ORLANDO, Fla. - The Food and Drug Administration has threatened regulatory action against Breathable Foods, the manufacturer of Aeroshot, a product marketed as a "dry energy shot dietary supplement."
In a letter to the company, the FDA indicated Breathable Foods may be engaged in "false and misleading" labeling.
Aeroshot, which contains 100 milligrams of caffeine (the equivalent of an eight-ounce cup of coffee) and B vitamins, was designed to be ingested, not inhaled into the lungs. Each small "puffer" contains a powder-like substance that, when released, is supposed to be absorbed into the tongue and throat. The FDA told the company its own product usage description is contradictory.
"For instance, the product label prominently features the claim 'BREATHABLE ENERGY Anytime, Anyplace,' as well as the instruction, 'Puff in'," said Michael W. Roosevelt, the acting director of the Food and Drug Administration's Office of Compliance in a letter to Thomas Hadfield, CEO of Breathable Foods. "In addition, your website includes headlines that describe your product as 'inhalable caffeine' and tout the invention of a 'caffeine inhaler.' Despite these suggestions that your product is intended for inhalation, you indicate in other statements that the product is intended for ingestion. By definition, dietary supplements must be intended for ingestion."
Roosevelt warned about the possible implications for consumers.
"Consumers may attempt to inhale your product, causing it to enter the lungs ... (The) FDA is concerned about the safety of any such use."
Roosevelt's letter also expressed concern about the product's appeal to young people, even though the packaging says the product is not recommended for people under 18. The FDA alleged the company, through images and text on its website, is actually targeting a younger population.
Breathable Foods has 15 days to respond to the letter. Tom Hadfield, the company's CEO, released a statement on Aeroshot's website, indicating his company will work closely with the FDA on the agency's request for labeling changes.
Roosevelt warned that if the company does not correct the violations cited in his letter, the FDA could take regulatory action, including the seizure of products and/or an injunction against sales.
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