number,
because to traditional Chinese drugs of production material,
the traditional Chinese drugs sliced medicinal herbs
lacks standard of scientific management, traditional
Chinese drugs material of our country, occupy high to
down for a long time qualification rate sliced medicinal
herbs quality traditional Chinese drugs, exceed other
drugs far. Traditional Chinese drugs material, improvement
of quality question restriction Chinese patent drugs
quality of traditional Chinese drugs sliced medicinal
herbs, have caused the decline of clinical curative
effect of traditional Chinese drugs, and have harmed
sound development of cause of traditional Chinese medical
science and traditional Chinese drugs. So, to those
traditional Chinese drugs material need and made quality
level. The traditional Chinese drugs sliced medicinal
herbs is produced and implements standardization, it
is very essential to standardize management. At the
same time, consider traditional Chinese drugs material,
the sliced medicinal herbs variety of traditional Chinese
drugs is diversified in specifications much more. Every
place gets used to with the drugs, the concocting method
is not unified, all bring into standardization, standardize
and manage reality tiredly difficult, so, revise the
drugs and manage the principle of the law and stipulate
newly: "Implement traditional Chinese drugs material
which approve gentle number, the sliced medicinal herbs
variety catalogue of traditional Chinese drugs supervise
the administrative department and manage the department
to make jointly with the traditional Chinese medical
science and traditional Chinese drugs of the State Council
" (The clause 31 ).
In addition, some traditional Chinese drugs sliced medicinal
herbs have no national standard. Production of these
traditional Chinese drugs sliced medicinal herbs should
be directly supervised province, autonomous region,
and direct municipality. So, the new drugs regulation
revised is fixed: " the traditional Chinese drugs
sliced medicinal herbs must conform to the national
drugs standard ". If there is no national drugs
standard, the traditional Chinese drugs sliced medicinal
herbs must conform to "the stipulation" of
province, autonomous region, direct municipality must
be reported the Central Government for the record. (The
clause 10 ).
(c) Further standard and manage that strengthens to
the drugs imported. It is safe to be effective to guarantee
to import the drugs, and adapt to our country joining
World Trade Organization (WTO ) new situation.
(c1) Determine and import examine and register system
manage the law and only propose to the drugs importing
for the first time by the request that approve by current
drugs, but to importing drugs validity, appraisal of
safety property and control of the quality of the products,
have not also put forward the request that has confirmed
clearly. In addition, current drugs regulation for importing
drugs has not met market economic development, because
it obscure with supervision of the drugs and the commercial
behavior. Then, the new drugs regulation revised newly
is fixed: " the drugs imported, must be organized
and examined by the drugs supervision administrative
department of the State Council ", Through examining
confirming according with quality level, safe to be
effectiveness, and approve importing, issue and import
the drugs certificate. (The clause 39 ).
have imported the、 clearly in above-mentioned drugs
regulation of examination and register the system, promptly:
The drugs that have already been listed to foreign countries
are entered before the market of our country should
be examined and registered by the National Bureau of
Supervision and Administration. The National Bureau
of Supervision and Administration check and verify to
technical data and relevant identification file that
declare, should carry on the clinical testing in our
country in case of necessity, drugs quality level should
carry on the laboratory and check examining, and confirm
its steerable drugs quality. After the quality of declaring
variety checks and study clinically, The National Bureau
of Supervision and Administration examine to the relevant
materials, fulfill requirements, authorize and"
import the drugs registration certificate". Then,
the foreign drugs enter China. If there is no identification
file and " import the drugs registration certificate",
the foreign drugs can not be sold in China.
(c2) The drugs that determine to import the drugs and
appointing the port are supervise examination of administrative
department to being put on record the system.
According to the current drugs regulation, before every
importing the drugs and enter the Chinese market to
sell, should examine and approve. In order to achieve
and already guaranteed the quality of importing drugs,
the purpose to link up with WTO's international trade
again, the new drugs regulation revised claim: "
the drugs must be imported from the port that allow
to import ", and supervision and administration
department to register and was put on record to the
port site drugs from the enterprise which import the
drugs. The ones that supervised the administrative department
and drew according to the drugs in the customs"
import the drugs list of the customs " to let somebody
pass. There are not ones that " import the drugs
list of the customs ", the customs can't let somebody
pass. Supervise administrative department of the port
site drugs it inform drugs it doesn't examine supervise
and manage as to importing go on and spot check and
examine at drugs regulation department according to
the State Council drugs at organization. And originally
accord to the second style regulation of the clause
41 obtain collect fee of examination. Allow drugs and
import by port to supervise propose jointly with General
Administration of Customs at administrative department,
and report to the State Council for approval. "
(The clause 40 ).
The above-mentioned regulation has determined to import
the drugs and appoint the port supervise examination
of administrative department, and was put on record
the basic principle of system : import the drugs to
import from the port that appoint . Our country is a
developing large country, with the deepening constantly
of reform and opening up to the outside world, and increase
constantly in the port opening to the outside world.
According to the incomplete statistics, our country
reaches 300 in the ports opening to the outside world
at present. Because need quite strong technical force
and equipment to inspection which import the drugs,
our country is unable to sets up one and imports drugs
and examines the organization in every port at present.
The new drugs regulation revised newly claim: department
of supervision and administration put forward jointly
with the General Administration of Customs by the State
Council drugs in the port that allow the drugs to import,
report to the State Council for approval. The enterprise
importing drugs must register and was put on record
to the port site drugs. Importing the drugs must get
the national drugs and supervise " importing the
drugs registration certificate" that the administrative
department issued at first to sell to enter the Chinese
market. However, have made " imported the drugs
registration certificate" and just won the market
which enter China and enter permitting accurately, should
still accept the Chinese drugs to supervise the supervision
of administrative department while importing each batch
of drugs. The way superintended an direct is to register
and was put on record. The drugs for the port site should
inform that supervise the regulation of managing the
department and spot check examining in importing the
drugs according to the State Council drugs to supervise
the administrative department, and examine the expenses
is collected according to the clause 41.
(d) Increase the drugs to supervised and manage to enforce
the law the administration compulsory measure. Increase
it to making punishment, selling the drugs of imitation
and poor quality and wait for the illegal activities,
attack dynamics and improve legal liability system and
administration enforce the law the means, Is rectify
drugs production further, the order of circulation has
offered the powerful legal means , and have embodied
it to the people and responsible for safe effective
height of drugs fully.
