Opinion

COA FS Recall: Understanding The FDA’s Regulatory Function In The Information Age

11 Mins read

We have been following with keen interest, the ongoing public spat between COA Herbal Centre, Cape Coast, and the Food and Drugs Authority (FDA) of Ghana, and the public debate it has engendered across the country. It is in the spirit of contributing to this national discourse, but more importantly, in contributing to and informing public health that we undertook the writing of this opinion editorial.

While we are neither manufacturers of drugs or food products/supplements (as COA Herbal Centre is), nor the regulators of such (as the FDA is), we believe that our training as pharmacists and pharmacy educators qualifies us to contribute to this discourse.

We – just like many well-meaning Ghanaians – were pleasantly surprised as early news of the FDA’s mandatory recall of COA FS, the much talked about “herbal immune booster” began to trickle in. Needless to say, our surprise was not because we thought COA FS was inviolable, after all, no FDA-licensed product is produced by angels. Rather, we wondered what could warrant such an expansive recall of a product of “international acclaim” by the FDA, effectively marking it as unsuitable for sale and/or consumption in Ghana. However, based on our professional training and familiarity with the FDA’s mandate and functions, we suspected that its action must be informed by strong and incontrovertible evidence of an unsafe product with the potential of causing harm or death to consumers.

In its press release dated 17th April, 2020 (Reference: FDA/CPED/PR/20/0004), the Food and Drugs Authority (FDA) – the statutory government agency tasked with exercising oversight over the manufacture and sale of food, cosmetic and medicinal products and devices – announced the mandatory recall of all batches COA FS Food Supplement, a herbal product manufactured by COA Herbal Centre, Cape Coast. Whereas the nationwide recall of the said product may have perplexed the general public, as well as healthcare professionals and businesses (e.g. pharmacies) due to its scope (all batches), the statutory mandate of the FDA to order such a recall was never in doubt. Specifically, the regulatory authority of the FDA as codified under part (7) seven of the Public Health Act, 2012 (Act 851) enjoins the FDA to “provide and enforce standards for the sale of food, herbal medicinal products, cosmetics, drugs, medical devices and household chemical substances”. Hence, whereas the general public may be ambivalent about the role of the FDA in safeguarding public health, its mandate in this regard is entirely guaranteed under the constitution of the Republic of Ghana.

In justifying its rationale for ordering such an expansive recall, the FDA outlined a series of safety concerns associated with the product, as well as infractions by the manufacturer that flouted the basic standards of the production of a safe product suitable for human consumption. Notably, the FDA highlighted safety issues across the production-market pipeline of COA FS Food Supplement including:

a) Excessive microbial, mold and yeast contamination; and

b) Contamination with E. coli, which must be absent in all products.

It is most important to emphasize that due to the potential for causing serious harm to consumers, observation of any of the aforementioned contaminants (above certain safe limits and/or in any quantity) in a food or drug product warrants their prompt removal and disposal to safeguard human health and safety. Thus, the FDA in acting as it did, carried out its statutory obligation of ensuring “adequate and effective standards for food, drugs, cosmetics, household chemicals, and medical devices” (Public Health Act, 2012, Section 82(a)).

We believe that much of the ongoing public debate regarding the “far-reaching” actions of the FDA is the consequence of lack of the awareness of full scope and importance of this state agency in protecting health and safety; in light of which we will attempt to share our unbiased opinions with the public.

Why recall COA FS?

We say, why not? Many manufacturers have had to recall their products at one time or another. This recall is not new; it is not the first, and it certainly will not be the last. Why should this product be treated differently? The prospect of infection and potential death should worry every conscientious person to laud the FDA’s action, but more importantly, to require a better production standard of the manufacturer. The FDA’s order for the product recall as clearly stated in its press release is sound and justified, and without equivocation. Failure or any delay in mandating a recall would constitute a wanton betrayal of its sacred duties. By its own public notice to “all key distributors and retailers of COA FS” and individuals in possession their products, COA Herbal Centre appears to have initiated a limited recall of two batch products (CFS00003 and CFS00004). While this exercise was prudent and noteworthy, it in no way precluded the FDA in ordering its recall based on the weight of its findings, nor should it have. In matters affecting human health and safety, it is most important to err on the side of caution, as is the case with the FDA’s issuance of a general recall of COA FS Food Supplements. This action puts a pause on the sale and manufacture of the product, while allowing both parties (COA Herbal Centre and FDA) the time to review the evidence, with the overall goal of safeguarding health and safety. It is therefore, important to emphasize that recalls are not bad, even if they tend to be disruptive. This is because it provides both parties the needed respite to make things better.

Why now?

