Center For Immunology Science, LLC
FDA issued a warning letter to Center For Immunology Science, LLC (CEO Bruce S. Gillis, M.D.) following an inspection revealing that the company conducted a clinical investigation of heat-killed Mycobacteria smegmatis on 200 human subjects without submitting a required Investigational New Drug (IND) application, in violation of 21 CFR 312. The company had marketed the substance as a dietary supplement/biotic to boost immune system and microbiome health, but FDA determined the investigation's intent was to treat or mitigate immune-deficiency diseases, qualifying it as a drug under the FD&C Act. The company's response claiming IND exemption under DSHEA was deemed inadequate because it lacked a corrective and preventive action plan. FDA warned that failure to adequately address the violations may lead to further regulatory action.
Flagged claims (3)
Mycobacteria smegmatis has immune-modulating effects that can stimulate or suppress the immune system and may help the body fight cancer, infection, or other diseases
Use of Heat-Killed Mycobacteria smegmatis as a nutritional supplement/biotic to boost immune system and microbiome health
information from the study may be used to produce an over-the counter product to boost immune system and microbiome health that may help reduce symptoms associated with an immune-deficiency medical disease
Required actions (2)
Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future.
you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action.
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