{"id":14823,"date":"2026-11-11T08:15:52","date_gmt":"2026-11-11T08:15:52","guid":{"rendered":"https:\/\/globalnigerianews.com\/index.php\/2026\/11\/11\/why-nafdac-must-rethink-the-approval-of-herbal-medicines-olatunde-isaac-businessday-ng\/"},"modified":"2026-11-11T08:15:52","modified_gmt":"2026-11-11T08:15:52","slug":"why-nafdac-must-rethink-the-approval-of-herbal-medicines-olatunde-isaac-businessday-ng","status":"publish","type":"post","link":"https:\/\/globalnigerianews.com\/index.php\/2026\/11\/11\/why-nafdac-must-rethink-the-approval-of-herbal-medicines-olatunde-isaac-businessday-ng\/","title":{"rendered":"Why NAFDAC must rethink the approval of herbal medicines \u2013 Olatunde Isaac – Businessday NG"},"content":{"rendered":"

Herbal medicine occupies an important place in Nigeria\u2019s healthcare system. For generations, Nigerians have relied on traditional remedies to prevent and treat illnesses, often drawing on knowledge passed down through families and communities. Despite advances in modern medicine, herbal products remain widely used and are frequently advertised as treatments for conditions ranging from malaria and diabetes to infertility and hypertension.\n<\/p>\n

However, the growing commercialisation of herbal medicine raises an important public health question: how much scientific evidence should be required before a herbal product is permitted to enter the market, particularly when its manufacturer claims that it can treat or cure a disease?\n<\/p>\n

At the centre of this debate is a fundamental scientific principle that should guide the regulation of medicinal products in Nigeria: preclinical safety assessments alone cannot establish clinical safety or therapeutic efficacy in humans.\n<\/p>\n

This distinction is particularly important because a product may appear relatively safe in laboratory animals and yet produce serious adverse reactions when administered to humans. Similarly, evidence that a product does not cause observable toxicity in animals does not establish that it can prevent, manage or cure any disease in humans.\n<\/p>\n

Animal studies play an important role in the development and evaluation of medicinal products. Before an experimental treatment is administered to humans, researchers commonly conduct preclinical investigations to identify potential toxic effects, understand how the substance behaves in a living organism and determine whether further investigation is justified. These studies are valuable, but they have limitations.<\/p>\n

Animals and humans differ in their physiology, metabolism, immune responses and susceptibility to particular substances. Consequently, a compound that produces no serious adverse effects in experimental animals may behave differently in humans. Equally, a substance that appears promising in animal models may fail to produce the expected therapeutic benefits in human populations.\n<\/p>\n

This is not an argument for abandoning animal testing. Rather, it is an argument against treating animal testing as sufficient evidence of clinical safety or therapeutic efficacy.\n<\/p>\n

A particularly instructive example occurred in the United Kingdom on 13 March 2006, when eight healthy male volunteers participated in a Phase I clinical trial at Northwick Park Hospital in London. The trial involved TGN1412, an experimental monoclonal antibody being investigated for its potential therapeutic applications.\n<\/p>\n

Before the trial, the compound had undergone preclinical testing, including studies in animals. These investigations had not predicted the catastrophic reactions that subsequently occurred.\n<\/p>\n

Of the eight volunteers, six received TGN1412, while two received a placebo. Shortly after administration, all six men who received the experimental compound developed severe and potentially life-threatening reactions. The volunteers experienced an overwhelming inflammatory response, commonly described as a cytokine storm, which resulted in serious systemic complications, including multiorgan dysfunction. All six survived, but the incident exposed serious limitations in the ability of preclinical animal studies to predict certain human responses.<\/p>\n

Although TGN1412 was a biotechnology-derived monoclonal antibody rather than a herbal medicine, the broader lesson is relevant to drug regulation: a favourable safety profile in animals cannot be regarded as conclusive evidence that a medicinal substance will be safe in humans.\n<\/p>\n

