FDA WARNING_LETTER - Terra Biological LLC

The FDA issued a Warning Letter to Mr. Cash regarding the product CRONaxal (Oxaloacetate), sold on www.cronaxal.com, following a website review in April 2017. The FDA determined that claims on the website establish CRONaxal as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) due to its intended use for the cure, mitigation, treatment, or prevention of disease.

Specific claims cited include: "Oxaloacetate supplementation reduces Glutamate levels in the brain in multiple laboratory animals. Glutamate overproduction is directly tied to the growth of malignant gliomas," and "CRONaxal...used with chemotherapy for the clinical dietary management of the metabolic imbalances associated with glial tumors."

The FDA stated that CRONaxal is an unapproved new drug under section 201(p) of the Act, as it is not generally recognized as safe and effective for its stated uses, violating section 505(a). Furthermore, the product is misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as it is intended for conditions requiring supervision by a licensed practitioner. The introduction of this misbranded drug into interstate commerce violates section 301(a).

Additionally, the FDA asserted that even if not an unapproved new drug, CRONaxal is misbranded as a