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The Uncoupling of Injury from Adulteration

The pyridoxamine example, well explained by Bethany in her blog post, proves the inherent pitfalls in 21 USC 321(ff)(3)(A)-(B).  As we have seen, the new interpretation given by FDA to the term “New Dietary Ingredient,” the FDA’s redefinition of adulteration standards through its Good Manufacturing Practice Guidelines, and the changes effected by the Food Safety Modernization Act in pre-existing adulteration standards (see Peter Arhangelsky’s excellent blog post on that) have had the Orwellian effect of uncoupling injury from the legal definition of adulteration.

Viewed correctly, in law and logic, there is a legitimate role for FDA in removing from the market finished products, foods and supplements, that present an imminent risk to public health due to the presence of contaminants.  As government moves away from a focus on case by case enforcement against those whose products actually cause injury to the adoption of prior restraint, it invariably abuses power.

The first iteration of this movement exists in the DSHEA adulteration provision in which “risk” of illness or injury is deemed adulteration, without need for causal proof that, in fact, the finished product is injurious.   The second, more attenuated, iteration of this movement exists in the form of FDA’s ephedrine alkaloid ban, wherein FDA banned ephedrine alkaloids at all dose levels despite the fact that its evidence only showed a risk of injury at levels in excess of 23 mg per day.  Moreover, that dose-independent general ban was given legal affirmation in the Tenth Circuit decision reversing the U.S. District Court (Utah) decision (which latter decision correctly held the ban unlawful), wherein the Tenth Circuit held that FDA could deem a supplement adulterated if FDA determined it to present an “unreasonable risk” of illness or injury without any necessity to prove a “significant” risk, thus reading the statutory provision on point to result in a gross deference to FDA wherein any supplement could be removed from the market upon assertion of the truism that at some dose level it could cause injury. The third, even more attenuated, iteration of this movement exists in the cGMP regulations where “adulteration” can be declared based not on evidence that a finished product is unsafe, or even on evidence that at some dose level injury will occur, but solely on, e.g., inadequate recordation (missing SOPs, insufficiently detailed master manufacturing record, lacked of finished product testing, etc.).  The fourth, most recent iteration of this movement, now underway pursuant to the Food Safety Modernization Act, permits a finding of adulteration upon a conclusion by FDA that a risk to public health from any nutrient is possible or probable, permitting an entirely hypothesized construct to support summary removal from the market without even so much as a need to present proof of a contaminated finished product, evidence of harm at some dose level, or a failure of record keeping.

The FDA’s evolutionary uncoupling of injury from adulteration is the most formidable for this agency to assert virtually unbridled discretion over what dietary supplements may be sold in the market.  It humbles to servitude all market players and elevates to imperial status the power of the FDA.  FDA has achieved through incremental assumptions of power over “safety,” with the assistance of complicit members of Congress, a complete reversal of a pre-existing burden of proof and scientific standard.  It has gained power and market control through this route what it failed miserably to gain through decades of attempting to reclassify supplements above RDI levels as drugs; to set maximum threshold levels for RDI ingredients; and to reclassify supplements as food additives.  It has become FDA’s key means to tame the supplement market, humble it, and make it subservient to FDA wishes.

Twenty years ago, FDA could not act to take a dietary supplement off the market unless it could prove that the supplement presented a significant or unreasonable risk of illness or injury at the dose level indicated and, even then, would act case by case rather than through some categorical ban (like the ephedrine alkaloid ban).  Today, FDA can take any dietary supplement or category of supplements off the market if the FDA summarily concludes there to be a potential to cause injury (including, based on the fact that the supplement (as in all things ingestible) could cause injury at some dose level; it was made by a company that did not satisfy GMP record keeping requirements; or it is a supplement that FDA believes could possibly cause injury to some segment of the population (e.g., again as in all things ingestible, it may cause an allergic reaction)).  There is in this no need to prove any finished product injurious and no limit to government power; it is unbridled discretion.  It means that no one who makes or distributes a dietary supplement can rest assured that a safe product is free from summary removal from the market by the FDA, according to that agency’s whim or caprice.

As an aside, while supplements are now in this precarious state, drugs may only be removed from the market following detailed evidentiary review and conclusions concerning risks and, even then, as we know from history, FDA ordinarily allows drugs that cause even extraordinary injury (like Vioxx) to remain on the market despite tens of thousands of deaths and serious injuries.

The FDA’s successful strategy of uncoupling injury from adulteration arises simultaneous with a shift in the burden of proof and a change in scientific standards.  For centuries the Paracelsian principle governed adulteration science and underpinned adulteration law.  Under that principle everything is understood to be toxic at some dose level and adulteration occurs at the provably harmful dose.  Consistent with that principle, the burden of proof in the law was against government intervention unless and until the government could prove that injury was likely to occur at the dose level sold.  In the last few decades, advocates of greater state control over food and supplement markets, particularly in Europe but now very much so at FDA, have caused the Paracelsian principle to be replaced with the precautionary principle.  Under the precautionary principle, a substance can be banned outright if at some dose level injury may occur (the ephedrine alkaloid ban, e.g.).  Since it is a truism, true of every substance including water, that at some dose level the substance will cause injury, reliance on the precautionary principle justifies removal of everything from the market.  Consistent with the principle, the burden of proof is shifted from the government to the maker of the food or supplement.  In other words, the food or supplement is presumptively unlawful to sell unless the manufacturer can prove it free of risk of injury at the dose level sold.  Because nothing can be proven completely risk free (allergy, for example, is a ubiquitous risk), if government wishes to remove a substance under this concept, it may (resulting in complete, unbridled government discretion over what foods and supplements may be sold in the market).

That unhappy state, where FDA can, based on a whim or caprice, remove any dietary supplement it wishes from the market has become our horrific reality.

Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.

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