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infant formula 7 articles

FDA sets new guidelines for manufacturers of infant formula

The Food and Drug Administration (FDA) has set new standards for manufacturers of infant formula in an ongoing effort to ensure the products are safe and support healthy growth in the babies who consume them. The new standards come from an interim rule that was published last February, and take into consideration comments received after that time. The finalized rule includes modifications and clarifications, and sets a Sept. 8, 2014, date for manufacturer compliance. Under the new rule, manufacturers of infant formula are required to test their products for harmful pathogens, and disease-causing bacteria such as Salmonella and Cronobacter. Manufacturers are ... Read More

FDA services scaled back, employees furloughed due to government shutdown

The government shutdown that began midnight Tuesday will result in the Food and Drug Administration (FDA) temporarily stopping routine facility and food safety inspections. However, the agency will continue to conduct activities vital to public health, including emergencies, high-risk recalls, civil and criminal investigations and import entry reviews. The FDA is a federal agency within the Department of Health and Human Services. The agency is charged with protecting the public health by assuring the safety, effectiveness, quality and security of human and veterinary drugs, vaccines and other biological products, medical devices, most of our nation’s food supply, all cosmetics, dietary ... Read More

FDA proposes new rules for food, drug, device recalls

Recalls of food, drugs and medical devices continue to make headlines as the Food and Drug Administration (FDA) works to implement the Food Safety Modernization Act (FSMA) and focus on compliance with current good manufacturing process (CGMP) requirements with all FDA-regulated products. As part of this effort, in January 2013 the FDA proposed a rule that would require manufacturers of food to maintain a recall plan that would evaluate the severity and scope of the recall; notify the FDA, consumers and the public; and secure insurance coverage for potential losses and liabilities. Manufacturers with no experience writing recall plans or ... Read More

FDA warns that SimplyThick may cause potentially deadly condition in infants

The Food and Drug Administration (FDA) is warning parents, caregivers and health care professionals that infants – regardless of age – who are fed SimplyThick thickening product may face an increased risk of developing necrotizing enterocolitis (NEC), a potentially deadly condition in which tissue in the intestines becomes inflamed and dies. Since May 2011, the FDA has identified 22 infants who developed NEC after being fed SimplyThick. Seven of those infants died. All but one of the infants had been born prematurely. Half of the infants developed the condition in the hospital, and half developed it after being sent home. ... Read More

FDA warns SimplyThick may cause deadly condition in preemies

The Food and Drug Administration (FDA) is warning parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to premature infants (born before 37 weeks gestation). The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue. The FDA first learned of serious problems possibly due to ingestion of the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed ... Read More

Chinese parents say tainted milk powder caused premature puberty

It seems China can’t stop producing tainted products. This time, pediatricians in the central province of Hubei are expressing concern over premature development of breasts in three infant girls, and are suggesting that milk powder manufactured by Synutra International is the culprit. The infants who were affected had levels of estradiol and prolactin, hormones that stimulate the production of breast milk, that were as high as those in adult women. One father in Beijing said his daughter not only had grown breasts but was also releasing vaginal discharge. A Health Ministry investigation of 73 baby-milk products manufactured by Synutra as ... Read More

Prescription infant formula recalled due to blending error

A prescription brand of hypoallergenic dry powder formula, Neocate manufactured by Nutricia, is being recalled because of a blending error that has resulted in the product having lower levels of protein than declared on the label, according to the Food and Drug Administration (FDA). The FDA this week notified pediatric health care professionals, pharmacists and caregivers about the recall of one lot (#P91877) of Neocate Infant Specialized Formula. The formula is packaged in 14-ounce cans that were distributed to pharmacies, health care professionals and consumers nationwide between September 1 and September 11, 2009. The lot number can be found at ... Read More