As reported earlier on earlightswindle.com, the U.S. Food and Drug Administration has refused the import of Valkee’s HumanCharger earlight headset into the States, when it was misbranded as a therapy device. But now Valkee Ltd actually did a re–re–re–re-launch of their hokuspokus in Canada and the US. How is this possible?
Valkee’s resellers explain on amazon.com, how Valkee circumvents FDA requirements.
Hold on to your seats!
“Doesn’t this need FDA approval?”
“Only if advertised for use in Seasonal Affective Disorder. The product is advertised for Winter Blues”
It can not make any effectiveness claims, it gets no FDA approval – but it works “for winter blues”? That’s a synonym.
The USA is a known minefield for health fraud businesses like Valkee’s, because of class action suits. Power Balance, the magnetic wrist band sellers, had to return most of their shady businesses’ profits, because they made false health claims.
Valkee really doesn’t know better than to fool around with U.S. legislation. On the other hand, there is nothing to regain from Valkee, as the Company has no assets. They didn’t make even profits.
Congratulations to Merieux Developpement, TEKES and SITRA for making these shameful maneuvres possible. This is what sustainable businesses look like (in Finland)!