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Wednesday, August 17, 2016

Nicotine Off Market as a Big Pharma "IND?"

This link describes how the FDA is generating new "guidance" (link here) related to supplements and the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Vapers' and vape-related businesses need to be concerned as to what date "nicotine" became available for sale relative to the passage of DSHEA as well as exactly what it is besides now being a "tobacco product" - or, more correctly, what it was...

The link describes various scenarios" "...[a] drug company decides to corner the market on a whole list of ingredients to keep them out of the hands of supplement formulators forever more. This could very easily be done under this [new] guidance. Remember that it is not always clear what counts as a NDI or what has been grandfathered, so drug companies can use this confusion to claim that supplements which have been around for decades have been sufficiently “altered” that they can be claimed as drugs."

The "NDI" designation indicates when a "supplement" appeared on the market (before DSHEA its grandfathered and after its "NDI").

"IND" means a new drug under these proposed regulations.

If a company attempts to make nicotine an ingredient in a new drug product, in an "IND," nicotine would lose its status as "NDI" and be forced off the market.

Nicotine, though now an "imaginary" tobacco product, it didn't used to be and I do not know what it was relative to this prior to 8/8/2016.

In any case please read and repeat:

If nicotine is an "NDI" and is incorporated into a new "IND" application its no longer salable as a supplement under these proposed regulations.

These proposed regulations provide a neat back door for Big Pharma (or anyone really) to potentially control nicotine and remove public access to it forever.

Can this happen?

Probably, though there would likely be lawsuits from other Big Pharma as no single company would get to control nicotine for vaping, its simply too profitable!

Also nicotine is now sort of an "imaginary" "tobacco product" which DSHEA specifically exempts (does not include, i.e., tobacco is not a supplement).

The proposed regulations place restrictions on nicotine but its unclear, and I have worked with a DSHEA lawyer on this, as to what DSHEA implies relative to "nicotine" which is why this is dangerous and important to vaping.

DSHEA really, I don't believe, thinks nicotine is tobacco.  Hence it must be "something else..."

But what???

I do not think we can fall back to the prior legal cases related to vaping and the FDA from 2007.  The reason for this is the court told the FDA it couldn't make vaping into a medical device.

This is a different animal in that nicotine could be controlled "by inclusion" in a "drug" application to the FDA.  Its not the FDA deciding what it is.

And this has happened already, a variant of vitamin B6 was eliminated from the market both as a drug and supplement because of its inclusion in an "IND."


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