Elysium Basis Listed in FDA Recall
Updated: Feb 5, 2020
UPDATE FEBRUARY 5, 2020: Elysium has obtained a note from Foley Lardner (counsel for ABH) affirming that Basis is not recalled and that Elysium was included on the ABH recall list by mistake:
The question remains how Elysium ended up on the list in the first place. We suspect that ABH and Elysium must have had some dealings of some sort, but it seems clear that whatever those dealings might have been, they never resulted in any goods manufactured by ABH for Elysium. _________________________________
The FDA posted a dietary supplement recall notice on its website (nationwide recall, all lots) that directs, "Consumers should check the attached list of companies who distributed the dietary supplements to determine if they have purchased a recalled product that needs to be returned or destroyed."
The attached list includes both "Elysium Health" (line 229 of the spreadsheet) and "Basis" (line 74 of the spreadsheet).
Here is the story. It begins more than seven years ago.
ABH, along with its subsidiary StockNutra, is a contract manufacturer of health supplements.
The FDA sent a warning letter to ABH in 2012 finding "serious violations of the Current Good Manufacturing Practice Regulation...for Dietary Supplements." The FDA warning letter said that ABH's response to the FDA's inspection report did not adequately address the violations noted.
The FDA visited the ABH facility again at least five more times, in July 2012, May 2013, August 2013, November 2016, and February 2018.
And then at one final visit in November 2018, six years after the first, the FDA found a long list of cGMP violations, including many of the same violations previously noted.
And this time the FDA threw the book at ABH.
Here is the FDA's Complaint and the resulting Consent Decree:
The FDA found that ABH:
1. Failed to test for identity, purity, strength, and composition
3. Failed to implement process controls
4. Failed to create required records
5. Failed to respond to a consumer complaint
and more. According to the FDA's complaint,
"Defendants repeatedly promised to correct their deviations from dietary supplement cGMP regulations. Defendants made such promises in their written responses to FDA's inspectional observations from each of the six FDA inspections noted above, and in discussion with FDA during the 2017 regulatory meeting. Yet, despite these promises, each new FDA inspection has revealed that Defendants continue to deviate from dietary supplement cGMP regulations. Far from correcting the deviations. Defendants have expanded their unlawful conduct, including by distributing unapproved new drugs and misbranded drugs in violation of the Act."
The consent decree kicks ABH out of the supplement business until it does a long list of difficult things, one of which (7.G) is to "recall and destroy...all dietary supplements...that were received, manufactured, prepared, packed, repacked, labeled, held, or distributed between January 1, 2013 and [December 2019]."
Paragraph 7.G seems to say that ABH has to recall everything it has made since 2013, but it doesn't exactly say that. What Paragraph 7 says is that ABH "is permanently restrained and enjoined...from manufacturing...dietary supplements...unless and until..." they do the recall and some other things. In other words, if they choose NOT to manufacture, then they need not recall. That's what the Consent Decree says, anyway. But if they DO want to return to business, then the recall is mandatory.
So how did Elysium get tangled up with ABH?
We don't know.
What we do know is that Elysium originally got its ingredients for Basis from ChromaDex.
Then Elysium erroneously concluded in 2016 that it could improve its business by cutting ChromaDex out.
It appears from the evidence that Elysium first attempted to convince Dartmouth and Grace, ChromaDex's patent licensor and contract manufacturer, to work directly with Elysium.
When that did not work, Elysium set up an alternate supply chain with PCI Synthesis as the manufacturer. PCI began producing NR in May 2017.
In his deposition, PCI Synthesis CEO Ed Price testified that Elysium's COO was a "bullshit artist" who was "difficult to work with" and that "we just don't trust them anymore." The relationship broke down, and Elysium eventually dropped PCI and abandoned 52 pallets of materials at PCI ("each pallet is four feet by four feet, with drums on top of it", said Price).
Elysium's second Mystery NR producer was Ampac Fine Chemicals. Ampac began producing NR for Elysium around September 2018.
According to the testimony of ChromaDex expert Randal Heeb, Elysium purchased nearly 6,600 kg of NR from PCI, "and as of April 2019 Elysium has purchased 4,457 kg of nicotinamide riboside in one year from AMPAC."
And after that, the trail goes cold.
As far as we knew, Elysium was still getting its Mystery NR from Ampac. I can't find any mention in the reports of either Elysium's expert (Iain Cockburn) or ChromaDex's expert (Randall Heeb) that Elysium was developing a third supplier.
But the FDA seems to be under the impression that ABH was producing Basis for Elysium Health.
Presumably if that happened, it would have been fairly recent, because the expert report suggests that Ampac was still producing NR for Elysium in 2019.
If the FDA is right, that obviously reflects very poorly on Elysium's safety and quality processes, because the FDA visited the ABH facility repeatedly starting in 2012 and found many serious violations. Indeed, what kind of inquiry in 2019 would NOT have found quality concerns with ABH?
I can't find any information about a recall on Elysium's website.
So maybe the FDA is simply wrong and attached the wrong file to its recall notice, and Elysium has nothing to do with this.
Or maybe Elysium did some preliminary work with ABH -- enough to get on an ABH customer list that got vacuumed up by the FDA -- but never actually received product from ABH.
Or maybe Elysium received product from ABH but never packaged it as Basis.
Only Elysium can say.
But since Elysium by now must know that it is listed on the FDA's recall notice, and remains silent, we will be inclined to draw a negative inference.
Quality standards are an issue in the New York litigation, so even if Elysium remains silent, we may expect some discovery on this issue, which eventually may become public, and throw some light on the matter.
UPDATE JANUARY 27, 2020: Somebody apparently sent a query to Elysium and says they received this response: "Thank you for your email. Basis has not been recalled and has never been recalled. Furthermore, ABH Nature's Products has never manufactured Basis or any potential or current products for Elysium Health. Our legal team is working on removing our name from the list entirely, as we never produced a product with them. Please let me know if I can provide further assistance."
I'd be curious to know what Elysium's theory is about why they got included on the ABH customer list. Was Elysium preparing to produce a product with ABH? We'll tell you if we hear anything...