Elysium's Additional Comment to the FDA
Elysium submitted a comment to the FDA regarding ChromaDex's supplemental petition to the FDA. You can read it here:
Here is the background:
Last August, ChromaDex filed a petition with the FDA complaining that Elysium's New Basis was contaminated with toluene residue and met the legal definition of adulterated.
ChromaDex's motion to dismiss the angry lawsuit was fully briefed in November, and we are now waiting for Judge Caproni's decision.
In January, ChromaDex filed a supplemental petition to the FDA arguing among other things that the comment Foley filed with the FDA demonstrated well why the FDA should crack down on suppliers like Elysium that appear to violate the rules with impunity.
We are not surprised that Elysium does not like the sequel petition any better than it liked the original, but several things about Elysium's new comment do surprise us. Here are the key points:
1. The new comment was filed by Skadden, not Foley
2. Elysium now claims that "the toluene has been removed from" Mystery Basis
3. Elysium now also claims that "the NR incorporated within Basis has NEVER contained any level of toluene" (emphasis added)
4. Elysium's NR is GRAS, and therefore Basis does not contain a new dietary ingredient that has not been demonstrated to be safe
5. Elysium is conducting testing in anticipation of submitting an NDIN to the FDA
It's clear why Elysium switched to Skadden for this comment, because Skadden is the king of Orwellian Double-Speak.
If you want a law firm to simultaneously assert that Elysium has removed the toluene AND that the toluene it removed was never there in the first place, you'll need Skadden for that.
And if you want to assert that the NR in Basis is not a new dietary ingredient AND that they are preparing a new dietary ingredient notification for it, then you'll need Skadden for that.
Footnote 1 of the comment perpetuates Elysium's Don Quixote crusade in support of the proposition that the ICH Guidelines governing pharmaceuticals and NOT supplements actually govern pharmaceuticals AND supplements.
Elysium has apparently read its own arguments so many times that it honestly believes that if you reference a standard for any purpose, then the standard becomes the legally governing standard for that purpose. I predict that Elysium will continue paying lawyers to make this assertion in public until some judge tells them to cut it out.
Appendix A and B are ChromaDex's NDIN and GRAS filings that mention the ICH Guidelines, without, despite what Elysium says, transmuting those Guidelines into something other than what they purport to be.
What's REALLY WEIRD to me, is that Elysium apparently accidentally forgot to attach Appendices C, D, and E, which no doubt provide evidence in support of Elysium's assertions that (1) New Basis no longer has toluene, (2) that New Basis never had toluene, and (3) that New Basis is GRAS.
Instead, we are implicitly invited to take Elysium's word for it.
This is audacious.
Here is Elysium's exact language in its comment:
Had ChromaDex re-tested Basis before filing its Supplemental Petition, it would have discovered that the toluene has been removed from Basis so that it currently is at or below non-detect levels for numerous forms of testing.
Elysium is correct that it's not hard to re-test, so where are the test results? It's no trouble to attach the one-page print-out that Elysium received from its independent lab showing toluene "at or below non-detect levels for numerous forms of testing" (whatever "below non-detect levels" might mean; I think that's just Skadden-speak razzle-dazzle).
There are already two appendices attached -- where are the rest?
I was ready to consider the question of whether Elysium's removing the toluene from Basis negates the harm complained about in ChromaDex's petition, or merely prevents the accumulation of additional damages.
I also was expecting to consider whether Elysium gets to ride on ChromaDex's GRAS and NDIN coattails with a different product that uses an undisclosed manufacturing process. I think that King & Spalding explained last month why Elysium does not get to do that.
But we don't even reach those issues.
Instead, we just have Elysium's contradictory factual assertions, which Elysium is unwilling or unable to support with the most basic evidence -- evidence that Elysium purports to have but refuses to disclose.
In other words, Elysium is using the FDA public comment repository the way most people use a toilet.