FDA WARNS ON THE IMPORTATION OF UNHYGIENIC BABY DIAPERS

The Food and Drugs Authority (FDA) in conjunction with the Ghana Revenue Authority (Customs Division) and the Ghana Standards Authority on 10th July 2023 issued a statement on the importation of unregistered baby diapers. The FDA wishes to remind manufacturers, importers and distributors of baby diapers that baby diapers, popularly known as bale diapers, are not permitted into the country. The importation of unregistered, poor quality and unhygienically packaged baby diapers into the country will result in their seizure and safe disposal at a cost to 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. These baby diapers are subsequently repackaged and offered for sale without adequate label information or no labelling information at all.

Importers are strongly cautioned that this practice goes against the FDA Guideline for Registration of Medical Devices (Appendix II) and the Ghana Standard Authority’s specifications for single-use disposable baby diapers (GS 1166:2017). The public is to note that materials used for baby diapers are tested by the Authority during the product registration process. This ensures that any dyes, skin irritants, or toxins are absent so as not to cause harm to babies. In addition, handling of bale diapers, frequently re-packed and relabelled under insanitary conditions, can cause germs to enter the genital region of a child, especially a girl child, further posing great danger to their health and well-being.

Imported finished baby diapers should be registered before importation, with an approved label and ready for sale. A finished registered baby diaper is a diaper that has been duly evaluated bythe FDA and conforms with GS 1166:2017. 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. The Authority also allows the importation of raw materials for the manufacture of baby diapers but the importer should have a licensed facility for the manufacture of baby diapers. All facilities, both local and foreign, for the manufacture of baby diapers, are subjected to Good Manufacturing Practice inspection. The relevant fees apply. The FDA commits to continue to collaborate with the GRA (Customs Division) to ensure that disposable baby diapers on the market are safe and meet the required standards.

The FDA also wishes to urge the public to help protect babies from the risk of infections by buying only FDA registered baby diapers. The list of registered disposable baby diapers can be found on the FDA website: www.fdaghana.gov.gh. For further information, please contact the FDA.