FDA Entry Review: PREDICT and the Notice of FDA Action Explained

What happens to an FDA-regulated parcel between arrival and release in the US, and what do the different Notices of FDA Action (may proceed, detention, refusal) mean for the consignee?

When an FDA-regulated article arrives in the United States, Customs and Border Protection (CBP) refers it to the Food and Drug Administration, and it is held while the FDA reviews it. The FDA's own wording is that during entry review the imported products must be held and may not be distributed into US commerce until the agency has determined their admissibility ^[1].

Most entries move through this stage without anyone noticing. A small number are flagged for a closer look, and for those the FDA issues a document called a Notice of FDA Action. This article describes the process, the document and the possible outcomes. It is descriptive only. It does not advise anyone on contesting a detention, and nothing here is a view on whether any particular material is admissible.

Who sees an entry

Three parties handle an import entry. The importer of record is legally responsible for it. The filer, usually a customs broker or a courier's brokerage, submits the entry information and payment to CBP on the importer's behalf. The consignee receives the goods and may be neither of the first two ^[1].

The FDA screens imports electronically before they enter. Its import page says imported FDA-regulated products are electronically screened, and that an online tracking system lets users check an entry's status, see an estimated lab completion date, submit documents and view Notices of FDA Action ^[4]. That system is called ITACS, and it is the channel for the consignee's side of the exchange where the consignee has been given access.

PREDICT: the first screen

PREDICT is the screening tool within the FDA's import system that helps identify higher-risk shipments. FDA procedure says that a may-proceed recommendation from PREDICT will typically result in the line being released without going to an FDA reviewer ^[5].

A may-proceed message needs careful reading. The manual states that it is not a determination that the product complies with the Federal Food, Drug, and Cosmetic Act, and that it does not preclude action if the product is later found violative ^[5]. Release at this stage means the screen did not flag the line. It does not mean the article was examined and approved.

Lines that PREDICT does not clear go to a reviewer, who may release them, request documents, collect a sample for analysis or detain them. The tool's criteria are not published, and this article does not speculate about them.

The Notice of FDA Action

If the FDA decides to examine or sample products, a Notice of FDA Action is issued to the importer of record, the consignee and the filer ^[4]. The same document form serves several purposes, and its heading tells you which. A notice marked Detained serves as the Notice of Detention and Hearing ^[2].

A detention notice lists the suspected violations as charges and gives a respond-by date. It is addressed to the responsible parties, which the FDA identifies as the importer of record, the owner or the consignee ^[2]. Read it as a statement of what the agency believes, and of when it expects to hear back, not as a final decision.

The manual also provides a discretionary outcome, release with comment, used mainly for personal-use imports. It records a warning that future shipments may be detained ^[5]. It is not a form of approval.

Import alerts and detention without physical examination

An import alert tells FDA field staff that the agency has enough evidence to act on a class of products or on products from a named source. The FDA lists more than 200 active import alerts ^[4]. They are grouped by subject, and Group 66 covers human and animal drugs ^[6].

Detention without physical examination, abbreviated DWPE, is the mechanism. Where a product falls within an alert, FDA staff can detain it without first inspecting it. The FDA's page adds that products can still be imported if the importer has demonstrated that the product is in compliance ^[4]. The alert changes who must bring the evidence. It does not remove the possibility of entry.

For the policy context behind recent changes, including the April 2026 changes to the FDA's bulk substance categories, the Q&A site covers the regulatory-category background. This article stays on the entry process.

The respond-by date and the channel

The FDA's Regulatory Procedures Manual allows ten business days from the date of detention. To allow for weekends, holidays and mailing time, the Notice of FDA Action generally specifies twenty calendar days from the detention date shown on it ^[2][5]. The date printed on the notice is the one that applies.

A hearing in this context is the opportunity to present evidence. The FDA describes it as ranging from emails and calls to a formal meeting, with the compliance officer named on the notice as the usual hearing officer. An extension may be requested within the original period, and if one is granted the new date appears on a new notice. If no response arrives, the compliance officer can issue a refusal of admission ^[2].

Refusal: destruction, export and the paper trail

When admission is refused, the FDA always issues a Notice of Refusal of Admission to the importer of record, and local practice may also send copies to the broker and the consignee. The FDA also notifies CBP ^[3].

The refused product must be destroyed or exported under the supervision of CBP and the FDA within 90 days ^[1][3]. CBP will ask the importer to redeliver the product to an approved location at the port of entry, and if that does not happen CBP may assess liquidated damages against the bond ^[3]. Refusals are also published: the FDA's Import Refusal Report lists them by country and by product industry, and is updated monthly ^[3].

What a consignee should keep from a detained entry

• The Notice of FDA Action itself, with its date, entry number, charges and respond-by date.
• The supplier's commercial invoice and any other document submitted with the entry.
• The carrier's tracking history, so the days between arrival and notice can be reconstructed.
• Every communication with the filer, the broker or the carrier about the entry, with dates.
• The final disposition: release, refusal, and the date of any destruction or export.

That list serves the goods-in record as much as any dispute. A shipment that never arrived needs the same paper trail as one that did.

Where this leaves a research buyer

The process described above applies to any FDA-regulated article, whatever its label says. The agency's test is what the article is and how it is offered, which the companion article on regulatory status at the border sets out. The entry process is the mechanism by which that test is applied to a parcel.

Practically, a buyer should know three things before ordering: who will be the importer of record, who the filer is, and how that party will tell you if a notice arrives. If the answer to the third is nobody, the first you learn of a detention may be a tracking status that stops moving. The article on customs tracking statuses covers how to read those.