FDA’s Office of Dietary Supplement Programs has responded to a new dietary ingredient notification regarding an ingredient called Oleandrin, the subject of several news stories in the mainstream media and trade press in recent weeks.
A biotech company in Texas that has researched its product to treat COVID-19 faces obstacles over its plans to market “Oleandrin” as a bulk dietary ingredient for use in dietary supplement products.
In response to a new dietary ingredient notification (NDIN) submitted by Phoenix Biotechnology Inc., an FDA official in the Office of Dietary Supplement Programs (ODSP) stated Oleandrin is excluded from the definition of a dietary supplement because, essentially, it was first studied as a drug.
The irony is that FDA cited drug trials by the same company that wants to market Oleandrin as a supplement—Phoenix Biotechnology. Oleandrin is a molecule extracted from the Nerium oleander plant. “Based on available information, FDA has concluded that ‘Oleandrin’ has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,” an FDA spokesperson, said in an email.
In response to warning letters, some companies have argued the “concept of ‘substantial clinical investigations’ isn’t well defined and may not be as easy a test to meet as FDA has suggested it is.
Phoenix Biotechnology could overcome the hurdle identified by FDA by establishing Oleandrin was marketed in a food or supplement before it was authorized for investigation as a new drug. According to FDA, it’s not aware of any evidence that Oleandrin was marketed as a food or supplement before it was authorized for investigation as a new drug.
Botanical experts warned oleander is dangerous and can even cause death. “With respect to oleander, all parts of the plant are highly toxic, dangerous and life-threatening when ingested” said executive director of the American Botanical Council (ABC). Consumer safety comes first, don’t risk getting shut out by the FDA for having unlawful ingredients for sale. HawkScanner is extremely essential for cases like this allowing you to act fast when issues come up and to focus on driving improvement. Sign up for an account at no cost today.