On Aug. 17, 2006, the U.S. Court of Appeals for the 10th Circuit ruled on Nutraceutical Corp. v. Von Eschenbach to uphold the Food and Drug Administrations (FDA) complete ban on ephedra dietary supplements, reversing a lower court ruling. The lower court held that FDA exceeded its authority under the Dietary Supplement Health and Education Act (DSHEA) when it concluded the use of ephedra presented an unreasonable risk to consumers, because the risks associated with its use outweighed any health benefits that the herb might provide. The lower court had also specifically rejected FDAs ban on low dose ephedra supplements. Thus, the 10th Circuit Courts reversalcoupled with a similar ruling by the 3rd Circuit in NVE Inc. v. HHShas the potential to strip away many of the protections the dietary supplement industry believed were bestowed upon it by DSHEA.
A review of the 10th Circuits well-reasoned 23-page decision makes it abundantly clear that the industry effort to attack FDAs ephedra rulemaking process (and any subsequent similar undertakings by the agency) was undermined by DSHEA itself. As originally passed by the Senate, the portion of DSHEA governing FDAs ability to remove unsafe supplements from the market read: [A food shall be deemed adulterated] if it is a dietary supplement that (1) the Secretary finds, after rule making, presents a substantial and unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling [emphasis added].
As part of the final compromise that allowed DSHEA to come to the floor of the House of Representatives, Rep. Henry Waxman (DCalif.), a long time opponent of the supplement industry, insisted on changing this language. Thus, the bill that was eventually enacted provides: [A food shall be deemed adulterated] if it is a dietary supplement that (1) presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling [emphasis added].
The importance of this change is amply demonstrated by the 10th Circuits statement that a plain reading of [DSHEA] directs FDA to restrict distribution of dietary supplements which pose any risk [emphasis added] that is unreasonable in light of its potential benefits. The court supported this conclusion by noting the term unreasonable risk is utilized with the identical meaning in other parts of the statute. It further explained that if Congress had intended otherwise, it would have imposed a standard other than simply unreasonable essentially what the Senates version did .
The effect of the small change that Rep.Waxman insisted upon now appears monumental. Consider that under the Senate version of the bill, FDA would have been required not only to demonstrate that the risk associated with a supplements use outweighed its benefits, but that the risk was also substantial. Websters Dictionary defines substantial as something that is not imaginary or illusory, considerable in quantity: significantly great. Thus, even if FDA had concluded there was some minimal risk of an adverse event associated with the use of ephedra, it would also need to demonstrate that the risk was not hypothetical (as with low dose ephedra), but of such quantity as to require regulatory action.
Because of Waxmans small alteration, the supplement industry finds itself in a position where FDAan agency with a well documented, long standing record of obstinate refusal to acknowledge the benefits of dietary supplementshas the power to remove any supplement from the market it believes poses any risk it finds to be unreasonable when compared to its potential benefits. When FDA refuses to acknowledge that a supplement has any benefit, any risk whatsoever becomes unreasonable. The reality of this threat has been amply demonstrated by the agencys ephedra regulation, and there appears to be nothing to prevent FDA from removing any other product from the market in light of potential health risks posed by supplements, whose benefits FDA will never acknowledge.
Should FDA ever rouse itself from the comatose state it seems to have entered concerning its oversight of the supplement industry and utilize this vast grant of powers bestowed upon it by DSHEAand reaffirmed by the 10th Circuitit will certainly seem that Rep. Waxman succeeded in neutralizing much of the intent of DSHEA and will get the last laugh on us all.
Marc Ullman is a partner with the Ullman, Shapiro & Ullman law firm.