Legislating Alkaloid Awareness

Concerns regarding the adverse health effects of ephedra-containing products led to Food and Drug Administration (FDA) special working group meetings in 1995 and 1996. As an invited member of this group, I reviewed information presented by individuals, industry, and state and federal governments. FDA considered our recommendations when it formulated the current proposed rule concerning dietary supplements containing ephedrine alkaloids.

These proposed rules, published in the Federal Register June 4, 1997, would strictly limit potency to less than 8 mg ephedrine alkaloids per serving and not allow labeling to suggest or recommend a dose of 24 mg or more ephedrine alkaloids in a 24-hour period. These rules would also prohibit label claims that promote long-term intake, prohibit combination with other known stimulants such as caffeine, and require some labels to bear the warning, "Taking more than the recommended serving may result in heart attack, stroke, seizure or death," and all labels to state, "Do not use this product for more than seven days."

Although the FDA federal regulations are still only proposed, a dozen individual states have adopted their own widely varying regulations. And on another regulatory front, because of the potential for ephedra alkaloid diversion into illicit methamphetamine production, the U.S. Drug Enforcement Agency is proposing regulations that would, among other things, cap the total ephedra alkaloid content of extracts at 2 percent.

—S.D.