(d1) The newly-increasing drugs department of supervision
and administration suspected being involved producing,
managing false drugs, the situation of the bad drugs
or serious bad reaction of emergence. But the regulation
of taking the administration compulsory measure or control
measure promptly is whole drugs once produce, the order
of circulation, accelerate drugs reform of circulation
system, attack and make the illegal activities of selling
the drugs of imitation and poor quality sternly, is
the focus question that the masses of member of a nationalities
of people masses pay close attention to. It manages
the administration that the regulation is fixed and
enforce the law the means to be relatively single current
drugs, no enough perfection of compulsory measure, strong,
in view of production, it sell it is of imitation and
poor quality it is too principle in regulation since
it is that illegal activities punish in drugs: The effectiveness
is not strong, supervise the enforcing the law and brings
the difficulty of the administrative department for
the drugs to a great extent. So, revise the drugs and
manage the law and increase and stipulate newly: "
the drugs supervise the administrative department proved
to thering are evidences may the drugs which is detrimental
to health and relevant material may take closing down
", detain and wait for the administration compulsory
measure, and make the administration place within seven
days pay attention to the decision. The drugs need examining,
must make the administration to deal with the decision
in 15 days since day the survey report is sent out "
(The clause 65 ), " the drugs of serious negative
reaction have taken place to already affirmation",
The State Council or province , autonomous region, can
adopt stopping producing and sell this drug. The ones
that use control the measure promptly , and should organize
and appraisal within five days, Since day the expert's
conclusion is made to make administrations and deal
with the decision in accordance with the law in 15 days"
(The clause 71 ).
(d2) Have expanded and assert making the behavior range
which sell the drugs of imitation and poor quality.
The standard is asserted and manage false drugs and
behavior that punish according to the false drugs that
the regulation fix according to the current drugs there
are six kinds. The ones that confirmed as bad drugs
were all right have three kinds in all. The drugs are
supervised and manage the experience that the administration
enforces the law to summarize in recent years. Manage
the law at false drugs and according to the false drugs
increase to eight kinds behavior that punish drugs revised
newly, and bad with punishing according to the bad drugs
in drugs the behavior increases to seven kinds: It is
for false drugs to have it is following one of situation!
(First) The composition that composition stipulate with
the national drugs standard that drugs include is not
accorded with. (Two)With pretending to be the drugs
or pretend to be this kind of drugs by a kind of drugs
by him. There are drugs of one of the following situation,
Punish according to false drugs: (First ) The State
Council drugs supervised the administrative department
and stipulated and forbade using. (Two ) Must approve
not undergoing to approve producing according to this
law, import or compound and examine and undergo and
examine and sell promptly according to this law. (Three
) The ones that went bad. (Four ) The ones that are
polluted. (Five ) Must make and approve gentle number
according to this law to use, and produce raw drug that
make approving gentle number for. (Six) Cured mainly
and goes beyond and stipulate the range meeting the
disease or functions that are indicated" (the clause
48 ). The composition of drugs that does not accord
with national drugs standard, is the bad drugs. There
are drugs of one of the following situation, Punish
according to drugs bad: (First ) the ones that have
not indicated term of validity or altered effective
one. (Two) The ones that do not indicate or alters production
lot number. (Three) The ones that exceed term of validity.
(Four ) Packing and container keeping in touch the drugs
directly do not undergo to be approved. (Five ) Interpolating
color pharmaceutical without authorization, antiseptic,
spices, rectify the pharmaceutical and auxiliary materials
one. (Six) others do not accord with drugs standard
and stipulate" ( The clause 49 ). At the same time,
in order to embody administrative supervision to supervise
for the principle that relies on with technology conscientiously,
the new drugs regulation revised claim: " except
that outside the copies of situation getting rid of
clearly ", to false drugs, the punishment notice
of drugs bad, must state clearly the quality inspection
result of the drug test (The clause 78 )" .
(d3) Increase production correctly, sell or compound
the behavior punishment dynamics of bad drugs and false
drugs.
It is very much harmful for society, if someone makes
and sells the false drugs to violate the masses' health
right behavior of breaking the law seriously on purpose.
Not only should confiscate breaking the law the income
and fine, of a serious nature, but also should revoke
the license yet. Make it lose production and manage
the drugs qualification. In addition, break the law
in making and sell the drugs of imitation and poor quality
the income difficult to collect evidence and calculate
question in practice, Consulting the regulations of
criminal law and product quality law, should fine the
drugs goods value in order to break the law clearly.
In order to punish of the amount of money, the base
figure increase the effectiveness that the administration
punishes, and aggravate dynamics of punishing.
So, the drugs management regulation revised newly is
fixed: " produce, sell false drugs, confiscate
and break the law to produce, the drugs and illegal
income sold, Production that and break the law in the
place, it is worth the fine under five times above two
times of amount of money to sell the drugs goods. There
are drugs that approve proving the canceling of the
file, and order stopping production, suspend business
to bring up to standard. Of a serious nature, revoke
" drugs production license", " the drugs
are managed the license " or" drug organization
manufacture license". The ones that form crime,
investigate the responsibility for a crime in accordance
with the law" (The clause 74 ). " produce,
sell drugs bad, confiscate and break the law to produce,
the drugs and illegal income sold, Production that and
break the law in the place , it is worth the fine under
three times above amount of money of one time to sell
the drugs goods. Of a serious nature, order stopping
production, suspend business to bring up to standard
or cancel the drugs and approve proving the file, can
revoke " drugs production license" , drugs
manage license or medical organization preparation license)
The ones that form crime, investigate the responsibility
for a crime in accordance with the law" (The 75
). In addition, also in order to make and sell the behavior
of offering convenient condition of drugs of imitation
and poor quality, Increase stipulates: " know or
should know that belong to the drugs of imitation and
poor quality to offer to and transport ", custody,
the storage waits for convenient condition, confiscate
all doors and transport, custody, the income of the
storage, and break the law and include hundred in the
place. The fine under 50 more than three times. The
ones that form crime, investigate the responsibility
for a crime in accordance with the law" (The clause
77 ).
(d4) Expand and punish to the punishment range of the
illegal activities and qualification of increasing.
By the look of reality, some units have produced, sold
and compounded drugs of imitation and poor quality and
often have the close relation with other direct responsibility
with its person in charge. Because manage the law and
settle to a punishment that people carry on current
drugs, However, manage the law and increase and stipulate
by what has been revised newly drugs: " Enterprise
engaged in production, selling the negative drug of
a serious nature or other units, their direct responsible
person in charge and other direct responsibility personnel
can't be engaged in drugs producing, and the business
activities in ten years. "" used in false
drug of production to the producer specially",
and confiscate the complementing material, originally
of negative drug, wrappings, production equipment, confiscate
" (The clause 76 ).
( d5 ) Increase legal liability, and embody the supervision
to whole course of drugs to manage.
In order to embody and develop to drugs fully, production,
management and supervision to manage in whole course
used, CNDRC revised managed in one chapter of legal
liability and increase the corresponding clause newly.
