Breathable Foods, Inc. 3/5/12
Mr. Thomas Hadfield, CEO
Breathable Foods, Inc.
300 Tech Square, Suite 301
Cambridge, MA 02139
Dear Mr. Hadfield:
On March 5, 2012, the Food and Drug Administration reviewed http://www.aeroshots.com1 in February 2012 and has determined that the product AeroShot is misbranded. FDA also has safety questions about the product. Labeling
Below are excerpts from the letter:
“AeroShots is misbranded. On the one hand, you indicate that AeroShot is intended for inhalation. For instance, the product label prominently features the claim “BREATHABLE ENERGY Anytime, Anyplace,” as well as the instruction, “Puff in.”
In addition, your website includes headlines that describe your product as “inhalable caffeine” and tout the invention of a “caffeine inhaler.” Your website also describes the product as “airborne energy” that “delivers a unique blend of 100 mg of caffeine and B vitamins in about 4-6 puffs.”
Despite these suggestions that your product is intended for inhalation, you indicate in other statements that the product is intended for ingestion. For instance, your label characterizes AeroShot as a dietary supplement, and your website describes the product as “ingestible food” and instructs users to swallow the product. Your website further states that “Breathable Foods is revolutionizing the delivery of nutrients to the mouth for ingestion . . .” and that “AeroShot provides a safe shot of caffeine and B vitamins for ingestion.”
By definition, dietary supplements must be intended for ingestion. A product intended for inhalation is not a dietary supplement.
“In addition to the misbranding violations described above, we have safety questions about possible effects of your product. As summarized above, your labeling suggests in several places that AeroShot should be inhaled. Because of those suggestions, consumers may attempt to inhale your product, causing it to enter the lungs. FDA is concerned about the safety of any such use because caffeine is not typically inhaled through the lungs, and the safety of such use has not been well studied. Your website addresses this issue in part by stating that “[d]ecades of research have shown that particles above 10 microns in size, if inhaled, fall out in the mouth and do not penetrate the respiratory tract,” and also that “[o]ur powders are of a median size much larger than 10 microns.” Please provide us with references to the research you cite so that we can evaluate that research. Please also submit the evidence you relied on in stating that the median size of your powders is “much larger than 10 microns.””
“Furthermore, although you have issued a statement in which you assert that “AeroShot is not recommended for those under 18 years of age,” some of your labeling indicates otherwise. Your label states that AeroShot is “not intended for people under 12 . . . .” This suggests that the product is suitable for children 12 and over. Please provide us with any safety evidence you have relied upon related to the use of your product by children and adolescents so that we can evaluate that evidence. In addition, in light of your statements that AeroShot is “not intended for people under 12” and is “not recommended for those under 18 years of age,” we question why your website states that your product is designed to be used when “[h]itting the books” and “study[ing] in the library.” These activities are commonly performed by children and adolescents. Indeed, your reference to these activities seems to target this population.”
“Finally, we note that your labeling conveys contradictory messages about the use of your 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.” Even though these news items express health concerns about taking AeroShot while drinking alcohol, your posting of the news items on the website where you promote and sell AeroShot publicizes such use. ”