- The Food and Drug Administration (FDA) has rescinded previous guidance that allowed certain FDA-regulated products under the $800 de minimis threshold to bypass full regulatory review.
- As of July 9, all FDA-regulated imports, regardless of value or quantity, must be submitted for full FDA screening.
- The FDA cited improvements in data-sharing and electronic processing as the reason for ending leniency on small shipments.
- The new rules affect a wide range of industries, including food, cosmetics, supplements, medical devices and more, particularly hitting e-commerce and small parcel shippers.
- Logistics professionals advise importers to review customs processes, ensure Prior Notice accuracy, update partners and use FDA resources to stay compliant and avoid penalties.
The Food and Drug Administration (FDA) has officially rescinded earlier guidance that allowed certain low-value, FDA-regulated products to bypass full regulatory review when imported under the Section 321 de minimis exemption.
Under Section 321 (19 U.S.C. § 1321(a)(2)(C)), shippers can claim duty-free entry for shipments under the $800 threshold. However, as of the FDA’s new guidance, released through the Cargo Systems Messaging Service (CSMS #65581188), all FDA-regulated imports regardless of value or quantity must undergo the same level of scrutiny as high-value shipments.
“Effective immediately, all FDA-regulated products must be submitted to the FDA for review. All prior communications exempting certain low-value FDA-regulated products are rescinded,” Customs and Border Protection said on July 9. (Related: Trump accused of ‘Deceptive’ tariff calculations – Asian economies deny claims of high import taxes.)
The FDA stated that advances in data-sharing and electronic processing have eliminated the need for leniency on small shipments. “All electronically transmitted FDA-regulated products offered for import, regardless of shipment quantity and value, to facilitate legitimate trade and prevent the importation of violative products,” the agency said in their notice.
These tightened rules impact a broad range of importers and sectors from e-commerce sellers to pharmaceutical distributors that routinely ship foods and beverages, dietary supplements, cosmetics and personal care items, medical devices and biological materials. Small parcel express carriers, including those operating in the growing direct-to-consumer health and wellness market, will no longer benefit from the previous exemption. All FDA-regulated items must now comply fully with applicable regulations, including accurate product declarations and documentation.
The FDA emphasized that its Prior Notice (PN) requirements for food and feed shipments remain in full effect. Regardless of shipment size or value, any food or feed product must have PN filed unless it qualifies for exemption under 21 CFR 1.277(b). Shipments lacking timely or accurate PN filings risk customs holds, refused entry or regulatory penalties.
Freight and logistics experts urge importers to comply immediately
In line with this, freight and logistics experts, including Future Forwarding, are urging importers to take swift action to align with the updated FDA policy.
A critical first step is to review internal processes to ensure that customs brokers and software providers are fully equipped to submit complete FDA data for all Section 321 shipments. Importers should also prioritize PN compliance by training staff and validating internal procedures to guarantee timely and accurate filings.
In addition, it is essential to communicate the new requirements to suppliers and other upstream partners to ensure that everyone in the supply chain is prepared for the increased scrutiny. To support compliance efforts, the FDA’s Supplemental Guide for ACE and its de minimis FAQs serve as valuable resources that importers should become familiar with.
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Sources include:
Reuters.com
FutureForwarding.com
GreenWorldWide.com
Brighteon.com
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