Date: Apr 20, 2005
The U.S. District Court for the District of Utah has delivered a potentially dramatic setback to the Food and Drug Administration's (FDA's) framework for regulating allegedly unsafe dietary supplements. As part a widely-publicized rulemaking action in 2004 to prohibit the marketing of dietary supplements containing ephedrine alkaloids, FDA concluded that it would balance the risks and benefits when determining whether a dietary supplement presented an "unreasonable risk of illness or injury" and thus could be prohibited from the market.
In a lawsuit brought by two manufacturers of a dietary supplement containing a low dose of ephedrine alkaloids, the District Court held, on April 13, 2005, that FDA did not have adequate scientific support to conclude that a daily dose of 10 milligrams or less of ephedrine alkaloids presented a significant or unreasonable risk of injury. The Court enjoined the Agency from taking enforcement action against the plaintiffs' product.
Far more significantly, the Court also concluded that FDA lacked the authority to impose a risk-benefit analysis for evaluating product safety and remanded the matter back to the Agency "for further rulemaking consistent with" the opinion. Although the Court's Order did not specifically address FDA's ban overall, the decision appears to completely undermine the basis on which FDA determined that ephedrine alkaloid-containing dietary supplements could be prohibited, and may very well prevent the use of this standard in the future.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which amended the Federal Food, Drug, and Cosmetic Act (FDC Act), a dietary supplement is deemed to be "adulterated" if it presents a "significant or unreasonable risk of illness or injury" under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use. FDC Act § 402(f)(1)(A). An "adulterated" dietary supplement may not be marketed. Under the statute, FDA bears the entire burden of proving that the "significant or unreasonable risk" standard has been met.
FDA used this authority for the first (and so far, only) time in 2004, when it issued a final regulation concluding that dietary supplements containing ephedrine alkaloids are "adulterated" under the FDC Act, prohibiting their sale effective April 12, 2004. 69 Fed. Reg. 6788 (Feb. 11, 2004). In the rule, FDA evaluated whether these products presented an "unreasonable" risk to health under their conditions of use and did not consider whether the "significant" risk prong was satisfied. After an analysis of the legal meaning of the criterion, FDA concluded that the assessment of an "unreasonable risk" required a weighing of a product's known and reasonably likely risks against its known and reasonably likely benefits. The Agency concluded that its burden of proof for establishing an "unreasonable risk" was satisfied when a product's risks outweighed its benefits in view of the product's use.
Under FDA's interpretation of this standard, there is no requirement that there be proof that the product in question has actually caused harm to particular individuals. Rather, the Agency asserted that there only needs to be sufficient evidence to support the existence of sufficient risk. As a result, FDA found that all dietary supplements containing any amount of ephedrine alkaloids were adulterated and prohibited from sale.
Shortly after FDA's rule went into effect, two companies filed a lawsuit in Federal court in Utah challenging the Agency's conclusion that a risk-benefit assessment was appropriate to determine whether a dietary supplement presented an "unreasonable" risk. In addition, the plaintiffs challenged FDA's determination that ephedrine alkaloids, regardless of how small the dose, met this standard. Nutraceutical Corp. and Solaray, Inc., v. Crawford, et al., Case No. 2:04CV409 TC (D. Utah) (filed May 3, 2004). On April 13, 2005, the Utah District Court granted the plaintiffs' motion for summary judgment on both issues. As a result, the plaintiffs are allowed to market their product containing a daily dose of 10 milligrams or less of ephedrine alkaloids.
By far, the more significant part of the decision is the conclusion that FDA's risk-benefit assessment is improper. FDA had justified this decision, in part, by reference to the interpretation of "unreasonable risk" under the medical device provisions of the FDC Act, along with similar language in the Toxic Substances Control Act (TSCA) (administered by the Environmental Protection Agency ). The Court rejected this comparison, noting that the medical device statutory provisions specifically require "weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use." FDC Act § 513(a)(2)(C). There is no such requirement for dietary supplements. Indeed, for nearly all purposes, a dietary supplement is deemed to be a "food" and, the Court noted, food manufacturers are not required to demonstrate that their products have a "benefit."
Thus, the Court concluded that FDA exceeded its statutory authority by defining "unreasonable" to entail a risk-benefit analysis. In addition, the Court determined that the standard effectively imposed a requirement that the proponent of a dietary supplement demonstrate a benefit for the product, which was inconsistent with the statutory requirement that FDA "shall bear the burden of proof on each element to show that a dietary supplement is adulterated." FDC Act § 402(f)(1).
The Court did not discuss what would be an appropriate definition of "unreasonable," but remanded the matter back to FDA "for further rulemaking consistent with" the conclusions of the opinion. Interestingly, the Court's Order does not specifically state that FDA's February 11, 2004, regulation was invalid, although that would appear to be the clear intent of the opinion.
For further information about this issue or FDA's regulation of dietary supplements generally, please contact Frederick A. Stearns at 202-434-4288 or via e-mail at firstname.lastname@example.org.