The US Food & Drug Administration (FDA or the Agency) is updating previously issued information
to clarify FDA expectations for the submission of shipments qualifying under Section 321 of the Tariff Act of 1930 containing FDA-regulated articles; i.e. those valued at $800 or less (“Section 321” or “de minimis” shipments).
On December 15, 1994, FDA identified five categories of regulated products which could be released by CBP without notification to FDA for the purposes of determining entry admissibility, if they were valued at or below the then de minimis level of $200 (see CSMS #94-001260, “FDA LOW VALUE SHIPMENTS”).
On March 9, 2016, CBP informed stakeholders of the de minimis value increase from $200 to $800 in CSMS #16-000181 (effective March, 10, 2016). This program change was implemented based on Section 321 validations.
Although the de minimis value has changed, FDA has not previously updated CSMS #94-001260. FDA revised the Regulatory Procedures Manual (RPM) Chapter 9, section 1 (https://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf) to reflect the new de minimis value of $800; however, based on conversations with stakeholders, FDA reporting requirements for de minimis shipments were unclear given FDA’s legacy CSMS messages on such low value shipments.
By virtue of this message, FDA is providing notification that CSMS #94-001260 applies to the same five product categories valued at or below the current de minimis level: for those same five product categories, a 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), if the shipment is valued at or below the current de minimis level (currently $800). Those five product categories are:
•Dinnerware (including eating and/or cooking utensils);
•Radiation emitting, non-medical devices (e.g. microwaves, televisions, CD players, etc.);
•Biological samples for laboratory testing; and,
•Food, excluding ackees, puffer fish, raw clams, raw oysters, raw mussels, and foods packed in air tight containers intended to be stored at room temperature.
Also by virtue of this message, FDA is providing notification that CSMS #95-000090 (issued January 27, 1995) is rescinded. FDA rescinds CSMS #95-000090 because the instructions therein for electronic declarations are no longer applicable due to implementation of ACE.
The 801(m) prior notice requirements must continue to be met on all food and feed shipments regardless of value or quantity. Unless otherwise exempt from the prior notice requirements for one of the indicated reasons under 21 CFR 1.277(b)(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1.277, there are no exemptions based on a de minimis value or quantity of food.
FDA will continue to work on an updated low value strategy outlining which FDA-regulated products require notification to the Agency for determination of admissibility, regardless of the value of the shipment upon entry.
FDA is issuing this ABI message as part of our continued outreach efforts to assist the importing community in realizing the benefits of the Automated Commercial Environment (ACE); please make this information available to importers of record, consignees, manufacturers, shippers and other stakeholders that may be affected by the Agency’s import program.
Questions related to the FDA reporting requirements for de minimis shipments may be submitted to FDA’s Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Additional References regarding TFTEA and relevant 19 CFR section:
TFTEA-Increase in the De Minimis Value Exemption: https://www.cbp.gov/document/fact-sheets/tftea-increase-de-minimis-value-exemption
19 CFR Section 10.151: http://www.ecfr.gov/cgi-bin/text-idx?SID=5b95595ce7f08b949577e28c599334ed&mc=true&node=se19.1.10_1151&rgn=div8