So far, two deaths have been attributed to the ingestion of highly concentrated caffeine. To prevent further deaths and to keep the public safe, the FDA is taking steps to prevent the sale of such products directly to consumers, especially in bulk quantities
Addressing The Caffeine Public Health Issue
In an effort to protect consumers from what has become a public health threat, the FDA released a new guidance document to clarify that the selling of dietary supplements with pure caffeine in bulk packaging directly to consumers is considered unlawful, whether it is in powder or liquid form.
The document is meant to assist manufacturers, marketers, or distributors of such products to determine whether their products or manner of selling is or would be considered unlawful. Since this is a significant public health concern, the new guidance is immediately in effect, and the agency is prepared to begin removing the unlawful products from the market.
To be clear, the guidance does not affect other products with caffeine such as over-the-counter drugs, food items, and coffee or other beverages with caffeine.
Pure Caffeine
Pure caffeine is vastly different from the caffeine content of coffee in that it is highly concentrated and can be potentially deadly. In fact, one teaspoon of powdered pure caffeine may contain up to 3,200 mg of caffeine while half a cup of its liquid form may contain 2,000 mg of caffeine.
That amount of caffeine is equal to about 20 to 28 cups of coffee, a potentially deadly dose. Further, less than two teaspoons of the pure powder could be deadly to adults, and even lesser amounts may be deadly to children.
The recommended safe dosage of pure caffeine powder is about 1/16 teaspoon, equal to 200 mg of caffeine. However, despite the small recommendation, the product is still sold in bulk. This is problematic since not all consumers have the appropriate tools to accurately measure the right and safe amount of product to use, and it also looks rather like many other household products, so it could be mistakenly used and in deadly amounts.
Persistent Pure Caffeine Problem
Since 2015, the FDA has been making significant efforts to crackdown on the sales of potentially hazardous pure caffeine. In fact, the agency has issued warning letters to seven distributors of such products, stating its potential dangers to consumers. However, pure caffeine continued to circulate in the market and even sold in bulk.