We say, especially now. COA FS, for whatever it is truly worth is a widely marketed product with a corresponding widespread public consumption. Importantly, the product has garnered a high level of public acclaim recently, subsequently feeding into high sales, thereby perpetuating a production-sales-consumption cycle that is the dream of every entrepreneur. Invariably, an increase in demand of a product with its attendant success also mean additional pressure on a manufacturer; supply chains have to be expanded, and production capacity has to scaled up, etc. Sadly, this is typically the stage where most enterprises go south. Poor internal accountability and oversight of line staff results in errors in the supply-production chain, ultimately resulting in a poor product. While the specific source/cause of contamination in COA FS raw materials and product may not be readily known, one thing is most certain; according to the FDA, some if not all COA FS products may be contaminated. Therefore, all COA FS products must be recalled and production paused, until such a time as when the FDA has been satisfied of the availability of a safe product suitable for human consumption. In exercising this mandate, the FDA is not acting beyond its jurisdiction but entirely within it, the penalty for flouting it being clearly spelled out under Section 111(a) – (d) of the Public Health Act, 2012.

We are also very clear-eyed about the pressure that is exerted on public officials in the line of their work (by forces, be it personal, political, corporate, etc.) to influence oversight and pervert the course of justice. It is most heartening to observe the FDA under its Governing Board, and most capable Chief Executive Officer (CEO) have dispensed of their duties in an unbiased, professional, and apolitical manner. To them all Ghanaians do owe a lot of gratitude for safeguarding their health and safety.

Conspiracy theories

We cannot seem to get enough of them in this era of COVID-19, can we? “Opinions are like noses, everybody has one….”, so the saying goes. Perhaps, a revision to, “conspiracy theories are like noses, everybody has one”, may be needed in the current decentralized information (and social media) landscape to describe some people’s rush to advance very outlandish opinions about incidents they are unequipped to explain. What was more surprising to us was the zest with which people jumped to vilify the FDA for doing its job. One would imagine that the FDA would be praised for looking out for the good of the public; after all, that is what they are paid to do by the taxpayer. Rather, the FDA had to assume a defensive posture as elements of the general public and surrogates of COA Herbal Centre, and not to mention the Chief Executive Officer (CEO) of COA Herbal Centre, Prof. Samuel Ato Duncan took the FDA to task.

The vitriol heaped on the FDA is evidence that some people do not perceive it as sacrosanct, neither do we. However, the FDA was designed by law to be above reproach, and that is what we believe it to be. It is important for all Ghanaians to know that constitutional provisions are included in the Public Health Act, 2012 (Act 851) for persons affected by the FDA’s enforcement action to seek redress through an appeals process. Specifically, persons or entities seeking redress for issues relating to product registration and/or marketing authorization are enjoined by the act to submit a written appeal directly to the Chief Executive Officer (Section 118(6). Additionally, the FDA has provided a guidance on its website for appealing an enforcement action. This avenue for redress is available to all affected persons or entities, which includes the manufacturer of COA FS, no less. It would, therefore, save COA Herbal Centre a great amount of time and effort if they withdrew their ‘arbitration’ of the FDA’s enforcement action against them from the court of public opinion and directed it through the appropriate channel.

Wasn’t it the same FDA that gave them authorization to market the product?

Certainly, and justifiably so. In accordance with Section 117(2) of Act 851, the FDA “shall register the drug, herbal medicinal product, medical device, cosmetic or household chemical substance if the Authority is satisfied that the drug, herbal medicinal product, medical device, cosmetic or household chemical substance complies with the prescribed standards and that the manufacturing operations for the article comply with the prescribed current code of good manufacturing practice.”

Importantly, the recall of a licensed product does not constitute the suspension of market authorization. While initial registration of a product is based on the preliminary assessment of adherence to requisite standards, non-compliance with good manufacturing practices (GMP) may warrant a recall. In keeping with its oversight responsibilities, the FDA periodically conducts post-registration/market surveillance as well as site inspections, per its scheduled timetable, or acting on suspicions or reliable whistleblower reporting. From experience we know some manufacturers would submit high quality products to the FDA, and wittingly market substandard products to the public. It is therefore, very bewildering that sections of the public, as well as certain representatives of COA Herbal Centre would have the temerity to chastise the FDA for carrying out its duties appropriately.

How come none of the adverse effects have been reported?

A common refrain has been, ‘how come people haven’t reported any sickness from consuming this product?’. This is a most valid question and worthy of a response. The tracking of adverse effects of food and drug products is effectively handled by a strong pharmacovigilance agency. Unfortunately, the work of most pharmacovigilance units in most countries is hampered by low funding and poor communication channels between patients/customers, healthcare professionals/institutions and the pharmacovigilance unit. Notwithstanding, the work of the any pharmacovigilance unit should complement efforts by the product manufacturer in ensuring quality control (QC) mechanisms are in place across the production pipeline to assure a safe and effective product. Indeed, many large pharmaceutical manufacturers rely on their own pharmacovigilance units to aid in proactively tracking safety concerns associated with their products. Therefore, the burden of the general recall of COA FS falls squarely on the COA Herbal Centre, which should have had strict QC protocols in place in order to ensure that their products meet the standards for safe human consumption.

