An FDA import alert lets a listed shipment be held at the border unopened

ON THIS PAGE

1. Key findings
2. What an import alert does
3. The law behind it: section 801 and the appearance standard
4. Red lists, yellow lists and green lists
5. Import Alert 66-41: unapproved new drugs
6. Import Alert 66-40: drugs from firms that have not met GMP
7. How a firm gets off a red list
8. How to search the import alert database
9. Limitations
10. Sources

An FDA import alert acts on a package before anyone in the United States opens it. Once a firm and its product are listed, FDA can hold the next shipment at the border without testing it.

That is the whole point of the tool. The burden moves. A listed shipment is detained and refused unless the importer shows it is not in violation, and FDA does not have to prove anything about that particular box first.

What an import alert does

It tells FDA staff, and the public, which products and firms to stop. FDA's import alerts page (content current as of March 3, 2025, read October 23, 2026) says the agency "can place a product on an Import Alert after discovering a violation and then detain future shipments of the product without having to test or otherwise physically examine it." FDA's name for this is "detention without physical exam," shortened to DWPE.

The same page sets out what happens next. A product subject to DWPE "will be detained and refused unless the importer can overcome the appearance of the violation(s)." Each alert's Guidance section says what evidence may work.

The law behind it: section 801 and the appearance standard

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 USC 381) is the authority. FDA's page says it "gives FDA the authority to refuse products that appear to be in violation of FDA laws and regulations," and that "this is known as the 'appearance standard'."

The word "appear" carries a lot here. FDA does not need a court ruling or a lab result on the shipment in hand. It needs the appearance of a violation.

Each alert also carries a note at its top saying it is FDA's "current guidance to FDA field personnel" and "does not operate to bind FDA or the public." An alert is instructions to staff. It is not a court finding about any firm.

Red lists, yellow lists and green lists

The list a firm sits on decides what happens to its shipments. FDA's search page spells it out:

• A firm or product on a red or yellow list is subject to DWPE under that alert.
• A firm or product not on the red or yellow list is not subject to DWPE under that alert.
• Some alerts work the other way, with a green list. A firm on the green list is exempt. Everyone not on it is subject to DWPE.

Both alerts read for this piece use red lists. A listing on one means FDA staff may hold that firm's named products without examining them.

Import Alert 66-41: unapproved new drugs

Import Alert 66-41 is titled "Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S." Its page on FDA's import alert database, read October 23, 2026, shows a published date of October 22, 2026. Its last revision of the guidance text is dated May 19, 2026.

The reason it gives is plain. FDA has not checked unapproved new drugs for safety or effectiveness, the alert says, and without that check "there is no way to know" whether they are made to a consistent quality or whether their labels are accurate. The charge it lists is refusal under section 801(a)(3), because the article "appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA)."

The label on the product does not settle it. The alert's Guidance section covers products that "appear to be labeled as dietary supplements" or as foods, and products that appear to be cosmetics, when their claims "appear to make the products unapproved new drugs."

Release of a single held shipment needs "evidence that the shipment does not contain unapproved new drug products." Removal from the red list needs information showing "the firm has resolved the condition(s) that gave rise to the appearance of a violation."

The red list, counted on October 23, 2026, held 1,925 firm entries, grouped by country. The oldest entry dates are from 2009. Thirty-seven entries carry a 2026 date.

Import Alert 66-40: drugs from firms that have not met GMP

Import Alert 66-40 is about how a drug was made, not whether it was approved. Its title is "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs." GMP stands for good manufacturing practice. Read October 23, 2026, its page shows a published date of October 1, 2026, and a revision dated July 15, 2025.

The alert says FDA inspects foreign drug makers and runs remote regulatory assessments. DWPE "may be appropriate" when an FDA inspection, a remote assessment, or an inspection by a foreign authority under an agreement shows a site "is not operating in conformity with" current good manufacturing practice. The charge is refusal under section 801(a)(3), because manufacturing methods and controls "do not appear to conform to current good manufacturing practices."

Getting off this list is harder. The alert says DWPE "may apply until FDA has confidence that future shipments will not appear violative," and that FDA may decide this "by inspection of the facility." Where a listing comes with a warning letter or other action, FDA "will generally conduct an inspection" before removing the firm.

Counted on October 23, 2026, its red list held 471 firm entries. The oldest entry dates are from 2009, and 42 entries carry a 2026 date.

How a firm gets off a red list

It sends evidence. FDA's page on removal from DWPE (content current as of October 9, 2024, read October 23, 2026) says FDA needs "evidence that the conditions that led to DWPE have been resolved and that future shipments of the product will be safe and compliant."

The page lists four things a red-list petition might cover: an investigation of how the problem happened, the corrective actions taken, the preventive measures added, and evidence they work. Its examples of evidence are "5 clean shipments" and a "third-party audit." FDA says it weighs "the totality of evidence."

How to search the import alert database

The database is public and FDA says it is "updated in real time." From the import alerts page, you can search by keyword, firm name or product. You can also browse every alert by country or area, by industry, by assigned number such as 66-41, or by last published date.

FDA's search note matters for firm names. The search "matches each word independently," so a firm name typed without quotes can match records that only share one word. Put the name in double quotes, as FDA suggests, and then open the alert itself. The entry on the red list is the record. A search result is not.

Limitations

The two alerts were read in full on October 23, 2026, and both change often: 66-41 was republished the day before. The firm counts are of firm entries on the page that day, and one firm may appear more than once under different addresses. Only two of FDA's import alerts were read. Nothing here says whether any product reaches a buyer, how often listed shipments are refused, or how long removal takes, because none of the pages read gives those figures. This piece is not legal advice.

The red list is a moving record. The version that counts is the one on FDA's page on the day it is checked.

Sources

All read 2026-10-23. FDA, Import Alerts, content current as of 2025-03-03. FDA, Removal from DWPE Under Import Alert, content current as of 2024-10-09. FDA, Import Alert 66-41, published date 2026-10-22. FDA, Import Alert 66-40, published date 2026-10-01.