- AeroShot's labeling is "false and misleading," FDA says
- Marketing seems to imply supplement can be inhaled, FDA says
- Breathable Energy says product is ingested, "not 'inhaled' into the lungs"
- FDA gives company 15 working days to respond or face possible regulatory action
The Food and Drug Administration has warned a company that markets caffeine and vitamin B as "breathable energy" it could face regulatory action over "false and misleading" labeling.
AeroShot comes in a lipstick-shaped dispenser that puffs out the white powdery mixture.
Pre-filled devices can be purchased online or in convenience stores in New York and Boston for about $3.
AeroShot's website says the product "gives you a higher level of freedom and control that you can only get from airborne energy." However, elsewhere it explains, "the powder in AeroShot reaches your mouth where it is swallowed and ingested."
"Your labeling is false and misleading because your product cannot be intended for both inhalation and ingestion," the FDA charges in a letter to the manufacturer Breathable Foods. "Consumers may attempt to inhale your product, causing it to enter the lungs. FDA is concerned about the safety of any such use."
The AeroShot packaging says the product is "not recommended for people ... under 18." But the FDA noted that the AeroShot website refers to "hitting the books" and "studying in the library" as activities that presumably could be enhanced by using the product.
"These activities are commonly performed by children and adolescents," the letter says. "Indeed, your reference to these activities seems to target this population."
The FDA also expressed concern over AeroShot's posting of news clips on its website that refer to the mixing of the product with alcohol as a party drug.
"Even though these news items express health concerns about taking AeroShot while drinking alcohol, your posting of the news items on the website where you promote and sell AeroShot publicizes such use," the letter states.
"We plan to work closely with the FDA to meet their requests for information and labeling changes to ensure compliance with dietary supplement requirements," Tom Hadfield, CEO of Breathable Foods, said in a statement. "AeroShot delivers a mix of B vitamins and caffeine to the mouth for ingestion and is not 'inhaled' into the lungs. AeroShot is not recommended or marketed to persons under 18 or for use with alcohol."
The FDA is giving Breathable Foods 15 working days to respond to the warning letter.
"You should take prompt action to correct the violations cited above," the agency said in the letter. "Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction."
In February, product inventor David Edwards told CNN it was safe and "thoroughly tested" before it was introduced.
"There are energy shots on the market that have 10 times the amount of caffeine in a single energy shot than we have in the AeroShot. ... The fact is we don't have that much caffeine in the product," he said.
One AeroShot contains 100 milligrams of caffeine dispensed in three to six "puffs."
"For most healthy adults, moderate doses of caffeine -- 200mg to 300mg, or about two to four cups of brewed coffee a day -- aren't harmful," according to The Mayo Clinic. It warns that more than 500-600 milligrams daily can cause problems such as insomnia, elevated heart rate, muscle tremors and stomach upset.
U.S. Sen. Charles Schumer, D-New York, sent a letter in December urging the FDA to examine the safety and legality of AeroShot.
"The bottom line is this product asks more questions than we have answers, and to have it on our shelves before those questions are answered is a serious, serious, serious mistake," he said in a news conference in February.
AeroShot falls under FDA regulations for dietary supplements. Those products include vitamin C pills, some weight loss products and certain energy drinks.
The company making them is responsible "for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading," according to the FDA website.
It's rare for the agency to prohibit a supplement. In 2004, it stopped the sale of the diet supplement Ephedra, but only after deaths and other serious side effects were reported.