主页 > 医学文档 >
【drug-news】FDA 发布新的维生素安全使用指南
For the first time, manufacturers of vitamins, herbal pills and other dietary supplements will have to test all of their products' ingredients. The Food and Drug Administration said Friday it is phasing in a new rule that is designed to address concerns that existing regulations allowed supplements onto the market that were contaminated or didn't contain ingredients claimed on the label.
Last year, the agency found that some supplements contained undeclared active ingredients used in prescription drugs for erectile dysfunction. In the past, regulators found supplements that didn't contain the levels of Vitamin C or Vitamin A that were claimed.
If, upon inspection, the FDA finds that supplements do not contain the ingredients they claim, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove an ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or even seek criminal charges.
Dietary supplements pills, liquids or other products are a $22 billion industry.
Most companies already test their raw ingredients, said Steve Mister, president and CEO for the Council for Responsible Nutrition, a trade association representing about 65 manufacturers.
"This raises the bar so that all have to comply," Mister said.
The new rule goes into effect Aug. 24 and will have a three-year phase-in that gives smaller manufacturers more time to comply. Even the largest of the manufactures won't have to comply until June 2008.
The rule applies to all domestic and foreign companies that manufacture, package and label supplements for sale in the U.S. It requires them to analyze the identity, purity and strength of all the ingredients that go into their products before they are distributed.
It also includes requirements for record keeping and handling consumer complaints.
Dr. Sidney Wolfe, who has testified before Congress on problems with dietary supplements, said the new rule does not ease his concern that unsafe supplements are too easy to bring to market.
"You still don't have to show the product is safe. You don't have to prove it works," said Wolfe, director of Public Citizen's Health Research Group
Consumers Union, publisher of Consumer Reports, called the rule a good step toward improving consistency in the ingredients that go into supplements.
"However, consumers still have no idea if a given product works, or whether it is dangerous," said Janell Mayo Duncan, senior counsel for Consumers Union, publisher of Consumer Reports.
Congress limited the Food and Drug Administration's oversight of vitamins and other dietary supplements in 1994. The new rule is a product of that law, meaning that the rule took nearly 13 years to develop.
Under the old regulations, supplements were governed by the same rules that applied to producing foods, such as cans of soup.
"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Dr. Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition. 加油 我支持你 哈哈 今天才发现这论坛 真不错 以后我应该是常客了 呵呵 还没译出来吗? 对于维生素, 中草药丸和其他营养补充剂的制造商而言, 政府将首次提出更严格的要求, 对上述产品的所有成分进行检验. 这是美国食品和药物管理局FDA的新规定.
FDA周五宣布将逐步实行新的规则,旨在解决消费者和业内人士的种种担心, 即现行法规允许上述产品在未经严格检测就被推向市场,消费者无法确信该产品是否受到污染或不含有标签所称的成份.
去年FDA曾发现在一些保健品中含有某些未经标示的处方药活性成份,比如治疗性功能障碍的药用成份, 此外,FDA还发现一些维生素C或维生素A的产品中并不含有足量或完全没有所标示的成分
新法实施后,如果FDA检查发现, 某保健产品不包含所标示的成分,将被视为搀假和假劣产品误导. 该机构可要求制造商撤离产品或或修改其标签. 更为严重的情况下,它能够封存没收这些伪劣产品,对厂商提起诉讼,甚至寻求刑事指控
营养保健品或添加剂是拥有是220亿美元的大产业.
Steve Mister史蒂夫是"责任感营养协会"的总裁兼CEO, 他的组织代表着约65个厂家的行业协会. 他认为,大部分公司已经测试自己的原材料,
8月24日起正式生效的新规则将提高行业的进入门槛, 为了照顾小企业的利益,新法规将分三年全面实施, 这样可以给予规模较小的厂商有更多的时间来调整适应新法规. 即使是大的生产厂也可以等到到2008年6月才按新规定办. .
该规则适用于所有国内和国外公司制造, 包装和标签所有营养保健品的厂商,只要它们有产品在美国销售, 在出厂销售前, 需要分析这些产品的成份, 纯度和含量; 同时还需要保存所有生产记录和处理消费者的投诉.
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-03-12 05:12
医学,生命科学网