U.K. National Charged with Shipping Mislabeled and Unapproved ‘Treatments’ for Patients Suffering from COVID-19

          LOS ANGELES – A British man was named today in a federal criminal complaint that charges him with smuggling into the United States mislabeled drugs purported to be a treatment for those suffering from COVID-19, the disease caused by the novel coronavirus.

          Frank Richard Ludlow, 59, of West Sussex, United Kingdom, was charged with one count of introducing misbranded drugs into interstate commerce, a felony offense that carries a statutory maximum sentence of three years in federal prison.

          According to an affidavit filed with the complaint, beginning on March 1, as the coronavirus global health crisis worsened, Ludlow repackaged preexisting “Trinity Remedy” kits as “Trinity COVID-19 SARS Antipathogenic Treatment” kits, even though the kits had not been approved by the U.S. Food and Drug Administration to treat COVID-19 – or for any other use.

          Every major health authority has warned that there is no specific antiviral treatment for COVID-19 and no vaccine to prevent coronavirus infection. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior FDA approval.

          “Hucksters who hawk ‘treatments’ for this deadly disease put consumers’ lives at risk by peddling unapproved drugs,” said United States Attorney Nick Hanna. “We are aggressively investigating all types of criminal activity associated with the current health emergency, and anyone attempting to cheat the public during this time will face severe penalties.”

          “The FDA is actively and aggressively monitoring for unproven COVID-19 products including those attempting to be imported into the country— as part of our ongoing efforts to protect Americans during this pandemic. Unproven health claims, tests, and medical products can pose serious health risks and may keep people from seeking care or delay necessary medical treatment,” said Catherine A. Hermsen, Assistant Commissioner for Criminal Investigations, FDA Office of Criminal Investigations. “The FDA will continue to take appropriate action to protect consumers from bad actors who take advantage of a pandemic to increase their profits while jeopardizing the public health.”

          “Drugs and medical devices are strictly regulated in order to protect the American consumer,” said David A. Prince, Special Agent in Charge for Homeland Security Investigations (HSI) Los Angeles. “Individuals who circumvent those regulations potentially expose patients to unsafe products that could cause serious harm. HSI will continue to target those whose actions put the health and safety of our citizens at risk.”

          Ludlow, who is not a doctor, allegedly smuggled the kits from the United Kingdom to the United States by shipping mislabeled parcels containing the kits to individuals in California and Utah. Ludlow’s business relationship with his Utah connection dates back to May 2017 when he sold her “Trinity Remedy,” a “miracle cure” for her severe medical issues, the affidavit states.

          This “cure” – later rebranded as “Trinity Mind, Body & Soul” – allegedly contained vitamin C, an enzyme mix, potassium thiocyanate, and hydrogen peroxide. Consumers were instructed to add 18 ounces of water, say a prayer, drink half of the solution, take a probiotic along with bee pollen, and then ingest the remainder of the solution, according to the affidavit.

          Between May 2017 and March 2020, Ludlow sold his Utah connection between 300 and 400 of these “treatments” for $50 per kit, many of which she gave away, but some of which she sold for as much as $200, the affidavit states.

          In February or March of 2020, Ludlow began selling kits named “Trinity COVID-19 SARS Antipathogenic Treatment,” and these kits had the same ingredients as “Trinity Mind, Body & Soul,” according to court documents. Ludlow allegedly shipped the kits from the United Kingdom to Ogden, Utah and to the Forestville, California home of the Utah woman’s boyfriend. Ludlow allegedly also shipped kits to the Draper, Utah home of his Utah connection’s parents. Federal law enforcement intercepted the kits before they reached their intended destinations.

          On March 23, British law enforcement arrested Ludlow and charged him with violating drug laws. He remains in custody in the U.K.

          This matter was investigated jointly by the Food and Drug Administration’s Office of Criminal Investigations and Homeland Security Investigations, with assistance from U.S. Customs and Border Protection and the United States Postal Inspection Service.

          This case is being prosecuted by Assistant United States Attorneys Matthew W. O’Brien and Mark A. Williams of the Environmental and Community Safety Crimes Section.