The National Agency for Food and Drug Administration and Control (NAFDAC) has raised an alert to Nigerians regarding the illegal distribution and sale of an unregistered brand of condoms called ‘Foula Condoms’ in Nigeria. In an official statement released on Thursday, NAFDAC announced the discovery of the unregistered product, found during a risk-based post-marketing surveillance study on condom brands. The product was detected in two locations: Abakaliki, Ebonyi State, and Zango, Katsina State.

NAFDAC emphasized that ‘Foula Condoms,’ packaged in units of three, had not received regulatory approval for sale or distribution in Nigeria. The agency noted that labeling on the product was not in English, making it inaccessible and confusing to many consumers. This absence of English labeling is also in direct violation of Nigeria’s regulatory standards for medical products, which mandate that labeling be in English for easy comprehension and adherence to safety guidelines.

“Condoms are an effective barrier method for the dual purposes of preventing unintended pregnancies and protecting against HIV and other sexually transmitted infections (STIs),” NAFDAC stated. “The safety, quality, and efficacy of any barrier method for contraception or infection prevention depend on proper use, which is supported by regulatory approval and comprehensive labeling.” The agency warned that unregistered condoms pose serious risks to public health as they bypass essential testing and quality assurance procedures.

The agency stressed that using poor-quality or counterfeit condoms undermines public health objectives by exposing users to unintended pregnancies and STIs due to possible failures like leaks or breaks. These risks threaten to reverse progress in sexual health education and HIV prevention campaigns in Nigeria.

As a precautionary response, NAFDAC has instructed all zonal directors and state coordinators to conduct extensive surveillance within their areas and immediately withdraw any ‘Foula Condoms’ found. The agency also called on importers, distributors, retailers, and healthcare professionals to remain vigilant in the supply chain to prevent further distribution of the unregistered product.

Consumers and healthcare professionals have been advised to verify the authenticity of all medical products through licensed suppliers only. NAFDAC emphasized that any signs of unregistered or substandard products should be reported to the nearest NAFDAC office or via NAFDAC’s toll-free line at 0800-162-3322 or email at sf.alert@nafdac.gov.ng. For reporting adverse reactions or product issues, the agency encouraged using the E-reporting platforms accessible on their website (www.nafdac.gov.ng), or through the Med-Safety mobile application available on Android and iOS. Reports can also be submitted directly via email at pharmacovigilance@nafdac.gov.ng.

The agency has reiterated its commitment to protecting the public from potentially harmful medical products and advised consumers to be cautious, only purchasing medical products from verified sources.