The U.S. Food and Drug Administration (FDA) has issued warning letters to five companies involved in the distribution of dietary supplements containing caffeine. These products all list “Caffeine Anhydrous” as their sole ingredient. Under the current recommended or suggested conditions of use of all these products, the FDA believes that they can lead to “significant or unreasonable risk of illness or injury.”
Because of this, the FDA sent stern warning letters to Bridge City Bulk LLC; Hard Eight Nutrition, LLC; Kreativ Health Inc. dba Natural Food Supplements; PureBulk, Inc.; and SPN, LLC dba Smartpowders. All warning letters were issued on August 27.
The FDA is concerned that caffeine is quite “a powerful stimulant.” And in fact, just one teaspoon of pure powdered caffeine is equivalent to drinking as much as 28 cups of coffee. A teaspoon of pure powdered caffeine is roughly equal to 2.7 grams.
For example, Bridge City’s Caffeine Powder (Synthetic) Caffeine Anhydrous recommends consumers to take about 50 to 200 mg up to three times daily. Moreover, the serving size prescribed is 200 milligrams. Meanwhile, the company’s Caffeine Anhydrous Natural Coffee Bean is posing a concern for the FDA as its 1 kg package actually contains as much as 123 tablespoons of powdered caffeine or about 5,000 servings of the product. At the same time, its 10 kg package offers 1,230 tablespoons of powdered caffeine or about 50,000 servings.
The FDA believes this poses a serious threat as the product is packaged in lethal amount. Moreover, there is also concern with the fact that a consumer would have to use a very precise scale in order to be able to get a safe serving of powdered caffeine. This poses risk of illness and injury that can be readily avoided.
The FDA reports that consuming just one teaspoon of pure powdered caffeine can lead to heart palpitations, vomiting, anxiety and nausea. Meanwhile, consuming one tablespoon of caffeine in pure powdered form can lead to serious conditions such as respiratory alkalosis, hypokalemia, tachycardia, bigeminy, elevated blood glucose, chest pains, irregular heartbeats as well as agitation. Moreover, it can also be deadly.
All five companies are required to respond within 15 days of receiving the warning letter. FDA is requiring all of them to outline steps that each will undertake in order to correct their violation. These should also cover products that are already being sold in the market.
Currently, Pure Bulk has already issued a warning regarding excessive consumption of caffeine powder on its website. The warning stresses the need for accurate measurement of the company’s Caffeine Synthetic Powder. The same warning is also displayed in a disclaimer in the product page. A customer must acknowledge the said disclaimer before any purchase can be made.