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Weekly UpdatesA March 1 inspection by FDA Investigator Sandra Shire, M.D., was performed to review the conduct of studies at Envita Natural Medical Centers. The inspection revealed that Envita manufactures a product using an SOP for Establishment of Long-Term 4NKT Cultures.
Shire noted that Envita's biological product was being administered to individuals to treat a variety of illnesses, including various cancers. The cell cultures were incubated before being re-administered to subjects.
However, FDA pointed out that 4NKT cultures should bear the description "Products are for research use only. Not for use in diagnostic or therapeutic procedures." Thus, Envita Natural was not using the biological cultures for approved uses.
Moreover, based on the aforementioned information, FDA determined that Envita Natural's treated cell cultures violated the Public Health Service (PHS) Act and the Federal Food, Drug and Cosmetic (FD&C) Act.
The treated cell cultures, the agency noted, are a biological product as defined in the PHS Act, in that they are a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product, or arsphenamine or derivative of arsphenamine, applicable to the prevention, treatment or cure of a disease or condition of human beings.
The treated cell cultures are also a drug within the meaning of section 201(g) of the FD&C Act, in that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man.
However, Envita Natural Medical Centers had neither a BLA nor an NDA in effect. And, therefore, te firm's cultures are also therefore considered unsafe, the agency emphasized, because a BLA or an NDA is issued only after a showing of safety, purity and potency (for a BLA) or safety and effectiveness (for an NDA) for the product's intended use.
Additionally, Envita Natural violated regulations governing the proper conduct of clinical studies involving INDs.
Specifically, Envita was cited for failure to submit an IND application to FDA, the failure to withhold administration of an IND until an IND application was in effect and the failure to meet the general requirements for use of an IND in a clinical investigation.
Lastly, the treated cell cultures are considered misbranded, CBER noted, because their labeling failed to bear adequate directions for use for the purposes for which the product was intended. BiMo, BLA, NDA, O-L Use; Doc. 13901W
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