Have stipulated correctly violate" produce strict
quality control standard drugs" and" manage
quality and manage the standard drugs", upset and
import drugs and control, defraud the license or drugs
and approve proving file, draw the false survey report
waiting for the punishment of the illegal activities.
(e ) Drugs of our country have been supervised by the
regulation and method with effective management since
receiving reform and opening up to the outside world
abundantly. Have stipulated drugs authentication system
of implementing, drugs classification management system
and drugs negative reaction and report system, etc.
(e1 ) Stipulate that implements drugs authentication
system. Management for research, production and operating
unit of drug need standardization, and promote drugs
quality further.
CDRA only ask that drugs manufacturing enterprise must
make and carry out and guarantee drugs quality rules
and regulations and hygiene demanded. According to experience
making and pursuing "Good Manufacturing Practice"
(GMP) and "Good Supplying Practice" (GSP)
in recent years in our country, CNDRC revised claim:
"drugs manufacturing enterprise accords with the
regulation of GMP, can be issued the authentication
certificate" (The clause 9). "Drugs department
supervision and administration manage the enterprise
and accord with carry on authentication request on GSP
to drugs according to the regulation, Qualified to authentication,
issue the authentication certificate " (The clause
16). Have made GMP clear in above-mentioned clause,
GSP legal status it is must not have been the strong
it promote it is last drugs, the consciousness that
the management enterprise raises the quality, and strengthen
strict quality control, transfer the focal point of
enterprise work. Come on moving and accelerate the technological
progress and improve the laborer's quality correct orbit.
CNDRA revised add and stipulate even: "Non clinical
research institution and clinical research institution
must carry out Good Laboratory Practice for Non.Clinical
Studies (GLP) and Good Clinical Practice (GCP). (The
clause 30)." Carrying on GLP and GCL, will impel
drugs to study more strict and cautious, scientific
and standard.
The drugs authentication system of CNDRA revised Includes
authentication of GMP, GSP, GLP, GCP, etc. Strictly
raise drugs production, drugs study and drugs management.
And improve drugs quality. In the form of law overcomes
to repeated competence from source in low levers. The
medicinal causes of our country develop the meaning
in a healthy way greatly to promoting.
(e2 ) Stipulate and implements the prescription with
classifying management systems in drug. The State Council
is about implementing drugs and classifies the determining
to bring into the legal track of management.
The prescription drug must be bought according to the
doctor's prescription, and drugs used under the guidance
of doctor. Only if Over-The-Counter (OTC) drug is after
practice patients can buy by oneself long-term and clinically
thinks through selecting by the expert, can use and
can guarantee drugs of security. To classify managing
prescription drugs and OTC drugs is a current drugs
management mode in the world. Through strengthening
supervision management to prescription drug and OTC
drug, Standardizing drugs production, managing the behavior,
guide masses' science to use the drug rationally, and
reducing drugs excessive use it with emergence of drugs
negative reaction. It is safe to be effective to protect
masses and use the drug. This is a more important thing.
In January of 1997," determination for reforming
the hygiene in the State Council " pointed out:
" the country sets up and improve with classifying
management systems in drug in prescription". However,
current management does not make the regulation to classifying
the management system. So, formulation of setting-up
of classifying the management system of drugs and every
related policy, lack the essential legal foundation.
Real constructing drugs has relatively great difficulties
to classify management systems. In view of this kind
of situation, carrying on drug classification of the
management system involves relevant medical system reform,
and so on. Still need to make administrative statute
and other relevant policies of forming a complete set.
So: the CNDRA revised claim: " the country implements
to drugs with classifying management systems in prescription
drug. The State Council makes the concrete method. "
(The clause 37 ).
(e3) Stipulate the country reports the system in drugs
negative reaction.
The negative reaction is directly relative to people's
livelihood lives and health. For subject observing drugs
negative reaction clearly, the ones that found the department
and drugs of the negative reaction report supervise
and manage the department and can take controlled the
measure promptly. The CNDRA revised is fixed: "
the country implements drugs negative reaction system
", " the concrete way is made jointly with
the department of hygiene administration of the State
Council and drug department of supervision and administration
of the State Council drugs ". " drugs of serious
negative reaction have taken place to already affirmation".
The State Council or province, autonomous region, municipality
directly may adopt stopping producing and selling, and
control the measure promptly, and should organize and
appraisal within five days. Since day the expert's conclusion
is made to make administrations and deal with the decision
in accordance with the law in 15 days" (The clause
71 ).
(f) Make the legal status of examining the organization
of drugs clearly, and reform drugs sampling action mechanism,
it is accurate and just to guarantee drugs and supervise
the science examined.
( f1 ) Make the duty of examining the organization of
drugs clearly.
The organization is supervisions management system of
important part of drugs that drugs are examined. It
is the government that implements the examining the
organization legally of technical supervision to drugs.
Organization of drugs supervising examination undertakes
examined work in accordance with the law by drugs that
the administrative department set up. At the same time,
in order to supervise the actual need of examining work
under some situations of meeting, other sampling action
organizations also undertake examined work. So, the
CNDRA revised is fixed: " setting up department
of drugs supervision and administration or drugs sampling
action organization, Bear to implement drugs in accordance
with the law to examined and approve and check the necessary
drugs with drugs quality control examining work "
(The clause 6 ).
(f2) Strengthen drugs charging management of supervision
and test. Legally propose the reform drugs sampling
action the request for mechanism, and protect the legitimate
right and interest of the relative people of administration.
Strengthen sampling action management charged to drugs
supervision, and reform drugs sampling action mechanism,
legally stipulate the inspection project that should
charge clearly. Stipulate that pays sampling action
the expenses by the country. This is to protect just
and fair important condition of drug supervision and
test. So, the CNDRA revised is fixed : " …The inspection
project of drugs and standard of charging are in charge
of the department to check and ratify and announce jointly
with the price of the State Council by the financial
department of the State Council . The fee of inspection
is take over ways to supervise and manage the department
to make jointly with the State Council drugs by the
financial department of the State Council " (The
clause 41). " drugs department of supervision and
administration according to supervising the need checked
", can spot check examining to drugs quality. Should
sample according to the regulation to examine to spot
check, and can't collect any expenses. The necessary
expenses stipulate that arrange to support according
to the State Council " (The clause 65 ).
(g) Strengthen regulation of drugs price correlated
with drugs rebate, drugs advertisement etc. Solve the
focus problem that the people and broad drug enterprise
pay close attention to in accordance with the law.
