Import Alert 57-22
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 57-22
Published Date: 05/20/2026
Type: DWPE
Import Alert Name:
“Detention Without Physical Examination of Unlicensed Biological Products Promoted in the U.S.”
Reason for Alert:
Unlicensed biological products present public health and safety risks because they have not been reviewed by FDA for safety, purity, and potency. Without FDA review, there is no way to determine if these biological products are safe, pure, and potent, and whether these biological products are manufactured, processed, packed, or held in a way that assures that the products continue to be safe, pure and potent. Unlicensed biological products have resulted in patient harm, and the agency works to protect patients from the safety risks posed by these products.
Section 351(i) of Public Health Service Act (PHS Act), U.S.C. 262(i), defines “biological product” as a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings. Biological products are also subject to the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act), U.S.C. 301 et seq. (see section 351(j) of the PHS Act, 42 U.S.C. 262(j)), and considered drugs or devices as defined in section 201(g)(1) or section 201(h) of the FD&C Act, 21 U.S.C. 321(g)(1) or 21 U.S.C. 321(h).
In general, a biological product may not be introduced or delivered for introduction into interstate commerce without a biological license from FDA in effect, as described in section 351(a)(1)(A) of the PHS Act, U.S.C. 262(a)(1).
This Import Alert pertains only to biological products regulated by the Center for Biologics Evaluation and Research (CBER) that are subject to licensure under section 351(a)(1)(A) of the PHS Act. This includes certain CBER-regulated medical devices. For more information on CBER-regulated medical devices that are subject to licensure, see the Intercenter Agreement Between the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health(https://www.fda.gov/combination-products/jurisdictional-information/intercenter-agreement-between-center-biologics-evaluation-and-research-and-center-devices-and). CBER-regulated biological products subject to Import Alerts 57-11, 57-15, and 57-21, as well as therapeutic biological products regulated by the Center for Drug Evaluation and Research (CDER), are considered out-of-scope of this Import Alert.
Section 351(i) of Public Health Service Act (PHS Act), U.S.C. 262(i), defines “biological product” as a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings. Biological products are also subject to the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act), U.S.C. 301 et seq. (see section 351(j) of the PHS Act, 42 U.S.C. 262(j)), and considered drugs or devices as defined in section 201(g)(1) or section 201(h) of the FD&C Act, 21 U.S.C. 321(g)(1) or 21 U.S.C. 321(h).
In general, a biological product may not be introduced or delivered for introduction into interstate commerce without a biological license from FDA in effect, as described in section 351(a)(1)(A) of the PHS Act, U.S.C. 262(a)(1).
This Import Alert pertains only to biological products regulated by the Center for Biologics Evaluation and Research (CBER) that are subject to licensure under section 351(a)(1)(A) of the PHS Act. This includes certain CBER-regulated medical devices. For more information on CBER-regulated medical devices that are subject to licensure, see the Intercenter Agreement Between the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health(https://www.fda.gov/combination-products/jurisdictional-information/intercenter-agreement-between-center-biologics-evaluation-and-research-and-center-devices-and). CBER-regulated biological products subject to Import Alerts 57-11, 57-15, and 57-21, as well as therapeutic biological products regulated by the Center for Drug Evaluation and Research (CDER), are considered out-of-scope of this Import Alert.
Guidance:
Divisions may detain without physical examination (DWPE), shipments of the unlicensed biological products listed on the Red List of this Import Alert.
Divisions should utilize affirmations of compliance to verify that biological products are subjects of an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application. Imported biologics with verified affirmations of compliance are not subject to this import alert.
Divisions should contact CBER’s Office of Compliance and Biologics Quality (OCBQ)for guidance for Personal Importation shipments of unlicensed biological products.
Recommendations for addition to DWPE of products not listed on the Red List and currently under detention status should be routed to CBER/OCBQ (listed in CMS as “CBER Immediate Office of the Director”) for review and concurrence for addition to this Import Alert. Addition to the Red List will be evaluated by CBER/OCBQ on a case-by-case basis. Recommendations for addition to DWPE of products not listed on the Red List that have been refused entry and approved by CBER/OCBQ for addition to import alert should be routed to OII’s Division of Import Operations (DIO) for review.
Release of Articles Subject to DWPE Under this Import Alert:
In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee and/or another responsible party for the affected goods should provide evidence that the shipment does not contain unlicensed biological products. Such evidence may include a copy of a valid BLA or IND covering the specific product and establishment. CBER/OCBQ will evaluate each shipment on a case-by-case basis.
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to FDA to adequately demonstrate that the firm has resolved the condition that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future entries will be in compliance with the PHS Act and the FD&C Act.
If a firm and/or a representative thereof would like to request removal from DWPE under this Import Alert, all relevant information supporting the request should be submitted to OII/OIO/DIO via email to: Importalerts2@fda.hhs.gov. Removal requests will be referred by DIO to CBER/OCBQ for evaluation.
Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/OIO/DIO (301) 796-0356 or Imports@fda.hhs.gov.
Questions or issues regarding compliance of imported biological products should be addressed to CBER/OCBQ at cberimportinquiry@fda.hhs.gov.
Divisions should utilize affirmations of compliance to verify that biological products are subjects of an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application. Imported biologics with verified affirmations of compliance are not subject to this import alert.
Divisions should contact CBER’s Office of Compliance and Biologics Quality (OCBQ)for guidance for Personal Importation shipments of unlicensed biological products.
Recommendations for addition to DWPE of products not listed on the Red List and currently under detention status should be routed to CBER/OCBQ (listed in CMS as “CBER Immediate Office of the Director”) for review and concurrence for addition to this Import Alert. Addition to the Red List will be evaluated by CBER/OCBQ on a case-by-case basis. Recommendations for addition to DWPE of products not listed on the Red List that have been refused entry and approved by CBER/OCBQ for addition to import alert should be routed to OII’s Division of Import Operations (DIO) for review.
Release of Articles Subject to DWPE Under this Import Alert:
In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee and/or another responsible party for the affected goods should provide evidence that the shipment does not contain unlicensed biological products. Such evidence may include a copy of a valid BLA or IND covering the specific product and establishment. CBER/OCBQ will evaluate each shipment on a case-by-case basis.
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to FDA to adequately demonstrate that the firm has resolved the condition that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future entries will be in compliance with the PHS Act and the FD&C Act.
If a firm and/or a representative thereof would like to request removal from DWPE under this Import Alert, all relevant information supporting the request should be submitted to OII/OIO/DIO via email to: Importalerts2@fda.hhs.gov. Removal requests will be referred by DIO to CBER/OCBQ for evaluation.
Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/OIO/DIO (301) 796-0356 or Imports@fda.hhs.gov.
Questions or issues regarding compliance of imported biological products should be addressed to CBER/OCBQ at cberimportinquiry@fda.hhs.gov.
Product Description:
Unlicensed Biological Products
Charge:
The article is subject to refusal of admission pursuant to section 801(a)(3)of the FD&C Act because it appears to be a biological product for which a biologics license is not in effect under section 351(a) of the Public Health Service Act, and also appears to be either: (1) a new drug under 201(p) of the FD&C Act that is not approved and is in violation of section 505(a) of the FD&C Act, or (2) a device under 201(h) of the FD&C Act that is in violation of sections 510(k) and 515(a) of the FD&C Act because it does not have an approved application for premarket approval in effect or a cleared premarket notification. The article is not the subject of an Investigational New Drug application or Investigational Device Exemption (IDE) that is in effect.
OASIS charge code: NO LICENSE
OASIS charge code: NO LICENSE