美国对所有国家含有槟榔的食品实施自动扣留措施

2023年4月27日，美国食药局(FDA)更新了进口预警措施(import alert)，对所有属于或含有槟榔(包括粉末、提取物和其他形式)的食品实施自动扣留措施，其中包括成品膳食补充剂和散装膳食原料。该进口预警措施不适用于含有烟草或与烟草包装在一起的槟榔。

Import Alert 23-15进口预警

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 23-15

Published Date: 04/27/2023

Type: DWPE

Import Alert Name:进口预警名称

"Detention Without Physical Examination of Food Products That Are, or That Contain, Areca (Betel) Nuts, Including Finished Dietary Supplements and Bulk Dietary Ingredients"

“自动扣留含有槟榔的食品，包括成品膳食补充剂和散装膳食成分”

Reason for Alert:发出预警的原因：

Areca nut is the fruit seed of the areca palm tree (Areca catechu), which grows primarily in South Asia and the Western Pacific islands. The nut is commonly referred to as "betel nut" because it is often wrapped in betel leaves for chewing. Areca nuts and food products containing areca nuts are imported to the US, often to be sold in Asian markets as food.

槟榔是槟榔树（槟榔）的果实种子，主要生长在南亚和西太平洋岛屿。这种坚果通常被称为“槟榔”，因为它经常被包裹在槟榔叶中咀嚼。槟榔和含有槟榔的食品进口到美国，通常作为食品在亚洲市场销售。Chewing areca nut results in exposure to alkaloids including arecoline, which is reported to have cytotoxic, genotoxic, mutagenic, and carcinogenic effects. In its 2004 and 2012 evaluations on the carcinogenic risks to humans from areca (betel) nuts, the World Health Organization's International Agency for Research on Cancer (IARC) stated that there is sufficient evidence to conclude that areca nut chewed with or without tobacco causes oral cancer in humans. It also stated that there is sufficient evidence in experimental animals for the carcinogenicity of areca nut with or without tobacco (IARC, 2004; 2012). Further, review of the literature indicates that regular consumption of areca nut and areca nut products is associated with a range of persistent adverse systemic health effects.

嚼槟榔会接触到包括槟榔碱在内的生物碱，据报道，槟榔碱具有细胞毒性、遗传毒性、诱变和致癌作用。在2004年和2012年关于槟榔对人类致癌风险的评估中，世界卫生组织的国际癌症研究机构（IARC）表示，有足够的证据表明，槟榔与烟草或不与烟草一起咀嚼都会导致人类口腔癌症。它还指出，在实验动物中有足够的证据表明槟榔含有或不含有烟草一起使用都具有致癌性（IARC，2004年；2012年）。此外，文献综述表明，经常食用槟榔和槟榔产品会对系统健康产生一系列持续的不良影响。

Guidance:指导意见：

Divisions may detain without physical examination all shipments of food products that are, or that contain, areca (betel) nuts (including powders, extracts, and other forms), including finished dietary supplements and bulk dietary ingredients.

各部门可以在未经检验的情况下扣留所有含有槟榔（包括粉末、提取物和其他形式）的食品，包括成品膳食补充剂和散装膳食成分。Note, this import alert does not apply to areca (betel) nuts that contain, or are packaged with, tobacco, which are considered tobacco products.

请注意，此进口预警不适用于含有烟草或与烟草一起包装的槟榔，这些槟榔被视为烟草产品。In order to secure release of an individual shipment that is subject to detention without physical examination in accordance with this import alert, the owner, consignee and/or other responsible party should provide all relevant information supporting their request for release to FDA. Information should be submitted to the FDA Division Compliance Office indicated in the 'Notice of FDA Action' notice of detention.

为了确保放行根据本进口预警在未经检验的情况下被扣留的个别货物，货主、收货人和/或其他责任方应向美国食品药品监督管理局提供支持其放行请求的所有相关信息。应将信息提交给扣留相关的美国食品药品监督管理局行动通知书中所示的美国食品药品监管局部门合规办公室。Questions or issues involving import operations, contact the ORA, Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

有关进口业务的问题或问题，请致电（301）796-0356联系进口业务部ORA或FDAImportsInquiry@fda.hhs.govQuestions or issues on policy or any other additional questions, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov

有关政策的问题或问题或任何其他附加问题，应向CFSAN/执法部门的食品掺假评估处提出，网址为CFSANEnforcement@fda.hhs.govProduct Description:产品描述

Food products that are, or that contain, areca (betel) nuts (including powders, extracts, andother forms), including finished dietary supplements and bulk dietary ingredients.属于或含有槟榔（包括粉末、提取物和其他形式）的食品，包括成品膳食补充剂和散装膳食成分。Areca nuts are also known by various other names such as arec, fructus areca, and semen arecae.

槟榔也被称为各种其他名称，如槟榔、槟榔果和槟榔精华液。

Import Alert 23-15  https://www.accessdata.fda.gov/cms_ia/importalert_1139.html