Additionally, the absence of reported cases of widespread adverse effects from the consumption of COA FS does not undercut the FDA’s duty to exercise its oversight responsibility as it has done in this case. The fact that widespread contamination has been discovered in the manufacturing process and in the marketed products absolutely justifies the FDA’s order for a product recall and suspension of manufacturing. We all know there are real challenges with reporting of adverse drug reactions (ADR) in Ghana so we do not need to wait for them occur before testing products. Besides, the FDA is not limited by ADR or the lack of it.

What next?

Perhaps, the most telling of the culture of safety at COA Herbal Centre is the strident but naïve posture of its representatives to this recall and its underpinnings. In a news report published on the online news portal – GhanaWeb.com – captioned, “The FDA, others trying to collapse my business – CEO, COA Herbal Center”, Prof. Samuel Ato Duncan, the Chief Executive Officer of COA Herbal Centre is quoted as saying, “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……since we announced that we were trying to investigate and develop the cure for HIV/AIDS, many people have developed a scheme to stop us” – (General News of Wednesday, 22 April 2020).

Indeed, the FDA will be doing the public a great service by completely cancelling the company’s authorization to market COA FS, until such a time when the full complement of the company’s employees has demonstrated a full understanding of their obligations as manufacturers of food supplement of the highest standard possible. On its face, Prof. Duncan’s admission that “two bags” (sic batches) of the product were contaminated constitutes an explicit acceptance of liability for putting the health and safety of consumers at risk. As written in Section 111(a) – (d) of the Public Health Act (Act 851), such betrayal of public trust may constitute an offence, viz.:

111. A person commits an offence if that person sells a drug, herbal medicinal product, cosmetic, medical device or household chemical substance which

a) has in or on it a substance that may cause injury to the health of the user when the article is used

i. according to the directions on the label accompanying the article; or

ii. for a purpose and by a method of use that is customary or usual;

b) consists in whole or in part of a filthy, rotten, decomposed or diseased substance or of a foreign matter likely to cause injury;

c) is adulterated; or

d) is prepared, preserved, packed or stored under insanitary conditions.

Importantly, Act 851 highlights the penalties for the above offence(s) under Section 129 as follows:

129. A person who contravenes sections 111 to 124 commits an offence and is liable on summary conviction to a fine of not less than seven thousand five hundred penalty units and not more than fifteen thousand penalty units or to a term of imprisonment of not less than fifteen years and not more than twenty-five years or to both.

Make no mistake, the FDA is fully vested with prosecutorial powers under the penal code as defined in Act 851, under Section 140 viz.:

140. The Authority may prosecute a person who contravenes a provision of this Part subject to section 56 of the Criminal and Other Offences (Procedure) Act, 1960 (Act 30).

Therefore, it should not come as a surprise to the public should the FDA exercise any of its prosecutorial powers in the exercise of its oversight responsibilities as related to COA Herbal Centre and COA FS.

What can COA Herbal Centre do?

First, accept complete responsibility for the recall of its products and the suspension of its manufacturing of the affected product. We gather from news reporting and COA Herbal Centre’s own recall notice that they either have complied or are in the process of complying with the FDA’s directives. Second, pledge its full cooperation with FDA in its quest to fully assess all aspects of the company’s manufacturing activities in the spirit of protecting the health of consumers. Third, commit to either provide a full refund or exchange for all returned (unopened) products; the latter might be less expensive and more convenient to do since it will likely buy them some time, while spreading the financial hit over a longer period of time as they restart production. Importantly, by offering an exchange at a later time, the company gets to keep its loyal customer following, and thus ensure a ready market for its products once it restarts production.

Disclaimer….

We make no representation as spokespersons for either the FDA or COA Herbal Centre. The opinions expressed herein are entirely ours as private citizens, and are based on information gathered from public sources and our interpretation thereof. Our opinions do not represent the views of our professional associations or employers.

About the authors:

John Nii A. Addotey, Dr. rer. Nat., M. Phil, B. Pharm: Dr. Addotey is a lecturer at the Department of Pharmaceutical Chemistry, KNUST.

Terrick Ajia-Badeck Andey, Ph.D., B.Pharm: Dr. Andey is an Associate Professor of Pharmaceutical Sciences, and Assistant Dean of Graduate Studies at Massachusetts College of Pharmacy and Health Sciences, USA.

Related posts
Opinion

Leaving Your Job for Entrepreneurial Aspirations? Keep These Things in Mind

3 Mins read
If you have entrepreneurial aspirations beyond your current 9 to 5 job, you aren’t alone. Fortune reported that as of last year,…
OpinionPolitics

Manasseh Azure Writes: Two Separate Videos On Akufo-Addo's Alleged Bribe

3 Mins read
A civil society advocate I respect very much sent me a video of the alleged Akufo-Addo bribe this morning, and said it…
OpinionPolitics

Kweku Baako Exposes The 'Villain' Behind Akufo-Addo's Alleged 'Bribe' Video

3 Mins read
Editor-in-Chief of the New Crusading Guide, Abdul Malik Kweku Baako, has exposed the individual behind the tape recording of President Nana Addo…

Leave a Reply

Your email address will not be published. Required fields are marked *