HerbalEGram: Volume 3

A three-judge panel of the 10^th Circuit U.S. Court of Appeals ruled in favor of the U.S. Food and Drug Administration (FDA) on August 17, 2006, in a case that had challenged the FDA's 2004 complete ban of ephedrine alkaloids in dietary supplements.¹
 
The Nutraceutical Corporation and its brand Solaray® brought a legal challenge against the FDA in May of 2004, a month after an FDA regulation banning ephedrine alkaloids at any level from dietary supplements went into effect.^2,3 Prior to that regulation, extracts of ephedra (Ephedra sincica Stapf, Ephedraceae) were common ingredients of several weight-loss products, including a dietary supplement produced and marketed by Solaray.² Nutraceutical Corp. challenged both the FDA’s use of a risk/benefit analysis in determining an “unreasonable risk” of ephedra, as well as the regulation’s ban on low dose ephedra products. Solaray’s dietary supplement was marketed as delivering less than 10 mg per day of ephedrine alkaloids. The U.S. District Court for the District of Utah ruled in favor of Nutraceutical Corp. on both of these causes of action in April of 2005, and these rulings have now been overturned by the Court of Appeals.
 
“If the 10^th Circuit decision remains unchanged, it bodes ill for the entire industry,” wrote Jonathan Emord, counsel to Nutraceutical Corp., regarding the decision (e-mail to C. Cavaliere, September 5, 2006). “It stands for the proposition that the new drug risk (safety)-benefit (efficacy) comparison may be adopted by FDA in the Food Adulteration context. That move is unprecedented and enables FDA to avoid the more rigorous precedent that has since the turn of the twentieth century compelled FDA to prove a risk of illness or injury under conditions of actual use, rather than on general pharmacologic principles and in reliance on hypothetical models.” According to Emord, FDA had no direct evidence that supplements containing low doses of ephedrine alkaloids presented any risk of illness or injury, and FDA officials instead paid an expert to extrapolate data from studies concerning the effects of the drugs epinephrine and ephedrine and apply them to the context of ephedrine alkaloid supplements. “Never before in the history of the Food Adulteration provision had FDA been allowed by a federal court the discretion to ban a dietary supplement outright based on indirect evidence and no establishment of a precise dose at which toxicity arises,” Emord wrote.
 
The FDA’s use of a risk-benefit assessment against ephedra also shows that the agency can strengthen its case against a product by declaring the product’s benefits as non-significant.⁴ For instance, FDA did not consider weight loss a significant benefit of ephedra. “FDA refused, in its rulemaking process, to acknowledge any benefits for ephedra, even for traditional uses,” stated Michael McGuffin, president of the American Herbal Products Association (AHPA) in an AHPA press release.² “If the benefit side is judged as ‘zero,’ the outcome of any risk/benefit analysis will necessarily be skewed. But this court has now specifically stated that FDA’s risk/benefit mechanism ‘correctly followed the congressional directive,’ and industry will need to evaluate the implications of this as precedent.”
 
According to Emord, Nutraceutical Corp. will file a petition for rehearing in front of the entire 10^th Circuit Court of Appeals at the end of September. If denied, the corporation will petition for a writ of certiorari from the Supreme Court. “To be sure, it is never easy to defeat the FDA, but if the rule of law is to have true meaning, and if the will of Congress and the rights of the regulated class are to be respected, we have no choice but to defeat the FDA,” wrote Emord. “Oftentimes necessity is the mother of invention. I do hope for the industry and for the rules of law that we prevail over this injustice.”
 
The 2004 ban of ephedra, which attracted much media attention, was the first time the FDA had removed a popular dietary supplement from the market under the provisions of the Dietary Supplement Health and Education Act (DSHEA) of 1994.⁵ The FDA ban was largely inspired by the high profile deaths of several sports figures who used the supplement, and it was preceded by ephedra bans within certain states and by various sports organizations. Nutraceutical Corp. earlier explained that its lawsuit against FDA was filed in an attempt to deter arbitrary rules by the FDA that could cause problems for the entire supplement industry, not to reinstate sales of ephedra supplements.⁶ The District Court of Utah’s 2005 ruling in favor of Nutraceutical Corp. determined that FDA’s use of a risk-benefit analysis was against the intent of Congress in passing the Food, Drug and Cosmetic Act, and that the FDA should first prove the dosage amount in a product that presents an unreasonable risk. That court’s decision only lifted the ban of products containing 10 mg or less of ephedrine alkaloids per daily dosage and did not have any effect in certain states. FDA recently released an updated warning against ephedra through its safety information and adverse event reporting program MedWatch, declaring it illegal to market dietary supplements with ephedrine alkaloids and stating that, “Dietary supplements containing ephedrine alkaloids, regardless of the dosage, are considered adulterated and pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure.”⁷

-Madeline Hollern and Courtney Cavaliere

References

1. Nutraceutical Corp v Von Eschenbach, No. 05-4151, 2006 WL 2374338 (10th Cir. Aug. 17, 2006). Available at: http://www.ck10.uscourts.gov/opinions/05/05-4151.pdf. Accessed September 5, 2006.
2. Appeals Court Rules for FDA in Ephedra Ban: Overturns Lower Court Finding in Nutraceutical v. von Eschenbach [press release]. Silver Spring: American Herbal Products Association; August 18, 2006.
3. U.S. 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).
4. Court backs FDA’s ephedra ban, risk-benefit ruling. Natural Product’s Insider; August 18, 2006. Available at http://www.naturalproductsinsider.com/hotnews/68h1816426.html. Accessed September 6, 2006.
5. Blumenthal M. FDA announces ban on ephedra supplements: Federal move follows bans by California, Illinois and New York. HerbalGram. 2004;61:64-65.
6. Amin RM, Blumenthal M. Federal court overturns FDA ban on ephedra at low doses. HerbalEGram. May 2005;2(2). Available at: http://www.herbalgram.org/default.asp?c=FDAephedra. Accessed September 6, 2006.
7. Dietary Supplements Containing Ephedrine Alkaloids. U.S. Food and Drug Administration MedWatch Web site. Posted August 22, 2006. Available at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Ephedrine. Accessed September 6, 2006.