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Law360 (April 1, 2020, 10:07 PM EDT ) A British man tried to ship a fake "miracle cure" panacea labeled as a treatment for the novel coronavirus from the United Kingdom to California and Utah in an effort to make money off the deadly pandemic, federal prosecutors allege in a complaint filed Wednesday in California federal court.
Frank Richard Ludlow, 59, of West Sussex in England, was charged with one count of introducing misbranded drugs into interstate commerce, a felony that carries a prison sentence of up to three years, according to the U.S. Attorney's Office for the Central District of California.
"Hucksters who hawk 'treatments' for this deadly disease put consumers' lives at risk by peddling unapproved drugs," U.S. Attorney Nick Hanna said in a statement Wednesday. "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."
Every major health authority has said there is no specific antiviral treatment or cure for COVID-19 and no vaccine to prevent coronavirus infection. Prosecutors said new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from the U.S. Food and Drug Administration.
Ludlow, who is not a physician, peddles a fake homeopathic panacea called "Trinity Mind, Body & Soul" that purportedly contains a mixture of vitamin C, enzymes, potassium thiocyanate and hydrogen peroxide, according to prosecutors. Consumers are instructed to add 18 ounces of water, "say a prayer," drink half of the substance, take a probiotic mixed with bee pollen, and then take the remainder of the substance, prosecutors said.
"Ludlow ... considered all of these ingredients to be natural and healthy," according to the affidavit.
The FDA has not approved Ludlow's concoction for any use, prosecutors said.
Dating back to May 2017, Ludlow has been selling the concoction to a business acquaintance in Utah as a "miracle cure" for her severe medical issues, according to the affidavit. Over the past three years, prosecutors said, Ludlow sold the woman 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 a pop.
But around February or March, as COVID-19 tore across the world, prosecutors said Ludlow began relabeling and selling his concoction as "Trinity COVID-19 SARS Antipathogenic Treatment." The mixture contained the same ingredients as the "Trinity Mind, Body & Soul" kit, according to the affidavit.
Ludlow tried to ship the newly labeled kits from the U.K. to his business acquaintance in Utah, as well as to her boyfriend in Forestville, California, according to prosecutors, but federal law enforcement officers intercepted the kits before they reached their intended destinations.
When the shipment was seized, the label description was "60 Water Treatment," according to the affidavit, but when law enforcement opened the box, it contained pink plastic kits bearing the name "Trinity COVID-19 SARS Antipathogenic Treatment."
Law enforcement has sent a kit to be tested by the FDA, according to the affidavit, and the results are still pending. Ludlow's Utah connection also agreed to surrender an additional 64 fake COVID-19 kits that she had received from Ludlow, according to the affidavit.
British law enforcement arrested Ludlow on March 23 and charged him with violating drug laws. He remains in U.K. custody, according to prosecutors.
"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," Catherine A. Hermsen of the FDA Office of Criminal Investigations said in a statement. "Unproven health claims, tests, and medical products can pose serious health risks and may keep people from seeking care or delay necessary medical treatment."
This isn't the first time the FDA has cracked down on people pushing unapproved coronavirus treatments.
Last month, the FDA sent letters to televangelist Jim Bakker, Vital Silver, Quinessence Aromatherapy Ltd. and other companies that sell or advertise teas, essential oils and other alternative therapies such as colloidal silver, ordering them to correct their websites or face legal action.
Contact information for Ludlow was not immediately available.
The government is represented by Matthew W. O'Brien and Mark A. Williams of the U.S. Attorney's Office for the Central District of California.
Counsel information for Ludlow was not immediately available.
The case is U.S. v. Frank Richard Ludlow, case number 2:20-mj-01469, in the U.S. District Court for the Central District of California.
--Editing by Daniel King.
For a reprint of this article, please contact reprints@law360.com.
