Import Alert 57-21
(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 # 57-21
Published Date: 09/01/2023
Type: DWPE
Import Alert Name:
Detention without Physical Examination Of Whipworms and Hookworms Including Eggs and Larvae
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 05/31/2023 updates the reason for alert and guidance sections, agency contacts, product description section and charge code language. Changes to the import alert are bracketed by asterisks (***).
Hookworms, Whipworms, Tapeworms, and their eggs, and larvae may be used as immunomodulators to treat patients with allergies, asthma, autism, Crohn's Disease, multiple sclerosis, Sjogren's Syndrome, and Ulcerative Colitis by deliberate self-infestation are considered to be biological products as defined in Section 351 of the Public Health Service Act(PHS Act). Entries have been declared for personal use only and are accompanied by a US Physician's prescription. Currently, there is no new drug application approval or biologics license application for this product and no IND has been filed with CBER ***for these indications. ***
FDA has concerns regarding the product's safety as the Agency does not have information regarding the manufacture, control, and release tests for this product. Specifically, the Agency has no information regarding testing at the manufacturing stages and in the final drug product for adventitious agents, including porcine or rodent viruses. Additionally, there is concern regarding the potential presence of other contaminants and/or allergens within the oral mixture that patients are being directed to consume.
Hookworms, Whipworms, Tapeworms, and their eggs, and larvae may be used as immunomodulators to treat patients with allergies, asthma, autism, Crohn's Disease, multiple sclerosis, Sjogren's Syndrome, and Ulcerative Colitis by deliberate self-infestation are considered to be biological products as defined in Section 351 of the Public Health Service Act(PHS Act). Entries have been declared for personal use only and are accompanied by a US Physician's prescription. Currently, there is no new drug application approval or biologics license application for this product and no IND has been filed with CBER ***for these indications. ***
FDA has concerns regarding the product's safety as the Agency does not have information regarding the manufacture, control, and release tests for this product. Specifically, the Agency has no information regarding testing at the manufacturing stages and in the final drug product for adventitious agents, including porcine or rodent viruses. Additionally, there is concern regarding the potential presence of other contaminants and/or allergens within the oral mixture that patients are being directed to consume.
Guidance:
***Divisions may detain without physical examination all imported Whipworm, Hookworm, Human Hookworm (Necator americanus), Human Whipworm (Trichuris trichiura), Pig Whipworm Eggs, Trichuris Suis (TSO),Rat Tapeworm (Hymenolepis diminuta),and their eggs or larvae, unless the importer has provided a valid investigational new drug application which is in effect, or a valid biologics license under section 351 of the PHS Act.***
These immunomodulators, for the above stated purposes, are considered to be biological products as defined in Section 351 of the PHS Act and are subject to refusal under 801(a)(3) of the Federal Food, Drug and Cosmetic Act (FD&C Act) if they are not manufactured at an establishment holding an unsuspended and unrevoked U.S. license issued under the PHS Act, Part F, Subpart 1 - Biological Products, Section 351 (a)(42 USC 262) or are not the subject of an Investigational New Drug application that is in effect. These products can also be subject to refusal under 801(a)(1) in that they appear to be manufactured, processed, or packed under insanitary conditions. See also 21 USC 351(a)(2)(A).
***Products for veterinary use and/or research purposes are not covered under this import alert. Only products intended for human use are subject to DWPE under this import alert.***
*** Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
For questions regarding these criteria and/or products covered, contact CBER's Office of Compliance and Biologics Quality, Division of Case Management at CBERImportInquiry@fda.hhs.gov or by phone at 240-402-9156.
***
These immunomodulators, for the above stated purposes, are considered to be biological products as defined in Section 351 of the PHS Act and are subject to refusal under 801(a)(3) of the Federal Food, Drug and Cosmetic Act (FD&C Act) if they are not manufactured at an establishment holding an unsuspended and unrevoked U.S. license issued under the PHS Act, Part F, Subpart 1 - Biological Products, Section 351 (a)(42 USC 262) or are not the subject of an Investigational New Drug application that is in effect. These products can also be subject to refusal under 801(a)(1) in that they appear to be manufactured, processed, or packed under insanitary conditions. See also 21 USC 351(a)(2)(A).
***Products for veterinary use and/or research purposes are not covered under this import alert. Only products intended for human use are subject to DWPE under this import alert.***
*** Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
For questions regarding these criteria and/or products covered, contact CBER's Office of Compliance and Biologics Quality, Division of Case Management at CBERImportInquiry@fda.hhs.gov or by phone at 240-402-9156.
***
Product Description:
Product
Description: ***Whipworm, Hookworm, Human Hookworm (Necator americanus), Human Whipworm (Trichuris trichiura), and Pig Whip Worm Eggs, Trichuris Suis Ova (TSO), Rat Tapeworm (Hymenolepis diminuta, eggs and larvae***
PRODUCT CODE(S):
57W[][]01, Immunomodulators-Whipworms, eggs and larvae
57W[][]02, Immunomodulators-Hookworms, eggs and larvae
57W[][]03, Immunomodulators-Tapeworms, eggs and larvae
Description: ***Whipworm, Hookworm, Human Hookworm (Necator americanus), Human Whipworm (Trichuris trichiura), and Pig Whip Worm Eggs, Trichuris Suis Ova (TSO), Rat Tapeworm (Hymenolepis diminuta, eggs and larvae***
PRODUCT CODE(S):
57W[][]01, Immunomodulators-Whipworms, eggs and larvae
57W[][]02, Immunomodulators-Hookworms, eggs and larvae
57W[][]03, Immunomodulators-Tapeworms, eggs and larvae
Charge:
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use.[Misbranded, 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT]
OASIS Charge Code: NO LICENSE
and/or
***The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.***
[Adulteration, Section 501(a)(2)(A), 801(a)(3)].
OASIS Charge Code: INSANITARY
OASIS Charge Code: NO LICENSE
and/or
***The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.***
[Adulteration, Section 501(a)(2)(A), 801(a)(3)].
OASIS Charge Code: INSANITARY
Countries
MULTIPLE COUNTRIES
-
(57 W - - 01) Whipworms, eggs and larvaeDesc: Immunomodulators-Whipworms eggs and larvae
-
(57 W - - 02) Hookworms, eggs and larvaeDesc: Immunomodulators-Hookworms eggs and larvae
-
(57 W - - 03) Tapeworms, eggs and larvaeDesc: Immunomodulators-Tapeworms eggs and larvae