In continuing with their valiant efforts to rid the pharmaceutical industry of potentially harmful products, the U.S. Food and Drug Administration (FDA) has recently issued a warning letter to Breathable Foods Incorporated. The warning letter acknowledges the FDA’s needs for additional information regarding the safety of AeroShot “caffeine inhalers.” Subsequently, the letter also suggested that Breathable Foods Inc. used false and misleading information in the labeling of their product.
AeroShot products tout themselves as a revolutionary new way to boost energy. Their next generation design delivers a unique blend of caffeine and B vitamins in a fine powdered aerosol form that goes to work fast. Each AeroShot contains 100 mg of caffeine, about the same amount contained in a large cup of coffee.
However, contradictory claims made by AeroShot developers caught the eyes of FDA officials. According to an FDA Press Statement, AeroShot products are the product of fraudulent marketing. The company claims AeroShot is designed to provide “breathable energy, anytime, anyplace.” The manufacturer also claims on its website that its product is intended to be ingested by swallowing. The company’s labeling is false or misleading because these two claims contradict each other. A product cannot be intended for both inhalation and ingestion because the functioning of the epiglottis in the throat keeps the processes of inhaling and swallowing separate.
Officials at the FDA are also concerned about AeroShot’s safety because label statements such as “breathable energy” may confuse consumers about the proper use of AeroShot and encourage them to try to inhale it into their lungs. Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied. While the company claims on its website that decades of research have established that the particles in AeroShot are too big to enter the lungs, the company does not point to any specific research in support of this claim.
Due to the unsubstantiated claims made by AeroShot, the FDA issued a warning letter to Breathable Foods Incorporated. Detailed in the letter were the previously mentioned violations, along with other concerns. The company’s website indicates that AeroShot is “not recommended for those under 18 years of age,” and the product label states that it is “not intended for people under 12.” However, the website also appears to target these age groups by suggesting it be used when studying.
According to the warning letter, FDA regulations require manufacturers to ensure that a product is safe and properly labeled before being brought to market. The unsubstantiated claims made by AeroShot products are in direct violation of this law. As a result, the FDA has instructed Breathable Foods Inc. to correct the previously mentioned violations cited in their warning letter. Subsequently, the letter has given the company 15 days to provide information on research the company cites so the agency can evaluate the research.
Neglect on behalf of Breathable Foods Inc. to comply with these demands may result in further and more strict actions taken by the FDA.
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