Research
The hearing before a shipment is refused entry
A refusal at the border is preceded by a written notice naming a place and a period to introduce testimony. The same statute also contains a route to destruction without any opportunity to export, and it turns on a dollar figure.
The sample comes first, and so does a hold
Before anything is refused, the agency takes a look. The statute directs the Treasury to deliver samples of food, drugs, devices, tobacco products and cosmetics being imported, on request, and to give notice to the owner or consignee.
The regulation adds the practical consequence. When a sample has been requested, prompt notice of delivery or of intention to deliver is given to the owner or consignee. On receiving that notice, the owner or consignee has to hold the article and not distribute it until further notice of the results of examination.
The person carrying that duty is defined precisely. The owner or consignee means the person who makes entry under section 484 of the Tariff Act, namely the importer of record.
There is even a rule about who pays for the sample. The agency pays for all import samples found to be in compliance. Payment is not made if the article is found to be in violation, even where it is later brought into compliance.
Billing runs the other way from what people expect. Reimbursement is claimed by the owner or consignee from the agency division where the shipment was offered for import, rather than deducted from anything.
The notice, and the right to introduce testimony
The statute gives the owner or consignee the right to appear and introduce testimony. The regulation says how that happens.
Two situations trigger the notice: it appears the article may be subject to refusal of admission, or a drug or device may be subject to destruction. In either case the division director gives the owner or consignee written or electronic notice to that effect, stating the reasons. The notice specifies a place and a period of time during which testimony may be introduced.
Two features of that are worth noticing. On timely request giving reasonable grounds, the time and place may be changed. And the testimony may be introduced orally or in writing, so an appearance in person is not the only route.
The scope is bounded. Testimony is confined to matters relevant to the admissibility or destruction of the article, which means it is not an occasion to argue about anything else.
Where the owner or consignee intends to apply for authorization to bring the article into compliance, that testimony has to include evidence supporting the application. If the application is not submitted at or before the hearing, the director sets a time limit for filing it.
A drug or device facing destruction can have both proceedings folded together. A single written or electronic notice may cover the refusal of admission and the destruction, and the two hearings may be combined into one proceeding.
The application to bring an article into compliance
A refusal is not always the end. The statute lets a final determination be deferred while an article is relabeled or otherwise brought into compliance, or rendered other than a food, drug, device or cosmetic.
The application may be filed only by the owner or consignee. It has to contain detailed proposals for what will be done, and specify the time and place where the operations will be carried out and the approximate time for completion.
An authorization, when granted, is not a permission slip. It may set the procedure to be followed, the disposition of rejected articles, a time limit for completion, and other conditions necessary to maintain adequate supervision and control. It may also require that the operations be carried out under the supervision of a federal officer.
A bond backs it. The bond conditions include redelivery of the merchandise on demand, and performance of whatever conditions are legally imposed for the relabeling or other action.
If ownership changes before the work is finished, the original owner is held responsible unless the new owner executes a bond and obtains a new authorization.
Extensions and amendments are contemplated. On a written request containing reasonable grounds, additional time may be granted. An authorization may be amended on a showing of reasonable grounds and the filing of an amended application, and a new authorization supersedes and nullifies any earlier one for the same article.
Supervision is billed, and the rate is written down
The cost of supervising the work is paid by the owner or consignee who applied for it and executed the bond. The regulation itemizes what that covers.
It includes travel expenses of the supervising officer and per diem in lieu of subsistence when the officer is away from a home station. It includes the charge for the officer's services, computed at a rate per hour equal to two hundred and sixty-seven percent of the hourly rate of regular pay of a grade GS-11 step 4 employee.
The analyst is billed separately, at the same multiplier applied to a grade GS-12 step 4 employee. The regulation prints the arithmetic behind the two hundred and sixty-seven percent figure in a table.
The minimum charge is one hour, and time after the first hour is computed in whole hours, disregarding fractional parts of less than half an hour.
None of that is a penalty. It is the cost of the supervision the reconditioning route requires, and it is the reason the route is not free.
The bond itself sits with customs rather than with the health agency. Liability for liquidated damages under it may be cancelled on an application for relief, on payment of a lesser amount or on other terms, but only where the agency division director is in full agreement.
Export, destruction, and the figure that separates them
Where an article is refused admission, the ordinary outcome under the statute is that it is exported within ninety days of the notice of refusal, or within such additional time as the regulations permit. Otherwise it is destroyed.
