Update: FDA Review Now Required for All Low-Value Shipments

On July 9, U.S. Customs and Border Protection (CBP) issued updated guidance regarding de minimis shipments that are subject to U.S. Food and Drug Administration (FDA) regulations. Low-value shipments of products such as cosmetics, dinnerware, radiation-emitting devices (non-medical), biological samples, and most foods were previously exempt from FDA oversight.

Effective immediately, all FDA-regulated products – regardless of value or quantity – must be submitted for FDA review. Previous guidance that allowed certain low-value FDA-regulated imports to bypass FDA screening has been rescinded.

This change in policy reflects advancements in technology that now allow the FDA to electronically review all shipments. The CBP and FDA jointly emphasize that even small shipments can pose health and safety risks. The update supports the agencies’ mission to protect public health while facilitating compliant trade.

Important Note: Prior Notice (PN) requirements still apply to all food and feed shipments unless explicitly exempt under 21 CFR 1.277(b).

At Allyn International, we are committed to supporting the global trade community with strategic, forward-thinking solutions to help navigate today’s complex tariff landscape. Whether you have questions about tariffs, trade agreements, or would like to explore strategies to reduce their impact on your business operations, our team is here to help. Contact us today for a consultation at sales@allynintl.com, call 239-489-9900, or reach out here.

Contributor: Rebecca Anderson

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About Allyn International

Allyn International is dedicated to providing high quality, customer centric services and solutions for the global marketplace. Allyn's core products include transportation management, logistics sourcing, freight forwarding, supply chain consulting, tax management and global trade compliance. Allyn clients range from small local businesses to Fortune 500 firms. Allyn conducts business in more than 20 languages and has extensive experience in both developed and emerging markets. Highly trained experts are positioned throughout North and South America, Europe and Asia. Allyn’s regional headquarters are strategically located in Fort Myers, Florida, U.S.A., Shanghai, P.R. China, Prague, Czech Republic, and Dubai, U.A.E. For more information, visit www.allynintl.com.