Tulare County Man Indicted for Falsely Marketing Herbal Mixtures as FDA-Approved Treatment for COVID-19
- Written by FBI
- Category: California News
Fresno, California – A Porterville man was arrested today after a federal grand jury returned a five‑count indictment on July 9, charging him with mail fraud and introducing a misbranded drug into interstate commerce with the intent to defraud, U.S. Attorney McGregor W. Scott announced.
According to the indictment, Huu Tieu, 58, is the president and chief executive officer of Golden Sunrise Pharmaceutical Inc. and Golden Sunrise Nutraceutical Inc., both headquartered in Porterville. From at least April 25 to July 9, through his companies, Tieu marketed and sold a package of herbal mixtures dubbed the “Emergency D-Virus Plan of Care,” which he claimed treated COVID-19. In materials posted on the companies’ websites and Facebook pages and in emails to the media, Tieu made a series of false statements about the Emergency D-Virus Plan of Care, including:
- That one of the mixtures in the product, called “ImunStem,” was the first dietary supplement in the United States to be FDA approved as a prescription medicine to treat serious or life-threatening conditions and had specifically been approved to treat COVID‑19. In reality, the FDA has never approved any Golden Sunrise product for any intended use and, on at least two occasions, has told Tieu in writing that ImunStem is not FDA approved; and
- That ImunStem was designated as a Regenerative Medicine Advanced Therapy (RMAT) under the 21st Century Cures Act. In reality, the FDA never granted an RMAT designation to any Golden Sunrise product, denied Tieu’s request for an RMAT designation for ImunStem in 2017, and reiterated that denial to Tieu in writing in 2019.
According to the indictment, Tieu made these misrepresentations for the purpose of soliciting customers, both patients and health care professionals, to acquire Golden Sunrise products so that he could submit reimbursement claims to the patients’ insurers, including Medicare and Medi-Cal. Tieu dispensed his products to customers in the Porterville area and also shipped the products to other parts of California and the United States.
On May 8, an undercover investigator with the Tulare County District Attorney’s Office met with Tieu in person, telling him her mother was 68 and very sick with COVID-19. The investigator asked Tieu if she should take her mother to the hospital. Tieu responded, “No. You cannot go in there,” and instead, encouraged her to use Golden Sunrise products.
“The FDA is actively monitoring the marketplace for fraudulent products claiming to treat COVID-19. Americans expect and deserve treatments that are safe, effective and meet appropriate standards, and the agency will continue to bring to justice those who place profits above the public health during this pandemic,” said Special Agent in Charge Lisa L. Malinowski, FDA Office of Criminal Investigations Los Angeles Field Office. “We commend the efforts of our law enforcement partners in this investigation and today’s announcement should serve as a reminder that we will take appropriate action against those who jeopardize the health of Americans while taking advantage of a crisis.”
This case is the product of an investigation by the Federal Bureau of Investigation, the U.S. Department of Health and Human Services Office of Inspector General, the U.S. Food and Drug Administration, the U.S. Postal Inspection Service, and the California Department of Health Care Services with assistance from the Tulare County District Attorney’s Office and the California Bureau of Medi-Cal Fraud and Elder Abuse. Assistant U.S. Attorneys Vincente Tennerelli and Alexandre Dempsey are prosecuting the case.
If convicted, Tieu faces a maximum statutory penalty of 20 years in prison and a $250,000 fine on the mail fraud counts and three years in prison and a $10,000 fine on the misbranding counts. Any sentence, however, would be determined at the discretion of the court after consideration of any applicable statutory factors and the Federal Sentencing Guidelines, which take into account a number of variables. The charges are only allegations; the defendant is presumed innocent until and unless proven guilty beyond a reasonable doubt.