Ghanaian Times: COA, FDA tango unhealthy!

It is a fact that the Food and Drugs Authority (FDA) was established to regulate the production of medicines particularly for human consumption among others.

The other fact is that they have to license all manufacturers before they can produce medicines in the country.

They have since their existence played this role effectively and have received commendation from both industry players and the public.

Thus far, there have been very little to warrant much criticisms of the FDA and its operations.

That is why their tango with Centre of Awareness (COA) Herbal Centre over the production of COA FS food supplement surprises everyone.

Under normal circumstances, this should have been an in-house matter that could have been resolved without controversy.

The FDA and COA Herbal Centre have been engaged in public spar following an order by the regulator to the manufacturer of the food supplement to withdraw its product from the market claiming that it is contaminated with yeast, mould and E-Coli.

It noted that the contamination poses serious health risks to consumers adding that the E. Coli contamination could cause diarrhea, abdominal pain and vomiting with instances of kidney failure in extreme circumstances.

But in a sharp rebuttal, the centre described the claims by FDA as untrue.

According to a statement released in response to the order, the centre stated that a microbial test for the identified samples with batch numbers CFS00003 and CFS00004 on reference samples from the microbiology laboratory of the Cape Coast Teaching Hospital and the result of the microbial test did not disclose contamination by yeast, mold and E-Coli as indicated in the FDA press statement.

“We are currently conducting similar tests on the above batches in other independent laboratories and we expect the results soon which will also be communicated to the general public. It, therefore, cannot be the case that COA FS produced by the COA Herbal Centre are contaminated,” it held.

The centre argued that the samples in question had been subjected to annual review and certification by the FDA under prescribed regulatory standards with the last approval given, to cover the year 2020.

“We are proud to say that COA FS, since its registration by the FDA in 2016 has passed all microbial tests and this anti-microbial activity has been experimentally confirmed. We therefore find the statement from the FDA that they detected a microbial contamination in COA FS as a surprise.”

“Contrary to their claims, the evidence rather indicates that people with weakened immune systems and/or kidney malfunctions, rather got better after taking COA FS. We find it unfortunate that the FDA seeks to associate the alleged contamination in COA FS to kidney failure.”

The Ghanaian Times is not interested in taking sides as this point in time but we are extremely concerned about the public exchanges between a regulator and a manufacturer.

We are mindful of the fact that the FDA is mandated to work to protect the health and safety of the citizenry and should be supported by all to do so.

This means that there should be an enviable rapport between a regulator and manufacturers to ensure the production of quality medicines and products that are safe and meet the needs of the citizenry.

A prolonged tango between the two is not in anybody’s interest. It would ultimately stagnate the much-needed growth we need in the food and drugs manufacturing sector because businesses would be pushed away from investing in the sector.

We call for an immediate ceasefire and engagement, devoid of the harsh exchanges, to resolve the differences and pave the way for effective partnership.