The National Agency for Food and Drug Administration and Control (NAFDAC), as part of its move against substandard products, has warned Nigerians against the consumption and distribution of infant formulas manufactured by a US-based company, Able Groupe.
The infant formulas from the company have been identified to have insufficient iron levels and did not meet up with other requirements of the US Food and Drug Administration (US-FDA).
This disclosure is contained in a statement issued by the Director-General, Prof. Moji Adeyeye, who said that the agency had received information from the US-FDA on the recall of certain infant Formulas.
According to NAN, Adeyeye 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.
According to the NAFDAC boss, these Able Groupe’s products include HiPP comfort milk formula, HiPP Dutch stage 1 combiotic Infant milk formula, HiPP HA Germany hypoallergenic stage pre combiotic infant milk formula.
Others are 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.
What the NAFDAC Director-General is saying
Adeyeye in her statement 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 the Code of Federal Regulations Title 21 (21 CFR 107.10 and 107.20).
She explained 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.
She added that these products 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 said, “Infant formula products that contain less than one milligram of iron per 100 calories are required to include a statement on the label indicating that additional iron may be necessary.
“NAFDAC implores importers, distributors, retailers and consumers, who have these products in storage to stop distribution, sale and use of these recalled products.
“NAFDAC encourages consumers and health care professionals to report adverse events related to the use of these recalled products to the nearest NAFDAC office.’’
The statement also notes that the public is also advised to report any issue relating to these infant formulas to NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or NAFDAC Med Safety Mobile App.
What you should know
Recall that in March 2020, NAFDAC warned that the widespread use of infant formula products will increase child morbidity and mortality in the country, describing the use of infant formula as “inappropriate” infant and young child feeding practice, which he said had continued to rise in spite of the effort to discourage the practice among mothers.
The food and drug regulator noted that breastmilk remains the appropriate feeding practice for infants and young children because of its rich nutrients and minerals compared to any infant formula.
