洗手液被苯污染。防晒霜和干洗发水也不例外。如今,广泛使用的消费品——痤疮治疗产品也被发现含有高浓度的致癌化学物质。
3月5日的晚些时候,一家独立检测实验室在向美国食品与药品监督管理局(US Food and Drug Administration)提交的一份请愿书中称,包括高伦雅芙(Proactiv)、塔吉特(Target Corp.)旗下的Up & Up和倩碧(Clinique)在内的品牌的祛痘产品中含有高浓度的致癌物质。该实验室要求美国食品与药品监督管理局在监管机构调查期间召回受污染的护理产品。这些产品都含有活性成分过氧化苯甲酰。
据美国疾病控制与预防中心(US Centers for Disease Control and Prevention)称,苯是汽油和烟草烟雾的天然成分,如果吸入高浓度的苯,可能就会导致白血病。在过去的三年中,在几种流行产品里检测出苯,这提高了消费者对浴室柜中潜在威胁的认识,也引发了人们质疑美国食品与药品监督管理局对该行业监管不力。包括强生公司(Johnson & Johnson)、联合利华公司(Unilever Plc)和宝洁公司(Procter & Gamble Co.)在内的公司已经召回了产品。
总部位于美国康涅狄格州纽黑文的检测实验室Valisure LLC于3月5日提交了请愿书,并揭露了之前发现的风险。该公司将自身定位为消费者的看门人。Valisure在产品研究方面声名鹊起,并与包括凯撒医疗机构(Kaiser Permanente)和美国国防部(US Department of Defense)在内的大型医疗保健系统达成协议,对其成员使用的药物进行检测,以剔除不达标的治疗产品。
在痤疮研究中,Valisure测试了66种过氧化苯甲酰产品,包括主要零售商柜台或处方销售的面霜、乳液、凝胶和洗剂。虽然根据美国食品与药品监督管理局的指南,允许苯的含量不超过百万分之二,但Valisure在一些治疗产品里发现的苯含量高达这一标准的九倍。当这些产品在更高的温度下进行测试时,苯含量明显升高,测试的目的是模拟产品随着时间的推移可能发生分解的情况。例如,如果产品存放在蒸汽弥漫的浴室的药柜中。
在Valisure的稳定性测试中,由Taro Pharmaceutical Industries Ltd.生产的高伦雅芙2.5%过氧化苯甲酰面霜里的苯含量高达百万分之1,761,而塔吉特的一款类似面霜的苯含量高达百万分之1,598,雅诗兰黛旗下倩碧的一款面霜的苯含量达到了百万分之401。利洁时集团(Reckitt Benckiser Group Plc)生产的Clearasil的10%过氧化苯甲酰面霜最初的测试结果刚刚达到美国食品与药品监督管理局的限值,但在高温下暴露两周多后,苯含量跃升至百万分之308。
利洁时集团在一份声明中表示:“利洁时确信,所有Clearasil产品在按照标签说明使用和储存时都是安全的。”利洁时称,公司的首要任务是保证产品的安全和质量。该公司没有回答是否检测了其祛痘霜里的苯含量。
美国食品与药品监督管理局、Taro Pharmaceuticals和雅诗兰黛的代表没有回应置评请求。塔吉特拒绝置评。伦敦股市收盘时,利洁时股价下跌2%,联合利华下跌0.4%;纽约股市收盘时,雅诗兰黛下跌1.3%,Taro Pharmaceuticals下跌2.4%。
据美国皮肤病学会(American Academy of Dermatology)称,痤疮是美国最常见的皮肤病,每年影响多达5,000万人。在青少年和年轻人中,这一数字甚至更高:12岁至24岁的人群里大约有85%的人患有某种形式的痤疮。
总部位于芝加哥的市场研究公司Circana的数据显示,2023年美国非处方痤疮治疗药物的销售总额达10亿美元,几乎是2019年5.93亿美元销售额的两倍。美国皮肤病学会指南把过氧化苯甲酰列为局部痤疮治疗的首选药物之一。
Valisure公司的总裁大卫·莱特指出,发生污染的原因是过氧化苯甲酰会分解并形成苯。
他在接受采访时说:“这一点早已众所周知。只是需要有人来检测一下。”
在2023年提交的一份专利申请中,莱特被列为发明人,该专利涉及一种防止药品里的过氧化苯甲酰分解成苯的方法。该实验室检测了其他种类含有不同成分(主要是水杨酸)的祛痘产品,但并未在这些产品中发现苯含量升高。
Valisure最引人注目的调查是对胃灼热药物善胃得(Zantac)的调查:在实验室发现该药物的活性成分雷尼替丁可能形成一种名为NDMA的致癌物几个月后,美国食品与药品监督管理局于2020年将善胃得及其仿制药从市场上撤下。
美国食品与药品监督管理局过去曾经对Valisure的检测方法提出过质疑。具体而言,该机构表示,独立实验室应该采用与药品生产商相同的流程,而这种流程往往比Valisure的检测方法成本更高。
Valisure坚持自己的检测方法,并指出自己获得了国际标准化组织(International Organization for Standardization)的认证。该组织为包括药品在内的各类产品制定了检测指南。Valisure在3月6日的一份声明里表示,该公司对痤疮治疗产品的研究得出的结论与对雷尼替丁产品的调查研究最为相似。
