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FDA tightens controls over supplements -- 美国食品及药物管理局加强对膳食添加剂的控制
Thursday,July 05,2007 Posted: 13:40 BJT(0540 GMT)  食品论坛



Makers of dietary supplements for the first time will have to identify and test all the ingredients in their products, the Food and Drug Administration said.

美国食品及药物管理局宣布,今后膳食添加剂的生产商必须标明并检验产品中的所有成分。

The FDA released a new rule establishing manufacturing procedures, such as quality-control procedures, designing and constructing manufacturing plants and testing ingredients. The rule applies to all domestic and foreign companies that manufacture, package and label supplements for sale in the United States.

美国食品及药物管理局发布的新规定涉及这类产品的生产程序,其中包括质量管理程序、生产场所的设计和建造以及对成分的检验等。新规定适用于国内外从事生产、包装和标注销往美国市场的膳食添加剂的公司。

"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said FDA Commissioner Andrew von Eschenbach.

美国食品及药物管理局局长说:“这一规定有助于确保膳食添加剂的质量,这样消费者就可以相信他们购买的商品包含标签上所标注的成分。”

Dietary supplements — multivitamins, minerals and herbs — are a $22 billion-a-year industry. Supplements are marketed for a broad array of uses, such as athletic-performance boosters, weight loss and treatments for anxiety.

膳食添加剂包括多种维生素、矿物质和中草药,是一个庞大的产业,其每年的产值达到220亿美元。膳食添加剂有广泛的作用,比如可以让运动员有更出色的表现,有助于减肥,甚至可以缓解焦虑。

The regulation will be implemented over three years beginning Aug. 24 with large businesses having to comply in the first year and smaller business allowed to take the entire three years to come into compliance.

新规定将于今年8月24日开始实施,大公司在规定实施的第一年就要达到要求,而规模较小的公司可以在3年内逐渐实现规定的要求。

The aim of the new regulation is to ensure that incorrect levels of vitamins or blatantly wrong ingredients do not show up in the products. Last year, the agency found that some supplements, such as those used for erectile dysfunction, used undeclared active ingredients. The FDA also has found supplements that didn't contain the levels of vitamin C or vitamin A that were claimed by the manufacturer.

新规定的目的是为了确保这类产品中不会出现维生素含量不合要求或者成分错误的问题。去年,美国食品及药物管理局发现一些膳食添加剂,如针对勃起功能障碍人群的添加剂,使用了一些标签上没有注明的活性组分。他们还发现,一些膳食添加剂中维生素C或A的含量和厂商标注的不一致。

Congress told the agency in 1994 it must issue a regulation tightening federal safety standards on dietary supplements. The industry reacted favorably to the new rule.

美国国会在1994年就敦促美国食品及药物管理局发布食品安全法规,以加强膳食添加剂的控制。业内对此项新规定表示支持。


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