The agency will continue to update this page in the event additional actions are taken related to pure and highly concentrated caffeine products. 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. On April 13, 2018, the FDA released a guidance for industry on highly concentrated caffeine in dietary supplements. The Agency issued two additional warning letters in March 2016 and then issued two more in June 2018. On September 1, 2015, the FDA issued warning letters to five distributors of pure powdered caffeine products. FDA Action on Pure and Highly Concentrated Caffeine If violations exist, the FDA can pursue enforcement action, such as seizure of the product or an injunction to prevent the firm from continuing to manufacture or market the product. Although an appropriate dose of caffeine can mitigate headaches due to migraine and post-dural puncture, overuse can lead to chronic forms of. The FDA aggressively monitors the marketplace for dangerous products, including dietary supplements consisting of pure and highly concentrated caffeine, and will continue to take action as appropriate. Caffeine can both trigger and alleviate headaches. Pre-existing conditions can intensify the effects of caffeine and make these products even more dangerous for some individuals. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. If you’re experiencing this problem, we regret that we’re unable to. We know that you may be having trouble finding some of our products and we are diligently working to ensure our production and inventory keep pace with the heightened demand. While consumers of commonly available caffeinated products such as coffee, tea, and soda may be aware of caffeine’s less serious effects – such as nervousness and tremors – they may not be aware that these pure and highly concentrated caffeine products are much more potent and can cause serious health effects, including rapid or dangerously erratic heartbeat, seizures and death. With more people staying at home, we’ve seen an increased demand for many of our beverages. These are toxic amounts that can have serious health consequences. Just one teaspoon of pure powdered caffeine can contain the same amount of caffeine as 28 cups of coffee, and a half cup of a liquid highly concentrated caffeine product contains the equivalent of more than 20 cups of coffee. These products are also often sold in ways that increase the likelihood of accidental measurement error. For many of these products, volume measures such as teaspoons are not precise enough to calculate how many milligrams of caffeine are in the recommended serving size. Safe quantities of these products can be difficult or nearly impossible to measure accurately with common kitchen measuring tools. The difference between a safe amount and a toxic or life-threatening amount of caffeine in these highly concentrated products is very small. These products are often marketed in bulk packaging with up to thousands of servings per container, requiring the consumer to measure out a safe serving from what can be a toxic or even lethal amount of bulk product. In recent years, dietary supplement products consisting of pure or highly concentrated caffeine in powder and liquid forms have emerged on the market. Variations of TaB released over the years included Root Beer, Lemon-Lime, Ginger Ale, Black Cherry, Strawberry, Orange, a clear cola, a caffeine-free version, and TaB Energy, which was produced in 2006 and was a different formula to the original drink.Pure and highly concentrated caffeine products present a significant public health threat and have contributed to at least two deaths in the United States. Popularity dwindled with the introduction of Diet Coke in the 1980s, but it continued to boast a small but devoted following.Įventually, Coca-Cola announced TaB was among the "underperforming products" it was retiring. Introduced in 1963, TaB was Coca-Cola's first diet drink and was a massive hit. TaB was produced for 58 years before it was discontinued by Coca-Cola in December 2020. Coca-Cola Co., PepsiCo Inc., and Cadbury Schweppes Plc, control over 91% of the U.S. The US annual soft drinks sales is approximately $66 billion. Cans of diet cola Tab brand soft drink produced by the Coca-Cola Company are displayed at a supermarket in the Brooklyn borough of New York, on Tuesday, July 26, 2011.
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