This blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.
Monday, December 12, 2016
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
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.
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
The rule clarifies that FDA can reject an entry for failure to
provide through ACE the complete and accurate information required by
----- 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
"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.]