The Food and Drugs Authority (FDA) has issued a stern warning to manufacturers, importers, and distributors of baby diapers regarding the importation of unregistered and unsanitary baby diapers, commonly referred to as bale diapers, into Ghana.
According to the FDA, importing such products goes against the FDA Guideline for Registration of Medical Devices (Appendix II) and the specifications outlined by the Ghana Standard Authority for single-use disposable baby diapers (GS 1166:2017).
In a press statement released on Monday, April 8, signed by the CEO of the FDA, Dr. Mimi Delese Darko, it was emphasized that importing unregistered, poor-quality, and unhygienically packaged baby diapers would lead to their seizure. Additionally, the statement highlighted that the safe disposal of these diapers would incur costs for the importer.
“The above notwithstanding, the Authority has noted with great concern the continuing practice where disposable baby diapers are still imported into the country, either unhygienically packaged in bales or hidden in bales of used clothing,” it added.
The FDA urged the public to purchase only registered baby diapers to safeguard babies from the risk of infection. It warned that some unregistered baby diapers were being repackaged and sold without proper label information, or sometimes with no labeling information at all.
Regarding the materials used in baby diapers, the statement reiterated that the FDA tests these materials during the product registration process to ensure the absence of any dyes, skin irritants, or toxins that could harm babies. It emphasized that handling bale diapers, which are frequently repackaged and relabeled under unsanitary conditions, could introduce germs into the genital region of infants, especially girls, posing significant health risks.
Importers were urged to register their products with approved labels before importing them for sale in the country, ensuring compliance with GS 1166:2017. While the FDA permits the importation of raw materials for baby diaper manufacturing, importers must possess licensed facilities for diaper production.
“All registered diapers imported into the country must be well-packaged and properly sealed to protect the product from moisture, soiling, contamination, and damage during transportation, storage and distribution throughout the product’s shelf-life,” it stressed.
“All facilities, both local and foreign, for the manufacture of baby diapers are subjected to good manufacturing practice inspection. The relevant fees apply,” it added.
Lastly, the FDA affirmed its commitment to collaborating with the Ghana Revenue Authority (GRA) Customs Division to ensure that disposable baby diapers available in the market meet safety standards and adhere to required regulations.
