UPDATE 1-J&J says new tests show no asbestos in Johnson's Baby Powder


2019-12-04 08:00:50 YAHOO!FINANCE


By Sanjana Shivdas and Carl O'Donnell Dec 3 (Reuters) - Johnson & Johnson said on Tuesday that recent tests showed that Johnson's Baby Powder was free of asbestos, after U.S. Food and Drug Administration investigations reported trace amounts of the material in the product earlier this year. A total of 155 tests were conducted by two different third-party labs using four different testing methods on samples from the same bottle tested by the FDA's contracted lab, the company said. The tests are the latest effort by J&J to prove the safety of its widely used consumer product after the test by the FDA prompted J&J to undertake a nationwide recall of one lot of Johnson's Baby Powder in October. The FDA was not immediately available for comment. However, in response to an October announcement from J&J that a smaller number of independent tests also found no asbestos, the regulatory agency said it stood by its findings. The different test outcomes could have resulted from the fact that contaminants are not uniformly dispersed throughout talc and there is no standard test for asbestos in talc, FDA officials told Reuters in October. Tests conducted by the third-party labs showed asbestos was not present in the single bottle that the FDA's contracted lab had tested, nor was it present in retained samples of the finished lot from which the bottle was produced, the company said on Tuesday. The company said its investigation concluded that the most probable root causes for the FDA's reported results were either test sample contamination or analyst error at the lab, or both. In October, J&J recalled around 33,000 bottles of baby powder in the United States after the FDA said it had found trace amounts of asbestos in samples taken from a bottle purchased online. The voluntary recall was limited to one lot of Johnson's Baby Powder produced and shipped in the United States in 2018, the company said at the time. That move marked the first time the company recalled its baby powder for possible asbestos contamination, and the first time U.S. regulators have announced a finding of asbestos in the product. Asbestos is a known carcinogen that has been linked to deadly mesothelioma. The recall was the latest blow to the more than 130-year-old U.S. healthcare conglomerate that is facing thousands of lawsuits over a variety of products, including baby powder, opioids, medical devices and the antipsychotic Risperdal. J&J faces more than 15,000 lawsuits from consumers claiming its talc products, including Johnson's Baby Powder, caused their cancer. (Reporting by Sanjana Shivdas in Bengaluru and Carl O'Donnell in New York; Editing by Neil Fullick and Rosalba O'Brien)
强生周二表示,最近的测试显示,强生公司的婴儿爽身粉中没有石棉,此前美国食品和药物管理局( FDA )今年早些时候的调查报告显示,该产品中含有微量的石棉. 该公司表示,共有155项测试是由两个不同的第三方实验室进行的,使用四种不同的测试方法对来自 FDA 签约实验室检测的同一瓶样品进行测试。 这些测试是强生公司为证明其广泛使用的消费者产品的安全性而做出的最新努力。此前,美国食品和药物管理局( FDA )的测试促使强生(J&J)公司在10月份在全国范围内召回了大量强生公司的婴儿爽身粉。 FDA 没有立即发表评论。然而,针对强生公司( J & J )10月份宣布的少量独立测试也未发现石棉的情况,该监管机构表示,它坚持其调查结果。 FDA 官员在10月对路透社说,不同的检测结果可能是由于污染物不会均匀分散在滑石中,并且滑石中没有石棉的标准检测。 该公司周二表示,第三方实验室进行的测试显示,在 FDA 签约的实验室测试的单瓶中没有石棉存在,也没有石棉存在于生产该瓶的成品批次的保留样品中。 该公司表示,调查得出的结论是, FDA 报告结果最有可能的根本原因要么是实验样本污染,要么是实验室分析人员的错误,要么两者兼而有之。 去年10月,强生(J&J)公司召回了大约3.3万瓶美国婴儿爽身粉,此前美国食品和药物管理局表示,从网上购买的一瓶奶粉中发现了微量石棉。 该公司当时表示,这次自愿召回仅限于2018年美国生产和发运的一批强生婴儿爽身粉。 此举标志着该公司首次召回可能污染石棉的婴儿爽身粉,也是美国监管机构首次宣布在该产品中发现石棉。石棉是一种已知的致癌物质,与致命的间皮瘤有关。 此次召回是对这家有着130多年历史的美国医疗集团的最新打击。该集团正面临着数千起针对各种产品的诉讼,包括婴儿爽身粉、阿片类药物、医疗器械和抗精神病药物 Rispedal 。 强生(J&J)公司面临着来自消费者的15,000多起诉讼,声称其滑石产品,包括强生公司的婴儿粉剂,导致了癌症。( Sanjana Shivdas 在 Bengaluru 和 Carl O'Donnell 在纽约的报道; Neil Fullick 和 Rosalba O'Brien 编辑)