FDA issued a warning
letter to Breathable Foods Inc., makers of AeroShot, for false or
misleading statements in the labeling of their “caffeine inhaler.” FDA finds
the labeling false or misleading because the company claims use for both
inhalation and ingestion. Breathable Foods claims AeroShot is designed to
provide “breathable energy, anytime, anyplace.” The company also claims
that its product is intended to be ingested by swallowing. FDA states that a
product cannot be intended for both inhaling and swallowing, noting that human
anatomy does not permit simultaneous inhalation and ingestion.
FDA continues that, “By definition, dietary supplements must
be intended for ingestion.” See FDCA §§ 201(ff)(2)(A)
and 411(c)(1)(B) [21 U.S.C. §§ 321(ff)(2)(A) and 350(c)(1)(B)]. “A
product intended for inhalation is not a dietary supplement.” Surprisingly, FDA
did not state the consequence of failing to be a dietary supplement — as far as
it is intended for caffeine inhalation, Aeroshot would be a drug and medical
device. I cover this in my book, Food
Regulation: Law, Science, Policy, and Practice, in discussion of the
case, United States v. Ten Cartons of
Ener-B Nasal Gel.
FDA is also concerned about AeroShot’s because of questions
about its safety. Terms such as “caffeine inhaler” and “breathable energy”
may encourage consumers to try to inhale AeroShot into their lungs. Caffeine is
not normally inhaled into the lungs and the safety of doing so has not been
well studied.
The FDA also expressed concern about the use of AeroShot by
children and adolescents. The company’s website indicates that AeroShot
is “not recommended for those under 18 years of age,” but the product label
states that it is “not intended for people under 12.”
FDA is also concerned about AeroShot website links to news
articles and videos that refer to use of the product in conjunction with
drinking alcohol. While using caffeine
when drinking may lead consumers to feel “less drunk,” it does not reduce blood
alcohol levels. FDA states, “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.”
Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius.
