Inspections, Compliance, Enforcement, and Criminal Investigations
Breathable Foods, Inc. 3/5/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
March 5, 2012
Mr. Thomas Hadfield, CEO
Breathable Foods, Inc.
300 Tech Square, Suite 301
Cambridge, MA 02139
Dear Mr. Hadfield:
This to advise you that the Food and Drug Administration reviewed your website at www.aeroshots.com in February 2012 and has determined that the product AeroShot is misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. We also have safety questions about the product, as described below. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Your AeroShot product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that your labeling is false or misleading. 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. See sections 201(ff)(2)(A) and 411(c)(1)(B) of the Act [21 U.S.C. §§ 321(ff)(2)(A) and 350(c)(1)(B)]. Your labeling is false and misleading because your product cannot be intended for both inhalation and ingestion. The functioning of the epiglottis in the throat keeps the processes of inhalation and ingestion mutually exclusive. The epiglottis is a cartilaginous structure that prevents choking or coughing during ingestion. The act of ingestion enables the tongue to push down on the larynx, which in turn elevates the hyoid bone, drawing the larynx upwards. This latter action forces the epiglottis to fold back, covering the entrance to the larynx and the airways, preventing food, drink and particulates from entering the airways and respiratory tract. When a person inhales, however, the epiglottis maintains its upright position, enabling air and particulate matter to enter the airways and ultimately the lungs. A product intended for inhalation is not a dietary supplement.
Your AeroShot product is also misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761(b) of the Act [21 U.S.C. § 379aa-1(b)], may receive a report of a serious adverse event associated with the product.
We also note that the Supplement Facts panel on the label of your AeroShot product does not comply with 21 CFR 101.36(e)(6) in that the dietary ingredients declared under 21 CFR 101.36(b)(2)(i) (ending with vitamin B12) are not separated from the dietary ingredients described in 21 CFR 101.36(b)(3) (starting with caffeine) by a heavy bar.
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. Any such publicity may have the effect of encouraging the combination of your product with alcohol---a scenario that raises safety concerns, as peer-reviewed studies show that ingesting these two substances together is associated with risky behaviors, such as riding with a driver who is under the influence of alcohol, which can lead to hazardous and life-threatening situations. Data and expert opinion also indicate that caffeine decreases the perception of intoxication, meaning that individuals who consume caffeine along with alcohol may consume more alcohol than they otherwise would and become more intoxicated than they realize. At the same time, caffeine does not change blood alcohol content levels, and thus does not reduce the risk of harm associated with drinking alcohol.
This letter is not intended to be an all-inclusive review of your product and its labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations. You should take prompt action to correct the violations cited above. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct the violations cited above and to prevent similar violations in the future. Your response should include documentation, such as revised labels or other useful information, which would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
Please send your reply to Quyen Tien, Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance (HFS-608), 5100 Paint Branch Parkway, College Park, MD 20740.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition