The Food and Drug Administration issued a warning letter to BreathableFoods, Inc., which makes AeroShot Energy®, an “inhalable”caffeine product, on March 5, 2012. According to the agency, the AeroShot product is misbranded because it is labeled as intended for inhalation while the company’s Website indicates that the product is intended for ingestion. “Your labeling is false and misleading because your product cannot be intended for both inhalation and ingestion,” states the letter. FDA also notes that the product label fails to include a domestic address or phone number through which reports of serious adverse events associated with the product may be received. The letter further informs the company that FDA has “safety questions about the possible effects of your product.”

FDA expresses concerns regarding “contradictory messages” about use of
the product “in combination with alcohol. On the one hand, your website
includes a posting of a news interview in which the inventor of your product,
David Edwards, states that he is not encouraging the mixing of AeroShot with
alcohol. On the other hand, your website includes clips of news videos related
to AeroShot, as well as links to news articles related to the product. Several of
these news items refer to the use of your product in combination with alcohol
or as a ‘party drug.’”

Additional information about the product and calls for an FDA investigation is
included in Issue 428 of this Update.

Meanwhile, Breathable Foods CEO Tom Hadfield reportedly said that the company would cooperate with FDA to resolve the issues raised in the warning letter. He was quoted as saying, “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.” He also reportedly denied that the product was marketed as a “party drug” for youths younger than 18. “AeroShot is not recommended or marketed to persons under 18 or for use with alcohol,” Hadfield said. According to the product’s inventor, other products relying on the delivery technology will be added to the marketplace in coming months; they include vitamins and minerals, confections and products related to oral health care. See, March 7, 2012.

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.