A new product, described as “inhalable” or “breathable” caffeine, has drawn the attention of the U.S. Food and Drug Administration (FDA) due to questions about its safety and suitability for the marketplace. This is due partly to recent incidents involving injuries and deaths allegedly caused by high-caffeine energy drinks, as well as the mixture of caffeine-containing energy drinks with alcohol. The apparent popularity of these products among college students and other young people is also a cause for concern.
“Breathable caffeine,” currently marketed as the AeroShot, reportedly contains 100 milligrams of caffeine in a single “shot.” This is roughly the same amount of caffeine contained in a large cup of coffee. The device resembles an asthma inhaler. The owners of the company that produces the AeroShot state in interviews that the product is not intended for anyone under the age of 18, nor should it be mixed with alcohol.
The FDA’s concerns primarily involve the labeling of the product in regards to whether consumers should inhale, drink, or eat it. In a letter sent to the company on March 5, the FDA notes that product labels and the website prominently describe the product as “breathable.” At the same time, other statements and materials describe it as “ingestible,” and refer to it as a “dietary supplement.” FDA regulations require clear labeling of a product as either “breathable” or “ingestible.” A “breathable” product cannot be described as a “dietary supplement.”
The FDA also expresses concerns about consumer safety in the absence of clear instructions about inhalation versus ingestion. If the product is intended for inhalation, ingestion could be dangerous, and vice versa. Very little research exists on the safety of inhaled caffeine products, which also worries the FDA.
Finally, the FDA notes concerns about the intended age of the product’s consumers and warnings about its use in combination with alcohol. While the company states that no one under 18 should use the product, some materials allegedly state the minimum age as 12. Marketing materials describe using the product when, for example, “study[ing] in the library,” an activity the FDA notes is most common among children and young adults. Publicity around the product featured on its website describes its use with alcohol as a “party drug.” This, according to the FDA, contradicts the company’s message that it should not be mixed with alcohol.