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

NOTE: Revision of this Import Alert dated 9/30/2011 includes new FDA product codes specific to the covered products and brings the language in the Reason for Alert section up to date. Changes are noted and bracketed with three asterisks (***)


*** Hookworms, Whipworms, and their eggs, and larvae used as immunomodulators to treat patients with allergies, asthma, autism, Crohn¿s Disease, multiple sclerosis, Sjorgrens 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. 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 with regard to testing for adventitious agents, including porcine viruses, at the manufacturing stages and in the final drug product. 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. ***

*** Districts may detain, without physical examination, all imported Whipworm, Hookworm, Human Hookworm (Necator americanus), Human Whipworm, (Trichuris trichiura), and Pig Whip Worm Eggs, Trichuris Suis Ova (TSO), eggs, and larvae; unless there is a valid investigational new drug application in effect, or a valid biological license under section 351 of the Public Health Service Act. ***

Whipworm, Hookworm, Human Hookworm (Necator americanus), Human Whipworm (Trichuris trichiura), and Pig Whip Worm Eggs, Trichuris Suis Ova (TSO), eggs and larvae

"The article is subject to refusal of admission pursuant to 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 Section 351(a) of the Public Health Service Act, and therefore it appears to be a new drug under the meaning of section 201(p) of the FD&C Act without an effective new drug application approval, as required by section 505 of the FD&C Act. [Unapproved new drug, section 505(a)]"

OASIS charge code - UNAPPROVED