AeroShot Energy, which was introduced to the US market in January as a dietary supplement, is designed to be ingested; users put one end in their mouth and breathe in, releasing a fine powder that dissolves almost instantly.
But this may not be clear to consumers, who might try to inhale the product and get caffeine in their lungs, said the FDA in a warning letter sent to Massachusetts-based brand owner Breathable Foods earlier this week.
Consumers might try to inhale the product
It warned:“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.”
It added: “Your AeroShot product is misbranded … in that your labeling is false or misleading. Your website includes headlines that describe your product as ‘inhalable caffeine’… Your website also describes the product as ‘airborne energy’.
“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.”
In an accompanying press release, FDA also encourages healthcare providers to "report to FDA any adverse events in their patients that are associated with AeroShot,” althought it stresses that no such reports have been received to date.
Breathable Foods boss: We will work closely with the FDA
Breathable Foods chief executive Tom Hadfield said the firm would co-operate with the FDA in a bid to resolve all of the issues raised in the warning letter.
He said: “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.”
But he rejected suggestions that AeroShot’s marketing gave the impression that it was a ‘party drug’ targeted at under-18s.
“AeroShot is not recommended or marketed to persons under 18 or for use with alcohol.”
100mg of caffeine in 4-6 puffs
AeroShot Energy, which is manufactured in France and retails for $2.99, provides 100mg of caffeine via 4-6 puffs, equivalent to a cup of coffee.
Unlike energy drinks that can be easily mixed with alcohol, AeroShot is not designed to have its contents poured into alcoholic beverages, and it is not intended for mixing with any liquids, said Hadfield.
He also claimed that “decades of research have shown that particles above 10 microns in size, if inhaled, fall out of the mouth and do not penetrate the respiratory tract” –a claim that the FDA has asked him to back up.
A novel solution to pill fatigue?
The AeroShot format had a lot of potential, inventor Dr David Edwards told NutraIngredients-USA last month, adding that more products were in the pipeline, both as novel solutions to pill fatigue for those looking for vitamins and minerals, and as a guilt-free indulgence for consumers with a sweet tooth.
He said: “We will over the next year be broadening the mainstream platform, of which the AeroShot is the lead product, to include vitamin, supplements, confections and many other things including products related to oral healthcare.”
“The platform potential is quite large. It is also specific as you can imagine. Where the goal is to deliver taste, or flavor, with minimum calories (essentially zero), breathable products are wonderfully useful.”
He added:“We will be furthering the technology to bring the costs down to be competitive with current vitamin and supplement delivery approaches and at that time will be making this line of products much more available to the public.”
Attorney: Interesting to see lengths FDA went to make its case
Washington DC-based advertising and labeling attorney Ivan Wasserman told NutraIngredients-USA that it was interesting to see the lengths to which the FDA was prepared to go to make its case:
"While the Warning Letter is certainly not unexpected, given the nature of the product and the Congressional-level attention it received, it is very interesting to read the lengths to which FDA went to make its case that the product violates the Act, even including a discussion of the function of the epiglottis."
He added: "On the safety side, it is interesting that FDA decided to delve into human psychology, suggesting the fact that if a manufacturer informs the public about dangers associated with a use of its product, in this case combining it with alcohol, it may, depending how it is done, actually encourage that use."