FDA Hits Terra Biological Over Misbranding

March 23, 2018

The FDA served Terra Biological a warning letter for marketing a misbranded, unapproved new drug product on its website.

The agency said the San Diego, California-based firm marketed the product CRONaxal (oxaloacetate) with claims that the product could be used to treat or prevent disease, making it a drug for regulatory purposes.

The website claimed the product could be used with chemotherapy for the “clinical dietary management of the metabolic imbalances associated with glial tumors,” in addition to claiming it “reduces Glutamate levels in the brain in multiple laboratory animals.”

The FDA noted that the product is not recognized as a safe and effective treatment for the uses it referenced, making it a “new drug” that may not be legally marketed in the U.S. without agency approval.

The product was also found to be misbranded, the warning letter stated, as it failed to bear adequate directions for use. CRONaxal was intended for treatment that required the supervision of a licensed practitioner, the agency said.

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