莱特在声明中说:“我们在防晒霜和其他消费品里发现的苯是来自受污染成分的杂质;而过氧化苯甲酰产品中的苯来自过氧化苯甲酰本身。”
2022年,在Valisure先前的研究发现苯之后,美国食品与药品监督管理局警告各公司评估自己产品形成这种化学物质的风险。该机构并不会定期检测其监管的产品。
康涅狄格州民主党众议员罗莎·德劳罗在一份声明里说:“Valisure关于过氧化苯甲酰痤疮治疗产品的发现令人深感不安,并再次强调,一旦我们意识到处方药或非处方药的危险,就必须授权美国食品与药品监督管理局立即采取行动。过氧化苯甲酰产品在目前的市场上已经达到饱和,数百万消费者在不知情的情况下使用了这种产品,就增加了他们接触危及生命的致癌物质的机会。”
德劳罗试图推动立法,赋予美国食品与药品监督管理局召回药品的权力,而不是与公司协商召回药品(在公司自愿的基础上)。
Valisure还检测了痤疮治疗产品周围空气的苯含量,发现即便是未开封的高伦雅芙产品,在104华氏度(40摄氏度,相当于热水浴的温度)的环境中放置近17个小时后,也会释放出大量的苯。美国国家环境保护局(Environmental Protection Agency)表示,长期吸入十亿分之0.4浓度的苯,可能会导致每10万人里多1人罹患癌症,这也是美国食品与药品监督管理局采用的风险衡量标准。(财富中文网)
译者:中慧言-王芳
洗手液被苯污染。防晒霜和干洗发水也不例外。如今,广泛使用的消费品——痤疮治疗产品也被发现含有高浓度的致癌化学物质。
3月5日的晚些时候,一家独立检测实验室在向美国食品与药品监督管理局(US Food and Drug Administration)提交的一份请愿书中称,包括高伦雅芙(Proactiv)、塔吉特(Target Corp.)旗下的Up & Up和倩碧(Clinique)在内的品牌的祛痘产品中含有高浓度的致癌物质。该实验室要求美国食品与药品监督管理局在监管机构调查期间召回受污染的护理产品。这些产品都含有活性成分过氧化苯甲酰。
据美国疾病控制与预防中心(US Centers for Disease Control and Prevention)称,苯是汽油和烟草烟雾的天然成分,如果吸入高浓度的苯,可能就会导致白血病。在过去的三年中,在几种流行产品里检测出苯,这提高了消费者对浴室柜中潜在威胁的认识,也引发了人们质疑美国食品与药品监督管理局对该行业监管不力。包括强生公司(Johnson & Johnson)、联合利华公司(Unilever Plc)和宝洁公司(Procter & Gamble Co.)在内的公司已经召回了产品。
总部位于美国康涅狄格州纽黑文的检测实验室Valisure LLC于3月5日提交了请愿书,并揭露了之前发现的风险。该公司将自身定位为消费者的看门人。Valisure在产品研究方面声名鹊起,并与包括凯撒医疗机构(Kaiser Permanente)和美国国防部(US Department of Defense)在内的大型医疗保健系统达成协议,对其成员使用的药物进行检测,以剔除不达标的治疗产品。
在痤疮研究中,Valisure测试了66种过氧化苯甲酰产品,包括主要零售商柜台或处方销售的面霜、乳液、凝胶和洗剂。虽然根据美国食品与药品监督管理局的指南,允许苯的含量不超过百万分之二,但Valisure在一些治疗产品里发现的苯含量高达这一标准的九倍。当这些产品在更高的温度下进行测试时,苯含量明显升高,测试的目的是模拟产品随着时间的推移可能发生分解的情况。例如,如果产品存放在蒸汽弥漫的浴室的药柜中。
在Valisure的稳定性测试中,由Taro Pharmaceutical Industries Ltd.生产的高伦雅芙2.5%过氧化苯甲酰面霜里的苯含量高达百万分之1,761,而塔吉特的一款类似面霜的苯含量高达百万分之1,598,雅诗兰黛旗下倩碧的一款面霜的苯含量达到了百万分之401。利洁时集团(Reckitt Benckiser Group Plc)生产的Clearasil的10%过氧化苯甲酰面霜最初的测试结果刚刚达到美国食品与药品监督管理局的限值,但在高温下暴露两周多后,苯含量跃升至百万分之308。
利洁时集团在一份声明中表示:“利洁时确信,所有Clearasil产品在按照标签说明使用和储存时都是安全的。”利洁时称,公司的首要任务是保证产品的安全和质量。该公司没有回答是否检测了其祛痘霜里的苯含量。
美国食品与药品监督管理局、Taro Pharmaceuticals和雅诗兰黛的代表没有回应置评请求。塔吉特拒绝置评。伦敦股市收盘时,利洁时股价下跌2%,联合利华下跌0.4%;纽约股市收盘时,雅诗兰黛下跌1.3%,Taro Pharmaceuticals下跌2.4%。
据美国皮肤病学会(American Academy of Dermatology)称,痤疮是美国最常见的皮肤病,每年影响多达5,000万人。在青少年和年轻人中,这一数字甚至更高:12岁至24岁的人群里大约有85%的人患有某种形式的痤疮。
总部位于芝加哥的市场研究公司Circana的数据显示,2023年美国非处方痤疮治疗药物的销售总额达10亿美元,几乎是2019年5.93亿美元销售额的两倍。美国皮肤病学会指南把过氧化苯甲酰列为局部痤疮治疗的首选药物之一。
