Eleventh Circuit Defers to FDA Rule Findings
 
November 10, 2008
 
Matthew Singer - Chicago

Recently, the Eleventh Circuit held that in an action to enforce a ban on the sale and distribution of dietary supplements containing ephedrine alkaloids (“ephedrine”), the FDA may rely upon its own rule as sufficient evidence that ephedrine is dangerous. Hi-Tech Pharmaceuticals, Inc. v. Crawford, Nos. 07-14309, 07-14312, 2008 WL 4479714 (Oct. 7, 2008). In other words, in the event that an existing FDA regulation or rule labels a product as dangerous, a court need not conduct its own investigation into the product. Instead, the court can defer to the FDA’s independent weighing and evaluation of evidence of a product’s potential dangers.

Background

In February 2004, the FDA issued a rule entitled “Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloid Adulterated Because They Present an Unreasonable Risk” (the “Rule”) that banned the sale and distribution of dietary supplements containing ephedrine.¹ Hi-Tech Pharms., Inc., 2008 WL 4479714 at *1. In the Rule, the FDA held that ephedrine is an “adulterated” product, in that it “presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling.” Id. The FDA issued the Rule after six-and-a-half years of investigation and consideration of various comments and evidence regarding the potential dangers of ephedrine. Id.

Despite the Rule’s enactment, Hi-Tech Pharmaceuticals continued to manufacture and distribute dietary supplements containing ephedrine. Id. In February 2006, U.S. marshals raided Hi-Tech and seized various dietary supplement products and ingredients containing ephedrine. Id. The government seized these products since their manufacture and distribution violated the express terms of the Rule.

After the seizure, Hi-Tech filed a declaratory relief action seeking return of the dietary products seized by the government. Id. at *2. Meanwhile, the government filed a separate action for forfeiture of the products seized. Id. The forfeiture action was based upon the Rule banning ephedrine-containing dietary products.² Id. The district court consolidated both the declaratory relief and the forfeiture actions. Id.

Both Hi-Tech and the government filed motions for summary judgment. Id. The district court denied Hi-Tech’s summary judgment motion and granted the government’s summary judgment motion. Among other things, the court held that the enactment of the Rule by the FDA qualifies as sufficient evidence that ephedrine is adulterated. Id. Hi-Tech appealed the decision.³ Id.

FDA Rule Satisfies Evidentiary Burden

In its appeal, Hi-Tech argued that the government may not rely upon its own rule to satisfy its evidentiary burden. Id. Specifically, Hi-Tech argued that an enforcement action under the FDCA requires the government to present new or additional evidence of a supplement’s dangers, and the Court must weigh this evidence de novo. Id. In turn, the court must find, after its own independent weighing of the evidence, that the government has established by a preponderance of the evidence that a product is adulterated. Hi-Tech argued that without this additional evidence, the government has not satisfied its burden and, therefore, Hi-Tech is entitled to the return of the seized products. In support of its position, Hi-Tech pointed to specific language in the FDCA which does mention “de novo”: “In any proceeding under [21 U.S.C. § 342(f)(1)], the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.” Id.

As a matter of first impression, the Eleventh Circuit examined the legislative history of the FDCA and concluded that the government must establish a product is adulterated by a preponderance of the evidence. Id. at *3. But the Court noted that the FDCA “empowers the FDA to settle the issue of adulteration through rulemaking and that additional proof to a court will not be necessary.” Id. Moreover, rules and regulations of the FDA, “have [the] force and effect of law,” and therefore, “violation of such regulations may ‘carry heavy criminal and civil sanction’, such as forfeiture.” Id. (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 151-53 (1967)). Therefore, the government may rely upon its findings in a regulation, which were conducted after extensive investigation, to satisfy this burden. Id. Because of the existence of the Rule, the government only need present evidence that “(1) the regulation exists and (2) it applies to the product that is the subject of the enforcement action.” Id. Since the government, in Hi-Tech, presented evidence that the Rule exists and it applies to the product at issue, summary judgment was appropriate.

For more information, contact:

Matt F. Singer
312.578.6645
matthew.singer@hklaw.com
toll free: 1.888.688.8500

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1 The FDA issued the Rule in accordance with the Dietary Supplement Health Education Act of 1994, which amended the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C § 301 et al. Id.

2 Rules and regulations of the FDA, “have [the] force and effect of law,” and therefore, “violation of such regulations may ‘carry heavy criminal and civil sanction’, such as forfeiture.” Id. (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 151-53 (1967)).

3 The full procedural history and lower court arguments are contained in
Hi-Tech Pharms., Inc. v. Crawford, 505 F. Supp. 2d 1341 (N.D. Ga. 2007).