It has been suggested that my analysis of Elysium's FDA comment on ChromaDex's supplemental FDA petition is does not cut Skadden much slack, and that I ought to attempt to reconcile Skadden's apparently conflicting statements.
Well, let's give it a try.
Riddle #1:
Skadden says that:
"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 elected to eliminate the presence of toluene from Basis as part of its continuing efforts to ensure superior product quality."
AND
"...the NR incorporated within Basis has never contained any level of toluene."
Solving Riddle #1
What can be removed,
even though it was never there
in the first place?
A possible solution to this riddle involves a finesse of the meaning of the words "Basis" and "NR."
A foolish lay person might assume that what we are talking about one consistent thing throughout, which is Elysium's Product, Basis, which both does and does not contain toluene.
But what if what Skadden means is that the toluene in Basis did not come from the NR, but from some filler ingredient admixed with the NR, or from the casing surrounding the NR?
Think about it: NR, by definition, contains only NR. And toluene contains only toluene. So if you think of the toluene in the NR not as toluene IN the NR but as ISOLATED toluene ADJACENTLY LOCATED IN SPACE AND TIME but nonetheless separate and distinct, then it would be possible for toluene to be removed from the product, but for the NR to always have been free from toluene.
If that is the solution to the riddle, then I have two objections.
First, Skadden could have said that.
Second, what Skadden instead said appears reasonably calculated to deceive someone into thinking that Basis never contained toluene, when we have unrebutted evidence that it does or did.
Riddle #2:
Skadden says that:
"ChromaDex's Supplemental Petition suggests that Elysium ignores the NDIN requirement...in reality, the NR within Basis enjoys GRAS status..."
AND
"Elysium is in the process of conducting further testing in support of an NDIN"
Solving Riddle #2
How can one prepare a New Dietary Ingredient Notification
for a product that does not contain a New Dietary Ingredient?
Now the cheap solution to the riddle would be to play on the word "ignore." Maybe Elysium did not "ignore" the NDIN requirement because it actually flouted the NDIN requirement. After all, flouting the requirement isn't the same as ignoring it, so it is possible for Elysium to fail to comply without ignoring it.
But that is too shitty even for Skadden.
What if what Skadden means is that an NDIN isn't required because NDIN's aren't required for substances that are GRAS. And Basis is GRAS just because Elysium declares it so?
Now if that's what Skadden means, then next suppose that Elysium is willing to grace the FDA and the public by filing an NDIN despite the fact that it has declared itself immune to the NDIN requirement?
This isn't a very satisfying solution to the riddle, because if Elysium really believes that it is immune to the NDIN requirement -- either because its own GRAS declaration without documentation is legally effective, or because it somehow believes that it is allowed to free-ride on ChromaDex's GRAS declaration without licensing ChromaDex's product -- then why WOULD Elysium go through the time and expense of preparing an NDIN that is not required? Just 'cause?
The Riddle of the Riddles
But what is even more unsatisfying to me is having to decode riddles at all.
I am a mere not-quite-Order-of-the-Coif attorney from a not-quite-top-ten law school -- a public school, no less! -- who could not score a job interview at Skadden Arps Slate Meagher and Flom even if I tried.
But even lowly I am WAY too smart to consider making these kinds of slippery arguments in a public legal forum.
The whole point of the superior advocacy that Skadden purports to purvey is that they can express complex ideas in compelling ways -- not that they can construct mysterious koans and riddles to be decoded by legal scholars.
A Helpful Analogy
For example, if I wanted to convey the idea that the ICH Guidelines only apply to pharmaceuticals, and Elysium Basis is not a pharmaceutical, and therefore the ICH guidelines do not apply to Elysium Basis -- Modus Ponens, that's Intro to Logic 1A! -- I would use an analogy.
Analogies are not the strongest form of argument, but they have the virtue of being really easy to understand.
So compare this situation:
Fluoride as a Tolerable Toxin
In 1945, the first US city started adding fluoride to its water to help prevent tooth decay. Seventeen years later, in 1962, the federal government provided guidance that optimal fluoride levels in drinking water were between 0.7 and 1.2 milligrams per liter.
Fifty-three years later, in 2015, the United States changed its guidance, and told cities it should be 0.7, and no higher.
That's just below one part per million.
Fluoride toothpaste contains over 1,000 parts per million, or a thousand times more fluoride than in drinking water. That's considered okay for toothpaste, because you don't drink the toothpaste; you just use a dab, and only a small portion of that dab gets inadvertently consumed.
Fluoride gels and varnishes professionally applied by dentists contain even MORE fluoride -- 5,000, 12,000, or even 22,000 parts per million. But that's considered okay, because it isn't done daily, and it is administered by a trained professional with a saliva-suction-thingy, so the risks are minimized.
So even non-lawyer humans TOTALLY GET IT that the same potentially toxic substance can have different safe exposure levels, depending on the nature and frequency of the exposure.
Moreover, safe levels may vary depending on the end-user (e.g., fluoride for pregnant women or kids is different), and, as we have seen, our best guess of safety levels may vary over time.
DSHEA
Making smart decisions about this requires a lot of science, and the science is always evolving.
And some people prefer to err on the side of safety. They might have a hunch that today's safe limits for toluene are a too generous, and may later be tightened, as they were for fluoride and for lead.
So we want our government to give it their best guess based on the most current science, but we also want to let consumers make their own decisions regarding their own health risks, which means we need transparency and disclosure.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) established the FDA's regulatory regime for food supplements, and attempts to achieve this level of transparency and disclosure by requiring suppliers of food supplements to provide public notification, testing, and disclosure for their products.
