Immune & Genetics Protocols, LLC
FDA issued a warning letter to Immune & Genetics Protocols, LLC (manager William Denizard-Flores) in March 2021 regarding their product 'Immune Bio Green Cell,' marketed via biogreencell.com and Facebook. The product's website and social media claims — including treating cancer, HIV/AIDS, autism, diabetes, Crohn's disease, and other serious conditions — caused FDA to classify it as an unapproved new drug and a misbranded drug under the FD&C Act. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (12)
Pathology: Diabetes Type 2 The active principle of Immune Bio Green Cell, is to activate the regeneration of the pancreatic cells so that these can produce sufficient insulin; hence, regulating blood levels.
Pathology: Crohn [sic] Immune Bio Green Cell could help you to have your immune system stopped [sic] attacking your own cells, thereby helping to deflate the parts of the gastrointestinal tract, thus returning cellular genetic recognition to your immune system.
Approved for sale by the 'USDA'. Manufactured and packaged in laboratory approved by the 'FDA' in the United States
Its [Immune Bio Green Cell's] ability to potentially help the immune system exercise its functions optimally, makes it the ideal choice for use as a preventive or as an adjunct treatment for chronic diseases . . .
Pathology: Asperger [sic] Immune Bio Green Cell may help due to its composition promoting the restoration of the neuronal synapse.
Pathologies: Renal, Liver and Spleen Immune Bio Green Cell is an immunomodulator that could return cellular genetic recognition to your immune system to act as a defensive mechanism on malignant cells.
Immune Bio Green Cell is a product approved as Immune System Enhancement Formula by USDA and is made in a laboratory registered with the FDA.
Pathology: Autism Immune Bio Green Cell may help due to its composition promoting the restoration of the neuronal synapse.
Some of the highly complex conditions that may benefit from its [Immune Bio Green Cell's] use are: o Cancer – All kinds o Lupus o Leukemia o HIV and AIDS o Tumors o Rheumatoid arthritis o Epidermolysis Bullosa o Psoriasis o Pulmonary hypertension o Multiple sclerosis
I was diagnosed with a progressive condition in my immune system . . . I never imagined the power and the reach so great that Immune Bio Green Cell could have. My tumor markers were reduced almost miraculously.
Immune Bio Green Cell . . . . By modulating your immune system . . . it would have the ability to fight and could help your immune system attack malignant cells while preventing your immune system from attacking and / or destroying good cells.
Integrative with Chemotherapy and Radiotherapy Immune Bio Green Cell could relieve and reduce side effects by strengthening your immune system.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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