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FDA’s Unbridled Discretion Over Supplement Adulteration

If you ask a consumer what makes a dietary supplement adulterated, he or she will say that it contains an ingredient or contaminant that makes it unfit for human consumption.  That is, of course, the logical and historically plain meaning of the term adulteration, but that is not the meaning of adulteration FDA gives to the term.  Indeed, a dietary supplement that is perfectly free of contaminants and is health enhancing may nevertheless be deemed adulterated by the FDA.

Under 21 USC 342, a dietary supplement can be deemed adulterated in the discretion of the FDA if it is not made in compliance with the Good Manufacturing Practice guidelines of the FDA.  That is true, according to FDA’s interpretation, even if the dietary supplement is in fact perfectly safe, even health enhancing, to consume.  In short, if, say, a dietary supplement manufacturer failed to create a master manufacturing record or failed to date and sign a disposition decision concerning a non-conforming batch or lot that was in fact destroyed.  Those acts violate the GMPs for supplements.  Even if they had no effect whatsoever on the dietary supplements, even if the finished dietary supplements are entirely safe to consume, by operation of law they are adulterated and unlawful to sell.

Moreover, by interpretation, FDA has succeeded in achieving Court acquiescence to a definition of adulteration, apart from its power under the GMP section of the Act, to declare any ingredient adulterated entirely within its subjective discretion.  In the Nutraceutical Corporation v. Von Eschenbach case, our firm argued on behalf of Nutraceutical Corporation that FDA’s ban on ephedrine-alkaloid containing dietary supplements violated the plain and intended meaning of 21 USC 342(f)(1), which provides that FDA bears the burden of establishing adulteration on proof that “a dietary supplement . . . presents a significant or unreasonable risk or illness or injury under . . . conditions of use recommended or suggested in labeling . . .”  Nutraceutical Corporation’s natural herbal ephedrine containing dietary supplement contained 10 mg or less of ephedrine alkaloids per daily dose.  The FDA’s scientific record underlying its total ban on the substances included no evidence that daily dose amounts of that quantity had any of the adverse cardiovascular effects that it deemed sufficient to ban the substance.  The United States District Court for the District of Utah agreed with us and interpreted the statutory section in accordance with congressional intent.  A political brouhaha followed with members of Congress decrying the decision, misinterpreting it to mean that all ephedra had been allowed back on the market.  The Court of Appeals reversed.  In doing so it ruled that FDA may ban a dietary ingredient from the market based on a finding that it presents an unreasonable risk even if it did not show the risk to be significant.  Moreover, the Tenth Circuit adhered to a doctrine of deference so profound that it in effect gives FDA the power to ban an entire ingredient from the market on proof that at some dose level the ingredient causes injury without requiring the agency to prove that at every dose level it causes injury.

The problem with that notion is that it creates a distinction without a difference in the law.  It is equally true of every nutrient that at some dose level the nutrient will cause injury.  To permit a blanket ban on that proof thus renders no ingredient safe from the discretionary proscriptions of the FDA.  Under the Tenth Circuit ruling in Nutraceutical Corporation, the FDA can remove anything from the market at its whim, including Vitamin C, because proof can be found that at some extreme dose level even Vitamin C can cause injury.

As the law presently stands, FDA can declare any company guilty of adulteration if it fails to satisfy the Good Manufacturing Practice guidelines for dietary supplements, even if the violation is one of record keeping without any proof that a finished product is unsafe.  Likewise FDA can ban nutrients from the market at every dose level solely on the argument that at some dose level those nutrients present a significant or unreasonable risk of illness or injury.  Needless to say, the law must be changed to deny FDA this enormous discretionary power beyond the limits of reason.  It must be changed either through further judicial construction or through an Act of Congress.

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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