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This dietary supplement supports brain health and is entirely safe, yet the FDA still wants to remove it from sale.
About a month ago we alerted our customers of an FDA plan to ban the sale of vinpocetine, an effective and entirely safe dietary supplement. The comment period on the Federal Register has passed, so now, we’re asking Congress to put a stop to this ludicrous plan.
Please ask your members of Congress to write to the FDA, asking the FDA where it gets the authority to remove a supplement from the market that has been approved and safely used as a dietary supplement for almost 20 years and conduct an economic analysis of this ban.
Despite the fact that plant-based vinpocetine had been previously approved as a new dietary ingredient (NDI), that is, a new dietary supplement, on numerous occasions by the FDA, the FDA has announced in the Federal Register that it plans on removing this beneficial dietary supplement from the marketplace.
This notice explains the FDA will ban vinpocetine by using the hook that it can’t qualify as a dietary ingredient, despite the fact that Vinpocetine, actually has not one, not two, but five (5!) acknowledgements from the FDA in their NDI Database. The first of which dates back to 1997—almost 20 years ago!
This means that vinpocetine has already undergone intense scrutiny five times over by the leading authority on food safety in the US. During this time, FDA had the ability to respond to vinpocetine submission with a letter declaring it as not a dietary ingredient. Each time, FDA responded with a letter that they had no concerns over the ingredient or the data provided in their safety dossiers. From the FR notice, FDA doesn’t appear to have any clear safety signal based on Severe Adverse Event Reporting (SAER) or other means. However, the agency is looking to remove the ingredient via an administrative action that they have been silent on up until present.
First, 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? Using this logic, the FDA could decide years from now that vitamin D isn’t actually a dietary ingredient, and move to pull it off the shelves. Furthermore, many believe the purpose of the FDA’s proposal to remove vinpocetine is to protect pharmaceutical interests. Based on its clinical benefits, there is a strong incentive to sell vinpocetine as an expensive prescription drug.