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Opinions of Tuesday, 28 April 2020

Columnist: Victor Wutor

Ghana FDA vs COA FS brouhaha


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“It’s like they are trying to collapse the company. The fact that two bags of the product was contaminated does not mean all the products in the market was not good for our consumers” … Prof. Samuel Ato Duncan, The Chief Executive Officer of COA Herbal Center (ghanaweb, General News of Wednesday, 22 April 2020).

The above statement gives me goose bumps and sends shivers down my spine! It either depicts absolute ignorance or complete misunderstanding of the point the Food and Drugs Authority (FDA) is making. Now, if one capsule (not even a bag/container, just one capsule) shows microbial contamination, you may have to pull the batch off the shelves and if more than one batch is implicated, you will have to pull the entire product from the market. The FDA may even ask for everything to be pulled off the shelves even if one batch was implicated and there is evidence to show failure in the quality assurance system. This is normal practice for all regulatory organizations around the World.

Also, for Prof Samuel Ato Duncan to go testing samples from some bottles at the Cape Coast Hospital lab (don’t labs need accreditation for such projects?) and using their negative result to chastise the FDA is just not acceptable. Why do I say this? Firstly, Test A may show negative results while Test B will be positive (e.g. growing microorganisms on agar plates vs using PCR based technique). Secondly, the fact that bottle A shows positive microbial contaminants does not mean that bottle B will do same (though they may come from the same batch).

Thirdly, the ability of the lab to perform tests that produce accurate, consistent and reliable report is important in such analysis and it is public knowledge that the FDA’s Microbiology lab which performed the test being contested by Prof Samuel Ato Duncan is accredited to the ISO/IEC 17025-2017 standard by the ANSI-ASQ National Accreditation Board /ANAB of the United States of America. This means that results from the FDA’s lab can be relied upon worldwide.

Microbial contamination can degrade products or, more concerning, can infect and injure patients. According to the US Pharmacopeia (USP), dietary supplement ingredients should be entirely devoid of Escherichia coli, Salmonella, Staphylococcus aureus, or Clostridium species! These are some of the bugs identified in COA FS on the Ghanaian market and at the manufacturing plant.

Pharmaceutical product recalls occur on regular basis all around the World and there are stringent conditions for manufacturers to satisfy before such products are allowed on the market again. Let me give you a few examples from other parts of the World.

Not quite long ago, two dietary supplements, “Zero For Him” and “Arthri-D” were recalled for possible Salmonella contamination in the United States. No illnesses had been reported to date in connection with this issue.

Zero for Him is a supplement that is distributed through Amazon. Routine testing by the company discovered Salmonella bacteria in one bottle. The product was tested and re-tested and no more bacteria were found, but the supplement was recalled out of an abundance of caution. Distribution of the product was suspended while the United States Food and Drugs Authority (US FDA) and the company investigated the problem. Arthri-D was recalled for the same issue. Routine testing by the company revealed the presence of Salmonella bacteria in one bottle. Again, the product was tested and retested and no more bacteria were found, but the recall was issued to protect consumers. The company stopped distribution of the product while an investigation continued.

Dietary supplement contaminated with bacteria/fungi/mold/yeast have been linked to patient harm. Below are three examples -

A bone marrow transplant recipient began taking multiple oral naturopathic supplements and developed hepatic mucormycosis. Fungi, including Aspergillus, Rhizopus, and Mucor, were identified in 4 of 10 different supplements, but it was Mucor indicus from the patient’s liver aspirate that DNA sequencing found to be identical to one of the contaminated dietary supplements (Occurred in the USA).

A 10-year-old girl developed appendicitis and liver abscesses from mucormycetes (Absidia corymbifera), which DNA sequencing identified from a probiotic she used (occurred in France).

A fatal case of gastrointestinal mucormycosis occurred in a premature neonate given a dietary supplement. DNA sequencing identified Rhizopus oryzae in a tissue sample that matched the dietary supplement (Occurred in the USA).

I strongly disagree with the argument that the FDA is being too harsh on the manufacturer of COA FS. Also, those who argue that the product should not have been approved initially for sale are speaking from a point of ignorance re protocols/procedures.

Now, if one submits an application to register a product as a food supplement, there is no need for clinical trials. This is a standard registration procedure. Once the active ingredients are known/listed, you get a market authorization after toxicity tests have been done to ascertain safety profiles. These were all done and the product passed! The fact that a product has passed such tests does not mean the FDA is done with their job. They have a responsibility to monitor every product on the market. Post-marketing surveillance (PMS) (also post market surveillance) is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.

It was during one of such monitoring episodes that the FDA detected microorganisms in more than one batch of COA FS and also at the manufacturing plant and immediately notified the company with directions/guidance. Unfortunately, they did not comply and resorted to an outmoded strategy of pitching the public against the FDA.

The FDA has a Safety Monitoring Department that derived their mandate to ensure the safety of regulated products from the Public Health Act, 2012, Act 851, Part 7, Section 125. The Department is mandated to continually monitor the safety of the products regulated under the Public Health Act 851 by analysis of the adverse effect or event reports and by any other means and take appropriate regulatory action when necessary.

Science may not have all the answers to our questions or problems, but we need to allow our institutions to work. The FDA is out to protect the public, and we should allow and support them to do their job!

Prof Samuel Ato Ducan, please work with the regulator to fix the problem, or go to court if you have evidence of any wrongdoing! Fighting them in the media is not the best way forward!

And for all those questioning the FDA's position, please ask yourselves if you will take a contaminated drug or give one to your child, parents or a loved one? At the end of the day, drug recalls are in the interest of public health and safety!

Disclaimer – I have NO interest in the Ghana FDA and DO NOT import/manufacture any product that competes with COA FS.

Victor Wutor

PhD, MBA, MSc, B.Pharm (Hons)

Lethbridge, AB. Canada

vcwutor@gmail.com

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