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Admissibility Entry Filing for de minimis Shipment (Section 321) Products Regulated by the FDA

Home News Admissibility Entry Filing for de minimis Shipment (Section 321) Products Regulated by the FDA

Admissibility Entry Filing for de minimis Shipment (Section 321) Products Regulated by the Food and Drug Administration (FDA)

In 2017 the Food & Drug Administration (FDA) released reporting requirements for “Section 321” or “de minimis” shipments (those valued at $800 or less) via CSMS# 17-000388 – Update to Food and Drug Administration Related Low Value Shipments.

Exponential growth in e-commerce, affecting both commercial and low-value shipments, has prompted Customs and Border Protection (CBP) and FDA to reinforce the requirements for de minimis entries.  The interdiction of illegal, illicit and dangerous products from entering the United States, including narcotics, unapproved prescription drugs, medical devices, counterfeit products, beauty products, and high-risk food, such as infant formula, regardless of value or entry type is a top priority for both agencies.

Currently, CBP, FDA, and other partner government agencies (PGAs) can clear de minimis/section 321 shipments electronically using Entry Type 86, as long as a 10-digit harmonized tariff schedule (HTS) is provided.

Whether entry type 86 or another form of entry, the FDA regulatory requirements remain the same. Refer to the FDA Supplemental Guide for a full list of data elements required to be transmitted.

When submitting such entries, filers must include the appropriate FDA product code. The FDA product code must match the actual product description for each FDA line item.  For information on building FDA product codes, refer to FDA’s website Product Codes and Product Code Builder and the online Product Code Builder application tool.

Below are examples that illustrate how FDA product codes and HTS codes are commonly used in combination (both subject to change):

·        Infant Formula: FDA Product Code 40N–01 which falls under HTS: 1901.10.4900

·        Sunglasses: FDA Product Code 86 HQY which falls under HTS: 9004.10.0000

·        Contact Lenses: FDA Product Code 86LPL which falls under HTS: 9001.30.0000

·        Partial Dentures: FDA Product Code: 76NSK which falls under HTS: 9021.21.8000

·        External Penile Rigidity Devices: FDA Product Code: 78 LKY which falls under HTS: 8413.20.0000

·        Viagra (Sildenafil Citrate): FDA Product Code: 65 P – – 02 which falls under HTS: 3004.90.9220

When importing food products, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires FDA receive prior notification of food, including animal feed, that are offered for import into the U.S. with specific timeframes that are dependent upon mode of transportation. For information regarding Prior Notice Exemptions refer to 21CFR 1.277(b).

For shipments with aggregate commercial quantities, brokers/filers are required to provide information for those establishments that are involved in the production, distribution, and sale of said product.

Filers are reminded to communicate with importers to obtain correct bill of lading information.

For additional links in importing FDA regulated commodity and de minimis entries visit Import Basics and Common Entry Types.

The information contained in this message does not replace the information issued via CSMS# 17-000388 – Update to Food and Drug Administration Related Low Value Shipments (govdelivery.com).

In addition, certain tobacco products and those goods taxed under the Internal Revenue Code, such as vaccines defined by 26 USC 4132, are not permitted for Section 321 entry.  For additional information refer to 19 CFR 10.153 (e) and (h) and CBP’s website Entry Type 86 Frequently Asked Questions.

Additional Information:

For information regarding FDA’s Personal Importation Policy visit the following link, Personal Importation.

For those five categories outlined in CSMS# 17-000388 – Update to Food and Drug Administration Related Low Value Shipments a manual release may be issued without notification to FDA for the purposes of determining entry admissibility under section 801(a) of the Federal Food, Drug & Cosmetic Act (the Act).

For information in importing FDA regulated commodities visit the following links: medical devices, radiation emitting products, drugs, tobacco and tobacco products, biologics, animal and veterinary, cosmetics and foods.

For FDA related inquiries, please contact the FDA’s Division of Import Operations via email at FDAImportsInquiry@fda.hhs.gov.

For CBP related inquiries, please contact CBP’s e-Commerce group via email at ecommerce@cbp.dhs.gov

Source: U.S. Customs & Border Protection (CBP); U.S. Food & Drug Administration (FDA)

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