The National Agency for Food and Drug Administration and Control (NAFDAC) has raised a serious alarm over the resale of a suspected revalidated SMA Gold First Infant Milk Formula (900g) found for sale in Kaduna State, Nigeria, alerting healthcare providers, caregivers, and the public over the product, which allegedly caused gastrointestinal distress in a 4-month-old infant after consumption.
SMA Gold Infant Formula is a nutritionally complete, whey-dominant formula designed to mirror the nutritional profile of breast milk for babies from birth to 6 months.
In a statement on the agency’s website cited by TVC News on Sunday, a Physical examination of the complaint product sample revealed clear indicators of date marking alteration.
According to the statement, the manufacturing and expiry date on the top preprinted sticker was inconsistent with the underlying, originally printed version, an action which confirms the suspicion of revalidation and tampering.
NAFDAC warned that the integrity of any product is dependent on compliance with regulatory requirements emphasing that any alteration or extension of the shelf life without regulatory approval poses significant risks to public health.
NAFDAC stated that date revalidation of infant formula is a critical violation, stressing that the alteration of date markings constitutes material misrepresentation of product quality and safety status, adding that false dating misleads consumers regarding product freshness and nutritional integrity.
In the risk of Public Health Endangerment, NAFDAC warned that expired infant formula may harbour microbial contamination and degraded nutrients, posing serious risks to vulnerable infants whose immune systems are still developing.
The agency further stated that infant formula is the primary nutritional source for many babies under six months, noting that reported adverse event of diarrhea in a 4-month-old infant suggests potential product deterioration that could lead to serious health issues including, acute gastroenteritis requiring hospitalization, dehydration and electrolyte imbalance in infants, malnutrition due to compromised nutritional content, secondary infections in immunocompromised infants, and fatal outcomes in severe cases if contaminated with pathogenic bacteria.
SMA GOLD
Status: Revalidated
Product name: SMA GOLD From Birth First Infant Milk, 900g
Stated Manufacturer: Nestle
Batch: 22939510A1206 07:35
Manufactured Date: 20-1-2025
Expiring Date: 20-1-2027
Stated NAFDAC Reg. No: B1-2783
The agency reaffirms its commitment to safeguarding public health and will continue surveillance activities to ensure the quality, safety, and efficacy of all NAFDAC-regulated products circulating in Nigeria.
The statement revealed that all NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the revalidated product if found within the zones and states.
The statement reads, “Distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the distribution, sale, and use of the SF product.
“All packaged food and medical products must be obtained from authorised/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.”
The statement added, “Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified regulated products to the nearest NAFDAC office, call NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng”
“Consumers are encouraged to report suspected availability of the revalidated SMA GOLD First Infant Milk, 900g, to the nearest NAFDAC office. Report adverse events or side effects related to the use of the implicated product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng,” the statement concluded.
