Import Alert 57-21

Import Alert # 57-21

Published Date: 03/11/2016

Type: DWPE

Detention without Physical Examination Of Whipworms and Hookworms Including Eggs and Larvae

NOTE: Revision of this Import Alert dated 3/11/2016 includes a new product code and to modify the existing two product codes for this Import Alert. A new product code 57W-03 for Rat Tapeworm (Hymenolepis diminuta), eggs and larvae is added and the existing two product codes 57W-01 & 57W-02 include "eggs and larvae" for clarification. CBER was informed by LOS-DO that 4 entries (AEK-1807556-1, AEK-1807568-6, AEK-1827599-1, AEK-1807540-5) of rat tapeworm, eggs and larvae where being offered for entry from Biome Restoration Ltd., Unit 848 Harpers Mill, White Cross Business Park, Lancaster, Great Britain, LA14XF, for human immune therapy. CBER/OCBQ has reviewed the entry documentation for the above 4 entries and support the detention and refusal. Based on CBER's determination to support detention and refusal of rat tapeworms under Import Alert 57-21, it is necessary to update the existing Import Alert. Changes are noted and bracketed with three asterisks (***)

NOTE: Revision of this Import Alert dated 01/12/2016 changes the CHARGES section and updates language in the GUIDANCE section. Changes are noted and bracketed with three asterisks (***).


Hookworms, Whipworms, *** Tapeworms,*** and their eggs, and larvae used as immunomodulators to treat patients with allergies, asthma, autism, Crohn's Disease, multiple sclerosis, Sjorgren'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.

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.

When the District encounters these articles, they may detain without physical examination all imported Whipworm, Hookworm, Human Hookworm (Necator americanus), Human Whipworm (Trichuris trichiura), Pig Whipworm Eggs, Trichuris Suis (TSO), ***and Rat Tapeworm (Hymenolepis diminuta), eggs, and 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).

For questions regarding these criteria and/or products covered, contact:
CBER's Office of Compliance and Biologics Quality, Division of Case Management at 240-402-9155.

For questions or issues involving import operations, contact Jeff Hilgendorf, CSO, Division of Import Operations at (313)393-2019

PRODUCT(S):
Whipworm, Hookworm, Human Hookworm (Necator americanus), Human Whipworm (Trichuris trichiura), and Pig Whip Worm Eggs, Trichuris Suis Ova (TSO), ***and 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 ***
57 [][][][] Bio & Licensed In-Vivo & In-Vitro Diag

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

If 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