|
News and updates about U.S. FDA import programs, policies and regulations
June 26, 2025
On July 9th, CBP issued an update to the trade community informing them that the FDA review exemption on importation of certain low-value FDA-regulated products has been rescinded.
All entries of FDA-regulated products must be reviewed for admissibility by the FDA, regardless of their quantity or value.
Previously, certain FDA-regulated products could be released by CBP without FDA notification, if eligible for exemption. Now, because technological capabilities of both the trade and the FDA have advanced significantly, it is necessary that even low-value entries ($800 or less) undergo FDA review to ensure they comply with FDA requirements.
This change allows FDA to review all electronically transmitted FDA-regulated products offered for import to facilitate legitimate trade and prevent the importation of violative products.
Through FDA and CBP's continued partnership, we have implemented this change to eliminate supply chain vulnerabilities that may pose a public health risk. This is another step that both agencies have taken to eliminate supply chain gaps and improve the quality of imported products that FDA regulates.
We anticipate that this decision will improve supply chain oversight, improve public health protection, and identify repeat offenders that are deliberately trying to evade FDA evaluation.
FDA will work with trade to answer questions and ensure clarity. Questions can be directed to imports@fda.hhs.gov.
An unofficial translation of this announcement is provided below.
翻译参考：
有关美国 FDA 进口项目、政策和法规的新闻和更新
2025年7月9日，美国海关与边境保护局（CBP）向贸易界发布最新通知，宣布取消对部分低价值的FDA监管产品进口的FDA审核豁免。
所有FDA监管产品的入境，无论其数量或价值多少，都必须经过FDA审查，以确定是否符合准入条件。
此前，部分符合豁免条件的FDA监管产品在进口时可由CBP直接放行，无需通知FDA。现在，由于贸易各方和FDA在技术能力方面都已显著提升，即使是低价值（800美元或以下）的进口产品也必须接受FDA审核，以确保其符合FDA的要求。
此项变更允许FDA审核所有通过电子方式申报的FDA监管进口产品，以促进合法贸易并防止违规产品的进口。
通过FDA和CBP的持续合作，我们实施此项变更，以消除可能对公共健康构成风险的供应链漏洞。这是这两个机构为消除供应链漏洞和提高FDA监管的进口产品质量所采取的又一举措。
我们预计，此决定将改善供应链监管，加强公众健康保护，并识别那些故意规避FDA审核的重复违规者。
FDA将与贸易各方合作，解答相关问题并确保政策信息透明。如有疑问，请发送邮件至：imports@fda.hhs.gov 。
Sincerely,
Sarah McMullen
Country Director
FDA China Office
Office of Global Operations
|
