The National Agency for Food and Drug Administration Control (NAFDAC) has raised an alarm on the circulation of an unregistered condom called Foula condoms.
In a statement issued on Thursday, the agency said the product, which is usually packed in 3s, was discovered in Abakaliki, Ebonyi State capital and in Zango, Kastina State.
NAFDAC said the discovery was made by the officials of the post-marketing Surveillance Directorate (PMS) while carrying out a Risk-Based Post Marketing Surveillance study on registered condoms in Nigeria.
It said unregistered condoms pose significant public health risks to users.
RISK
NAFDAC said the condoms are likely to lack the necessary quality and safety checks, leading to a higher likelihood of breakage or leakage, which can increase the spread of sexually transmitted infections (STIs), including HIV, and contribute to unintended pregnancies.
It said one primary concern is that unregistered condoms may not meet the strict standards for material durability and effectiveness enforced to ensure the condoms’ material strength and integrity, essential for providing reliable protection.
The Foula product is not registered by NAFDAC for use in Nigeria, and according to the agency, it is not labelled in English.
According to NAFDAC, the condom is “a dual-purpose method for both prevention of unintended pregnancy and protection against HIV and other sexually transmitted infections (STIs).”
It said: “To be most effective, any barrier method used for contraception or preventing infection must be used correctly.”
“The illegal distribution or sale of unregistered condoms poses a risk as the safety, quality, and efficacy of the products are not guaranteed.”
The agency also said the purchase and use of poor-quality condoms will affect every aspect of condom promotion for the prevention of unintended pregnancy and protection against HIV and other”
“If condoms leak or break, they cannot offer adequate protection,” it said.
DIRECTIVE
NAFDAC said its zonal directors and state coordinators have been instructed to conduct thorough surveillance and remove unregistered products from circulation within their respective zones and states.
The agency also urged traders, healthcare professionals, and consumers to be cautious to prevent the importation, distribution, sale, and use of unauthorised products.
The agency urged that medical products and devices should be sourced exclusively from authorised or licensed suppliers, with careful attention given to verifying each product’s authenticity and physical condition.
“Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the e-reporting platforms available on the NAFDAC website.
“Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS),” the statement read.