FDA Warns Maker of Inhalable Caffeine Product Over False or Misleading Labeling

The U.S. Food and Drug Administration (FDA) issued a warning letter Tuesday to the maker of the inhalable caffeine product AeroShot Pure Energy, stating its labeling is false or misleading.

The FDA says the company, Breathable Foods Inc., labeled the product as both inhaled and ingestible. “The company’s labeling is false or misleading because these two claims contradict each other,” the FDA said in a statement. The agency added that “caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied.”

Aeroshot, introduced earlier this year in the United States as a calorie-free breathable energy product, delivers caffeine through a gray and yellow device that resembles a cross between a lipstick and a shotgun shell, Reuters reports. The caffeine is mixed with B vitamins and delivered in a fine powder that dissolves in the mouth. One AeroShot contains about the same amount of caffeine as a large cup of coffee, according to the article.

The FDA notes the product’s label has conflicting statements about whether it is appropriate for those under 18. The agency says some videos on the company’s website appear to encourage people to use AeroShot in combination with alcohol. The agency asked Breathable Foods to correct the violations, and to provide more information on research.

In reponse to the FDA letter, AeroShot issued a statement that said, “We plan to work closely with the FDA to meet their requests for information and labeling changes to ensure compliance with dietary supplement requirements. AeroShot delivers a mix of B vitamins and caffeine to the mouth for ingestion and is not ‘inhaled’ into the lungs. AeroShot is not recommended or marketed to persons under 18 or for use with alcohol.”

In December, U.S. Senator Charles Schumer urged the FDA to review the safety and legality of Aeroshot. “This stern warning is the clearest indication yet that AeroShot needs to be taken off the market until these concerns can be addressed and the product’s safety can be confirmed,” Senator Schumer said in a statement.