FDA推进与大麻产品相关的工作,重点是保护公共卫生,提供市场清晰度

食品和毒品专员的声明 - 食品和药物管理局
Stephen M. Hahn医学博士2020年3月5日

Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.

今天,我们正在介绍我们在这一领域的最新努力,包括在教育、研究和执法领域采取的若干新步骤,最终目标是继续保护公众健康,并努力提供市场透明度。

教育公众使用CBD的潜在风险

We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons.

But as the agency has stated before, we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.

我们仍然专注于教育公众关于仍然存在CBD安全的问题数量。在从您的医疗保健提供者的处方的监测设置之外使用CBD产品之前可能需要考虑风险。

特别是,该机构最近更新了公众担心CBD产品的潜在危害,包括潜在的肝脏损伤、与其他药物的相互作用、男性生殖毒性,以及嗜睡等副作用。此外,还有很多我们不知道的其他潜在风险。例如,除了已批准的处方药外,我们对持续和/或累积使用CBD、与其他药物联合用药的潜在影响,以及对儿童、孕妇和哺乳期妇女、老年人、未出生儿童和某些动物种群等弱势群体的风险知之甚少。这并不意味着我们知道CBD是不安全,这些人群或在这种情况下,但考虑到我们目前的知识缺口,我们已确定的已知风险,也不是在一个地方我们可以得出结论,未经批准的CBD产品安全使用。我们鼓励美国人在使用CBD产品前咨询他们的医疗服务提供者。

我们将继续在这方面扩大我们的教育努力。这包括广泛的消费者,具体群体,其中有额外的,重要的健康考虑,以及在与患者交谈时必须了解这些风险的医疗保健专业人员。我们也将继续更新我们的在线资源对于消费者,研究人员和行业,以及在联邦,州,地方,地区,部落和国际层面的联邦,行业,研究人员和我们的监管合作伙伴维持多条沟通,以分享和收集所需信息并听取各种各样的信息观点。

查看完整的FDA语句

有关CBD产品辅料的作用,请参阅我们的文章

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