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FDA: 'Puffing' a Supplement is Misleading
March 6, 2012
4 Min Read
COLLEGE PARK, Md.FDA said labeling for AeroShot's "breathable energy" supplement is false and misleading because it isn't clear on if the product should be inhaled or ingested, according to a warning letter the agency sent Thomas Hadfield, CEO of Breathable Foods Inc. Beyond that, FDA said the product raises safety issues because inhaled caffeinethe key component of AeroShotshas not been studied well enough for toxicity.
AeroShots came to public attention when Sen. Charles Schumer (D-NY) requested FDA review the product; his major concern was adolescents who may mix the product with alcohol.
Labeling
False or Misleading LanguageIn the warning letter, FDA pointed out the incongruity of AeroShot's marketing. The agency said the labeling is false and misleading because the product says it is intended for both inhalation and ingestion. FDA noted, by definition, dietary supplements must be intended for ingestion, not inhalation.
Some marketing on the aeroshot.com and on the label indicates AeroShot is intended for inhalation. For instance, the product label features the claim BREATHABLE ENERGY Anytime, Anyplace," as well as the instruction, Puff in." In addition, the website includes headlines that describe the product as inhalable caffeine" and tout the invention of a caffeine inhaler."
Yet, other statements indicate the product is intended for ingestion. For instance, the label characterizes AeroShot as a dietary supplement, and the website describes the product as ingestible food" and instructs users to swallow the product.
Missing InformationFurther, FDA said the product is also misbranded because its label doesnt have a domestic address or phone number that a person could contact in case of a serious adverse event.
Safety
InhalationFDA said the false or misleading labeling may also cause safety issues because consumers may try to inhale AeroShots. FDA said it is concerned about this because caffeine is not typically inhaled, and the safety of such use has not been well studied. While the website says the powders are too big to actually be inhaled into the lungs, FDA requested research references to back this claim.
Age RestrictionFDA also requested safety evidence the company used to determine the product is suitable for children aged 12 and older, per the label claim that says AeroShot is not intended for people under 12 . . . ." FDA also noted a different statement from the company that said the product is not recommended for people younger than 18.
Despite these age restrictions, FDA pointed to marketing that said the product is designed to be used when [h]itting the books" and study[ing] in the library," activities common to children and adolescents.
AlcoholFDA said AeroShot is again contradictory when it comes to combining the product with alcohol. The website includes a posting of a news interview where product inventor David Edwards said he doesn't encouraging the mixing of AeroShot with alcohol. However, the website includes clips of news videos and articles on AeroShot that refer to using the product in combination with alcohol or as a party drug." FDA said posting these news items on a website that promotes and sells AeroShot publicizes the use of AeroShot/caffeine combination. The agency said using caffeine in combination with raises safety concerns, as peer-reviewed studies show that ingesting these two substances together is associated with risky behaviors.
FDA gave the company 15 working days from the receipt of the letter to outline the specific actions it is taking to correct the violations cited above and to prevent similar violations in the future.
INSIDER's take: FDA requires clear direction on how a product is to be consumed and requires products to carry contact information. Without clear direction of use, FDA said safety issues are raised about how products are consumed. Further, FDA requested more information on how the company determined age requirements, and said adding news articles that mention mixing the product with alcohol is the same as if the company promoted such use on its own.
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