Department of Justice
Western District of Missouri
FOR IMMEDIATE RELEASE
Wednesday, July 27, 2022
At Least 10 Patients Suffered Injury from Treatment with Chinese Products
KANSAS CITY, Mo. – The former owner of a Kansas City, Mo., medical spa pleaded guilty in federal court today to providing illegal treatments to his patients, several of whom suffered adverse effects from the foreign products.
Richard B. Smith III, 46, of Shawnee, Kansas, waived his right to a grand jury and pleaded guilty before U.S. District Judge Howard F. Sachs to a federal information that charges him with one count of receiving misbranded drugs (foreign and unapproved Botox) and delivering them for pay with the intent to defraud or mislead, and one count of receiving adulterated devices (Juvederm Ultra 3) and delivering them for pay with the intent to defraud or mislead.
Smith owned and operated Tap and Blade, located at 7208 Wornall Road, Suite 206, in Kansas City, Mo. Tap and Blade offered medical services, such as injections of prescription drugs, including Botox, and prescription devices to enhance facial features, including Juvederm Ultra 3. Tap and Blade also offered cosmetic services, such as microblading, brow shading, and cool sculpting. Smith was the only employee of Tap and Blade and performed all the procedures offered at the clinic.
The U.S. Food and Drug Administration, Office of Criminal Investigations began investigating Tap and Blade in December 2020 based on information that multiple patients suffered injuries after receiving treatment at Tap and Blade. Agents executed a search warrant at Tap and Blade on April 7, 2021, and found boxes of Juvederm Ultra 3 as well as three syringes filled with Botox.
By pleading guilty today, Smith admitted that he obtained Botox and Juvederm Ultra 3 over the internet and without a prescription from a website in China. Smith purchased the products from Alibaba.com because the foreign products were significantly cheaper, which allowed him to lower his cost compared to his competitors and led him to gain more customers.
Smith admitted he never told his patients he was using foreign prescription drugs and devices that had not been approved by the FDA. Smith estimated he treated approximately 50 to 60 customers. Smith treated at least 10 patients who suffered a bodily injury after being treated with Juvederm Ultra 3.
During the more than three years Tap and Blade operated, from Jan. 1, 2018, to April 30, 2021, there was never a medical doctor associated with the spa, nor was there a doctor overseeing procedures. Smith admitted that he knew his patients should have seen a doctor prior to receiving treatment, and that he told them there was a doctor on staff. Prior to opening Tap and Blade, Smith practiced injections on honeydew fruit, fake heads, and fake skins.
The FDA approval of Botox limits the drug to use under the supervision of a licensed practitioner, thus, it is a prescription drug. Smith admitted that the foreign and unapproved Botox he purchased for use at his spa was misbranded because it did not bear adequate directions for use.
Upon being injected beneath the skin’s surface, Juvederm adds volume and lift to smooth wrinkles and folds. Juvederm products are regulated as devices because, when injected, they are intended to reside under the skin and do not achieve their primary intended purpose through chemical action or metabolization. The FDA’s approval for Juvederm products limits them to use under the supervision of a licensed practitioner, thus, they are prescription devices. Juvederm Ultra 3 is not legal for distribution in the United States because it lacks FDA approval.
Under federal statutes, Smith is subject to a sentence of up to six years in federal prison without parole. The maximum statutory sentence is prescribed by Congress and is provided here for informational purposes, as the sentencing of the defendant will be determined by the court based on the advisory sentencing guidelines and other statutory factors. A sentencing hearing will be scheduled after the completion of a presentence investigation by the United States Probation Office.
This case is being prosecuted by Special Assistant U.S. Attorney Bradley Cooper. It was investigated by the Food and Drug Administration Office of Criminal Investigation.
USAO - Missouri, Western