Catch-22? Supplements May Be Trapped By FDA’s Risk/Benefit Standard
This article was originally published in The Tan Sheet
Executive Summary
Some legal experts contend that a glass ceiling built into FDA's risk/benefit analysis of dietary supplements could leave certain products more vulnerable to regulatory scrutiny in the wake of the agency's outright ban of ephedra
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Some legal experts contend that a glass ceiling built into FDA's risk/benefit analysis of dietary supplements could leave certain products more vulnerable to regulatory scrutiny in the wake of the agency's outright ban of ephedra. In its final rule on the ban, FDA describes a regulatory framework for determining a product's "unreasonable risk" that involves weighing the benefit of a supplement against its risks (1 (Also see "DSHEA “Unreasonable Risk” Standard Does Not Require Proof Of Harm – FDA" - Pink Sheet, 9 Feb, 2004.), p. 9). Because dietary supplements may not claim to diagnose, treat or cure disease, the best defense of benefit for many supplements rests on a product's strongest allowable structure/function claim, according to an industry attorney. If labeling were to claim greater benefits, the product would be regulated as a drug and must either conform to an OTC monograph or have been the subject of a new drug application. The attorney cited kava supplements as an example, noting the products may claim to be useful for relaxing and may have calming effects, but manufacturers may not make sedative claims, despite the fact that the effects of kava may be similar to those of a sedative. If the benefit of a supplement is perceived as relatively low, that would put the product at a disadvantage when evaluating risk. Such concerns would appear to apply to products, such as botanicals, that may elicit perceptible biological effects but have not been subjected to extensive clinical research on safety and effectiveness. A more obvious example may be stimulants like bitter orange, which has been the subject of recent Congressional letters to FDA (2 (Also see "Bitter Orange Safety Concerns Raised By Sen. Schumer, Rep. Waxman" - Pink Sheet, 9 Feb, 2004.), p. 11). Although the agency recognizes in the rule that supplements are not required to be supported by the kinds of clinical trials necessary for drugs, the reg still reflects a bias toward drug standards, according to the lawyer. Some industry stakeholders disagree that supplement claims are limited by a glass ceiling and point out supplements are eligible for stronger health claims under the law. In a Feb. 12 joint statement on the ban, the Council for Responsible Nutrition, National Nutritional Foods Association and the Utah Natural Products Alliance announced they would not take legal action against the agency to challenge the action. "While the associations do not agree with every point in FDA's justification for the final rule, they believe the agency has presented a balanced rationale," the release states. Consequently, many industry watchers believe the final reg, scheduled to be implemented April 12, would be upheld in court even if it were challenged. A second industry lawyer agrees the reg would be upheld in court but for a somewhat different reason, noting courts usually consider the agency to be experts, and it is difficult "to take a stand against FDA," but added, "they are not bullet-proof." In the rule, FDA addressed potential criticism that its decision to ban an entire category, rather than individual ephedra-containing products, could be found "arbitrary and capricious" in a court review. "We do not agree that we may not regulate the entire category of dietary supplements containing ephedrine alkaloids through rulemaking," the agency states. "We recognize that there are differences between different dietary supplements containing ephedrine alkaloids. However, we conclude, based on available science, that all dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury, regardless of how they are formulated or labeled." FDA's decision not to define its "unreasonable risk" standard could be a sticking point in court; the agency lost the First Amendment case Pearson v. Shalala when it did not define the "significant scientific agreement" standard necessary to support a health claim. However, in the rule FDA maintains "we are not required to issue a separate rule or guidance defining the [unreasonable risk] standard before issuing such a regulation." |