Public Alert No. 31/2026- Recall of Sexual Enhancement Product Due to Undeclared Pharmaceutical Ingredients

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued Public Alert No. 31/2026, announcing the voluntary recall of all lots of WAP Sensual Enhancement capsules by Best Supplements Best Prices Company. This action follows the detection of undeclared pharmaceutical ingredients, specifically sildenafil, tadalafil, and flibanserin, by the U.S. Food and Drug Administration (US FDA). These undeclared substances, which are active ingredients in prescription drugs, pose significant health risks, particularly for individuals with underlying medical conditions or those taking nitrate-containing medications. The recall underscores NAFDAC's commitment to safeguarding public health and highlights the stringent regulatory requirements for product registration and market surveillance in Nigeria.

The National Agency for Food and Drug Administration and Control (NAFDAC) recently released Public Alert No. 31/2026, drawing attention to a critical public health concern: the voluntary recall of all lots of WAP Sensual Enhancement capsules. This recall, initiated by Best Supplements Best Prices Company, stems from the discovery of undeclared pharmaceutical ingredients within the product, a finding first made by the U.S. Food and Drug Administration (US FDA). The presence of these hidden substances transforms what is marketed as a dietary supplement into an unapproved drug, carrying substantial and potentially life-threatening risks for consumers.

This development is not merely an isolated incident but a stark reminder of the persistent challenges in regulating the vast market of health supplements and the critical role played by regulatory bodies like NAFDAC. The agency's swift action, even when prompted by international findings, demonstrates its unwavering commitment to public health and safety in Nigeria. For legal professionals, this alert highlights the complex interplay of national and international regulatory frameworks, product liability, and consumer protection laws, demanding a thorough understanding of compliance obligations for manufacturers, importers, and distributors of regulated products within the Nigerian jurisdiction.

The core issue revolves around the violation of stringent product registration and labeling requirements, which are fundamental to NAFDAC's mandate. The article will delve into the legal and regulatory landscape governing such products in Nigeria, analyze the implications of this specific recall, and outline the broader lessons for practitioners navigating the country's consumer protection and public health regulations.

The National Agency for Food and Drug Administration and Control (NAFDAC) is the principal regulatory body in Nigeria charged with safeguarding public health. Established by the National Agency for Food and Drug Administration and Control Act Cap N1, Laws of the Federation of Nigeria (LFN) 2004, NAFDAC is mandated to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale, and use of food, drugs, cosmetics, medical devices, packaged water, chemicals, and detergents, collectively known as 'regulated products'. A cornerstone of NAFDAC's regulatory framework is the mandatory registration of all regulated products before they can be manufactured, sold, or distributed in the Nigerian market.

Product registration with NAFDAC is a rigorous process, requiring comprehensive documentation including a certificate of incorporation, a power of attorney for foreign manufacturers, a certificate of manufacture and free sale, a comprehensive certificate of analysis, and samples for laboratory analysis. This process ensures that products meet established safety, quality, and efficacy standards. The NAFDAC Act also grants the agency powers to conduct inspections, monitor advertisements, and initiate recalls of substandard or falsified products. Beyond NAFDAC, the Federal Competition and Consumer Protection Act (FCCPA) 2018 provides a broader framework for consumer protection, establishing the Federal Competition and Consumer Protection Commission (FCCPC) to protect consumer interests and ensure access to safe products.

The dangers associated with undeclared pharmaceutical ingredients in products marketed as dietary supplements are well-documented. Such products often contain active pharmaceutical ingredients (APIs) like sildenafil or tadalafil, which are phosphodiesterase-5 (PDE-5) inhibitors used in prescription drugs for erectile dysfunction, or flibanserin, used for low sexual desire in women. When these potent drugs are not declared, consumers are exposed to serious health risks, including dangerous interactions with other medications, particularly nitrates used for heart conditions, which can lead to life-threatening drops in blood pressure. The lack of proper dosage control and medical supervision further exacerbates these risks, turning seemingly innocuous supplements into dangerous, unapproved drugs.

