The Vitamin Importer's “Ace in the Hole”

The Vitamin Importer's “Ace in the Hole” Automated Commercial Environment (ACE) Import Data System This Vitamin Consultancy Newsletter focuses on an important aspect of business for the natural nutrient products market -- using the new ACE system to comply with requirements for importing FDA regulated products. The new system will make it easier for FDA to block what it considers contraband, but it will also largely take the risk out of importing: you should know in advance whether your shipment would be stopped if shipped, thereby avoiding the expenses of rejected and returned shipments. What follows are excerpts from the FDA announcement of its new imported products data requirements * that must be met at the point of entry.  Use of the ACE - Automated Commercial Environment - data system will be required as of December 29, 2016. This applies to all FDA regulated products imported into the United States. The regulation does not distinguish between Foods and Dietary Supplements, treating DSs as Foods. Whenever you intend to import a food product, you are required to notify the FDA. Key regulation points: 1. "The owner or consignee of an FDA-regulated product is now defined as the importer of record." 2. "FDA can reject an entry for failure to provide through ACE the complete and accurate information required by the rule..." 3. "FDA will continue to provide assistance to filers working to properly submit the required data." 4. Intended Use Code (IUC) ** required for ACE submittal. Practice Guide: Use the email and phone contacts below to make successful import filings.  FDA will walk you through your first use of ACE. Ralph Fucetola JD Source: http://blogs.fda.gov/fdavoice/index.php/2016/11/trade-alert-fda-issues-new-import-data-requirements/?source=govdelivery&utm_medium=email&utm_source=govdelivery From: Trade Alert: FDA Issues New Import Data Requirements Posted on November 30, 2016 by FDA Voice by: Howard Sklamberg, J.D. (Deputy Commissioner for Global Regulatory Operations and Policy) "One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six million import entries in 2002 to 35 million in 2015." "...A final rule published on November 29 in the Federal Register specifies certain data that must be submitted in ACE when an FDA-regulated product is offered for import into the United States..." "The rule also includes technical revisions to certain sections of FDA regulations:     "The owner or consignee of an FDA-regulated product is now defined as the importer of record. This brings FDA regulations up to date with previous revisions to customs laws. (21 CFR 1.83 and 21 CFR 1005.2)     FDA will now directly provide a notice that an FDA-regulated product is to be sampled, rather than having to go through CBP to provide that notice. (21 CFR 1.90)     FDA may now provide written notices electronically to the importer of record about FDA actions to refuse FDA-regulated products and/or subject certain drug products to administrative destruction. (21 CFR 1.94)     The rule clarifies that FDA can reject an entry for failure to provide through ACE the complete and accurate information required by the rule." ----- Important Resources ----- "FDA will continue to provide assistance to filers working to properly submit the required data. Some of the measures we have instituted:       We are offering telephone meetings with importers, customs brokers, and other stakeholders, in real-time, while they are filing entries in ACE. Request a meeting by emailing ACE_Support@fda.hhs.gov.     An ACE Support Center is staffed 24/7. Reach FDA staff by email at ACE_Support@fda.hhs.gov or by phone at a domestic toll-free line (877-345-1101) or a local/international line (571-620-7320).     Upon request, FDA will assist in a filer’s first ACE submission, or for filers who import various commodities, FDA will assist with every first submission of a particular commodity.     Additional assistance for general import operations and policy questions, including FDA product codes and entry requirements, is available via email at FDAImportsInquiry@fda.hhs.gov or by calling 301-796-0356." There are various other requirements that may delay importation, or add costs to it, *** but food importation notices through ACE have the potential to simplify importation red tape. ------------------------------------------- * The Data Requirements are set forth in the Federal Register: https://www.federalregister.gov/documents/2016/11/29/2016-28582/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment ** Intended Use Codes (IUC): https://www.cbp.gov/document/guidance/appendix-r-intended-use-codes-ace  -- "Base Code 230.000 - For Consumer Use as Human Food - A human food product intended for distribution in the general public supply chain or military commissaries in its present form with or without repackaging or with minimal processing such as cooking, slicing, or peeling. Examples include packaged food products, pre-packed salads, fresh chopped or cut vegetables and fruits, bulk fruits for consumer packaging, and convenience foods." [Dietary Supplements, as "packaged food products..." are included in Base Code 230.00.] *** The General Enforcement regulations are at: https://www.gpo.gov/fdsys/pkg/CFR-2016-title21-vol1/xml/CFR-2016-title21-vol1-part1.xml  - Subpart E relates to imports and exports. 05 December 2016