We told you recently that the FDA is set to yank
vinpocetine from the shelves, even though it had been previously approved as a
new dietary ingredient (NDI), that is, a new supplement. Why? Two reasons.
Because the agency all of a sudden found that an investigational new drug
application (IND) had been filed in the 1980s—meaning that a drug company was
researching vinpocetine for use in a drug. When an IND has been filed before an
NDI has been filed, that substance can no longer be marketed as a dietary supplement.
It doesn’t matter if the IND was dropped.
The second reason is that the FDA decided that
vinpocetine wasn’t a dietary ingredient—a perplexing conclusion since the
agency said it was a dietary ingredient when it approved NDIs for vinpocetine
in the late 1990s.
This is an extremely bad precedent. It is absurd
that the FDA can retroactively and unilaterally decide that a supplement is not
a dietary ingredient, after it has already said that it is. If this ridiculous
precedent is allowed to stand, what other supplements will the FDA
retroactively decide are not dietary ingredients and yank from the shelves?
Presumably any supplements that Big Pharma wants to turn into synthetic drugs!
Using this precedent, the FDA could decide years down the road that vitamin D
isn’t actually a dietary ingredient, and move to pull it off the shelves.
Write to your representative and senators and ask them to question the FDA on where they get the authority to pull vinpocetine, and to
ask the agency to extend the comment period on this issue. We’ll also send a
copy of the request to the FDA.
Please help save vinpocetine
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]