FDA Issues Warning On 'Breathable' Caffeine
WASHINGTON, D.C. -- The Food and Drug Administration (FDA) issued a warning letter yesterday to Breathable Foods Inc., maker of the inhalable caffeine product AeroShot. The warning applies to "false or misleading statements" in the product’s labeling, plus the use of AeroShot by minors and in conjunction with alcohol are also concerns, according to the agency.
The product provides "breathable energy, anytime, anyplace," according to Breathable Foods, yet the FDA noted that information on AeroShot's website instructs consumers to swallow. This is contradictory because a product cannot be inhaled and ingested at the same time, the FDA stated in its warning letter. Additionally, the FDA expressed concern over potential confusion that may lead consumers to try and directly inhale AeroShot. While AeroShot's website states that its caffeine particles are too large to enter the lungs, it does not cite any research to back up this claim, and the safety of inhaling caffeine has not been studied, according to the FDA.
Another discrepancy comes from a disclaimer on AeroShot website's that says it is not recommended for individuals under 18 years old, while the product is labeled as not intended for those under 12 years old. However, the FDA said AeroShot may be seen as targeting those age groups due to its suggestion that the product be used when studying.
The FDA also expressed concern over online videos and news articles that reference the use of AeroShot while consuming alcohol. Although the videos and news items do not advocate the combination and express health concerns about such a practice, this "publicizes and therefore may encourage the use of AeroShot with alcohol," the FDA stated.
Finally, the warning letter also pointed out that AeroShot's product label does not contain contact information for the company, through which consumers could report adverse events to the product, as required under federal law. The FDA said it had not received any adverse event reports as of March 6, but that consumers who believe they have suffered illness or injury from using AeroShot should report it to their regional FDA Consumer Complaint Coordinators.
The FDA, which requires manufacturers to ensure a product is safe and labeled properly before bringing it to market, instructed Breathable Foods to correct the violations listed in the warning letter and provide information on its cited research for evaluation. Breathable Foods has 15 business days to respond to the warning letter with a plan to bring AeroShot into compliance with FDA regulations.