Warning Letters Issued to Two Companies for Illegally Selling Probiotic Products to Treat Diseases in Preterm Infants

向两家公司发出警告信，非法销售益生菌产品治疗早产儿疾病

SILVER SPRING, Md., Oct. 26, 2023 /PRNewswire/ -- As part of the U.S. Food and Drug Administration's commitment to protecting public health, the agency is advising the public, including healthcare providers, of the possible risks that products containing live bacteria or yeast, which are commonly called probiotics, pose to preterm infants in hospital settings.

SILVER SPRING，医学博士，2023年10月26日/PRNewswire/-作为美国食品和药物管理局致力于保护公众健康的一部分，该机构正在向公众（包括医疗保健提供者）通报含有活细菌的产品可能存在的风险或酵母，通常称为益生菌，在医院环境中对早产儿造成影响。

The agency recently sent a letter to healthcare providers warning them about this topic and has issued two warning letters to companies for illegally selling their products for use in treating or preventing certain diseases in preterm infants..

该机构最近向医疗保健提供者发出了一封信，警告他们这个话题，并向公司发出了两封警告信，非法销售其产品，用于治疗或预防早产儿某些疾病。。

Probiotic products contain live organisms such as bacteria or yeast and are commonly marketed as foods, including as dietary supplements. The FDA is concerned as these products can be dangerous for preterm infants and are being illegally sold to treat or prevent diseases in preterm infants in hospital settings, such as to reduce the risk of necrotizing enterocolitis.

益生菌产品含有活生物体，如细菌或酵母，通常作为食品销售，包括作为膳食补充剂。FDA担心这些产品可能对早产儿有危险，并且被非法销售用于治疗或预防医院环境中的早产儿疾病，例如降低坏死性小肠结肠炎的风险。

Preterm infants who are administered a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics..

给予益生菌产品的早产儿有由益生菌中含有的细菌或酵母引起的侵入性，潜在致命性疾病或感染的风险。。

The FDA is aware that certain probiotic products used in hospital settings to prevent necrotizing enterocolitis have contributed to invasive disease, including one infant death in 2023, and have been associated with more than two dozen other reported adverse events in the United States since 2018. The agency is also concerned about and is investigating reports that these products may have contributed to additional adverse events, including death, and is working to obtain the proper evidence and medical records, where possible.

FDA意识到，医院环境中用于预防坏死性小肠结肠炎的某些益生菌产品导致了侵袭性疾病，包括2023年的一名婴儿死亡，并且自2018年以来与美国其他二十多例报告的不良事件有关。该机构还关心并正在调查这些产品可能导致包括死亡在内的其他不良事件的报告，并正在努力在可能的情况下获得适当的证据和医疗记录。

Any death or adverse event in an infant following the use of a probiotic product is very concerning, and the FDA is actively working with healthcare providers to better understand the link between the probiotic products used and the adverse events in preterm infants reported by these institutions..

使用益生菌产品后婴儿的任何死亡或不良事件都非常令人担忧，FDA正在积极与医疗保健提供者合作，以更好地了解所使用的益生菌产品与这些机构报告的早产儿不良事件之间的联系。。

Importantly, the FDA has not approved any probiotic product for use as a drug or biological product in infants of any age. Unapproved, unlicensed probiotics that are used to treat or prevent a disease or condition in preterm infants have not undergone the agency's thorough premarket evaluation for safety and effectiveness.

重要的是，FDA尚未批准任何益生菌产品用作任何年龄的婴儿的药物或生物制品。用于治疗或预防早产儿疾病或病症的未经批准的未经许可的益生菌尚未经过该机构对安全性和有效性的全面上市前评估。

Further, they have not been evaluated for compliance with the agency's rigorous manufacturing and testing standards for drugs and biological products, including testing for other organisms. For these products to be lawfully marketed as drugs and biological products, the FDA requires approval of a Biologics License Application to ensure they have been appropriately evaluated.

