LOS ANGELES (CNS) - A federal criminal complaint filed today in Los Angeles charges a British man with smuggling into the United States mislabeled drugs purported to be a treatment for those suffering from COVID-19.
Frank Richard Ludlow, 59, of West Sussex, is charged with one count of introducing misbranded drugs into interstate commerce, a felony offense that carries a sentence of up to three years in federal prison, according to the U.S. Attorney's Office.
Federal law enforcement intercepted the so-called coronavirus “treatments” before they reached their intended destinations, prosecutors allege. British law enforcement arrested Ludlow last week and charged him with violating drug laws, and he remains in custody in the U.K., according to federal prosecutors.
Beginning on March 1, as the coronavirus global health crisis worsened, Ludlow allegedly 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, according to an affidvit filed with the complaint.
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 U.S. Attorney Nick Hanna in Los Angeles. “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.”
Ludlow, who is not a doctor, allegedly smuggled the kits from the U.K. to the U.S. by shipping mislabeled parcels containing the kits to individuals in California and Utah. Ludlow's business relationship with his unnamed Utah connection dates back to May 2017 when he sold her “Trinity Remedy,” a “miracle cure” for her severe medical issues, the affidavit alleges.
The purported 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 last month, Ludlow sold his Utah connection between 300 and 400 of the “treatments” for $50 per kit, many of which she gave away, but some of which she sold for as much as $200, the affidavit alleges.
In February or last month, Ludlow began selling kits named “Trinity COVID-19 SARS Antipathogenic Treatment,” which 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, prosecutors said.
“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,” said Catherine A. Hermsen, assistant commissioner for criminal investigations at the FDA Office of Criminal Investigations.
“Unproven health claims, tests, and medical products can pose serious health risks and may keep people from seeking care or delay necessary medical treatment,” she said.