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FDA Final Rule on the Submission of Import Data

Written by Michael A. Walsh on December 5, 2016

On November 29, 2016, the Food and Drug Administration (FDA) issued a Final Rule on the Submission of Import Data in the Automated Commercial Environment (ACE). The final rule specifies certain data that must be submitted when an FDA-regulated product is offered for import into the United States. The effective date of the rule is December 29, 2016. ACE replaces the Automated Commercial System, an older electronic submission system. As of July 23, 2016, ACE became the sole electronic data interchange (EDI) system authorized by the Customs and Border Protection Agency (CBP) for entry of FDA-regulated articles into the United States. This change is in part due to the increase in volume of imports from 6 million import entries in 2002 to 35 million in 2015.

The rule is designed to allow FDA to focus on high risk products. According to the FDA, ACE has already shown promise in accomplishing the dual goal of protecting public health while also serving the trade by facilitating a more efficient review for admissibility of compliant products. According to the FDA, with the new system processing times for both automated and manual review have been substantially reduced by approximately 75% and 93% respectively compared with the agency’s processing times in the previous system.

The Final Rule requires that information material to import admissibility for any FDA regulated article that is being imported or offered for import into the United States be submitted in ACE or any other CBP-authorized EDI system. It is expected that this rule will expedite automated ‘‘May Proceed’’ determinations by the FDA for low-risk FDA regulated products. This should allow the FDA to focus its resources on products that may be associated with a greater public health risk.

The Rule sets forth the information required for all products including:

(a) Product identifying information for the article that is being imported or offered for import. This consists of:

(1) FDA Country of Production, which is the country where the article was last manufactured, processed or grown (including harvested, or collected and readied for shipment to the United States). The FDA Country of Production for an article that has undergone any manufacturing or processing is the country where that activity occurred if the manufacturing or processing had more than a minor, negligible or insignificant effect on the article;

(2) The Complete FDA Product Code, which must be consistent with the invoice description of the product; and

(3) The Full Intended Use Code.

(b) Importer of record contact information, which is the telephone and email address of the importer of record.

The rule also sets additional requirements for specific categories, such as food contact substances, drugs, biological products, human cell and tissue products (HCT/Ps), medical devices, radiation-emitting electronic products, cosmetics and tobacco products.

The rule also includes technical revisions including:

  • The owner or consignee of an FDA-regulated product is now defined as the importer of record. This change conforms FDA regulations to customs laws.
  • FDA will now directly provide a notice that a product is to be sampled, as opposed to CBP to providing that notice.
  • FDA may now provide written notices electronically to the importer of record about FDA actions to refuse products, or to take other actions such as administrative destruction.
  • The rule clarifies that FDA can reject an entry for failure to provide complete and accurate information required by the rule.

The FDA will assist filers via telephone and on request a meeting can be arranged at and FDA has 24/7 support at (877-345-1101) or a local/international line (571-620-7320).

Additionally, ACE provides an efficient single window for importers. Prior to the development of ACE, importers of products regulated by multiple government agencies could in some cases be required to submit information more than once.

As the volume of FDA regulated products entering the US increases the regulations governing entry are being updated to keep pace and to ensure more stringent requirements for admissibility are met while expediting those low risk products.