Valisure公司的总裁大卫·莱特指出,发生污染的原因是过氧化苯甲酰会分解并形成苯。
他在接受采访时说:“这一点早已众所周知。只是需要有人来检测一下。”
在2023年提交的一份专利申请中,莱特被列为发明人,该专利涉及一种防止药品里的过氧化苯甲酰分解成苯的方法。该实验室检测了其他种类含有不同成分(主要是水杨酸)的祛痘产品,但并未在这些产品中发现苯含量升高。
Valisure最引人注目的调查是对胃灼热药物善胃得(Zantac)的调查:在实验室发现该药物的活性成分雷尼替丁可能形成一种名为NDMA的致癌物几个月后,美国食品与药品监督管理局于2020年将善胃得及其仿制药从市场上撤下。
美国食品与药品监督管理局过去曾经对Valisure的检测方法提出过质疑。具体而言,该机构表示,独立实验室应该采用与药品生产商相同的流程,而这种流程往往比Valisure的检测方法成本更高。
Valisure坚持自己的检测方法,并指出自己获得了国际标准化组织(International Organization for Standardization)的认证。该组织为包括药品在内的各类产品制定了检测指南。Valisure在3月6日的一份声明里表示,该公司对痤疮治疗产品的研究得出的结论与对雷尼替丁产品的调查研究最为相似。
莱特在声明中说:“我们在防晒霜和其他消费品里发现的苯是来自受污染成分的杂质;而过氧化苯甲酰产品中的苯来自过氧化苯甲酰本身。”
2022年,在Valisure先前的研究发现苯之后,美国食品与药品监督管理局警告各公司评估自己产品形成这种化学物质的风险。该机构并不会定期检测其监管的产品。
康涅狄格州民主党众议员罗莎·德劳罗在一份声明里说:“Valisure关于过氧化苯甲酰痤疮治疗产品的发现令人深感不安,并再次强调,一旦我们意识到处方药或非处方药的危险,就必须授权美国食品与药品监督管理局立即采取行动。过氧化苯甲酰产品在目前的市场上已经达到饱和,数百万消费者在不知情的情况下使用了这种产品,就增加了他们接触危及生命的致癌物质的机会。”
德劳罗试图推动立法,赋予美国食品与药品监督管理局召回药品的权力,而不是与公司协商召回药品(在公司自愿的基础上)。
Valisure还检测了痤疮治疗产品周围空气的苯含量,发现即便是未开封的高伦雅芙产品,在104华氏度(40摄氏度,相当于热水浴的温度)的环境中放置近17个小时后,也会释放出大量的苯。美国国家环境保护局(Environmental Protection Agency)表示,长期吸入十亿分之0.4浓度的苯,可能会导致每10万人里多1人罹患癌症,这也是美国食品与药品监督管理局采用的风险衡量标准。(财富中文网)
译者:中慧言-王芳
Hand sanitizers were tainted by benzene. Sunscreens and dry shampoos too. Now acne treatments are joining the list of widely used consumer products found to contain high levels of the chemical linked to cancer.
Acne products from brands including Proactiv, Target Corp.’s Up & Up and Clinique have elevated levels of the carcinogen, an independent testing laboratory said in a petition filed with the US Food and Drug Administration late March 5. The lab asked the FDA to recall the affected treatments — all of which contain the active ingredient benzoyl peroxide — while regulators investigate.
Benzene is a natural component of gasoline and tobacco smoke and can cause leukemia in high amounts, according to the US Centers for Disease Control and Prevention. Over the past three years it’s been detected in several popular products, heightening consumers’ awareness of the potential threats in their bathroom cabinets and raising questions about the FDA’s oversight of the industry. Companies including Johnson & Johnson, Unilever Plc and Procter & Gamble Co. have recalled products.
