--- title: "欧盟监管机构称 Charlotte's Web 大麻 CBD 的安全性 “无法确定”——那么为什么它会进入 Medicare？" type: "News" locale: "zh-CN" url: "https://longbridge.com/zh-CN/news/285778843.md" description: "欧盟监管机构认为，Charlotte's Web 的大麻 CBD 产品的安全性 “无法确定”，原因是存在显著的数据缺口。尽管如此，美国医疗保险和医疗补助服务中心（CMS）已启动一项计划，允许在没有 FDA 批准的情况下向医疗保险受益人提供这些产品。这引发了对患者安全的担忧，尤其是对于可能容易受到药物相互作用影响的老年人。一项联邦诉讼正在挑战该计划的合法性，质疑在科学验证之前是否应允许获取这些产品" datetime: "2026-05-08T21:30:50.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/285778843.md) - [en](https://longbridge.com/en/news/285778843.md) - [zh-HK](https://longbridge.com/zh-HK/news/285778843.md) --- # 欧盟监管机构称 Charlotte's Web 大麻 CBD 的安全性 “无法确定”——那么为什么它会进入 Medicare？ _**"As a Federal Lawsuit Challenges the CMS Cannabinoid Program, Questions Mount Over Safety Standards, Scientific Validation, and Patient Protections" stated Duane Boise CEO MMJ International Holdings.**_ **WASHINGTON, DC / ACCESS Newswire / May 8, 2026 /** A growing conflict between international scientific findings and U.S. healthcare policy is raising urgent questions about whether Medicare beneficiaries are being exposed to cannabinoid products that have not been proven safe. In March 2026, the **European Food Safety Authority (EFSA)** issued a formal scientific rejection of Charlottes Web hemp product submission concluding that the safety of a carbon dioxide extract derived from _Cannabis sativa L._ - including products associated with leading U.S. brands - **"cannot be established."** **That conclusion was not based on politics. It was based on data.** According to EFSA, critical gaps included: - Significant portions of the product remaining uncharacterized - Lack of reliable toxicological studies on the actual material - Absence of human clinical data - Unknown allergenicity and long-term safety profile The agency's bottom line was clear: **The safety of the product could not be determined.** **Meanwhile in the United States** At nearly the same time, the Centers for Medicare & Medicaid Services (CMS) launched the **Substance Access Beneficiary Engagement Incentive (BEI)** program. The initiative allows participating healthcare providers to **discuss and furnish certain hemp, marijuana derived cannabinoid products** to Medicare beneficiaries under Innovation Center authority. Unlike traditional drug pathways, the BEI program does **not require approval from the** U.S. Food and Drug Administration. That distinction is central to a federal lawsuit now pending: **Smart Approaches to Marijuana (SAM), et al. v. Robert F. Kennedy Jr., et al.** **Case No. 1:26-cv-01081 (U.S. District Court for the District of Columbia)** **The Scientific Gap** Under the FDA framework, products intended for therapeutic use typically undergo: - Controlled clinical trials - Dose standardization - Safety and toxicology evaluation - Manufacturing and stability validation The BEI program operates outside that structure. While CMS has described the initiative as an **innovation model**, critics argue it effectively introduces products into federally funded care environments **before those scientific benchmarks are met**. **Why This Matters for Seniors** Medicare beneficiaries represent one of the most medically complex populations in the healthcare system. Many patients: - Take multiple medications (polypharmacy) - Have chronic conditions - Are more vulnerable to drug interactions Cannabinoid compounds, including THC, are known to interact with metabolic pathways such as **CYP450 enzymes**, which are involved in processing many common medications. Without controlled studies in this population, the full safety profile remains uncertain. **Rapid Supply Chain Expansion** At the same time the program launched, several companies publicly announced positioning within the emerging healthcare supply chain: - Charlotte's Web highlighted alignment with CMS guidance - Cornbread Hemp announced institutional distribution through a national group purchasing organization These developments signal rapid commercialization of a category that has **not undergone FDA drug approval review**. **A Regulatory Tension** The situation creates a notable contradiction: - International regulators say safety cannot be established - The FDA has not approved these products as medicines - Yet a federal healthcare program is enabling access within Medicare-linked systems That tension is now at the center of federal litigation. **What the Court Will Decide** In **SAM v. Kennedy (1:26-cv-01081)**, the court is evaluating whether CMS exceeded its statutory authority by introducing cannabinoid furnishing pathways without: - Formal rulemaking - Public notice and comment - FDA validation standards A ruling is expected to determine whether the program: - Proceeds as implemented - Is narrowed or modified - Or is halted pending further review **The Core Question** This debate ultimately comes down to a fundamental issue in healthcare policy: **Should access to therapeutic products come before scientific validation-** **or should science remain the gatekeeper?** **Closing Perspective** The EFSA conclusion does not ban CBD products. But it does highlight a critical reality: **The scientific evidence needed to establish safety is still incomplete.** As federal policy evolves, the question is not whether innovation should occur- but whether it should occur **before the science is fully understood**, particularly for the nation's most vulnerable patients. **CONTACT:** Madison Hisey MHisey@mmjih.com 203-231-8583 **SOURCE:** MMJ International Holdings View the original press release on ACCESS Newswire ### 相关股票 - [CWBHF.US](https://longbridge.com/zh-CN/quote/CWBHF.US.md) - [ACCS.US](https://longbridge.com/zh-CN/quote/ACCS.US.md) ## 相关资讯与研究 - [Charlotte's Web Holdings, Inc.｜8-K：2026 财年 Q1 营收 11.16 百万美元](https://longbridge.com/zh-CN/news/286248662.md) - [美国大麻运营商 MariMed 预计明年初产生许可收入 俄亥俄州新店年底前开业](https://longbridge.com/zh-CN/news/286441508.md) - [信通院&清华提出 FedRE：用「纠缠」搞定联邦学习三难困境 | CVPR 26](https://longbridge.com/zh-CN/news/286727776.md) - [瑞银上调爵士制药评级：核心业务韧性强劲，新药 Ziihera 成增长引擎](https://longbridge.com/zh-CN/news/286920691.md) - [FDA 药物中心主任在局长离任后被解职](https://longbridge.com/zh-CN/news/286647408.md)