DEBUNKED: Prothione not a Covid-19 supplement
Rwanda Food and Drugs Authority (FDA) on Sunday debunked circulating claims about the presence of a dietary supplement called Prothione to be used in the management of Covid-19.
The authority also dismissed the registration certificate Rwanda FDA-FS-MA-0023 being circulated to justify registration status for the product as misleading since it was issued upon registration of a different product.
“Rwanda FDA has not registered any indication of this product for the management of Covid-19. Instead, Rwanda FDA regulated a phase II clinical study that evaluated The efficacy and safety of Prothione Capsules for mild to moderate Coronavirus Disease 2019 (Covid-19),” the agency said in a statement.
“This is not equal to registering the concerned product; nor authorising it to enter the market,” further states the statement.
The authority argues that the circulating registration certificate was issued upon registration of a dietary supplement called Immune Formulation 200 (IF200).
“From the regulatory perspective, IF200 and Prothione are two different products.”
According to FDA, IF200 is a dietary supplement not a pharmaceutical product.