中英双语新闻-美国FDA加强对膳食添加剂的控制

FDA tightens controls over supplements
美国FDA加强对膳食添加剂的控制

By Gregory Lopes
THE WASHINGTON TIMES
June 23, 2007

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 yesterday.
美国FDA昨日宣布，今后膳食添加剂的生产商必须表明并检验产品中的所有成分。

The FDA yesterday 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.
FDA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。新规定适用于生产、包装和标注销往美国市场的膳食添加剂的国内外公司。

"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.
FDA局长Andrew von Eschenbach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，每年的产值达到220亿美元。根据宣传资料，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.
新规定将从今年8月24日开始实施，大公司在规定实施的第一年就要遵守该规定，规模较小的公司可以在3年之内逐渐做到所规定的内容。

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.
实施新规定的目的是确保这类产品中不会出现维生素含量不合要求或者掺入错误成分的现象。去年，FDA发现一些膳食添加剂，如针对勃起功能障碍人群的添加剂，使用了标签上没有表明的一些活性组分。FDA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。

Under the old regulations, supplements were governed by the same rules as food products.
旧法规中膳食添加剂是按照食品的相关规定来管理的。

The industry reacted favorably to the new rule, which has been pending for more than three years and took more than 13 years to develop. Congress told the agency in 1994 it must issue a regulation tightening federal safety standards on dietary supplements.
业内赞同此项新规定的产生，此项规定在13年前就开始筹备，最近3年多来一直悬而未决。国会在1994年就督促FDA发布食品安全法规，来加强膳食添加剂的控制。