A guide to care questions / What is unknown
What is known about harm?
A missing side-effect list does not establish that TB-500 is harmless.
The gaps in what is known about harm
FDA’s review found no human studies to establish TB-500’s side effects.
FDA also found no TB-500 animal studies checking harm from short-term or repeated use.
FDA found none checking pregnancy, cancer or damage to genes, the instructions inside cells, for TB-500.
This means the chance of harm is unknown; it does not establish that TB-500 is harmless or that it always causes harm.
As recorded in September 2026, TB-500 had no FDA-approved label.
There was no FDA-reviewed advice on effects alongside other medicines, or use in pregnancy, breastfeeding or children.
FDA warns that the body may react against a shot
FDA warned that a TB-500 shot may make the body react against the injected substance.
FDA says the concern may be greater if the short TB-500 chains stick together or if other unwanted substances are present.
FDA describes possible reactions to a TB-500 shot ranging from no visible problem to life-threatening harm.
FDA does not give a measured figure for how often people have such reactions to TB-500.
FDA found no human study testing this response for TB-500.
A test sheet cannot fill the gaps
FDA reviewed a sample TB-500 test sheet, not test results for every product.
That sheet lacked checks for unwanted substances, harmful material made by bacteria and TB-500 chains stuck together.
A purity figure tells how much of a sample matches the named substance.
A purity result alone does not show that a batch is free of germs or harmful material made by bacteria.
Ask which tests were actually done and what each test can establish.
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