The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians to stop consuming and distributing infant formulas manufactured by Able Groupe, a US based company.
She said that the recalled products were sold under the brand names HiPP, Holle, Bioland and Kendamil, adding that they were recalled because the required pre-market notifications for these new infant formulas had not been submitted to the FDA.
Adeyeye identified the Able Groupe’s products, to include HiPP comfort milk formula, HiPP Dutch stage 1 combiotic Infant milk formula, HiPP HA Germany hypoallergenic stage pre combiotic infant milk formula.
Also, Holle Bio Stage 1 organic infant milk formula, Holle Bio stage pre organic infant milk formula, Lebenswert Anfangsmilch stage 1 organic infant milk formula, and HiPP UK stage 1 Combiotic first infant milk formula.
She said that the products contained less than one milligram of iron per 100 calories, and that the eight infant formula product labels failed to have the required ingredient, including not being labelled as required by Code of Federal Regulations Title 21 (21 CFR 107.10 and 107.20).
Adeyeye said that the recalled products were intended as a complete or partial substitute for human milk for children aged 12 months and below, but by containing less than one milligram (1mg) of iron per 100 calories may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight.
Similarly, they may also not be suitable for those who have low iron levels at birth, or those who are at risk for becoming iron deficient due to illness.
She explained that inadequate intake of iron at infancy may lead to anaemia, iron deficiency which, if untreated, has irreversible cognitive and functional development outcomes.
“NAFDAC implores importers, distributors, retailers and consumers, who have these products in storage to stop distribution, sale and use of these recalled products.
The public are also advised to report any issue relating to these infant formulas to NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via [email protected] or NAFDAC Med Safety Mobile App. (NAN)