The National Agency for Food and Drug Administration Control (NAFDAC) has raised the alarm over the circulation of an unregistered condom called Foula condoms.
In a statement issued on Thursday, the agency said the product, which is normally packaged in packs of 3, was discovered in Abakaliki, Ebonyi State capital, and Zango, Kastina State.
NAFDAC said the discovery was made by officials of the Directorate of Post-Marketing Surveillance (PMS) while conducting a risk-based post-marketing surveillance study on condoms registered in Nigeria.
He said unregistered condoms pose significant public health risks to users.
Risks
NAFDAC said condoms are likely to lack necessary quality and safety checks, leading to a higher likelihood of breaking or leaking, which can increase the spread of sexually transmitted infections (STIs), including HIV, and contribute to to unwanted pregnancies.
He said a major concern is that unregistered condoms may not meet the strict material durability and effectiveness standards required to ensure the strength and integrity of condom material, essential for providing reliable protection.
The Foula product is not registered by NAFDAC for use in Nigeria and, according to the agency, is not labeled in English.
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According to NAFDAC, the condom is “a dual-purpose method for both the prevention of unwanted pregnancies and protection against HIV and other sexually transmitted infections (STIs).”
It said: “To be most effective, any barrier method used for contraception or to prevent infection must be used correctly.”
“The illegal distribution or sale of unregistered condoms represents a risk since the safety, quality and effectiveness of the products is not guaranteed.”
The agency also said that the purchase and use of poor quality condoms will affect all aspects of condom promotion for the prevention of unwanted pregnancies and protection against HIV and others.
“If condoms leak or break, they cannot provide adequate protection,” he said.
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Directive
NAFDAC said its zonal directors and state coordinators have been instructed to carry out extensive surveillance and remove unregistered products from circulation within their respective zones and states.
The agency also urged traders, healthcare professionals and consumers to exercise caution to avoid the importation, distribution, sale and use of unauthorized products.
The agency urged that medical products and devices be obtained exclusively from licensed or licensed suppliers, paying special attention to verifying the authenticity and physical condition of each product.
“Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicines or devices to the nearest NAFDAC office, or by using the electronic reporting platforms available on the NAFDAC website.
“Furthermore, please note that this advisory will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS),” the statement read.