FDA Hits Terra Biological Over Misbranding

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.”