On January 12, 2009, the FDA ruled that products containing pyridoxamine are excluded from the definition of dietary supplements as defined by the
Dietary Supplement Health and Education Act of 1994.
[11] The FDA stated that the status of Pyridorin as an investigational new drug, as a result of an application filed by BioStratum in July 1999 and effective on September 1, 1999, meant that "the marketing of pyridoxamine in a dietary supplement is essentially equivalent to the marketing of an investigational new drug as a dietary supplement"
because there was an "absence of independent, verifiable evidence that the substance was marketed as a food or a dietary supplement prior to its authorization for investigation as a new drug."[13]
In 2006, Biostratum licensed its rights in Pyridorin to another company, NephroGenex
[14] In 2008, NephroGenex restarted the clinical development of Pyridorin, which as of 2012 is still ongoing.