The U.S. Food and Drug Administration (FDA) is investigating four consumer complaints of infant illness related to powdered infant formula produced from Abbott Nutrition’s Sturgis, Mich., facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection* in infants. “All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case,” says the U.S. FDA.
*Notes: Cronobacter bacteria can cause severe and life-threatening infections (sepsis) or meningitis. Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, and abnormal movements. Cronobacter infections are rare, but they can be deadly in newborns. Most people infected with Salmonella develop diarrhea, fever, and stomach cramps 6 hours to 6 days after being exposed to the bacteria. Children younger than 5 years old, adults equal to or above 65 years old, and people with weakened immune systems are more likely to have a severe illness. (Source: U.S. Center for Disease Control and Prevention) |
Investigation Progress
After the event, Abbott conducted testing for Cronobacter sakazakii and other pathogens in its manufacturing facilities. During the testing in Sturgis, Mich., facility, Abbott found evidence of Cronobacter sakazakii in the non-product contact areas of the plant but no evidence of Salmonella Newport. Abbott’s announcement further revealed that “no distributed product has tested positive for the presence of either of these bacteria, and we continue to test.” On Feb. 17, 2022, Abbott Nutrition initiated a voluntary recall of certain batches of powdered infant formulas produced in the involved facility, including Similac, Alimentum or Elecare powdered infant formula. (Consumers can check if their powdered formula is part of the recall on the company’s website)
Up until today, findings by the U.S. FDA include several positive Cronobacter results from environmental samples and adverse inspectional observations by FDA investigators. FDA also disclosed that the review of the firm’s internal records also indicated environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to Cronobacter. This investigation is ongoing.
Warnings Released by Other Countries
According to Abbott, recalled products were distributed to the following countries and regions: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, Chinese mainland, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong (China), India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan (China), Thailand, United Arab Emirates, United Kingdom, and Vietnam.
At present we saw countries and regions like Singapore and Mainland China release their warnings regarding to this case. The Singapore Food Agency (SFA) has directed Abbott Laboratories (Singapore) Private Ltd to recall the implicated batches in Singapore. As for the situation in Mainland China, General Administration of Customs (GACC) confirmed Similac HMFortifi, a food for special medical purpose (FSMP) product, produced by the Sturgis, Mich., facility, has exporting records to China. GACC also suggests that consumers should not purchase the implicated products through any channel, such as overseas online shopping. At present, Abbott China has already launched the recall.
Voices from Consumer End in Chinese Mainland
Abbott’s recall was a hit to Chinese consumers. The news went viral on China’s social media quickly on Feb. 21, 2022. Some are shocked and angry by this news. Some are worried if other products of Abbott will be influenced. Others reiterate the benefit of breastfeeding.
Moreover, the involved product in China is a nutrition supplemental powder (consumed by mixing the powder with breast milk) designed especially for premature/low birth weight infants. For the parents of this group of infants, they prefer to change a brand even though the batches they purchased are not impacted. Out of safety concern, products traded to China via general trade instead of overseas online shopping is a better choice since such products satisfy China’s regulation, which are more reliable. But the problem is they are facing limited choices. Due to stringent supervision and technical requirements as well as large cost, at present only 15 products (3 of them are nutrition supplemental powder products) designed for premature/low birth weight infants have obtained Foods for Special Medical Purpose (FSMP) registration approval in China.
Nevertheless, due to the large market demand, FSMP sector is gaining more and more attention from the government, hospitals, enterprises and consumers in recent years. ChemLinked also believes that it has a very promising future. To better help overseas enterprises open FSMP market in China, ChemLinked, together with Reach24h Consulting Group, launches FSMP registration services this year. With successful registration experience, we are capable of handling related consultation and inquiry. For details about FSMP registration service, please email contact@chemlinked.com.
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