WASHINGTON — The maker of a breathable caffeine product has received a warning letter from the Food and Drug Administration.
In its letter, the regulatory agency said that Breathable Foods' AeroShot product contained false or misleading statements on its labeling. The FDA also said it is concerned about the use of the product by children and adolescents, as well as the general safety of using the "caffeine inhaler." The FDA also noted that the product label does not include contact information for consumers to report any adverse events to the company, as required under federal law.
Click here to view the full warning letter.
The warning follows concern expressed by Sen. Charles Schumer, D-N.Y., who last month called on the FDA to conduct a full review of the safety and legality of the product and also questioned whether or not the product is legally marketed as a dietary supplement.
The company has 15 business days to respond to the agency with a plan to bring the product into compliance with FDA regulations.