Elysium Is Indignant About Toluene Complaint
Elysium Health has filed with the FDA an indignant objection to ChromaDex's complaint that Basis contains residual quantities of Toluene. You can read Elysium's indignant objection here:
The gist of Elysium's objection, as I understand it, is:
1. Toluene isn't dangerous in small quantities
2. ChromaDex knows that, because ChromaDex's own Pterostilbene has also included toluene residue
Elysium is especially butt-hurt that ChromaDex filed the petition "not out of concern for public safety, but instead to disparage Elysium publicly for its own commercial gain."
Would that Elysium was so concerned with good intentions that in their federal litigation they expressed comparable outrage at themselves for having placed giant orders in June 2016 apparently lacking the good intention to meet rapidly growing demand with ingredients that they intended to pay for.
However, what is annoying about Elysium's petition -- the ChromaDex/Elysium dispute has taught me why people hate lawyers so much; I honestly did not understand before -- is that Elysium struts around like a wet hen but ignores the main point of the petition they are objecting to, which is that Elysium is selling a supplement for which there is neither an New Dietary Ingredient Notification (NDIN) nor a Generally Recognized As Safe (GRAS) determination. If a supplement doesn't have an NDIN and isn't GRAS, and it contains an unsafe substance, then it is adulterated. And selling an adulterated substance has legal consequences. That's the point of ChromaDex's petition.
So, yes, ChromaDex pointed out that toluene is unsafe and that Basis contains toluene, but the point of the petition wasn't to establish that trace amounts of toluene are unsafe, but to establish that Basis is an adulterated substance in violation of FDA regs.
So to read Foley go on and on about how safe toluene is at low-doses, but ignore the REASON why those low doses were mentioned in ChromaDex's petition, makes Foley either stupid or cagey.
Did you guess "cagey?" That's right! And it's why people hate lawyers.
If you read ChromaDex's petition, it requests two types of relief:
(1) Make a determination that Basis is adulterated, and
(2) Make a determination that Basis contains a new dietary ingredient for which an NDIN was not filed.
There is no request that the FDA find that Basis is unsafe, or find that toluene at low levels is unsafe.
ChromaDex does assert that the presence of toluene in Basis renders Basis "injurious to health," but the standard under the federal food adulteration statute (21 U.S.C. § 342(a)(1)) is that food adulteration shall be found if the added poisonous substance "may render it injurious to health" (emphasis added).
Of course, I have no particular expertise in FDA law, but ChromaDex's petition was also covered by a better publication than this blog, NutraIngredientsUSA, as I noted here, and NutraIngredientsUSA absolutely DOES have expertise in FDA law.
In their excellent article, ChromaDex Alleges in Petition that Elysium Health Product Is Adulterated, author Hank Schultz quoted an expert attorney as predicting that the FDA would not act on ChromaDex's petition, but conceding that such petitions were a useful vehicle for alerting the industry as to what's going on.
My read is that ChromaDex's petition properly serves both purposes.
If I believe that someone is violating their legal obligations, what should I do?
One option would be to attempt to disrupt that person's business by, say, ordering millions of bottles of Basis with no intent to pay for it and see if that teaches them a lesson. That's self-help dispute resolution, and the legal system is supposed to frown upon it.
Option Two would be to file a petition with the FDA and complain that somebody isn't playing by the rules. That would be the civil way to proceed, and the legal system is supposed to favor it. And if the FDA sits on the petition for six months or forever, at least the industry is alerted to what is going on, and people can make their own decisions about whether they care.
So Elysium's indignation about this petition is poorly taken. ChromaDex did the right thing, the right way, for the right reason, and Elysium has not even attempted to respond to the questions raised about whether Basis contains a new dietary ingredient without an NDIN or is adulterated, regardless of whether Elysium, ChromaDex, or anybody thinks that trace amounts of toluene are safe
I myself think that trace quantities of toluene might be safe, as I suggested here. But the legal question that ChromaDex posed and Elysium refuses to answer isn't about safety, it's about adulteration.
Elysium seems to believe that if you express enough contempt for your adversary then no one will notice how much contempt you also have for the regulatory process itself. Time will tell.