— -- A snortable cacao-based powder whose manufacturer claims offers "euphoric energy" and "calm focus," has hit the market in the U.S., but the new supplement -- which is not regulated by the U.S. Food and Drug Administration -- has been met with widespread skepticism from the medical community.
Coco Loko, produced by the Florida-based group Legal Lean, is marketed as "infused raw cacao snuff" with "a special energy blend," on its website. The chocolate powder is also described by the manufacturer as a stimulant that provides an endorphin rush AND A serotonin rush, which, they say, provides both energy and focus.
CEO of Legal Lean, Nick Anderson told ABC News that his company’s powder product is "probably equal to about two energy drinks."
"It's designed to give you an endorphin rush and a serotnin relelease. It gives you euphoric energy a little pep in your step, somethin extra to party and makes you get in the mood to enjoy your night," Anderson explained of the raw cacao, taurine and B6 blend.
The FDA told ABC News in a statement that it "isn’t aware of any consumer complaints or illnesses associated with this product at this time."
The government agency added that it is "not prepared to issue a determination regarding whether and how this product is subject to FDA jurisdiction at this time. In reaching that decision, FDA will need to evaluate the product labeling, marketing information, and/or any other information pertaining to the product's intended use."
The product’s introduction to the market has been met with skepticism and concern from some members of the medical community.
"It sure doesn’t sound good," Dr. Christopher Holstege, the chief of the Division of Medical Toxicology at the University of Virginia, told ABC News of the snortable chocolate, adding that he was especially concerned for people who have asthma or children with growing lungs.
Holstege added that lungs are not typically able to absorb supplements into the body, and the few medicines that are inhaled are often purified and have been extensively studied.
Dr. Jason Russell, an osteopathic physician in the Department of Toxicology at the Nationwide Children's Hospital in Columbus, Ohio, also raised concerns over the new product, saying it has the same risk factors as other energy supplements on the market--such as increased blood pressure, insomnia and increased heart rate. He added that these risk factors are multiplied, however, when you absorb a supplement through inhalation, as this process bypasses the mechanisms in your body that would help prevent caffeine toxicity.
But Anderson ensured the ingredients are OK to consume even saying he samples the product himself.
"We order our ingredients from very reputable websites and they give toxicology reports and analysis and I have to try all the batches," Anderson said. "I try it myself before I release anything and make sure it's up to the right levels before I release anything," he explained.
Russell also cautions that consumers can also easily snort more than intended, which could potentially cause an injury to your nasal passages and sinus tracts.
A final red flag for Russell is that Coco Loko does not provide any information on its caffeine content.
Anderson countered that overdose risk is highly unlikely.
"There is a very little bit of guarana, very little bit of the taurine, there is a very little bit of everything, it's mostly the raw cacao," Anderson said. "It makes up nearly 90 percent of the ingredients, so to overdose on chocolate and to have any health concerns you would have to eat like 10 pounds or some huge number," he added.
Anderson said the product is marketed to consumers 18 and over, but some parents may have concerns about teens using the product.
"As a parent of two teenagers, I think this is concerning. I think what’s also concerning is that teenagers will hear, ‘Oh it's natural, it's chocolate that means safe,'” Dr. Jennifer Ashton, ABC News' senior medical contributor, said on "Good Morning America." "There are a lot of drugs that are natural. Cocaine is natural, marijuana is natural ... that doesn't mean it is safe."
Though he didn't consult with medical professionals, he said he thinks the success of a product on sale in Europe that inspired his own, combined with the warning on Coco Loko packaging enough to keep consumers safe.
"I didn't consult with any medical professionals. I basically just saw what they were doing in Europe. There are no health issues, it’s been out two, three years, everyone seems fine," Anderson said.
"It says not to do more than half the container, I think everything is self-explanatory, there are warning labels on it and I don't think I would be responsible," Anderson explained.