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informing them that the FDA review exemption on importation of certain low-value FDA-regulated products has been rescinded.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.
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