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These are the facts about FDA’s recall of dietary supplement, COA FS

Popular drug which was alleged to cure coronavirus, COA FS, has been recalled by the Food and Drugs Authority – news websites

True, the FDA issued a release on April 17, 2020, notifying the public that the drug has been recalled over contamination.

Full Text

COA FS is a locally manufactured drug in Ghana, which serves as a dietary supplement to support the Human Immune System to help fight a variety of diseases.

The drug was approved by the Food and Drugs Board as an immune booster for general well-being and was officially launched by its manufacturers, the Centre of Awareness Global Peace Mission, on June 11, 2019.  

Although a number of Ghanaians have attested to the drug’s efficacy after usage, the drug gained its utmost prominence among Ghanaians last month when it was alleged to be a cure for the novel COVID-19. 

It is on this premise that Dubawa took to verifying developing claims on the drug. 

Dubawa found that Professor Samuel Ato Duncan, the executive president of the centre, had suggested to the government and research institutions globally to further research the drug to determine its effectiveness against COVID-19 on the basis of its immune-boosting potential.  

Thereafter, stories emerged revealing that Ghana’s leading research institution, the Noguchi Memorial Institute, had responded to this suggestion by the manufacturers of the drug, adding that ‘clinical trials were ongoing on the drug’ to properly test and assess it. This was a process that was ongoing at the Institute, the Food and Drugs Authority, and the Centre for Plant Medicine.

Yet, some news sites had headlines which claimed the Institute had approved the drug to fight coronavirus. 

Dubawa further found that Noguchi Memorial Institute and the Food and Drugs Authority had both refuted the claim that the drug had been approved as a coronavirus cure.

Subsequent to this, a news report flagged to fact-checkers by Facebook as part of its Third-Party Fact-Checking Partnership claims the popular immune booster, COA FS, has been recalled by the Food and Drugs Authority (FDA).

Verification

Dubawa found that the Food and Drugs Authority (FDA)  issued a press release on April 17, 2020, notifying the public of a recall of COA FS as a result of laboratory analysis of samples of the drug which indicated excessive microbial, mold, yeast and E. Coli contamination.

The FDA indicated in the release that the contamination poses serious health risks such as abdominal pain, nausea and vomiting to consumers and that it can also lead to kidney failure and weakened immune systems. 

Dubawa also spoke to the Head of Communication at Food and Drugs Authority, James Lartey, who confirmed the information. He stated that the contamination is subsequent to the approval of the drug by the FDA, although it appears it has been there for some time. 

Mr Lartey emphasized that the drug itself is a good product and that it is just unfortunate that samples on the market have been contaminated. 

He further stated that the recall does not affect the registration of the COA FS drug by the FDA in any way.

The FDA, in interviews with the media, has defended its claims and explained how it arrived at the conclusion that the drug is contaminated.

Manufacturers Contest FDA’s Claims

The manufacturers of COA FS are however contesting FDA’s claim. In a press statement on April 21, they stated that results of microbial tests conducted on their product by the microbiology department of the Cape Coast Teaching Hospital do not support the FDA’s claims of contaminations. They added that similar tests are being conducted in other independent laboratories.

Conclusion

The COA FS drug, an immune booster, which has recently gained popularity among Ghanaians as a potential cure for Coronavirus, has been recalled by the FDA, following laboratory results which indicated contamination of samples of the drug. The Head of Communication at the FDA, Mr Lartey, has stated that the recalling of the contaminated drugs does not, however, affect the registration of the drug under the FDA.

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