It is also important to recognise that clinical trials are not without risks. Indeed, the TGN1412 incident demonstrates why trials must be carefully designed, independently reviewed and conducted under strict ethical and scientific safeguards. Nevertheless, the possibility of adverse events during clinical trials does not justify bypassing clinical evaluation. Instead, it reinforces the importance of rigorous, phased and closely monitored human studies.\n<\/p>\n

In Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) is responsible for regulating medicinal products, including herbal medicines. The agency has established regulatory procedures for herbal products, including requirements relating to product quality, manufacturing practices, labelling and safety assessments.\n<\/p>\n

However, an important distinction exists between the listing of herbal medicines and their registration following clinical evaluation. Under NAFDAC\u2019s regulatory framework, certain herbal products may be listed without clinical evidence establishing their therapeutic efficacy. Such listing is not equivalent to scientific confirmation that the product can treat or cure a particular disease. Products seeking approval for specific therapeutic claims are subject to additional evidentiary requirements, including clinical evaluation where applicable.\n<\/p>\n

This distinction deserves greater public attention. How many consumers understand that a herbal product bearing a NAFDAC number may not necessarily have undergone clinical trials demonstrating that it is effective against the disease for which it is being promoted? How many consumers distinguish between regulatory permission to market a product and scientific confirmation of its claimed therapeutic benefits?<\/p>\n

These questions are especially important in a country where regulatory identification numbers are sometimes interpreted by consumers as official endorsements of medicinal effectiveness.\n<\/p>\n

The central concern, therefore, is not simply whether a herbal product has passed laboratory tests. It is whether the evidence supporting its intended use is adequate, whether its therapeutic claims have been scientifically substantiated and whether consumers are sufficiently informed about the limits of its regulatory approval.\n<\/p>\n

One of the most important distinctions in medicine regulation is the difference between safety and efficacy. Safety concerns the potential of a medicinal product to cause harm when used under specified conditions. Efficacy concerns whether the product produces the intended therapeutic benefit.\n<\/p>\n

A herbal preparation may demonstrate low toxicity in laboratory investigations without possessing any meaningful therapeutic effect against the disease it is advertised to treat. For example, a herbal product may produce no significant toxic effects in experimental animals. That finding alone does not establish that it can treat malaria, control blood glucose, reduce blood pressure or cure an infection. Such claims require appropriate scientific evidence.\n<\/p>\n

Even when traditional experience suggests that a plant possesses medicinal properties, historical use should not automatically be treated as proof of clinical effectiveness. Traditional knowledge can provide a valuable starting point for scientific investigation, but it cannot answer every question about dosage, drug interactions, long-term safety, treatment effectiveness or potential adverse effects in different patient populations.<\/p>\n

This distinction becomes even more important when herbal products are used by pregnant women, children, older persons or individuals living with chronic diseases.\n<\/p>\n

The consequences of inadequate evaluation may extend beyond direct toxicity. Patients who rely on ineffective herbal treatments may delay seeking appropriate medical care, discontinue effective medicines or expose themselves to preventable complications.\n<\/p>\n

Nigeria does not need to prohibit herbal medicine merely because it originates from traditional knowledge. Such an approach would be unnecessarily restrictive and could undermine legitimate opportunities for scientific discovery, pharmaceutical innovation and the development of indigenous medicinal products.\n<\/p>\n

What Nigeria needs is a regulatory system that distinguishes traditional use from scientifically established therapeutic claims.\n<\/p>\n

Where a manufacturer claims that a herbal product can prevent, treat or cure a particular disease, that claim should be supported by evidence appropriate to the nature of the product and the risks associated with its intended use. For products containing novel ingredients, unfamiliar formulations or substances with uncertain safety profiles, appropriately designed clinical trials may be essential.<\/p>\n

For other traditional herbal products, a proportionate regulatory approach may consider the quality of existing scientific evidence, documented traditional use, toxicological findings and the specific claims being made.\n<\/p>\n

The objective should not be to impose identical regulatory requirements on every herbal preparation, regardless of its intended purpose. Rather, it should be to ensure that the level of scientific scrutiny corresponds to the risks and therapeutic claims associated with the product.\n<\/p>\n

