The FDA on Friday gave its safety thumbs down to Oleandrin — the extract the MyPillow CEO has pushed as a possible coronavirus cure.
Oleandrin, could not “reasonably be expected to be safe” as a dietary supplement, the Food & Drug Administration wrote in a letter to Phoenix Biotechnology, which had applied for the agency’s approval.
MyPillow CEO Mike Lindell, who sits the board of Phoenix Biotechnology, was touting Oleandrin to President Trump and the White House last month as a promising — but unproven — “cure” for the coronavirus, Axios reported at the time.
“This thing works — it’s the miracle of all time,” Lindell, said in a contentious CNN interview Anderson Cooper while discussing the possible use of Oleandrin as coronavirus antidote last month.
Trump, when asked about the extract last month, said the White House would “look at it” as a possible way to fight the virus.
“We’ll look at it. We’re looking at a lot of different things,” Trump told reporters at the time.
It’s not clear if the president ever pressed the FDA on exploring the drug to beat back the coronavirus and the FDA’s letter, dated Aug. 14, doesn’t address its potential use for COVID-19.
“We also note that, even if ‘Oleandrin’ was not excluded from the definition of dietary supplement, the agency has significant concerns about the evidence included in your submission as a basis for concluding that a dietary supplement containing ‘Oleandrin’ will reasonably be expected to be safe under the conditions of use described in your notification,” the FDA wrote.
The agency reasoned that Phoenix Biotechnology had already explored Oleandrin as a potential prescription drug and could not simultaneously try to get permission for its sale as a supplement, a designation with fewer regulations.