The U.S. Food and Drug Administration has issued a warning to the makers of the AeroShot “caffeine inhaler,” citing potential safety concerns and “false or misleading statements” in the product’s labeling.
In a consumer alert posted on the agency’s Website, the FDA also expressed concerns about the use of AeroShot – made by Breathable Foods Inc. -- by children and adolescents, and in combination with alcohol.
Regulators issued the warning letter to AeroShot’s makers over marketing claims that the product provides “breathable energy, anytime, anyplace.” The company also claims on its website that its product is intended to be ingested by swallowing. But FDA officials said the company’s labeling is false or misleading “because these two claims contradict each other.” The agency also said the label statements about “breathable energy” may confuse consumers and encourage them to try to inhale it into their lungs. Among other agency concerns cited in the warning:
• The company’s website indicates that AeroShot is “not recommended for those under 18 years of age,” but also appears to suggest it be used when studying.
• The AeroShot website also includes links to news articles and videos that refer to use of the product in conjunction with drinking alcohol and may encourage the use of the product with alcohol.
FDA has instructed Breathable Foods Inc. to correct the violations and provide information on research the company has used to inform its claims, so the agency can evaluate it. The company has 15 business days to respond to the agency.
FDA urged consumers who believe they have suffered illness or injury from using AeroShot to report those events to the FDA
For more information, contact the FDA at 888-INFO-FDA