Dietary Supplements Containing Ephedrine Alkaloids

The Food and Drug Administration (FDA) is proposing to make a finding, which will have the force and effect of law, that a dietary supplement is adulterated if it contains 8 milligrams (mg) or more of ephedrine alkaloids per serving, or if its labeling suggests or recommends conditions of use that would result in intake of 8 mg or more in a 6-hour period or a total daily intake of 24 mg or more of ephedrine alkaloids; require that the label of dietary supplements that contain ephedrine alkaloids state ``Do not use this product for more than 7 days''; prohibit the use of ephedrine alkaloids with ingredients, or with ingredients that contain substances, that have a known stimulant effect (e.g., sources of caffeine or yohimbine), which may interact with ephedrine alkaloids; prohibit labeling claims that require long-term intake to achieve the purported effect (e.g., weight loss and body building); require a statement in conjunction with claims that encourage short-term excessive intake to enhance the purported effect (e.g., energy) that ``Taking more than the recommended serving may result in heart attack, stroke, seizure or death''; and require specific warning statements to appear on product labels. FDA is proposing these actions in response to serious illnesses and injuries, including multiple deaths, associated with the use of dietary supplement products that contain ephedrine alkaloids and the agency's investigations and analyses of these illnesses and injuries. FDA is also incorporating by reference its Laboratory Information Bulletin (LIB) No. 4053, that FDA will use in determining the level of ephedrine alkaloids in a dietary supplement.