There is a narrower path written alongside it. The health department may destroy a drug, device or tobacco product refused admission, without the opportunity for export. Two conditions apply: the article is valued at two thousand five hundred dollars or less, and it was not brought into compliance.
Congress attached process to that power. The department is directed to issue regulations providing notice and an opportunity to appear and introduce testimony on destruction. Those regulations are to provide that appropriate due process is available to an owner or consignee seeking to challenge the decision.
The regulation implementing it allows the two proceedings to be combined. A single notice may cover both the refusal of admission and the destruction, and the two hearings may be combined into one proceeding.
The customs side of the same arrangement is short. No food, drug, device or cosmetic subject to those rules is released except in accordance with the laws and regulations applicable to it, and exportation of a refused article happens under customs supervision.
Key takeaways
- A sample request triggers a duty on the importer of record to hold the article and not distribute it until the results arrive.
- A refusal is preceded by written or electronic notice stating reasons and naming a place and period to introduce testimony.
- Testimony may be oral or written, and is confined to the admissibility or destruction of the article.
- An application to relabel or recondition can defer a final determination, and it comes with conditions, a bond and a deadline.
- Supervision of that work is billed to the applicant at a published multiple of federal salary rates, with a one-hour minimum.
- A refused drug or device valued at two thousand five hundred dollars or less may be destroyed without an opportunity to export it.
Frequently asked questions
Does anyone get told before a shipment is refused?
Yes. Where it appears an article may be subject to refusal of admission, the division director gives the owner or consignee written or electronic notice stating the reasons. That notice specifies a place and a period of time during which testimony may be introduced. On timely request with reasonable grounds, the time and place may be changed.
Who counts as the owner or consignee in these rules?
The regulation defines the term as the person who makes entry under section 484 of the Tariff Act of 1930, namely the importer of record. That is the party who receives the notice of sampling, who holds the article pending results, who may apply to bring it into compliance, and who is liable for supervision costs.
Has testimony to be given in person?
No. The regulation states that testimony at a hearing on refusal of admission may be introduced orally or in writing. It also confines that testimony to matters relevant to the admissibility or destruction of the article, so the proceeding is bounded in subject matter rather than in format.
What does an authorization to relabel or recondition involve?
An application filed by the owner or consignee sets out detailed proposals, the place and time of the work, and when it will be finished. An authorization may prescribe the procedure, the disposition of rejected articles, supervision by a federal officer, a completion deadline and other conditions. A bond is filed with customs, conditioned on redelivery on demand.
Who pays for the supervision of that work?
The owner or consignee who applied for it and executed the bond. The regulation itemizes travel and per diem for the supervising officer. It charges that officer's services at a rate equal to two hundred and sixty-seven percent of the hourly pay of a grade GS-11 step 4 employee. The analyst's services are charged at the same multiplier on a GS-12 step 4 rate. The minimum charge is one hour.
Can a refused shipment be destroyed rather than sent back?
The statute provides for export within ninety days of the notice of refusal, and destruction otherwise. It also allows the health department to destroy a drug, device or tobacco product refused admission, without any opportunity for export. That applies where the article is valued at two thousand five hundred dollars or less and was not brought into compliance. Notice and an opportunity to appear are required first.
Sources
Each document below is named as it names itself, with the date printed on that document rather than the day it was read.
- 21 U.S.C. 381 — Imports and exports, subsections (a) through (c), read for the right to introduce testimony, the ninety-day export window, the destruction provision for articles valued at $2,500 or less, and the charges owed by the owner or consignee — Office of the Law Revision Counsel, United States Code, September 2026
- 21 CFR 1.83, 1.90 and 1.91 — Definitions of owner or consignee and division director, notice of sampling and the duty to hold the article, and payment for import samples — Office of the Federal Register, Electronic Code of Federal Regulations, September 2026
- 21 CFR 1.94, 1.95 and 1.96 — Hearing on refusal of admission or destruction, application for authorization to relabel and recondition, and the five conditions an authorization may carry — Office of the Federal Register, Electronic Code of Federal Regulations, September 2026
- 21 CFR 1.97 and 1.99 — Bonds satisfying the statutory bond requirement, and costs chargeable in connection with relabeling and reconditioning inadmissible imports — Office of the Federal Register, Electronic Code of Federal Regulations, September 2026
- 19 CFR 12.1, 12.3 and 12.4 — Cooperation with certain agencies, release under bond and liquidated damages, and exportation of refused merchandise under customs supervision — Office of the Federal Register, Electronic Code of Federal Regulations, September 2026