The public interest might be well-served by a regime of voluntary reporting and transparency, but only if the suppliers cooperate.
The system doesn't work if suppliers like Elysium exempt themselves from its requirements, and then obfuscate in their public statements.
THAT is what ChromaDex is complaining about in their FDA petitions.
What Elysium is free to argue (for example) is that if municipal water suppliers fluoridate at 1,000x higher than what is expected, that might still be safe, because it is well-within the accepted guidelines for fluoride levels in toothpaste, which is, admittedly, put inside people's mouths and occasionally swallowed
What Elysium does NOT get to argue is that fluoride levels appropriate for toothpaste meet the standards for fluoride levels in drinking water. They don't get to say that, because those are different standards based on different uses.
I hear Elysium making two different arguments.
The first argument I am hearing is that the ICH safe levels for toluene in pharmaceuticals provide evidence that the same amount of toluene in a food supplement should be considered safe, too. That's a good argument. It might be right. I buy it, although I know reasonable people who don't buy it.
But that isn't the ONLY argument Elysium seems to be making.
ChromaDex's primary complaint in their supplemental FDA petition, as I understand it, is not that Basis isn't safe, but that Elysium isn't playing by the same rules as everybody else -- that they haven't disclosed their manufacturing process, that they haven't tested their product for safety. It might or might not be safe, but it can't "reasonably be expected to be safe" without adquate disclosures or test data.
I don't think Elysium can have any proper response to the argument besides, "Whoops, sorry, what are the civil fines for that?"
But that's not what Elysium says. Instead, what Elysium says is that Elysium's compliance with pharmaceutical guidelines is adequate legal compliance for a seller of food supplements. That's crazy? Here is where they say that:
Foley's Response to the Original Petition
"[ChromaDex] knew or should have known that the FDA had adopted the ICH guidelines for residual solvents in pharmaceuticals, which set acceptable amounts of toluene...[ChromaDex] knew or should have known that the FDA had not prohibited the use of toluene as a residual solvent in dietary supplements."
The problematic pivot is from "adopted guidelines for pharmaceuticals" to "has not prohibited...in dietary supplements."
First, there's no explanation of how we got from pharmaceuticals to supplements.
Second, ChromaDex did not say that the use of toluene was prohibited, but that no safe level has been established (and therefore safety cannot be assumed).
Skadden's Response to the Supplemental Petition
"ChromaDex claims in the Supplemental Petition that FDA's Center for Food Safety and Applied Nutrition ("CFSAN") has 'never applied those guidelines to dietary supplements.' This is false. CFSAN regularly accepts applications from dietary supplement manufacturers that make reference to the ICH Guidelines to establish the safety of residual solvent levels in dietary supplements.
The problematic pivot here is from "applied those guidelines" to "make reference to the" guidelines.
The pharmaceutical guidelines govern pharmaceuticals, not supplements. I think that's just a true factual statement.
Elysium is trying to make the leap that since the ICH guidelines are "referenced," that they are therefore "applied," in the governing sense. It doesn't follow.
Elysium's Complaint in the SDNY
"ChromaDex misleadingly stated in its petition that FDA has not set standards allowing for the inclusion of toluene in a dietary supplement, omitting that FDA has adopted certain standards from the International Conference on Harmonisation ("ICH") for pharmaceuticals and regularly accepts submissions from dietary supplement manufacturers that apply those standards to nutritional supplements, and that the tiny amounts of toluene ChromaDex alleged to be included in Basis were well below the ICH limits for toluene. By intentionally omitting that fact, and misleadingly stating that FDA had "not set any allowed level of exposure to toluene in a dietary supplement," ChromaDex knowingly created the false impression that the small amounts of toluene it claimed to have found in Basis did not conform to any safety standard accepted by FDA.
The problematic pivot here is from "inclusion of toluene in a dietary supplement" to "did not conform to any safety standard accepted by the FDA."
As we saw with our Fluoride example, different standards have different purposes, and the fact that Elysium complies with one does not by itself establish its safety in a different context.
Moreover, if you read ChromaDex's original petition, it does NOT say that toluene "did not conform to any safety standard accepted by the FDA." That's Skadden-speak. Here is what ChromaDex actually said in the petition:
"FDA has not set any allowed level of exposure to toluene through oral ingestion of a dietary supplement. Toluene is not listed as a solvent permitted in food for human consumption."
So over and over again we see Elysium trying to build this argument that because toluene residue in pharmaceuticals is permitted, therefore it is also permitted in supplements or in food.
That's not a valid argument. The valid argument would be "Because toluene residue in pharmaceuticals is permitted, therefore it also should be considered SAFE in supplements or food."
The problem for Skadden is that that argument does not solve Elysium's legal problem, which is not that Basis is definitely unsafe, but that Elysium did not follow the rules.
So they keep making this leap from "Basis OBVIOUSLY is safe" to "therefore, Elysium must have adequately complied with the safety rules."
That's now how the law goes, though. And if it were, then Skadden wouldn't be performing verbal acrobatics and spinning us riddles. They would just say, "Here is the rule, and here is where we followed it."
But they can't.
So what is the penalty for free-riding on someone else's safety research, but without licensing the product that was shown to be safe?
I don't know what the FDA will say, but one penalty that we all suffer is that we have to read through a bunch of legal sophistry designed to bamboozle hapless judges and regulators in hopes of winning a war of attrition, in which the reader gives up or stops caring.
I am quite certain that these Skadden lawyers, except in private moments of self-doubt, actually believe that they are advancing the interests of the legal system through zealous representation.
But that's bullshit. They should be clarifying the situation, not confusing it.
Hey Skadden, if your argument is any good, how come you can't state it as clearly as I just did?