Nutraceutical Corporation v. Lester Crawford, D.V.M., et al., Case No. 2:04CV409TC, U.S. District Court for the Central District of Utah
One year and one day after the Food and Drug Administration (“FDA”) implemented its Final Rule banning the sale of all ephedrine-alkaloid dietary supplements (“EDS”), a U.S. District Court has determined that the Final Rule is invalid. Dietary supplement companies should not rejoice just yet, however, without a more complete understanding of the impact and scope of the court’s decision.
Plaintiff Nutraceutical sold a product containing 375 mg of Ephedra sinica, and the label recommended taking one capsule no more than twice per day. The recommended dose of the product yielded less than 10 mg of ephedrine alkaloids per day. The Final Rule prohibited Nutraceutical from marketing or selling the product by declaring that all EDS, regardless of dosage, are adulterated and present an unreasonable risk of illness or injury.
Nutraceutical brought an action against the FDA, among other defendants, challenging the validity of the Final Rule as inconsistent with the Food, Drug and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act (“DSHEA”). The court granted summary judgment to Nutraceutical and denied the FDA’s cross-motion for summary judgment, after considering the following questions:
• Whether the FDA’s use of a risk-benefit analysis is appropriate under DSHEA; and
• Whether the FDA has provided sufficient evidence to support the conclusion that EDS containing 10 mg or less per day of ephedrine alkaloids pose a significant or unreasonable risk of illness or injury.
In response to the first question, the court explained that under DSHEA, a dietary supplement—as with any food—is presumed to be safe. Food producers are not required to establish a benefit before selling their products. The court determined that the imposition of a risk-benefit analysis improperly required sellers of EDS to establish a benefit and unfairly alleviated the burden Congress placed squarely on the government to demonstrate the existence of a significant or unreasonable risk.
With respect to the second question, the court first explained that the government has the burden to establish that EDS pose a significant or unreasonable risk of illness or injury by a preponderance of the evidence. Therefore, to declare all EDS adulterated, the FDA must prove that any dose amount, no matter how small, presents an unreasonable risk. After considering the evidence presented, the court determined that the FDA failed to prove that the risks identified by the FDA are associated with the intake of low-dose EDS.
The court ordered that the FDA conduct further rulemaking consistent with the court’s direction and enjoined the FDA from taking any enforcement action against Nutraceutical for their sale of a dietary supplement containing 10 mg or less of ephedrine alkaloids per daily dose.
What happens next?
Companies considering launching new EDS products should do so with caution. It is very likely that the FDA will appeal this decision. Further, the decision only covers EDS products that contain 10 mg or less of ephedrine alkaloids per daily dose—a much lower dosage than previously used in many weight loss products. They should also consider the fact that EDS products are still unlawful in certain states that have banned the ingredient (e.g., California, Illinois and New York). However, the decision nonetheless marks a significant victory for dietary supplement companies concerned about how courts will construe DSHEA. It demonstrates that the FDA will have to demonstrate, by a preponderance of the evidence, that dietary supplements present an unreasonable risk of illness or injury to justify a ban and that sellers of EDS are not required to establish a benefit prior to sale.
Blair Connelly, Esq. is a Partner resident in the New York office of Latham & Watkins LLP, a global litigation firm with over 1,600 attorneys in 21 offices around the world. Mr. Connelly has extensive experience in dietary supplement litigation, and has served as National Coordinating Counsel for lawsuits against Weider Nutrition International, Inc. involving products that contain the herb ephedra. Mr. Connelly participated in Weider’s successful defense in Garrett v. Weider, a product liability case involving Weider’s "Ripped Force" product. This was only the second case involving ephedra to go to trial in the United States, and the first successful verdict for a manufacturer. Mr. Connelly can be reached at (212) 906-1658.
Shane H. Freedman, Esq. is a senior associate in the firm’s New Jersey office. Mr. Freedman previously served as General Counsel to Nutraquest, Inc., makers of Xenadrine RFA-1. He has been quoted extensively in national publications such as USA Today, Newsweek and Forbes relating to dietary supplement issues. Recently, he was a speaker at the Ninth Annual Program on Advanced Issues in Drug and Medical Device Litigation. He is scheduled to speak at the World Obesity & Weight Loss Congress, September 13-14, 2005 and at the International Conference & Exhibition on Nutraceuticals and Functional Foods, October 16-19, 2005. Mr. Freedman can be reached at (973) 639-7532.