As Kentucky residents may know, the use of a powdered caffeine supplement caused the death of two men last year. However, the Food and Drug Administration is currently unable to ban its sale. It has posted a warning on its website about using the product, and the agency is asking anyone who suffered an adverse side effect from powdered caffeine to contact them.
Caffeine is a substance found in medical products, which are regulated by the FDA. Supplements do not require FDA approval, and the agency’s options are limited. Under a 1994 amendment to the Federal Food, Drug and Cosmetic Act, the FDA regulatory framework was enhanced to include supplements. The FDA is charged with regulating products that are shown to be unsafe or that make misleading claims or have inadequate labeling.
In the case of pure powdered caffeine, the FDA has the authority to send warning letters to companies that sell the product. Using this tool, energy drinks containing alcohol were voluntarily removed from the market. Some lawmakers are asking the FDA to ban powdered caffeine.
Twenty-five cups of coffee are equal to 1 teaspoon of the powdered caffeine substance, and 2 teaspoons is a lethal dose. Powered caffeine is marketed with labeling that instructs the user to limit daily intake to 1/64 to 1/16 teaspoon. The FDA has said it is virtually impossible for a consumer to measure that amount accurately at home.
If a consumer is injured by a product, they may file a lawsuit claiming the manufacturer or seller was negligent if the product is shown to be defective or dangerous. An attorney may assist the individual by reviewing flaws in the marketing of a product and file a lawsuit to recover damages.
Source: FDA, “Q&A on Dietary Supplements,” 2014
Source: US News, “FDA Hands Tied in Powdered Caffeine Abuse Cases“, Kimberly Leonard, December 29, 2014