Cargo Systems Messaging Service

CSMS #42082100 - Disclaim B Should Not Be Used for Food and Drug Administration (FDA) Entries

FDA has become aware filers are incorrectly transmitting Disclaim B for FDA regulated products. Please note that the only valid disclaim code for FDA is “A”. CBP and FDA plans to REJECT entries submitted with a disclaim code other than “A” starting on or about April 18, 2020.

Prior to ACE, trade would see FD0 flags associated with some HTS codes; the FD0 flag indicated that the data was not required per agency guidance.  It was decided that FD0 flags would not be utilized in ACE. Disclaim B (data not required per agency guidance) was removed from the FDA ACE Supplemental Guide on March 31, 2016, which is reflected in the change log of the guide. In 2017, FDA and CBP provided CSMS#17-000227, which reminded trade there is no FD0 Flag in ACE. 

The planned deployment schedule is as follows:

• Saturday, March 21, 2020: Changes will be available for testing in the ACE Certification Test Environment.
• Saturday, April 18, 2020: Planned deployment to ACE Production Environment. Users will be sent another message confirming the date of Production deployment. Entries submitted with Disclaim B will be REJECTED once the fix is deployed.

Trade may continue to use Disclaim A for products that are not regulated by the FDA.

For further questions on this or regarding HTS flags, please contact: FDAImportsInquiry@fda.hhs.gov.

For ACE inquiries, contact FDA ACE Support, 877-345-1101,  ACE_Support@fda.hhs.gov. ACE Support Hours: Monday - Friday, 6AM-8PM EST, Saturdays, 8AM-4PM EST. ACE Support is Closed on Sundays.