Food and Drug Administration officials have issued a warning letter to the makers of the inhalable caffeine product AeroShot, saying they have questions about its safety and concerns about how children and adolescents may use it. The lipstick-sized AeroShot went on the market in January in Massachusetts and New York, and it’s also available in France. Consumers put one end of the plastic canister in their mouths and breathe in, releasing a fine powder that dissolves almost instantly. The product’s website calls it “a revolutionary new way to get your energy.”
According to the FDA, the Massachusetts-based company behind AeroShot, Breathable Foods, misled consumers by saying the product can be both inhaled and ingested, which is not possible. The agency said it is concerned consumers may try to inhale it into their lungs, which may not be safe. The letter also pointed out that the company’s website says it is not recommended for those under the age of 18, while the product label says it is not recommended for those under 12. At the same time, the FDA said, the company targets both age groups by suggesting it be used while studying.
Another problem cited by the FDA related to links on the company’s website to articles that mention using the caffeine product with alcohol. The FDA has attempted raise awareness about the dangers of the combination of caffeine and alcohol in recent years, saying it can lead to “a state of wide-awake drunk” and has caused alcohol poisoning, car accidents and assaults. The agency cracked down on the sale of the energy-alcohol drink Four Loko in 2010, forcing the makers of that product to remove the caffeine.
Since AeroShot is sold as a dietary supplement, it didn’t require FDA review before hitting the U.S. market. FDA regulations require supplement manufacturers to be responsible for their products’ safety. If the agency decides a product isn’t safe, it can take action, including taking the product off store shelves. The company had 15 days to respond to the letter, which asked Breathable Foods to correct the violations the FDA cited and to submit its research on the product’s safety to the agency.
Sen. Charles Schumer, D-N.Y., urged the FDA to crack down on the product, which is being sold in his state, saying children and adolescents may abuse it. He had this to say:
This stern warning is the clearest indication yet that AeroShot needs to be taken off the market until these concerns can be addressed and the product’s safety can be confirmed.
I have never believed leaving a product of any sort to the manufacturer works well when it comes to safety issues. Hopefully, there will be changes in this industry giving the FDA authority to fully regulate the products made and sold.
Source: USA Today
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