NAFDAC should also strengthen its oversight of herbal medicine advertisements. A product that has merely satisfied requirements for listing should not be promoted in a manner that suggests its ability to cure diseases has been clinically established. Regulatory approval must not become a substitute for scientific evidence.\n<\/p>\n

A stronger regulatory framework would benefit not only consumers but also credible practitioners and manufacturers of herbal medicines. Producers who invest in scientific research, standardised manufacturing and clinical evaluation should not be placed at a competitive disadvantage by manufacturers who make extravagant therapeutic claims without adequate evidence.\n<\/p>\n

Nigeria has considerable potential for research into medicinal plants and the development of locally produced therapeutic products. Realising this potential will require greater collaboration among universities, research institutes, pharmaceutical scientists, traditional medicine practitioners and regulatory authorities.<\/p>\n

Government should encourage such collaboration through research funding, technical support and clear regulatory pathways for evaluating promising herbal formulations.\n<\/p>\n

At the same time, consumers must be protected from misleading claims. NAFDAC should communicate more clearly what different categories of herbal product authorisation mean, particularly whether a product\u2019s therapeutic efficacy has been clinically evaluated. Manufacturers should also be required to ensure that their advertising accurately reflects the evidence supporting their products.\n<\/p>\n

Post-market surveillance must be strengthened to identify adverse reactions, detect quality problems and respond promptly to emerging safety concerns.\n<\/p>\n

The debate over herbal medicine regulation should not be reduced to a contest between traditional knowledge and modern medicine. Both can contribute to healthcare, but claims about the safety and effectiveness of medicinal products must be subjected to appropriate scientific scrutiny.\n<\/p>\n

The 2006 Northwick Park Hospital incident provides a reminder of the limitations of preclinical testing. If an experimental compound that had undergone animal studies could produce such severe and unexpected reactions in humans, regulators must remain cautious about the conclusions drawn from animal toxicity studies alone.<\/p>\n

This does not mean that every herbal product is dangerous or that every traditional remedy must undergo an identical programme of clinical trials. It means that the scientific evidence required for regulatory approval should reflect the risks, intended uses and therapeutic claims of each product.\n<\/p>\n

Ultimately, preclinical safety assessments alone cannot establish clinical safety or therapeutic efficacy in humans.\n<\/p>\n

That principle should be central to Nigeria\u2019s approach to herbal medicine regulation. NAFDAC must ensure that regulatory authorisation is not mistaken for clinical validation and that no herbal product is permitted to make claims of treating or curing diseases without adequate supporting evidence.\n<\/p>\n

The protection of public health requires nothing less.\n<\/p>\n

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Businessday NG<\/div>\n","protected":false},"excerpt":{"rendered":"

Herbal medicine occupies an important place in Nigeria\u2019s healthcare system. For generations, Nigerians have relied on traditional remedies to prevent and treat illnesses, often drawing on knowledge passed down through… <\/p>\n","protected":false},"author":1,"featured_media":14824,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-14823","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business"],"_links":{"self":[{"href":"https:\/\/globalnigerianews.com\/index.php\/wp-json\/wp\/v2\/posts\/14823","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/globalnigerianews.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/globalnigerianews.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/globalnigerianews.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/globalnigerianews.com\/index.php\/wp-json\/wp\/v2\/comments?post=14823"}],"version-history":[{"count":0,"href":"https:\/\/globalnigerianews.com\/index.php\/wp-json\/wp\/v2\/posts\/14823\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/globalnigerianews.com\/index.php\/wp-json\/wp\/v2\/media\/14824"}],"wp:attachment":[{"href":"https:\/\/globalnigerianews.com\/index.php\/wp-json\/wp\/v2\/media?parent=14823"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/globalnigerianews.com\/index.php\/wp-json\/wp\/v2\/categories?post=14823"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/globalnigerianews.com\/index.php\/wp-json\/wp\/v2\/tags?post=14823"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}