(g1) Strengthen management to drugs advertisement further,
and forbid the prescription drug to carry on advertising
in the media of mass media, directed against advertisement
too much of drugs, crossing excessively, and the efficiency
to drugs is propagated falsely. The CNDRA revised has
strengthened management to drugs advertisement in phenomenon
of misleading the consumer. It has reiterated: "Drugs
advertisement must pass to approve by drug department
of supervision and administration of province of enterprise
site, autonomous region, the direct municipality, and
approve gentle number for drugs advertisement "
(The clause 60 ), and strengthened person who examines
and approve advertisement duty that the right advertisement
supervision is checked, The regulation: Province, autonomous
region, and direct municipality should check to drugs
advertisement that it approves for to supervise the
administrative department by civil administration office
drugs, Advertisement when" the People's Republic
of China advertising for law" for copies of law
of violating: Should supervise and manages the office
to notify and proposes that deal with proposing to advertisement.
Advertisement is supervised and should handle it in
accordance with the law to manage the office "
(The clause 62 ). The prescription drug is opened drugs
that the prescription used by the doctor, and should
only wait for the professional personnel to do proper
advertising in view of the doctor. Forbid the prescription
drug to do the method for advertising on the medias
of masses. Already those been accepted by most countries.
However, The CNDRA revised has pointed clearly: "
the prescription drug can be introduced on the professional
publication of pharmacy appointed by the hygiene administrative
department of the State Council together and drug department
of supervision and administration of the State Council,
but must not issue in the media of mass media or advertisement
carries on advertising taking as target with other ways
" (The clause 60).
(g2) Strengthen management for drugs price and drugs
rebate, and limit high pricing, and guarantee the legitimate
right and interest of consumer using drug.
At present, drugs price is too high, unreasonable, empty
high pricing with large discount, high rebate, it has
aggravated the burden of the country and patient individual
greatly, and bring out the corrupt behavior too. Reflect
the strong drugs price question to the people, and then
CNDRA revised has added essential content: " implement
government pricing in accordance with the law",
drugs that the government guides the price, the government
price person in charge should fix the principle of prices
according to what" Price Act of the People's Republic
of China" stipulate to pay attention to the department,
according to the society, make and adjust prices rationally
in market supply and demand state and social ability
to bear, and accomplish the quality price to agree with,
dispel the empty high price, and protect proper interests
of person who uses drug. Drugs manufacturing enterprise,
management enterprise and medical organization must
carry out government pricing, and government instructing
price. They can not willfully carry the high price without
authorization." "Drugs manufacturing enterprises
should offer the production operating cost of drugs
strictly according to the facts to the government responsible
institution in accordance with the law, and can't refuse
report, make a false report and hide the truth."
(The clause 55 ). "In order that consumer use drugs
with rational price, drugs manufacturing enterprise,
management enterprise and medical organization that
implement price decided by market demand drugs in accordance
with the law, should make prices in principle that the
quality price is agreed with, according to fair, rational
and honest credit." "Drugs manufacturing enterprise,
management enterprise and medical organization should
observe the price regulation on drug price management
of responsible institution of the State Council, and
make and indicate drugs retail price, and forbid the
sudden huge profits and harm consumer interests and
swindle the behavior" (The clause 56 ). "Drugs
manufacturing enterprise, management enterprise and
medical organization should offer the purchasing and
sale prices and purchase and sale materials such as
quantity, etc. actually of its drugs to the government
price responsible department in accordance with the
law" (The clause 57 ). " Medical organizations
should offer the prices inventory of drugs that are
spent according to patient's request, and should announce
the purchase price of its daily drugs and price sold
to the patient strictly according to the facts according
to the regulation even in the medical organization by
fixed position in medical insurance. The concrete way
is stipulated by the hygiene administrative department
of the State Council"" (The clause 58 ). "
During drugs purchase and sale, it is forbidden that
Drugs manufacturing enterprise, management enterprise
and medical organization receive rebate or other interests
in the dark outside. It is forbidden that drugs manufacturing
enterprise, management enterprise and medical organization
or other agent offer property or other interests to
the responsible for somebody of the medical organization
which uses their drugs with any name, personnel purchasing
drugs, and the doctor, and so on. It is forbidden that
the responsible for somebody of the medical organization,
personnel purchasing drugs, and the doctor receive property
or other agents." (The clause 59 ).
(g3 ) Forbid district obstacles. Implement the regulation
protected in place, promote the market in order setting
up unified, great fair environment for proper competition
of drugs.
In the past, in order to prevent in the place and repel
other places enter this market of drugs, some districts
adopt and break the law to force examining in places
and set up " selling permit ", and "
entering permit " etc. Those violate the socialist
market economic law totally, and violate relevant legal,
and the method of regulation. The CNDRA revised pointed:
" the local people's government and drug department
of supervision and administration should not ask to
implement drugs supervision and examination, and repel
that no local drugs manufacturing enterprise enter here
district." (The 69 ).
(g4 ) Permit drugs manufacturing enterprise to accept
the commission production drugs, and reduce reconstruction.
Permit drugs manufacturing enterprise with certain condition
to accept the commission production drugs, and can utilize
the existing working condition fully, reduce repetition
making the investment and reconstruction, and helpful
to the resources optimization, help to promote the structure
adjustment of pharmaceutical industry. CNDRA revised
is fixed: "After national drug department of supervision
and administration or drug department of supervision
and administration of province, autonomous region, the
direct municipality authorized by national drug department
of supervision and administration approve that drugs
can accept commission and produce drugs to produce.
(The clause 13 )".
(h) Strengthen department and personnel of drug supervision
and administration, and legally build the work ranks
of the diligent in government affairs, honest practical
and high-efficient drugs supervision.
In order to ensure department of drug supervision and
administration according to law, enforce the law justly,
and set up a work ranks of the diligent in government
affairs, honest practical and high-efficient drugs supervision.
The CNDRA revised pointed: While strengthening duties
department of drug supervision and administration and
drugs test organization, have stipulated corresponding
legal liability in view of the behavior not fulfilling
duty or abuse one's power in accordance with the law
either. There is relevant content of CNDRA:
(h1) Show breaking the law for the relevant certificate
or approve proving the legal liability of the file clearly.
The CNDRA revised claim: Department of drug supervision
and administration illegally issues GMP, " GSP
", " drugs production license", "
drugs management license ", "Preparation license
for medical organization", "import drugs certificate
of registry or approve carrying on clinical testing,
issue new drug certificate, approve gentle number for
drugs," or control the office responsibility by
its higher level competent authority". Take back
illegally issue the certificate and or cancels drugs
and approves proving the file, and demoted to person
in charge and other direct responsibility personnel
that take charge of directly in accordance with the
law, dismiss from one's post, the administration place
expelled. If forms crime, investigate the responsibility
for a crime in accordance with the law " (The clause
94 ).
(h2) Forbid department of drug supervision and administration
and staff member of drugs test organization participate
in drugs production and the business activities.
