Unanswered Rare form of B-6 sold otc as a sup then banned

[stimtron]

Invalid Link Removed

WTF.

 

[kisaj]

This should come of no surprise to anyone. The FDA is in bed with the drug companies and really doesn't have the public's interest at heart when making any regulations.

 

[stimtron]

This should come of no surprise to anyone. The FDA is in bed with the drug companies and really doesn't have the public's interest at heart when making any regulations.

I've never seen a drug company try to get a drug approved, pressure the FDA to removes anyone selling it as a sup the after failing approval try then to sell it as a sup. This is highly unusual.

 

[VaughnTrue]

On January 12, 2009, the FDA ruled that products containing pyridoxamine are excluded from the definition of dietary supplements as defined by the Invalid Link Removed.Invalid Link Removed 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."Invalid Link Removed

In 2006, Biostratum licensed its rights in Pyridorin to another company, NephroGenex Invalid Link Removed In 2008, NephroGenex restarted the clinical development of Pyridorin, which as of 2012 is still ongoing.

I hate this crap as much as anyone, but according to DSHEA the FDA acted appropriately on this decision. If a product was not sold prior to 1994, and no NDI was submitted/approved by the FDA, then it is not a dietary supplement and cannot be sold as one.

Again, I hate this stuff, but it doesn't meet the regulations of dietary supplements.

 

[stimtron]

I hate this crap as much as anyone, but according to DSHEA the FDA acted appropriately on this decision. If a product was not sold prior to 1994, and no NDI was submitted/approved by the FDA, then it is not a dietary supplement and cannot be sold as one.

Again, I hate this stuff, but it doesn't meet the regulations of dietary supplements.

Naturally occuring vitamin B-6 found in food does not meet the definition of a dietary supplement or because a drug company filed to make it a drug and no supplement company was aware of this they didn't fight it? If it was sold prior it should have been exempt from NDI but according to the FDA it is up to the dietary sup companies to prove this.