Oleandrin Rejected As Food Supplement Ingredient By FDA

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Last month Mike Lindell, CEO of MyPillow, who recently joined the Phoenix Biotechnology board and owns a financial stake in the company, said he attended a July White House meeting with the President Donald Trump regarding the use of oleandrine as a potential therapy. for the coronavirus.

The extract comes from the Nerium oleander plant; raw oleander is very poisonous and its consumption can be fatal. There are no published peer-reviewed studies on the impact of oleandrin on Covid-19, and there is no public evidence that it has been studied in patients with Covid-19. .

On June 2, Phoenix Biotechnology submitted oleandrine to the FDA as a new ingredient in dietary supplements, outlining the dosage and saying it is only for adults. If a dietary supplement contains a new ingredient, manufacturers must notify the FDA, and the agency will review it for safety – not effectiveness – and determine if it can be marketed as a dietary supplement.

The FDA’s response letter, dated August 14, was released by the agency on Wednesday. He said the company had already tested oleandrin as a potential prescription drug and at the same time couldn’t apply for approval to sell it as a supplement – a category that was almost unattended.

Even though it had not been excluded from the definition of a dietary supplement under the law, the agency had “significant concerns about the evidence included in your submission as a basis for concluding that a dietary supplement containing ‘ Oleandrin ‘should be reasonably careful’ if used in the manner described by the company.

The FDA said Phoenix Biotechnology provided evidence of a history of medicinal use of Nerium oleander extracts and evidence from preclinical and clinical studies, but the safety evidence was not “qualitatively and quantitatively” related with oleandrine as a supplement.

“Studies in advanced cancer patients generally cannot establish the safety of your ingredient in its target population of normal, healthy adults, and you have not provided any information indicating that such extrapolation between different populations would be scientifically. valid, ”reads the letter from the FDA.

The letter from the FDA did not mention the use of the extract as a treatment for Covid-19.

Lindell, who has no scientific or medical training, previously said he was so excited about the product as a Covid-19 treatment that he started taking the extract prophylactically and encouraged his friends to do the same.

He had brought his research to Housing and Urban Development Secretary Dr Ben Carson, a member of the White House Coronavirus Task Force. Lindell said in July that Carson was “just amazed” and thought “it was very exciting to see all the data. ”

After Lindell met Trump in July, he described the president’s response to the snippet as “enthusiastic.” Lindell told CNN in July that Trump wanted the FDA “to catch on.”

Asked about the snippet in August, Trump said he had ‘heard’ about oleander and said, ‘We’re going to watch it, we’re going to watch it, we’re looking at a lot of different things. It is not known if Trump raised the issue with the FDA.

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