The CNDRA revised fix: If department of drug supervision
and administration and staff member of drugs test organization
participate in drugs production and the business activities,
" or controls the office and orders correcting
by its higher authorities", The ones that broke
the law and included confiscated, of a serious nature,
person in charge and other responsibility personnel
that are responsible for directly correctly offer disciplinary
sanction in accordance with the law ". To participating
in the relevant staff member of drugs production business
activities, " offer disciplinary sanction in accordance
with the law". (The clause 95 )
(h3) Forbid department of drug supervision and administration
and drugs test organization illegally collect examine
the expenses.
The CNDRA revised is fixed: department of drug supervision
and administration and drugs test organization illegally
collect examine the expenses, ordered and returned by
the government department concerned", " Depend
on to person in charge and other direct responsibility
personnel that are responsible for directly. The law
offers disciplinary sanction ". The drugs test
organization to drugs of a serious nature is canceled
its inspection qualification " (The clause 96 ).
(h4 ) Show malfeasance behavior legal liability of neglecting
one's duty of relating to the fact that make and sell
drugs of imitation and poor quality clearly.
The CNDRA revised is fixed: "the enterprise that
have already gotten drugs production license and drugs
management license produces and sell false drug, and
poor drug, besides investigate the legal liability of
this enterprise in accordance with the, to neglecting
one's duty, drugs of behavior of malfeasance supervise
the direct responsible person in charge and other direct
responsibility personnel of administrative department
and offer disciplinary sanction in accordance with the
law. Form crime, investigate the responsibility for
a crime in accordance with the law " (The clause
97 ).
(h5 ) Have made clear and implement the management regulation
of a layer of supervision in drugs monitor system.
The CNDRA revised is fixed: " While the subordinate
has behavior of violating a law, department of drug
supervision and administration order correction within
a definite time. No ones that do not exceed the time
limit and correct, have the right to change or cancel
" (The clause 98 ).
(h6) Make clear drugs supervision and administrative
staff's illegal activities, and the legal liability
that should be born.
The CNDRA revised is fixed: " drugs supervision
and administrative staff's abuse one's power administrative
staff drugs", do wrong to serve one's friends or
relatives, neglect one's duties, form crime, investigate
the responsibility for a crime in accordance with the
law; and still not to form crime, offer disciplinary
sanction in accordance with the law" (The clause
99 ).
(h7) Make clear that the legal liability that the test
organization and personnel who concerned neglect one's
duties should bear.
The CNDRA revised is fixed:" While the test organization
or personnel draw the false test report ", Form
crime, investigate the responsibility for a crime in
accordance with the law. If do not form crime, order
and correct, warn, to the fine under 50,000 RMB Yuan
above of 30,000 RMB Yuan of the unit and place. To person
in charge and other direct responsibility personnel
that take charge of directly in accordance with the
law, dismiss from one's post, and the punishment expelled,
and the fine getting along with under 30,000 RMB Yuan.
The ones that there is illegal income, confiscate breaking
the law the income, of a serious nature, cancel its
inspection qualification.
The inspection result that the organization draw is
not real that drugs are examined. If suffering heavy
losses, should bear corresponding compensation responsibility
" (The clause 87 ).
Cosmeceuticals are a hot topic on the international
science. The literature has expanded rapidly, presenting
a great variety of views dictated by special interests.
A number of forces have converged to account for this
surge of interest.
（3）The Federal Food, Drug and Cosmetic act of 1938
Legislative History
FDA's power to regulate cosmetic products appeared for
the first time in the FDCA Government regulation of
cosmetics had not been included in the 1906 Food and
Drug Act,13 a lacuna that was noted by an agency official
in 1917:"While the accomplishments of the Food
and Drug Act have been considerable, it must be admitted
that it has its serious limitations. Especially conspicuous
ones are…the limitations placed upon the term 'drug'
by definition which render it difficult to control injurious
cosmetics…"14 Senator Copeland of New York took
up the challenge in 1933,motivated by reports from the
agency of cosmetic injury from such products as "Koremlu
Cream," a depilatory containing thallium acetate,
a highly poisonous chemical. The product, as stated
by FDA in its annual report in 1933, had been represented
as "entirely harmless and actually beneficial to
the skin," and its widespread popularity had caused"
many cases of severe injury to users before the manufacturer
was forced into bankruptcy by accumulation of damage
suits. The Federal Government, lacking legal authority
to control cosmetics, was unable to give the consumer
the protection that should have been afforded"15Coneland
thus introduced S.1994, the first of several versions
of the Act, on June 6,1933.The Senate's concern over
cosmetic safety was manifest in section 5 of the bill,
which prohibited adulterated cosmetics. Under the proposed
legislation, a cosmetic would be deemed adulterated
if it was or could be "injurious" to the user
under the usual or prescribed conditions of use, or
if it contained any "poisonous or deleterious ingredient"
limited or prohibited by agency regulation.40The breadth
of s.1994, the first of several versions of the Act,
on June 6,1933. The Senate's concern over cosmetic safety
was manifest in section 5 of the bill, which prohibited
adulterated cosmetics. Under the proposed legislation,
a cosmetic would be deemed adulterated if it was or
could be "injurious" to the user under the
usual or prescribed conditions of use. Or if it contained
any" poisonous or deleterious ingredient"
limited or prohibited by agency regulation40The breadth
of s.1994.however,"met with violent opposition
from every section of the country,"41and its substitute,S.2000,
changed the first part of section 5 to define an adulterated
cosmetic as one that "bears or contains any poisonous
or deleterious substance" that might render it
injurious to the user under the usual or prescribed
conditions of use .18The change, which substantially
was maintained in later versions of the bill, thus focused
FDA regulation on the composition of the cosmetic as
the source of injury.
Another change in the legislation as it passed through
its various versions occurred in the definition of the
term "drug." In the original Senate bill,
as in the FDCA as it now reads, food was excluded from
the last portion of the definition of " drug":"
all substances, preparations, and devices (other than
food) intended to affect the structure of any function
of the body," By the time the bill reached the
House Committee on May 31.1935,both food and cosmetics
were excluded from the definition19This version of the
bill died in the House, however, and when the bill was
reintroduced as S.5 in the Senate on January 6,1937,
the cosmetics exception was no longer present20 As a
result, the definitions of "drug" and "cosmetic"
are not mutually exclusive, and a product that fits
both definitions must comply with both sets of regulations.21
（4）The Regulation of Cosmetics and Drugs Under the FDCA
The regulation of cosmetics under the FDCA differs from
the regulation of drugs in one significant respect:
Cosmetic manufacturers are exempt from premarket review
of their products. This means that a potentially dangerous
cosmetic usually is discovered only after it has reached
the market and caused conspicuous harm to a consumer.