The recall of WAP Sensual Enhancement capsules by Best Supplements Best Prices Company, prompted by the US FDA's detection of undeclared sildenafil, tadalafil, and flibanserin, squarely falls under NAFDAC's regulatory purview concerning product quality, safety, and proper labeling. Under the NAFDAC Act, it is prohibited to manufacture, sell, distribute, or advertise unregistered food, drugs, or drug products. The presence of undeclared pharmaceutical ingredients means the product is misbranded and adulterated, rendering its registration, if any, invalid or subject to revocation. Products containing such ingredients cannot legally be marketed as dietary supplements.

NAFDAC's Guidelines for the Recall of Defective Medical Products outline the procedures for both voluntary and statutory recalls. In this instance, the recall was initiated voluntarily by the manufacturer, Best Supplements Best Prices Company, following the US FDA's findings. However, NAFDAC retains the authority to order a statutory recall if a manufacturer fails to act, based on reports from various sources, including international regulatory authorities. The manufacturer, as the Certificate of Registration Holder, is responsible for bearing the cost of a voluntary recall of substandard or falsified products.

The undeclared ingredients, sildenafil and tadalafil, are prescription medications for erectile dysfunction, while flibanserin is a prescription drug for low sexual desire in women. Their inclusion in a 'sensual enhancement' supplement without declaration poses severe health risks. Sildenafil and tadalafil can cause a significant and life-threatening drop in blood pressure when combined with nitrates, commonly prescribed for individuals with heart disease, high blood pressure, or diabetes. Flibanserin, on the other hand, can induce drowsiness, sedation, dangerously low blood pressure, and fainting, especially when consumed with alcohol or other medications. These risks highlight a clear violation of consumer safety rights enshrined in the Federal Competition and Consumer Protection Act (FCCPA) 2018, which aims to facilitate access by all citizens to safe products.

This case also underscores the importance of international regulatory cooperation. The US FDA's laboratory analysis and subsequent public alert directly informed NAFDAC's action, demonstrating a global effort to combat the circulation of harmful products. NAFDAC actively participates in such information sharing, receiving alert notifications on recalls and safety information on regulated products from international bodies. Manufacturers and distributors operating in Nigeria, especially those dealing with imported products, must therefore be acutely aware of not only NAFDAC's requirements but also international standards and alerts, as these can trigger domestic regulatory actions and liabilities. The penalties for non-compliance with NAFDAC regulations can include product seizure, fines, and legal prosecution, emphasizing the need for rigorous adherence to all regulatory guidelines.

The NAFDAC Public Alert No. 31/2026 regarding the recall of WAP Sensual Enhancement capsules serves as a critical reminder for legal practitioners and businesses operating within Nigeria's regulated product sectors. It reinforces the imperative of strict adherence to NAFDAC's comprehensive product registration, labeling, and quality control regulations, as stipulated in the NAFDAC Act Cap N1 LFN 2004. The detection of undeclared pharmaceutical ingredients highlights the severe legal and public health consequences of non-compliance, including potential criminal liability, product seizure, and significant reputational damage.

Practitioners advising clients in the food, drug, and cosmetic industries must emphasize robust internal compliance mechanisms, thorough due diligence on product formulations, and continuous monitoring of both national and international regulatory alerts. The collaboration between NAFDAC and international bodies like the US FDA demonstrates an increasingly interconnected regulatory landscape, where a violation detected in one jurisdiction can swiftly trigger action in another. Businesses must ensure that their products are genuinely what they purport to be, free from undeclared substances, and that all marketing claims are substantiated and approved by NAFDAC. Failure to do so not only jeopardizes public health but also exposes companies to substantial legal and financial repercussions under both NAFDAC regulations and the broader consumer protection framework of the Federal Competition and Consumer Protection Act 2018. Vigilance and proactive compliance are paramount to navigating Nigeria's dynamic regulatory environment and safeguarding consumer trust.