March 6, 2012 - The U.S. Food & Drug Administration (FDA) issued a warning letter today to Breathable Foods Inc., makers of AeroShot, for false and misleading statements in the labeling of their product. The warning letter also states that it has safety concerns about the ‘caffeine inhaler,’ which has reportedly been used by children and adolescents in combination with alcohol. Additionally, the FDA expressed concerns about AeroShot’s safety because label statements such as ‘breathable energy’ may confuse consumers into believing they can inhale the product into their lungs.
Free AeroShot Caffeine Inhaler Lawsuit Evaluation: If you or a loved one has suffered a serious injury you feel may have been caused by the AeroShot caffeine inhaler, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the AeroShot caffeine inhaler and we can help.
Update: FDA Bans Caffeine Sold in Bulk Following 2 Deaths
April 16, 2018 - The Food and Drug Administration announced Friday that it is banning the sale of pure and bulk caffeine products after 2 young men died from an accidental overdose. Dietary supplements that contain pure or highly concentrated caffeine in powder or liquid forms “present a significant public health threat,” FDA said in a Public Health Alert.
What’s the problem?
According to Breathable Foods Inc., AeroShot is designed to provide ‘breathable energy, anytime, anyplace.” At the same time, the company contradicts this claim on their website by stating that its product is intended to be ingested by swallowing. The FDA’s warning letter states that a product cannot be intended for both inhalation and ingestion because the functioning of the epiglottis in the throat keeps the process of inhaling and swallowing separate.
The administration believes that this marketing angle may confuse consumers and encourage them to inhale the product into their lungs. Caffeine is not meant to be inhaled directly, and this method of intake has not been properly studied or tested. While Breathable Foods says on its website that time-tested scientific evidence has established that the particles in AeroShot are too big to realistically enter the lungs, the company does not cite any specific sources to back this claim.
Additionally, Breathable Foods indicates that AeroShot is not recommended for minors, but the website reportedly targets this age group by suggesting it be used while studying for exams.
The AeroShot website also includes a number of links to videos and news articles referring to the use of the product in conjunction with alcoholic beverages. Although the consumption of alcohol in combination with AeroShot is not specifically advocated, the presence of the links and videos on the website may encourage the practice. And while consuming caffeine when under the influence of alcohol may lead users to feel less inebriated, it does not under any circumstances reduce blood alcohol levels.
Federal laws require manufacturers to ensure that a product is safe and properly labeled before being introduced into the market. In its warning letter, the FDA ordered Breathable Foods to correct the above-listed violations and provide a plan to bring AeroShot into compliance with federal regulations within 15 days.
Additionally, the FDA warning letter states that AeroShot product labels do not include contact information for consumers to report adverse events to the company, as is mandated by federal law. Consumers who have taken AeroShot and subsequently suffered serious injuries should report their case to their regional FDA Consumer Complaint Coordinators. To date, there have been no serious illnesses or injuries reported in connection with AeroShot use.
Do You Have an AeroShot Caffeine Inhaler Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in AeroShot caffeine inhaler lawsuits. We are handling individual litigation nationwide and currently accepting new illness and injury cases in all 50 states.
Free AeroShot Caffeine Inhaler Lawsuit Evaluation: If you or a loved one has suffered a serious illness or injury you believe may have been caused by the AeroShot caffeine inhaler, you should contact our law firm immediately. You may be entitled to compensation by filing an AeroShot caffeine inhaler injury suit and we can help.