Allegations involving foreign-sourced Botox and unapproved Juvederm have a Tulsa, OK spa owner in serious hot water.  According to a recent U.S. Department of Justice (DOJ) press release, Elisa Kaye Sanders was indicted on multiple mail fraud and wire fraud charges related to the purported use of Botox and Juvederm from “unauthorized sources” on unwitting clients of L’Chaim Medical Spa (formerly Enhance Skin and Body Medical Spa).

The DOJ press release references some pretty egregious conduct. For instance, Sanders allegedly used foreign-sourced Botox on spa clients, sent altered medical records to a client’s doctor, and funneled Botox from unauthorized sources to a third-party’s business after being warned by FDA about this illegal activity in 2016.

Although FDA has repeatedly warned the medical community about risky and illegal sourcing practices, rogue medical spas are either not getting the message or they are simply ignoring it altogether.  As a result, vulnerable clients of these spas will continue to be at risk unless FDA adopts a different approach.  A greater role by the agency’s Office of Criminal Investigations (OCI) is needed, but opioid and other controlled substance cases appear to be pulling OCI in a different direction.  OCI’s press releases over the last several years support this conclusion. It seems as if OCI’s mission-creep has turned into a full-fledged mission-leap.

OCI and its law enforcement counterparts are understandably scouring international mail facilities for smuggled opioids and other controlled substances. Whether foreign versions of Botox and Juvederm (and many more) are being overlooked in the process remains to be seen.  One thing is for certain, criminals will continue to exploit our nation’s legitimate drug and device supply chain without a more robust presence from OCI.  Rogue medical spas might just be the tip of the patient-safety iceberg.