Cosmetic regulation is delineated in sections 361 to
363 of title 21 of the United States Code, which, in
conjunction with section 331,prohibit the adulteration22
or misbranding23 of any cosmetic in interstate commerce.
Thus, a cosmetic product can be unlawful either as a
result of its substance or as a result o it's labeling.
A cosmetic product is unlawful if it contains a "poisonous
or deleterious substance which may render it injurious"
pursuant to customary use;24 if it contains a "filthy,
putrid, or decomposed substance";25or if it has
been manufactured or packaged under unsanitary conditions.26
A cosmetic also may be found unlawful if its label or
container is false or misleading27 or if it fails to
bear required information.28The FDCA thus gives FDA
the authority to regulate products on the market that
are found to be particularly harmful or for which misleading
claims have been made. But because the FDCA does not
require cosmetic manufacturers to submit any information
to the agency, regulation must be conducted entirely
on the basis of information voluntarily supplied by
manufacturers29 or on a postmarket basis in response
to consumer complaints or other alerting mechanisms.
Drug regulation, by contrast, is considerably more extensive
with much of the statutory subchapter devoted to safety.30
As with cosmetics, the adulteration of drugs is prohibited,
although the FDCA further provides that a drug may be
considered adulterated if it is not manufactured in
accord with "current good manufacturing practices"
to ensure safety, quality, and purity.31 A drug, like
a cosmetic, is unlawful if it is misbranded, that is,
if its label is false, misleading, fails to give adequate
directions for use, or otherwise does not conform to
the law,32 or if the drug is dangerous to healthy when
used as recommended.33 Here, however, the similarity
to cosmetics regulation ends. The FDCA further provides
that all drug manufacturers must register with the Secretary
of the Department of Health and Human Services (DHHS)
and provide a list of all drugs manufactured.34 Furthermore,
no new drug may be placed on the market without application
to and approval from the agency. The application must
contain full reports of research conducted as to the
safety and efficacy of the drug; a complete list of
the drug's ingredients and description of its manufacturing
process; and a sample of the proposed labeling for the
drug.35 Once the drug has been approved, the manufacturer
must submit to the agency any information regarding
clinical trials or any other information that suggests
that the drug is a hazard to public health,36 and the
agency may revoke its approval upon review of this information.37
In sum, the FDCA provides for considerable premarket
review of any new drug, particularly with respect to
the safety and efficacy of the drug. No such review
takes place for new cosmetics, nor are cosmetic manufacturers
required to register with FDA, a situation that has
concerned Congress enough to initiate hearings and legislation,38
but not enough to amend the FDCA.39
Of course, how a product is to be regulated depends
entirely on how it is defined, The FDCA defines "cosmetic"
as
(1.1) Articles intended to be rubbed, poured, sprinkled,
or sprayed on, introduced into, or otherwise applied
to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the
appearance, and (2.2) articles intended for use as a
component of any such articles; except that such term
shall not include soap,40and "drug" as "(B)
articles intended for use in the diagnosis, cure mitigation,
treatment, or prevention of disease in man or other
animals; and (C) articles (other than food) intended
to affect the structure or any function of the body
of man or other animals…."41The Supreme Court has
tended to read this definition expansively and thus
not confined itself to the strict medical definition
of the word "drug," 42 "Congress fully
intended," the Court noted in 1969,"that the
Act's coverage be broad as its literal language indicates-and
equally clearly, broader than an strict medical definition
might otherwise allow."43 This creates considerable
problems for manufacturers of many cosmetic products
because almost any cosmetic can be said to have some
effect on the structure of the body, however minute.44
In reality, the practical distinction has come to be
that a cosmetic is a substance that engenders a temporary,
superficial effect, linked closely to one's appearance,
while a drug is a substance that causes a more permanent,
structural change in one's health. There is no requirement,
however, that a product's effects take place as a result
of chemical or metabolic action for the product to be
consider a drug-the agency interprets the statutory
definition of "drug" simply as ": a chemical
or a combination of chemicals in liquid, paste, powder,
or other drug dosage form that is ingested, injected,
or instilled into body orifices, or rubbed or poured
onto the body in order to achieve its intended medical
purpose"45 To date. FDA has declined to establish
guidelines that would elucidate the cosmetic drug distinction,
stating that each claim has to be examined in context46
The key to both definitions, however, is the word "intended"-a
product can be classified as a drug or as a cosmetic
only if it is intended to be used as one. Thus, both
definitions are driven not by the chemical composition
of the product but rather by the objective intent47
of the manufacturer in marketing the product-until recently,
whether the manufacturer promoted the product as having
therapeutic or merely superficialeffects.48As the Second
Circuit noted in 1969,"Regardless of the actual
physical effect of a product, it will be deemed a drug
for purposes of the Act where the labeling and promotional
claims show intended uses that bring it within the drug
defintion."49This focus has resulted in a rather
untenable system, in that the status of a product may
change according to the whims of the manufacturer, depending
on the advertising claims the manufacturer has promulgated,
the label, promotional material and "any other
relevant source."50A savvy manufacturer could keep
its product from extensive regulation and premarket
testing, regardless of the product's safety, merely
by couching any advertising claims in vague, unverifiable
language.51Moreover, whether a product actually has
an effect on a structure or function of the body would
be irrelevant: If the manufacturer claims it does, it
is considered a drug; if it does not, it is considered
a cosmetic. A dangerous chemical for which only cosmetic
claims were made might avoid premarket regulation, whereas
a claim that a product consisting wholly of water52
would "plump up skin cells" would cause the
product to be regulated as a drug53.
The incongruity of such a system of regulation is best
illustrated by three cases in the late 1960s and early
1970s in which courts grappled with the cosmetic/drug
distinction in considering whether a "wrinkle remover"
should be considered a cosmetic or a drug.54 Although
marketed by a different company and under a different
name in each case, the product was identical- a combination
of bovine albumin and water, when applied to the face,
formed a film that temporarily smoothed out wrinkles.
