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FDA cracks down on caffeine-loaded supplements

The United States Food and Drug Administration (FDA) took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products.

These products present a significant threat to public health due to the high risk that they will be misused in excessive and potentially dangerous doses.

Caffeine in high concentrations and pure, often sold in bulk packs, has been linked to at least two deaths in otherwise healthy people.

The agency released a  new guide  to make it clear that food supplements that contain pure or highly concentrated caffeine, whether in liquid form or in powder form, are considered illegal when sold directly to wholesale consumers.

Given the important public health problem, this guide becomes effective immediately. The FDA is prepared to take immediate action to initiate the recall of illegal products from the market.

Commando from the FDA. “We are making it clear to the industry that these highly concentrated presentations of caffeine that are being sold in bulk packages are generally illegal, according to current laws, and we will act to remove these dangerous bulk products from the market.”

One-half cup of highly concentrated liquid caffeine may contain approximately 2,000 mg of this substance, and just one teaspoon of pure caffeine powder may contain approximately 3,200 mg. This equates to about 20 to 28 cups of coffee, a potentially toxic dose of caffeine. In fact, less than two teaspoons of some pure powdered caffeine formulations can be deadly for most adults, while even smaller amounts can endanger children’s lives. The risk of excessive consumption and misuse is high when highly concentrated caffeine is sold wholesale and consumers are expected to measure a very small and accurate recommended portion. Regardless of whether or not they contain a warning label,

The recommended safe portion for highly concentrated or pure caffeine products is usually 200 mg of caffeine, which is equivalent to 1/16 teaspoon of pure powder or approximately 2.5 teaspoons of liquid. However, despite these small serving sizes, powdered presentations of caffeine are sold in large bags, and liquid ones are sold online, in bottles that may contain one gallon or more. Frequently, consumers lack the right tools to correctly measure such a small amount. Even if they do, simple and common mistakes, such as compressing the powder too hard or using a “spoonful” instead of a “spoonful”, can increase the amount of caffeine in a single dose, with detrimental results. Consumers could also make similar mistakes with highly concentrated liquid caffeine products. By way of comparison, a can of soda with caffeine contains approximately 35 mg of this substance, which would be equivalent to less than half a teaspoon of highly concentrated liquid caffeine.

In addition, these products often look a lot like safe household items, which can lead to possible accidental and dangerous ingestions. Highly concentrated caffeine in a clear liquid presentation could easily be confused with commonly used liquids, such as water or distilled vinegar, and pure, powdered, with flour or sugar. The consequences of a consumer mistakenly mistaken for one of these products could be toxic or even deadly.

When formulated and marketed properly, caffeine can be used as an ingredient in a food supplement. For example, the guide describes how dietary supplements containing caffeine in certain presentations are less likely to present the same safety risks, including those sold in pre-measured packages or containers, or in solid dosage forms such as tablets or capsules, or when they are sold in formulations that are not of high concentration.

In addition, this guide does not affect other types of products that may also contain caffeine, such as prescription or over-the-counter medications, or conventional foods such as drinks that traditionally contain caffeine.

In 2015 and 2016, the FDA issued warning letters to seven distributors of pure caffeine powder, several citing that the products were dangerous and presented a significant or unacceptable risk of consumers becoming ill or injured. Since then, the FDA has continued to observe a proliferation of the sale of similar products online. The FDA intends to carefully evaluate any dietary supplement containing potentially dangerous amounts of caffeine, at any presentation, and will continue to act when the products put consumers at risk.

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