The FDA’s new rules spell out a process for evaluating the tests, but not the manufacturers. As a result, even companies led by CEOs with a history of legal entanglementsResponding to USA TODAY’s findings, the FDA said in a written statement that it takes fraud seriously and “continually monitors and conducts surveillance for fraudulent and inappropriately marketed medical products, including tests.
Edalat has a history with the FDA. In 2014, the agency went to court to stop his company, SciLabs Nutraceuticals, from selling dietary supplements, alleging the products had not been tested to ensure they contained only dietary ingredients. At the time, Edalat said: “We would rather work with the FDA than fight them; they play a critical role in consumer safety.”
“Defendant Paul Edalat is a fraud,” the investor lawsuit alleges. It contends he tried to fool investors with his extravagant lifestyle: staying in luxury suites, “wearing a diamond-studded gold Rolex watch which he brags that he purchased for more than $50,000,” and “driving fancy cars, including two Rolls-Royces, three Lamborghinis, a Land Rover, a BMW, a Ferrari, and a Hummer, among others.”