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:
I
visited my friends and fellow trustees, Dr. Laibow and Gen. Stubblebine
(at JFK Hospital, Edison, NJ) where Gen. Bert has been for the last 120
days a couple days ago. Gen. Bert is improving and we had a chance to
catch up about the election and other strategic health freedom-related
issues. His take? 2016 was not a good year for health freedom. Except
for our amazing court victory the week before Christmas in which a
Judge of the NJ Superior Court confirmed once again the right of
Informed Consent, even in hospitals! Bert lives. Nutritional therapy works, when hospitals allow it.
