11/01/2024 | Press release | Distributed by Public on 11/01/2024 10:27
BOSTON - A Stoughton woman has been arrested and charged in connection with smuggling goods into the United States and selling/dispensing counterfeit drugs and devices.
Rebecca Fadanelli, 38, was charged by criminal complaint with one count of illegally importing merchandise contrary to law, one count of selling or dispensing a counterfeit drug, and one count of selling or dispensing a counterfeit device. Fadanelli was arrested this morning and will appear in federal court in Worcester at 1 p.m. this afternoon.
According to the charging documents, since March 2021, Fadanelli, the owner of Skin Beaute Med Spa with locations in Randolph and South Easton, Mass., has been importing counterfeit Botox, Sculptra and Juvederm from China and Brazil and performing thousands of injections of counterfeit drugs and devices for which she received over $900,000 in client payments. It is alleged that Fadanelli consistently represented to clients and employees that she is a nurse; in fact, Fadanelli is an aesthetician and is not licensed nor certified to dispense or administer prescription drugs or devices. According to payment records, from approximately March 2021 through March 2024, Fadanelli completed approximately 1,631 Botox appointments, totaling $522,869 in client payments, and 1,085 filler appointments, totaling $410,545 in client payments.
"For years, Ms. Fadanelli allegedly put unsuspecting patients at risk by representing herself to be a nurse and then administering thousands of illegal, counterfeit injections. Protecting the people of Massachusetts covers a wide range of conduct and here it involves an individual who ignored safety regulations against bringing unapproved, counterfeit drugs and devices into our country and endangered the health of hundreds of her clients. The type of deception alleged here is illegal, reckless and potentially life-threatening," said Acting United States Attorney Joshua S. Levy. "Today's arrest underscores our commitment to protecting the public from fraudulent and dangerous practices in the medical and cosmetic fields."
"Individuals who dispense and administer counterfeit injectable cosmetic drugs or medical devices, such as Botox or Juvederm, put the health of unsuspecting American consumers at significant risk," said Special Agent in Charge Fernando McMillan, FDA Office of Criminal Investigations New York Field Office. "We will continue to pursue and bring to justice those who choose to subvert the safeguards of the legitimate drug and device regulatory regime and supply chain and jeopardize the public health."
"Every day, our frontline CBP officers and agriculture specialists work tirelessly to protect the American public from illegal and harmful counterfeit products being smuggled into the United States. This case is a prime example of the collaborative efforts that are taken by our law enforcement community to bring these violators to justice," said Jennifer De La O, Director of Field Operations for U.S. Customs and Border Protection in Boston.
The charge of importing merchandise contrary to law provides for a sentence of up to 20 years in prison, three years of supervised release and a fine of $250,000. The charges of knowingly selling or dispensing a counterfeit drug or counterfeit device each provide for a sentence of up to 10 years in prison, three years of supervised release and a fine of $250,000. Sentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and statutes which govern the determination of a sentence in a criminal case.
If you or a family member believe you received services involving a counterfeit drug or counterfeit device from Fadanelli and/or Skin Beaute Med Spa between 2021 through and including to the present date, please complete the questionnaire located on the FDA's website at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/criminal-investigations/oci-vw-assistance. Information about the status of the case is located on the U.S. Attorney's Office website: https://www.justice.gov/usao-ma/victim-and-witness-assistance-program/united-states-v-rebecca-fadanelli.
Acting U.S. Attorney Levy, FDA OCI SAC McMillan and CBP Field Operations Director De La O made the announcement today. Assistant U.S. Attorneys Leslie Wright and Sarah Hoefle of the Criminal Division are prosecuting the case.
The details contained in the charging documents are allegations. The defendant is presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law.