Two of the courts found the product to be a drug; one
found it to be a cosmetic. The Second Circuit held that
because the manufacturer claimed that the product would
give a "face lift without surgery" and would
"lift out puffs," it should be deemed a drug.55
Similarly, he Third Circuit held that because the manufacturer
included such phrases in its advertising as "super-active,"
"amazing protein lotion," and "tightening
the skin," it implied that the product was therapeutic
rather than cosmetic in nature and thus should be regulated
as a drug.56 In contrast, a federal district court in
Maryland held the product to be a cosmetic, finding
that the claims made for the product under consideration
(which included the claim that the product was a "pure
protein" that caused an "astringent sensation")
did not approach the level of the claims made for the
other two products.57
This relatively settled equation of intent and product
claims has been called into question by a federal district
court ruling in North Carolina that upheld FDA's power
to regulate tobacco.58The industry had claimed that
a product/s intended use could be established only by
the claims of manufacturers and that, because cigarette
manufacturers had made no advertising claims regarding
nicotine's effect on the structure or function of the
body, nicotine could not be regulated as a drug.59 The
court rejected this position, holding that the "plain
meaning" of "intend" in the FDCA "does
not indicate that intent must be proven by any particular
kin of evidence."60 Furthermore, the district court
noted that although no court had found intent without
manufacturers' claims," no court has held that
intended use can be established solely by promotional
representantions."61As a result, it held that FDA's
reliance on the foreseeable and actual use of the product
to prove intent (in other words, that consumers would
be expected to and do use nicotine for its effects on
the body) was a reasonable interpretation of the FDCA
and thus entitled to deference.62
Whether this ruling, if upheld on appeal, 63 will impact
FDA's regulation of cosmetics is unclear. The mystique
of the cosmetics industry relies heavily on advertising,
so it is unlikely that manufacturers will cease to make
claims about the efficacy of their products. If this
holds true. Coyne Beahm may not have much effect on
cosmetics regulation, and things will continue as before.
In the absence of such claims, however, and given the
notoriety of AHAs, the court's ruling could open the
door to stricter FDA regulation.
There are signs that FDA may seek this kind of expansive
definition of intent for cosmetics, one that would encompass
the formulation of the product as evidence of its intended
use. "If an active ingredient is present in a therapeutic
concentration, the product is a drug, even if
That product does not claim to produce the effect that
will result from the action of the therapeutically effective
ingredient," said John Bailey, Director of FDA's
Office of Cosmetics and
Colors in 1996. "The presence of the ingredient,
even if used in non-therapeutic amount, must be considered
when determining its regulatory status. Therefore, the
mere presence of the ingredient could make the product
a drug regardless of the claims that are made on the
label."64 For example, a product that includes
the word "hormone" in its labeling or ingredient
list will be deemed to convey an implied drug claim
and will be regulated as a drug even if no other claims
appear on the product's container65. Thus, how FDA will
regulate AHAs will depend, in part, on how the agency
chooses to define "intent" in light of its
regulatory goals with respect to cosmetics.
Either Drug or Cosmetic in 1938 FDC Act
In 1938, the US Congress passed the Food, Drug and Cosmetic
Act, a statute that officially defined cosmetics and
drugs in detailed terms, setting up formal criteria
for classifying a product as either a drug or a cosmetic.
It recognizes only two polar groups: drugs and cosmetics.
No intermediate category exists, though it was appreciated
that a topical could be both a cosmetic and a drug at
the same time.
It is noteworthy that the 1938 act came into being as
a corrective reaction against the ludicrous number of
elixirs and patent drugs, some dangerous, that promised
help and cures for all human ailments.
According to this 1938 definition, a cosmetic was, in
pertinent part, an "article intended for beautifying
and promoting attractiveness."
By contrast, a drug was defined as an article for use
in the diagnosis, cure, treatment or prevention of disease,
intended to affect the structure and function of the
body. This last clause is legally determinative of whether
a formulation is a drug or a cosmetic. This narrow phrase
prompted me to introduce the term cosmeceutical.
That brings us to this important point: It is not the
ingredients in a product but the claims in labeling
or advertising that determine whether the article will
be classified as a cosmetic or a drug. Also note that
the US Congress declared the "intended" use
as determinative of a product's classification. Thus,
if the claims relate to the diagnosis and treatment
of a disease, that article is a drug If the intended
use as described in advertisements is the promoting
attractiveness, then the article is a cosmetic.
Cosmeceuticals as Middle Ground
New biologic reality: When the 1938 law was writer the
science of cosmetology was primitive and crude, steeped
in folkloristic beliefs and unsupported claims. The
1938 definition of a drug is now completely archaic,
and in fact an oxymoron. With the great advances in
our understanding of skin physiology, it is impossible
to think of a single substance that cannot, under some
circumstances, alter the structure and function of skin.
The most compelling example is water, the milieum that
all vital processes occur. In the popular mind, water
the supreme symbol of innocuousness. However, when water-moistened
cotton pad is sealed to human skin for two days, pro-inflammatory
substances such as interleukins are released from the
dead stratum corneum. These incite series of cytotoxic
changes in the viable epidermis below. In another few
days, an inflammatory reaction is provoked in the dermis.
This is the basis for the adverse clinical events associated
with prolonged exposure to water. One sees these events
in, for example, in daily housework or in bartending,
canning and other occupations. So water can sometimes
be beneficial in emulsions that hydrate xerotic skin:
it can also be harmful under intensive exposure.
Another traditional substance that everyone agrees is
quite inert is petrolatum. Yet, various studies show
that petrolatum promotes healing of wounds and that
it prevents UV-induced tumors, even though it is not
a sunscreen. These are clearly medicinal effects that
alter the structure and function of skin.
No rational person would want petrolatum or water to
be reclassified as a drug. These and many other examples
demonstrate that nearly all cosmetic articles would
have be reclassified as drugs, if we followed a strict
interpretation of the "structure and function"
proviso of the 1938 act.
Most skin-care products lie somewhere between drugs
and cosmetics. They comprise a continuous spectrum of
substances intermediate between the two polar categories
defined by congress. Some traditional cosmetics are
more drug-like in their beneficial effects and the impact
of some drugs is principally on appearance. It is this
intermediate, broad-spectrum range of substances that
behave as both drugs and cosmetics that justifies the
fusion term cosmeceuticals. This is proved and unites
the term cosmeceuticals (Cosmetics word head Cosme add
to word Pharmaceuticals tail ceuticals it form Cosmeceuticals
function cosmetics, ) is rational. This is simply a
biologic concept that recognizes the new realities of
skin-care products.
The regulatory reality: This acceptance of biologic
reality does not mean that we need new laws that officially
define in statutory terms the category of cosmeceuticals.
The US Food and Administration (FDA) has always had
the authority to determine from the advertising claims
and labeling whether a product promoted as a cosmetic
has crossed the line that would require its reclassification
as drug.
Cosmeceutical is a pragmatic term that enables us to
state without pretense the benefits of a product. It
is not an invitation to pass new laws. A strict letter-of-the-law
interpretation of the 1938law would necessitate the
conversion of innumerable active cosmetics to drugs.
This would be a disaster of the first magnitude. It
would immediately stifle innovation and creativity.
Drug development is slow and mostly, requiring proof
of efficacy and safety. Cosmetics, on another and creativity
hand, do not require pre-marketing clearance and can
be rapidly commercialized provided that the claims are
not grossly misleading.