New Haven, Connecticut-based Valisure LLC, the testing laboratory that filed March 5’s petition and uncovered the previous risks, has positioned itself as a gatekeeper for consumers. Valisure gained prominence conducting product research and has deals with large health-care systems, including Kaiser Permanente and the US Department of Defense, to test drugs used by their members and weed out substandard treatments.
For its acne research, Valisure tested 66 benzoyl peroxide products, including creams, lotions, gels and washes available either over the counter from major retailers or via prescription. While FDA guidelines allow up to 2 parts per million of benzene, Valisure found up to nine times that amount in some treatments. Those levels jumped significantly when the products were tested at higher temperatures designed to replicate how they might break down over time, for example if stored in a medicine cabinet in a steamy bathroom.
Proactiv’s 2.5% benzoyl peroxide cream, manufactured by Taro Pharmaceutical Industries Ltd., contained as much as 1,761 parts per million of benzene during Valisure’s stability testing, while a similar cream from Target reached 1,598 parts per million and a treatment from Estee Lauder Cos.’s Clinique hit 401 parts per million. A 10% benzoyl peroxide cream from Reckitt Benckiser Group Plc’s Clearasil initially tested just at the FDA limit, but jumped to 308 parts per million of benzene after being exposed to high temperatures for more than two weeks.
“Reckitt is confident that all Clearasil products, when used and stored as directed on their labels, are safe,” the company said in a statement. The safety and quality of products are its top priority, Reckitt said. It didn’t answer questions about whether it had tested its acne cream for benzene.
Representatives for the FDA, Taro Pharmaceuticals and Estee Lauder didn’t respond to requests for comment. Target declined to comment. Reckitt fell 2% and Unilever dipped 0.4% in London, while Estee Lauder slid 1.3% and Taro tumbled 2.4% at the close in New York.
Acne is the most common skin condition in the U.S., and affects as many as 50 million people each year, according to the American Academy of Dermatology. The numbers are even higher among teenagers and young adults: about 85% of those aged 12 to 24 have some form of the condition.
Sales of over-the-counter US acne treatments totaled $1 billion last year, almost double the $593 million in sales in 2019, data from Chicago-based market research firm Circana showed. The AAD guidelines name benzoyl peroxide as one of its top recommendations for treating acne topically.
Valisure President David Light said the contamination happens because benzoyl peroxide can break down and form benzene.
“This has been well known for a long time,” he said in an interview. “All that was needed was for someone to check on it.”
Light is listed as an inventor on a patent filed last year for a method to prevent benzoyl peroxide from breaking down into benzene in drug products. The lab tested other kinds of acne products with different ingredients, mainly salicylic acid, and did not find elevated benzene levels in those.
Valisure’s most high-profile investigation was into heartburn drug Zantac, which the FDA pulled from the market along with generic versions in 2020, months after the lab discovered the drug’s active ingredient — ranitidine — could form a probable carcinogen called NDMA.
The FDA has questioned Valisure’s testing methods in the past. Specifically, the agency has said the independent lab should follow the same process that drug manufacturers use, which tends to be costlier than the way that Valisure tests.
Valisure stands behind its testing methods and points to its certification from the International Organization for Standardization, which sets testing guidelines for all kinds of products including drugs. In a statement on March 6, Valisure said the results from its research on acne treatments were most similar to its investigation into those ranitidine products.
“The benzene we found in sunscreens and other consumer products were impurities that came from contaminated ingredients; however, the benzene in benzoyl peroxide products is coming from the benzoyl peroxide itself,” Light said in the statement.
In 2022, following Valisure’s previous benzene findings, the FDA warned companies that they should assess the risk of the chemical forming in their own products. The agency doesn’t regularly test products it oversees.
“The discovery made by Valisure regarding benzoyl peroxide acne treatment products is deeply troubling and gives renewed importance to the need to empower the FDA to immediately act once we are made aware of the dangers of prescription or over-the-counter drugs,” US Representative Rosa DeLauro, a Connecticut Democrat, said in a statement. “Benzoyl peroxide products saturate the current market and millions of consumers are unknowingly using a product that increases their exposure to life-threatening carcinogens.”
DeLauro has attempted to push legislation that would give the FDA the authority to recall drugs rather than negotiate with companies to do so on a voluntary basis.
Valisure’s testing also examined benzene in the air surrounding acne treatments and found that even an unopened Proactiv product leaked high levels when kept at 104 degrees Fahrenheit, the temperature of a hot shower, for almost 17 hours. The Environmental Protection Agency has said inhaling benzene at levels of 0.4 parts per billion chronically over a lifetime could result in one additional cancer per 100,000 people, a measure of risk the FDA also uses.