Kelly Luanne Schaible, Misbranded Drugs and Devices, Nevada 2017

Counterfeit beauty products have flooded the market in recent years, but few cases have reached the level of desperation as seen in the indictment of Kelly Luanne Schaible, 55, of Henderson, Nev.

Schaible is accused of selling non-FDA approved prescription drugs containing Botulinum Toxin Type A, also known as Botox, and non-FDA approved prescription devices containing hyaluronic acid, also known as Juvederm related products. The indictment alleges that she knowingly marketed, sold, and distributed these products on her company’s websites, AAE d/b/a Basics, Inc.; Basics, Inc.; and Basics Inc., Ltd.

The indictment charges Schaible with nine-counts of wire fraud, six-counts of mail fraud, four-counts of introduction of misbranded drugs into interstate commerce, five-counts of introduction of misbranded medical devices into interstate commerce, and one-count of destruction of evidence. The maximum statutory penalty for these charges is up to 20 years in prison and a $250,000 fine.

Schaible sold approximately 9,500 units of misbranded prescription drugs containing Botulinum and received approximately $1.7 million in sales revenue. She also sold approximately 4,000 units of misbranded Juvederm products and received approximately $630,000 in sales revenue.

The indictment further alleges that after a search and seizure by FDA Special Agents, Schaible attempted to destroy a plastic bag containing vials of Botulinum for the purpose of preventing and impairing the investigation.

The case is being investigated by the Food and Drug Administration-Office of Criminal Investigations, and prosecution is being handled by Assistant U.S. Attorney Carla B. Higginbotham. The trial is scheduled for May 8, 2017.

The public is reminded that an indictment is merely an accusation, and a defendant is presumed innocent unless and until proven guilty in a court of law. This case serves as a warning to those who attempt to introduce illegal products into the U.S. marketplace.

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