The woman who operated numerous beauty product websites pleaded guilty to selling $2.3 million in non FDA-approved and misbranded drugs and medical devices according to a press release by the U.S. Department of Justice (DOJ). Kelly Luanne Schaible originally faced 25 counts, but pled guilty to one count of wire fraud and one count of introduction of misbranded medical devices into interstate commerce.
According to the indictment, starting sometime in 2009 and continuing until at least 2014, Schaible operated multiple companies to manage various aspects of her business, including registering and operating websites she operated as online retail stores. On her websites, Schaible sold non FDA-approved Botox and Juvederm and misrepresented to her customers that those products were safe to be used in a do-it-yourself manner with no prescription required. Multiple false statements were found on Schaible’s various websites, including, “A prescription is not required as [Schaible’s various companies] are… Oceania-based,” and “Non-controlled FDA approved medications can be imported for personal use.”
From 2009 until 2014, the DOJ alleges that Schaible made $1,700,000 selling approximately 9,500 units of the misbranded Botox and $630,000 selling approximately 4,000 units of the misbranded Juvederm. Around the time that a search warrant was executed on Schaible’s house in Henderson, Nevada, on June 18, 2014, the defendant attempted to destroy or dispose of a plastic bag containing vials of a white powder that later tested positive as botulinum toxin type A, the same ingredient that is in FDA-approved Botox. The active ingredient in Botox is a neurotoxin, but injecting the wrong kind into a human body can have long-lasting consequences. When Dr. Bach McComb injected three other people and himself with botulinum toxin not approved for human use, all four ended up being hospitalized and two were paralyzed for weeks.
Schaible is scheduled to appear in court on October 25, 2018 for sentencing. She faces up to 20 years in prison for the wire fraud charge and three years for the introducing a misbranded device into interstate commerce charge. The judge may order Schaible to pay fines in excess of $250,000. The U.S. Food and Drug Administration’s Office of Criminal Investigations investigated this case, and Assistant U.S. Attorney Carla Baldwin Carry is prosecuting the case.