Just updated: Your cheat sheets for understanding health care's legal landscape. The agency said the guidance "clarif[ies] 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.
However, FDA noted that its guidance documents "do not establish legally enforceable responsibilities. According to CQ Health , pure caffeine, which typically is sold in a concentrated liquid or powered form, is often sold online in bulk and is fairly easy to purchase.
But FDA said it can be difficult to measure out a safe serving of such products, as one teaspoon of powdered pure caffeine is similar in potency to up to 28 cups of coffee, "a potentially toxic dose of caffeine," FDA warned. Understand the wellness spectrum. FDA said pure caffeine products "have been linked to at least two deaths in otherwise healthy individuals.
FDA Commissioner Scott Gottlieb said the agency decided to take action after its previous efforts to limit sales of concentrated caffeine did little to stem "a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities.
FDA said the guidance also "does not affect other types of products that might also contain caffeine, such as prescription or over-the-counter drugs or conventional foods, like traditionally caffeinated beverages. The agency said the ban focuses on liquids and powders containing pure or highly concentrated caffeine, which are often sold in large tubs containing thousands of servings — not everyday products like coffee and energy drinks.
One teaspoon of pure powdered caffeine is equivalent to 28 cups of regular coffee, the FDA says. Amounts that tiny can be tough to measure, and slight variations can be deadly. Two healthy young men, an year-old and a year-old , died from caffeine overdoses in Their families met with the FDA, which then started warning consumers about concentrated caffeine products. The Agency issued two additional warning letters in March and then issued two more in June On April 13, , the FDA released a guidance for industry on highly concentrated caffeine in dietary supplements.
This document provides guidance for companies who manufacture, market, or distribute dietary supplements containing pure or highly concentrated caffeine, or are considering doing so, in order to help them determine when a product is considered adulterated and illegal by the FDA. The agency will continue to update this page in the event additional actions are taken related to pure and highly concentrated caffeine products. Dietary Supplement Ingredient Advisory List. Kreativ Health Inc.
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