此外，尚未评估它们是否符合该机构严格的药物和生物制品制造和测试标准，包括对其他生物的测试。为了使这些产品作为药物和生物制品合法销售，FDA要求批准生物制品许可证申请，以确保它们得到适当的评估。

In the absence of an approved product, healthcare providers who administer products containing live bacteria or yeast to treat, mitigate, cure or prevent a disease or condition are required to submit an Investigational New Drug application to the agency to ensure the investigational use of an unapproved product is conducted with the appropriate safeguards..

在没有获得批准的产品的情况下，管理含有活细菌或酵母的产品以治疗，减轻，治愈或预防疾病或病症的医疗保健提供者必须向该机构提交研究性新药申请，以确保研究性使用未经批准的产品是在适当的保障措施下进行的。。

'Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,' said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research.

'使用益生菌后任何婴儿的不良事件都是FDA关注的问题。FDA生物制品评估和研究中心主任Peter Marks博士说，我们特别想明确指出，含有活微生物的产品可能会给医院环境中的早产儿带来严重风险。

'With today's message, we want to warn parents, caregivers and healthcare providers that if these products are used for the prevention or treatment of disease, they have not undergone the agency's rigorous premarket process to evaluate their safety, effectiveness and quality for these medical uses.'.

“今天的消息是，我们想警告家长，护理人员和医疗保健提供者，如果这些产品用于预防或治疗疾病，他们还没有经过该机构严格的上市前程序来评估这些产品的安全性，有效性和质量医疗用途“。

The agency is committed to ensuring that any violations and safety issues presented by these products are addressed by their manufacturers. The agency issued a warning letter to Abbott Laboratories on Oct. 24, 2023, for its product, Similac Probiotic Tri-Blend, which contains B. infantis (Bb-02), S.

该机构致力于确保制造商解决这些产品带来的任何违规和安全问题。该机构于2023年10月24日向雅培实验室发出了一封警告信，其产品为Similac益生菌三混合物，其中含有婴儿双歧杆菌（Bb-02），S。

thermophilus (TH-4) and B. lactis (BB-12). Of note, this product is not an infant formula and is not related to the previous issues the agency has noted with powdered infant formula manufactured by Abbott Nutrition. Abbott has agreed to discontinue sales of its Similac Probiotic Tri-Blend product and is working with the FDA to take additional corrective actions..

嗜热菌（TH-4）和乳双歧杆菌（BB-12）。值得注意的是，该产品不是婴儿配方奶粉，与该机构注意到的由Abbott Nutrition生产的婴儿配方奶粉以前的问题无关。雅培已同意停止销售其Similac益生菌三混合产品，并与FDA合作采取额外的纠正措施。。

The warning letter notes the company sells the probiotic product for use in hospital settings for preterm infants. Based on the intended uses on the company's websites and Abbott's marketing materials, the product is an unapproved new drug and an unlicensed biological product being sold in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act.

警告信指出，公司销售益生菌产品，用于早产儿的医院环境。根据公司网站的预期用途和雅培的营销材料，该产品是未经批准的新药和违反联邦食品，药品和化妆品法案（FD＆C法案）和公共卫生服务的未经许可的生物制品法案。

Additionally, the product is an adulterated dietary supplement under the FD&C Act because, when intended for consumption by preterm infants, the Bb-02 and TH-4 ingredients have not met the applicable safety requirements..

此外，该产品是根据FD＆C法案掺假的膳食补充剂，因为当打算供早产儿食用时，Bb-02和TH-4成分未满足适用的安全要求。。

The agency also recently issued a warning letter to Infinant Health, Inc (formerly Evolve BioSystems Inc.) regarding its probiotic product, Evivo with MCT Oil, an unapproved and unlicensed product sold for use in treating or preventing disease in preterm infants, in violation of the FD&C Act and the Public Health Service Act.

该机构最近还向Infinant Health，Inc（前身为Evolve BioSystems Inc.）发出了一封警告信，内容涉及其益生菌产品Evivo with MCT Oil，这是一种未经批准和未经许可的产品，用于治疗或预防早产儿疾病，违反FD＆C法和“公共卫生服务法”。

The product was intended to be added to food for preterm infants and as such was also found to be an adulterated food under the FD&C Act. This product has since been voluntarily recalled and is no longer available in the U.S..

