美國日前至少有2名民眾疑似因食用含高咖啡因的補充品而死亡，為保障消費者的健康，FDA將禁止市面上販售高劑量或純咖啡因的膳食補充品。
FDA聲明中提到，這些高劑量或純咖啡因的膳食補充品會造成嚴重的公共健康威脅，其產品很容易誤導消費者，導致他們超劑量服用，嚴重威脅健康，甚至造成死亡。這些膳食補充品是違法的，未來將禁止販售。
一茶匙量的純咖啡因含有3200毫克（mg）的咖啡因，等同於喝下20到28杯咖啡，恐產生噁心、嘔吐、教造、易怒和心悸等現象，嚴重者會胸痛、心律不整，甚至死亡。
FDA強調，不管產品包裝上是否標示清楚，高劑量咖啡因皆有致命的風險，對消費者的健康有相當大的危害。根據統計，美國目前至少有2名民眾因服用粉狀咖啡因膳食補充品而死亡的事件。
Today, the U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products. These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses. Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals.
The agency issued a new guidance to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers. Given the significant public health concern, this guidance is immediately in effect. The FDA is prepared to take steps right away to begin removing illegal products from the market.
“Despite multiple actions against these products in the past, we’ve seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container. We know these products are sometimes being used in potentially dangerous ways. For example, teenagers, for a perceived energy kick, sometimes mix dangerously high amounts of super-concentrated caffeine into workout cocktails. The amounts used can too easily become deceptively high because of the super-concentrated forms and bulk packaging in which the caffeine is being sold,” said Scott Gottlieb, M.D., FDA commissioner. “We’re making clear for industry that these highly concentrated forms of caffeine that are being sold in bulk packages are generally illegal under current law. We’ll act to remove these dangerous bulk products from the market.”
連結：Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements（美國FDA公告）
Products consisting of or containing only pure or highly concentrated caffeine have been linked to at least two deaths in the United States in the last few years, and continue to present a significant public health threat. Many products that consist of only or primarily pure or highly concentrated caffeine are sold as dietary supplements. FDA considers some such products to be adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(f)(1)(A)], because they are dietary supplements that present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling or, if no conditions for use are suggested or recommended, under ordinary conditions of use.