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GNC就俄勒冈州检察长指控的回应

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  GNC就俄勒冈州检察长指控的回应

  PR Newswire

  美通社

  23 October 2015

  2015年10月23日

  GNC Holdings, Inc.倒YSE: GNC), a leading global specialty retailer of health andwellness products, announced today that it has filed a motion to remove to Federal Court the lawsuit filed against it by the Oregon Attorney General. In making the filing thecompany issued the following statement:

  GNC Holdings, Inc.(纽约证券交易所:GNC),一家全球领先的健康及营养产品专业零售商,今日宣布其己提出申请将俄勒冈州检察长针对其提起的诉讼移送至联邦法院。公司在提交的申请中作出如下声明:

  "GNC believes that the lawsuit filed by the Oregon Attorney General is without merit,and the Company intends to defend itself vigorously against this unfair action.

  "GNC相信俄勒冈州检察长提起的诉讼并无依据,并且公司将针对该等不公正的指控作出有利的抗辩。

  Regrettably, despite our best efforts, we were unable to reach an agreement with theOregon Attorney General. As a next step, the Company filed today to have the action moved to Federal court. Products sold by GNC are regulated by the U.S. Food and DrugAdministration. GNC's vendors certify that they are in full compliance with the Food, Drug and Cosmetic Act (FDC Act), and to guarantee that their products meet all applicable Federal and state laws.:

  令人遗憾地是,尽管我们己尽最大努力,我们仍未能与俄勒冈州检察长达成协议。作为下一步行动,公司己于今日递交申请将该诉讼移交联邦法院。GNC销售的产品受美国食品和药品监督管理部门的监管。GNC的供应商保证其完全遵守食品、药品及化妆品法案((FDC法案),并保证其产品符合所有适用的联邦及州法律。

  Consistent with retail standard practice, GNC has appropriately relied on the guaranteesof suppliers that their products are lawful. This is a basic tenet of retail sales and isrecognized in federal law in the FDC Act and what is known nationally as the "FDAGuarantee." GNC is contractually entitled to indemnification by its third-party vendorsrelated to these guarantees and requires appropriate levels of third party vendor insurance.

  与零售行业标准实践相一致的是,GNC适当地依赖其供应商关于其产品合法性的保证.这一点是零售行业的基本原则,己在FDC法案中被联邦法律所认可,并被称为,"FDA保证”为全国所熟知。GNC拥有合同上的权利,就与该等保证相关的事项,自其第三方供应商获得赔偿,并且要求第三方供应商拥有符合适当标准的第三方供应商保险。

  GNC takes the quality of its products and compliance by third parties seriously, and the Company takes responsible measures to review any concerns when raised by the FDA or other regulatory bodies. With respect to the two ingredients at issue in the Oregon Attorney General's lawsuit, picamilon was included as an ingredient in dietary supplements widely sold by major retailers up to the time ofthe filing of Oregon's lawsuit on October 22, 2015, and products containing BMPEA were also widely available until the FDA issued a warning letter in April, 2015. There is no basis for the Oregon Attorney General's assertion that GNC or any other retailer "knew or should have known" that these ingredients were not legal for use in dietary supplements. As a matter of law, this critical legal issue remains undetermined as neither FDA nor any court has issued a legally binding determination of the status of these ingredients.

  GNC重视其产品质量以及第三方的合规性,且公司采取负责任的措施以审核FDA或其他监管机构提出的任何疑虑。就俄勒冈州检察长提起的诉讼中所涉及的两种原料,截至俄勒冈州于2015年10月22日提起诉讼之时,匹卡米隆作为一种原料被用于主要零售商广泛销售的日常膳食补充中,而截至FDA于2015年4月发出警告函之时,含有类安非他命物质(BMPEA)的产品也同样常见。俄勒冈州检察长关于GNC或其他任何零售商“己知或应当己知”该等原料用于日常膳食补充系非法的指控,是毫无依据的。从法律上而言,不论FDA或任何法院均未就该等原料是否可用于日常膳食补充作出任何法律上具有约束力的决定,因此该至关重要的法律问题并无定论。

  GNC stopped selling products with BMPEA and picamilon, immediately upon learning indirectly, rather than from notice directed at GNC, that FDA did not view BMPEA and picamilon as legal dietary ingredients. Neither picamilon nor BMPEA were included in a previous FDA warning letter or other FDA notification. Further, GNC took action to remove BMPEA and picamilon products even though the FDA did not raise any safet, concerns with respect to these ingredients, and neither notice constituted a legally binding FDA action on the legal status of these ingredients. Products containing BMPEA and picamilon were produced by third parties and accounted for less than one percent of the Company's sales.

  GNC已于间接获知(而非通过任何直接致送GNC的通知获知)FDA未将类安非他命物质及匹卡米隆视为合法的膳食原料之时,立即停止销售含有类安非他命物质及匹卡米隆的产品。不论匹卡米隆抑或类安非他命物质均不曾出现在此前的FDA等告函或其他FDA通知中。此外,即使FDA未就该等原料提出任何安全方面的疑虑,GNC仍采取行动以撤除类安非他命物质及匹卡米隆产品,而且,FDA的通知也并不构成其针对该等原料的法律状态而采取的具有法律约束力的行动。含有类安非他命物质及匹卡米隆的产品系由第三方生产并且在公司销售额中占比小于百分之一。

  GNC will continue to play a leading role in setting industry quality and compliance standards, as we always have. We are committed to providing our customers with the highest quality supplements available, using the purest and most effective ingredients, to help them live healthier lives."

GNC就俄勒冈州检察长指控的回应 公司新闻

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