首页 > 资讯 > FDA对含Kratom的膳食补充剂执法行动

出自识林

2016-01-12

近日，FDA采取行政行动在边境扣留了含有kratom的产品，kratom是一种可能有潜在滥用和潜在严重健康后果的植物材料。美国司法部代表FDA在美国联邦地区法院提出控告，“其中，指控kratom是一种新的膳食成分，没有充分信息提供合理保障该成分不会产生显著的或不合理的疾病或伤害风险；因此，根据FD&C法案，含有kratom的膳食补充剂是掺杂的。”

1月6日，FDA发布新闻稿公布美国联邦执法局应FDA要求查获近9万瓶标识含有kratom的膳食补充剂。该产品由位于伊利诺伊州South Beloit市的Dordoniz天然产品公司生产制造，以品牌名RelaKzpro销售，价值超过40万美元。

FDA于2014年2月首次表达了对此类物质的关注，并发布进口禁令，其中FDA指出，尽管根据FD&C法案满足膳食补充剂的定义，kratom是一种新的膳食成分，其首次上市日期在1994年10月15日祖父日期之后，因此需要在上市前通知FDA证明该膳食成分是安全的。并没有机构提前通知，根据新闻“实际上，科学文献公开了关于kratom在多器官系统中毒性的严重关注。Kratom的摄入可能导致一系列健康影响，包括呼吸抑制、精神紧张、情绪激动、焦虑、失眠、幻觉、妄想、颤栗、性欲减退、体重减轻、便秘、皮肤色素沉着、恶心、呕吐，并且具有麻醉药品和兴奋剂般的效果和严重的戒断症状和体征。没有使用历史或其它安全性证据确定合理地预期kratom作为膳食成分是安全的。Kratom和含kratom的膳食补充剂和散装膳食补充剂，根据FD&C法案402(f)(1)(B) Act [21 U.S.C. 342(f)(1)(B)]，是掺杂的，因为含有新膳食成分，该膳食成分没有足够的信息对不会出现严重或不合理的疾病或伤害风险提供合理的保障。”

FDA必须对保护美国消费者免受潜在危险产品的伤害而尽职尽责。关于膳食补充剂安全性和有效性的持续讨论，我们之前曾报道过多次，随着FDA步入新的一年，或许我们会看到更多执法行动，以及对于整个膳食补充剂问题的公开辩论。

Mitragyna Speciosa，俗称kratom，是一种天然生长于泰国、马来西亚、印度尼西亚和巴布亚新几内亚的植物物质。

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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Dietary Supplement Actions Continue By Bob Pollock | January 11, 2016

Recently, FDA took administrative action by detaining at the border a product containing kratom, a plant material that may have the potential for abuse and potential serious health consequences. Then the Department of Justice filed a complaint in US District Court on behalf of the FDA “alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act.” The announcement of the seizure conducted by US Marshalls can be found [here in a news release from FDA.

The FDA first expressed concern about the substance in February 2014 and issued an import alert (here) wherein the FDA noted that, while meeting the definition of a dietary supplement under the Act, kratom was a new dietary ingredient, which was first marketed after the grandfather date of October 15, 1994, thus requiring notice to the Agency prior to marketing demonstrating that the dietary ingredient was safe. This was not done by anyone and, according to the news release “[I]n fact, the scientific literature disclosed serious concerns regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms. In the absence of a history of use or other evidence of safety establishing that kratom will reasonably be expected to be safe as a dietary ingredient, kratom and kratom-containing dietary supplements and bulk dietary ingredients are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. 342(f)(1)(B)], because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”

The FDA must remain diligent to protect the American consumers from potentially dangerous products. We have posted multiple times (here, here, here, and here) regarding the continuing discussions about both the safety and efficacy of dietary supplements and, as the Agency moves into the new year, perhaps we will see additional enforcement action and potentially a public debate relative to the entire dietary supplement issue.