The US Supreme Court announced on May 14, 2007, that it would not consider an appeal by the company Nutraceutical Corporation, which sought to challenge a 2006 ruling by a federal appeals court upholding the US Food and Drug Administration’s (FDA) ban of the controversial herb ephedra (Ephedra sinica, Ephedraceae) from dietary supplements.1,2 According to Nutraceutical’s legal counsel, Jonathan Emord, the court’s refusal to hear the appeal ends the present litigation but does not foreclose the company from bringing new challenges to the ban either by petitioning for rulemaking or by raising new issues in the enforcement context (e-mail, June 4, 2007).
Nutraceutical Corporation and its wholly owned subsidiary Solaray® first brought a legal challenge against the FDA in May 2004, a month after an FDA regulation went into effect banning ephedrine alkaloids at every dose level from dietary supplements, but allowing ephedrine alkaloids to be sold in foods in common form (ephedra teas), in traditional Asian medicines, and in over-the-counter drugs.3,4 Prior to the regulation, extracts of ephedra were common ingredients of dietary supplements marketed for performance enhancement or weight-loss, including a supplement produced and marketed by Solaray that contained a low dose (less than 10 mg per day) of ephedrine alkaloids.4 The ban was largely inspired by the high profile deaths of several sports figures who used ephedra, albeit direct causality between the deaths and the use of ephedra was alleged but never established.
Nutraceutical challenged the FDA’s use of a risk/benefit comparison extrapolated from the agency’s new drug approval standard in determining an “unreasonable risk” of ephedra, as well as the regulation’s ban on low-dose ephedra products. The US District Court for the District of Utah ruled in favor of Nutraceutical on both issues in April 2005. A 3-judge panel of the 10th Circuit US Court of Appeals, however, overturned those rulings in August 2006, siding with the FDA. Nutraceutical then approached the US Supreme Court, which recently denied its request for an appeal.
“I was not surprised by the [Supreme Court] decision because so few petitions for certiorari* are granted each term,” said Emord. “The Court’s denial of a petition for certiorari is not a decision on the merits of the appeal. It does not affirm or deny the 10th Circuit decision, albeit the effect of not hearing the case is to leave in place the 10th Circuit decision.”
“Many people do not realize that we also pursued a case on remand before the US District Court in Utah while the appeal to the Supreme Court was pending,” he continued. “In that case, the judge ruled that FDA’s ‘risk-benefit comparison’ standard applied only to ephedrine alkaloids. The FDA did not appeal that decision and neither did we. While the decision upheld the regulation, it severely truncated it, effectively achieving a major Nutraceutical Corp. goal. Nutraceutical’s primary objective in filing suit was to prevent FDA from reinterpreting the Dietary Supplement Health and Education Act (DSHEA) adulteration provision in a way that imposed a proof of benefit requirement on all dietary ingredients and removed the well-established dose dependency principle from adulteration law. The second decision by the district court holding the FDA Final Rule to apply only to ephedrine alkaloids and not to dietary supplements in general achieved that primary objective.”
In the 2006 article, “Appeals Court Sides with FDA in Ephedra Ban Case,” published in HerbalGram issue 72, Emord stated that the FDA’s ban of ephedra, if upheld by the federal courts system, could have negative ramifications for the entire supplement industry.4 He argued that the FDA banned ephedra at every dose level—even down to a molecule—without any scientific evidence of harm below 20 mg per daily dose. FDA failed to establish a precise dose at which toxicity arises. Moreover, Nutraceutical criticized the FDA’s unprecedented use of a drug risk-benefit comparison, by which the FDA held that any evidence of even an infinitesimal risk at some dietary supplement dose level constituted proof of adulteration at all dose levels (unless the industry could prove based on generally accepted scientific evidence a substantial health benefit to FDA’s satisfaction). Such measures and procedures were not authorized under DSHEA.
The Natural Products Association (NPA, formerly the National Nutritional Foods Association), a trade association representing the natural foods industry, filed an amicus brief with the Supreme Court on April 6 in support of Nutraceutical’s appeal.5 In its brief, the association argued that the failure to overturn the federal court ruling could cause the distinction between dietary supplements and drugs to “effectively evaporate” and force dietary supplement producers to conduct the same rigorous clinical tests required of the pharmaceutical industry. In a press release, NPA’s Executive Director and CEO David Seckman stated, “We’re not arguing with the decision, we’re arguing that FDA used the wrong legal route to get there. And unless the court gets this right, there could be huge consequences for consumers, retailers, and manufacturers of dietary supplements.”5
According to Emord, although the 10th Circuit Court upheld the FDA’s reinterpretation of the dietary supplement adulteration provision and the US Supreme Court denied Nutraceutical’s appeal, the recent ruling of the Utah district court has truncated the scope and effect of the FDA’s Final Rule by declaring that rule only applies to ephedrine alkaloids and not to dietary supplements in general. “As the law now stands, FDA may be loathe to extend the risk-benefit comparison to other supplements,” explained Emord. “If it makes that move, it would face a legal challenge based in part on that second Utah district court decision. Without FDA undertaking a new rulemaking, the Utah District Court decision stands in the way of an immediate application of the risk-benefit comparison to another dietary ingredient.”
- Associated Press. Supreme Court turns down appeal of FDA ban on ephedra. Boston Herald.com. May 14, 2007. Available at: http://business. bostonherald.com/businessNews/view.bg?articleid=1001189. Accessed May 22, 2007.
- Supreme Court denies ephedra appeal. NutraIngredients.com. May 15, 2007. Available at: http://www.nutraingredients-usa.com/news/ng.asp?n=76556nutraceutical-corporation-fda-ephedra. Accessed May 22, 2007.
- US Food and Drug Administration. Final rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk; final rule. 69 Federal Register 6787 (2004) (codified at 21 CFR § 119).
- Hollern M, Cavaliere C. Appeals court sides with FDA in ephedra ban case. HerbalGram. 2006;No. 72:55.
- Natural Products Association urges Supreme Court to clarify standard for banning dietary supplements [press release]. Washington DC: Natural Products Association; April 6, 2007.
* Certiorari—a Latin word meaning “to be informed of, or to be made certain in regard to”—is a term used by the US Supreme Court in the context of appeals. A party submits a “petition for certiorari” to the Supreme Court to ask for its review of a decision from a lower court.