![]() ![]() 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. 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. 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. 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. 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. 2007, 247, 26.Pure and highly concentrated caffeine products present a significant public health threat and have contributed to at least two deaths in the United States. 4) The enigmatic effects of caffeine in cell cycle and cancer (a review).3) Regulation of the G2/M transition by p53 (a review).1) Actions of caffeine in the brain with special reference to factors that contribute to its widespread use (a review).3) (The product is for research purpose only.) References 3,4) Caffeine has been used to help delineate the role of p53 (cellular tumor antigen p53 gene) in the G2 arrest that occurs in response to DNA damage. 2) Besides, it has been reported that caffeine is capable of abrogating cell cycle checkpoints in several different mammalian cell types. Caffeine, a mimic of adenosine, has the opposite effect of adenosine, and causes most of its biological effects via antagonizing all types of adenosine receptors (ARs), such as A 1, A 2A, A 3, and A 2B. 1) It has been known that adenosine is a modulator that has a pervasive and generally inhibitory effect on neuronal activity. Call a POISON CENTER/doctor if you feel unwell.Ĭaffeine is widely contained in foods and beverages and is the most widely consumed central-nervous-system stimulant. P304 + P340 + P312 : IF INHALED: Remove person to fresh air and keep comfortable for breathing. P301 + P310 + P330 : IF SWALLOWED: Immediately call a POISON CENTER/doctor. P308 + P313 : IF exposed or concerned: Get medical advice/ attention. P280 : Wear protective gloves/ protective clothing/ eye protection/ face protection. P264 : Wash skin thoroughly after handling. P271 : Use only outdoors or in a well-ventilated area. P201 : Obtain special instructions before use. P202 : Do not handle until all safety precautions have been read and understood. ![]() P270 : Do not eat, drink or smoke when using this product. P261 : Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray. P501 : Dispose of contents/ container to an approved waste disposal plant. H412 : Harmful to aquatic life with long lasting effects. H360 : May damage fertility or the unborn child. ![]()
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