Report: FDA lacks authority over supplements

The Food and Drug Administration does not have the information, resources or recall ability necessary to adequately regulate dietary supplements, according to a Government Accountability Office report released this week.
Congress requested the evaluation of how the FDA regulates these popular products. The Nutrition Business Journal reports that 79% of adult Americans take dietary supplements.

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, [+ @- L  Y3 k1 u3 Z% uVITAMINS: Give 'em an 'F' in cancer prevention
BETTER LIFE: Vitamin use common in kids
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The GAO listed a number of areas in which the FDA has little oversight. For example, supplement companies don't have to tell the FDA what products they sell or ingredients they use.
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The report did note that in 2007, the FDA began requiring dietary supplement manufacturers to report "serious adverse events," such as hospitalizations, birth defects or death. The agency also issued Good Manufacturing Practices specific to the industry. GMPs outline how manufacturers must establish controls and testing to ensure that products have consistent identity, purity and strength. In the case of herbal and botanical goods, tests must ensure that the correct plant species are being used.

$ N3 ~3 j" W2 i3 dFIND MORE STORIES IN: Food and Drug Administration | Government Accountability Office | Public Interest | Center for Science | Wild West | Council for Responsible Nutrition | Susan Cruzan | Nutrition Business Journal | Steve Mister | Bruce Silverglade
The Center for Science in the Public Interest, a consumer advocacy group, has long called for the FDA to more strictly regulate supplements.

6 J# {4 W  b* F1 B# |: t"It's like the Wild West, and the bad guys know they don't have to take the sheriff seriously," says the center's legal director, Bruce Silverglade.
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The Council for Responsible Nutrition, a supplement industry trade group, agrees that the FDA needs more resources, says president Steve Mister. "It is time for the FDA to focus its energy and resources on inspections and enforcement actions directed at the small minority of companies that are giving those in the majority a black eye," Mister says.

4 C$ q, M" a5 k6 u+ m8 q) {& @: Q% ^1 Z6 HThe report also found that the FDA does too little consumer education on the safety and efficacy of dietary supplements. Though polls show that a majority of Americans believe a government agency must approve supplements before they are marketed to consumers, they're wrong.
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Unlike drugs, which must be approved for safety and efficacy before entering the market, dietary supplements marketed before 1994 are presumed safe. FDA must demonstrate that a product presents a significant or unreasonable risk to the public to get it off the market.
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' t' C. A* n) b* o: O; x3 nThe GAO recommends that the FDA seek more authority to require more information from dietary supplement makers; provide guidance on what ingredients must be documented; and determine what can be marketed as supplements or foods.
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5 ?: y7 S$ ?& u& `! V& _. Y0 VThe agency welcomes the report "as a means of calling attention to the challenges that the agency faces" in regulating dietary supplements, says FDA spokeswoman Susan Cruzan.

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碰巧要开始做膳食补充剂（dietary supplements）GMP方面的课题，尝试翻译了一下，不足之处请各位版友斧正：

报告：FDA对膳食补充剂管理乏力

" s* \9 O5 g7 L: H9 {% M7 K& F+ i8 C根据美国政府问责局(GAO)本周发布的报告，FDA缺乏必要的信息，资源或召回能力以充分管理膳食补充剂。
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国会要求对FDA如何管理这些畅销产品进行评估。营养学商业期刊报告说79%的美国成年人服用膳食补充剂。
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, I0 }1 l0 ?  w7 ^, M" o3 H7 |- e# TGAO列举了许多FDA缺乏监管的领域。比如，膳食补充剂公司无需告诉FDA他们出售什么产品或产品里含有
; k# }" U7 }, H+ I2 M+ `- ^: j9 x什么成分。

报告指出，2007年FDA开始要求膳食补充剂制造商报告有关产品的“严重不良反应”，比如住院，出生缺
1 m# Y9 Q- E. R$ L. T) G: Q陷或者死亡。FDA还颁布了业界的良好生产规范（GMP）。GMPs规定了制造商必须建立控制和检测措施以保
0 A/ J3 H5 D! F证产品的稳定特性，纯度和纯度。对于草药和植物性产品，检测必须保证使用了正确的植物品种。

公众利益科学中心(一个消费者权益保护组织)长久以来号召FDA加强对膳食补充剂的监管。

/ f5 B& z- B8 d2 b8 S: ~9 a2 \; D) `7 b“这就像西部荒漠，坏人知道用不着一本正经地对待政府。”中心的法务总监Bruce Silverglade如是说。

7 F( {$ y7 t3 a5 _* j6 D2 n' M/ ^可靠营养协会(一个膳食补充剂业贸易组织)主席Steve Mister，赞同FDA需要更多的资源：“是到了让FDA
0 O, W1 O$ c) ^) y1 K把精力和资源都集中到对那些鱼目混珠的少数小企业进行监管和执法行动上来的时候了。”
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报告还发现，FDA对消费者关于膳食补充剂安全和疗效的教育不足。调查显示，虽然大部分美国人认为政
7 `- t9 K+ t+ ]  q. D府机构必须对上市补充剂进行审批，但事实并非如此。
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不像药品上市前必须经过安全和疗效的审批，1994年以前上市的膳食补充剂被认为是安全的，FDA必须证
/ f5 B) f! f. }4 r明一个产品有显著的或不合理的风险存在才能将其退市。

7 c0 u$ A7 W" W  UGAO建议，FDA应该：寻求更多的权力以从膳食补充剂生产者那里获取更多的信息；为需要文件化证明的成
分提供指南；决定产品是按照补充剂还是食品上市。
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报告受到FDA的欢迎，FDA发言人Susan Cruzan说，报告被评价为在膳食补充剂管理方面“将注意力转移到机构所面临的挑战的一个指南。”