One has to praise the FDA for being flexible and permissive
in the way in which it has viewed claims over the years,
some of which are grossly exaggerated. The trouble comes
when some cosmetic manufacturers are emboldened to make
frank drug claims for their products. In this case,
the FDA sends out warning letters that require relabelling
of the products without necessarily changing any of
the ingredients. Competitors who are prudent and conscientious
may be at a disadvantage if they make less aggressive
claims, in issue highlighted by the "antiaging"
claims made for α-hydroxy acids.
Conclusion: Cosmeceuticals enable cosmetic scientists
to communicate with each other regarding the standards
that must be met to justify performance claims, without
resorting to hype.
1.5 Regulatory Policies for cosmeceuticals
compared in developed countries
(功能化妆品在发达国家法规管理比较)
There are three main international trading blocks: the
US, Europe and Japan. Clearly, globalization as an integrated
free-trade network cannot work if each block classifies
and regulates skin-care products differently. Unfortunately,
no international consensus currently exists, sparking
disputes and trade practices that may gravely disadvantage
some producers.
I'll touch briefly on the regulatory policies of Europe
and Japan. Even a cursory look at the regulatory disparities
show the profoundly troublesome, destabilizing effects
of not establishing uniform, international standards.
These examples will illustrate the chaotic and irrational
quandaries that now prevail. It is to be hoped that
some consensus will soon emerge to avoid high visibility
quarrels.
Europe: In the European Economic Community's (EEC) Cosmetic
Directive of 1993,the requirements for the label ling
of cosmetics are formidable and daunting.66 The product
information that must be made available to official
encompasses the following:
Qualitative and quantitative composition of the product.
Specifications of raw materials.
Methods of manufacture.
Safely assessments.
Proof of effectiveness.
(In the US, cosmetic manufactures are not required to
demonstrate either safety or efficacy prior to marketing,
as the case for drugs.) All this is topped by the EEC's
admonition that testing animals would be prohibited
after January 1998, since delayed to June 2000, this
is unrealistic and, worse, irresponsible.
Japan: Authorities in Japan have created their own laws
in response to the problem that many skin-care products
are neither pure drugs nor pure cosmetics in the traditional
sense, but are mixtures or hybrids of the two. What
I call cosmeceuticals are called "quasi-drug in
Japan.66 They allow cosmetics to include pharmacologically
active ingredients, provided that the medicinal effect
are mild and the products have beer demonstrated to
be safe. The law leaves lots of room for ambiguities
and ad hoc interpretations that some perceive as a restraint
of trade.
US: In the US, the following agents regulated as drugs
while they are cosmetics in Europe, according to EEC
rulings: antiperspirants, antidandruff greater choice
of ingredients.
Paradoxes abound in the US. For ample, retinol (vitamin
A) can be sold a cosmetic but its oxidation product
retinoic acid, is regulated as a drug, furthermore,
the FDA recently approve retinoic acid product as a
cosmetic, on purely cosmetic claims relating only to
improving appearance. However, the product is available
only as a drug; it requires a doctor's prescription!
On the other hand, minoxidil, a drug that purports to
grow air and improve attractiveness thereby satisfying
the basic definition of a cosmetic, is available without
a prescription.
Sometimes, the many statutory exceptions and loopholes
downright dangerous. For example, theophyllin is a powerful
drug with a narrow therapeutic index used in the treatment
of asthma, for which frequent blood level measurements
are advised. Yet, this same agent can be sold in earth
food stores as an unregulated cosmetic when incorporated
in topical formulations for the treatment of cellulite.
What to do ?
A recommendation: author will close this controversy-laden
essay by recommending that all interested parties read
the ensible and scholarly treatise prepared by Vermier
and Gilchrest. They argue that cosmeceuticals already
exist; they are in fact desirable as intermediates between
cosmetic and drugs; and they should continue to be regarded
as cosmetics. The current legal definitions are archaic
and unworkable. The authors move toward the European
position by recommending that it is in the interest
of manufacturers to prove the efficacy of active cosmetics.
1.6 Different opinions on cosmeceuticals among American,
European and Japan
(西欧美国和日本对功能化妆品的不同见解)
Survey of opinions on "cosmeceuticals"
Despite lack of formal recognition to cosmeceuticals,
the term cosmeceutical is widespread and international,
and the debate is intensifying over the creation of
a third category of product lying between cosmetics
and pharmaceuticals. The writings on this subject are
fascinating and cover a remarkable range of divergent,
confusing and conflicting opinions from all over the
globe.66 Recent papers strongly express the feelings
and beliefs of major players in this field.
UK: Dweck's paper provides the British perspective.
He begins as follows:" What on earth is a cosmeceutical?
Is it an attempt to convince the consumer that their
skin-care product is really a topical drugs without
a proper license, or is it a genuine category that attempts
to provide a mild product that has been more stringently
tested that normal skin-car product?"68 He recommends
reading an official drugs leaflet as a guide to deciding
what is a medicinal product. His conclusion is that
future discussions will be full of debate. At best ,
the British have deepened the controversy debate to
clarification.
Continental Europe: Wittern takes up the issues from
a European perspective. He is decidedly not enamored
of the term cosmeceutical.69He considers "that
the existing legal regulations are precise and clearly
distinguish between cosmetic and pharmaceutical efficacy."
They do not allow for the introduction of a new class
of products such as cosmeceuticals. He recounts that
introduced the term but didn't bother to define it.
He writes," Obviously, Kligman didn't know what
he was starting." I plead guilty to not knowing
what controversial storms would follow a new concept.
Germany: the piece de resistance of the cosmeceutical
imbroglio is the text entitled"Cosmeceuticals:
The Future of Cosmetics," By Umbach of Dusseldorf,
Germany.70 He states:" At the moment, there is
hardly a topic in the consequence of old laws.
Umbach thinks cosmeceuticals meet consumer demanded
for high efficacy. But from a consumer and regulatory
point of view, having a separate cosmeceutical class
in neither helpful, scientifically suitable nor juridical
necessary according to Umbach. The cosmeceutical concept
is superfluous, he writes. The most sensible and useful
service we can give the consumer, legislator and manufacturer
is to advise against the further use of this term!
US: Steinberg presents the American perspective in his
piece:"Cosmeceuticals"71 He endorses the term
and thinks its introduction of a drug and a cosmetic
and to steel international agreements on the kinds of
regulatory actions that might be enacted.
Japan :In Japan, Takamatsu66 describes quite a differed
situation in his disquisition entitled" How can
we define cosmeceuticals." It runs out that the
Japanese government early on recognized the problems
that were coming to the fore as a result of the cosmetic
industry's ability to create "performance"
products that did more than beautify.
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