该产品旨在添加到早产儿食品中，因此也被发现是FD＆C法案下的掺假食品。此后，该产品已被自愿召回，并且不再在美国提供。。

'Protecting public health, especially of the most vulnerable populations such as preterm infants, is one of the highest priorities for the FDA,' said Jim Jones, the FDA's Deputy Commissioner for Human Foods. 'We are encouraging all involved in the care of preterm infants, including parents, caregivers and healthcare providers, to be aware of the possible risks associated with the administration of probiotic products to preterm infants in hospital settings.

FDA人类食品副专员吉姆·琼斯（Jim Jones）说：“保护公众健康，特别是早产儿等最脆弱人群的健康是FDA的首要任务之一。“我们鼓励所有参与早产儿护理的人，包括父母，护理人员和医疗保健提供者，意识到在医院环境中向早产儿施用益生菌产品可能带来的风险。

The FDA continues to investigate these incidents and is committed to using our available resources and authorities to identify and address potentially unsafe products in the market.'.

FDA继续调查这些事件，并致力于利用我们可用的资源和当局来识别和解决市场上潜在的不安全产品。

The FDA understands there are conflicting data in the literature on the safety and effectiveness of probiotics for the prevention of necrotizing enterocolitis, and that the study of the use of probiotics has been complicated by several factors, including the use of different probiotics in different trials.

FDA了解文献中关于益生菌预防坏死性小肠结肠炎的安全性和有效性的数据存在矛盾，并且益生菌使用的研究由于若干因素而复杂化，包括在不同试验中使用不同的益生菌。

Because of the potential for harm posed by these products in highly vulnerable individuals, such as preterm infants, the agency urges the industry, clinical and research funding communities to focus on high quality clinical trials with products meeting quality criteria to provide definitive evidence to inform the use of these products by healthcare providers and, where appropriate, to support applications for drugs and biological products for use in infants of any age..

由于这些产品可能对早产儿等高度脆弱的个人造成伤害，该机构敦促行业，临床和研究资助团体将重点放在高质量的临床试验上，产品符合质量标准，以提供明确的证据，告知医疗服务提供者使用这些产品，并在适当情况下，支持任何年龄的婴儿使用的药物和生物制品申请。。

The agency continues to carefully review and investigate adverse event reports for probiotics. To inform the agency's surveillance efforts, and to better understand these issues to help protect public health, the FDA encourages healthcare providers and caregivers to report adverse events following use of probiotics to the manufacturer, the FDA's MedWatch program and CFSAN's Adverse Event Reporting System.

该机构继续仔细审查和调查益生菌的不良事件报告。为了通知该机构的监督工作，并更好地了解这些问题以帮助保护公众健康，FDA鼓励医疗保健提供者和护理人员在向制造商使用益生菌，FDA的MedWatch计划和CFSAN的不良事件报告系统后报告不良事件。

Caregivers may also speak with their healthcare provider regarding concerns or questions with these products..

护理人员也可以与他们的医疗保健提供者谈论这些产品的疑虑或问题。。

Additional Resources:

其他资源：

Dear Healthcare Provider Letter: Warning Regarding Use of Probiotics in Preterm Infants

亲爱的医疗保健提供者信函：关于在早产儿中使用益生菌的警告

Warning Letter: Abbott Laboratories

警告信：雅培实验室

Warning Letter: Infinant Health, Inc formerly Evolve Biosystems Inc.

警告信：Infinant Health，Inc以前是Evolve Biosystems Inc。

Media Contact: Carly (Kempler) Pflaum, 240-672-8872; Courtney Rhodes, 202-281-5237Consumer Inquiries: Email, 888-INFO-FDA

媒体联系人：Carly（Kempler）Pflaum，240-672-8872；Courtney Rhodes，202-281-5237消费者查询：电子邮件，888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. .

FDA是美国卫生和人类服务部的一个机构，通过确保人类和兽药，人类使用的疫苗和其他生物制品以及医疗器械的安全性，有效性和安全性来保护公共健康。该机构还负责我国食品供应，化妆品，膳食补充剂，辐射发射电子产品和烟草制品的安全保障。 .

SOURCE U.S. Food and Drug Administration

来源美国食品和药物管理局