FDA Warns Parents Not To Use “Mother’s Touch Formula”, Due to Lack of Nutrients For Infants

Federal health officials are warning for parents and caregivers to stop feeding babies Mother’s Touch Formula, after determining the products may cause nutrient deficiencies or toxicity in infants, and may also contain harmful bacteria.

The U.S. Food and Drug Administration (FDA) issued a Mother’s Touch Formula warning on September 6, advising parents to stop buying and feeding infants the formula, after the agency determined it is being marketed without the required pre-market notification by the agency, and is not in compliance with formula safety regulations.

Officials indicate the infant formula products have not been properly screened for harmful bacteria; specifically cronobacter, which is a type of bacteria that recently led to a massive Similac formula recall, and may cause infants to experience serious and potentially life-threatening infections.

Do Not Use Mother’s Touch Formula

The FDA warning applies to Mother’s Touch Formula sold at local markets in Kinzers, Loganton, and Gap, Pennsylvania and were available for purchase directly from Mother’s Touch website.

The agency indicates the products were not granted enforcement discretion under the “Infant Formula Enforcement Discretion Policy: Guidance for Industry” issued in May 2022, meaning the formula does not comply with certain statutory and regulatory requirements ensuring the safety and nutritional adequacy.

Officials have determined Mother’s Touch Formula fails to meet minimum nutrient levels for protein, linoleic acid, calcium, sodium, potassium, and chloride, which are critical for the development of an infant and could cause nutrient deficiencies or toxicity that could lead to long-term health consequences.

The infant formula was also found to contain levels of iron that exceeded the maximum allowable limits in infant formula, which studies have shown can lead to severe adverse health events such as swollen liver, cirrhosis of the liver, edema, enlarged heart, and heart failure, among other severe health effects.

Parents and caregivers are being instructed to stop using Mother’s Touch Formula immediately and to throw it away. Parents who have fed their infants Mother’s Touch Formula and are concerned about the health of their child should contact their healthcare provider.

Any and all adverse events including illness or serious allergic reactions should be reported to the Department of Health and Human Services through the Consumer Voluntary Reporting form. Parents may also call an FDA Consumer Complaint Coordinator from their state.

Baby Formula Contamination Recalls

The warning comes as the country tries to claw back from an infant formula shortage which occurred following a Similac, Alimentum and Elecare formula recall, due to the products potentially being contaminated with cronobacter, salmonella and other bacteria. The contamination was linked to several confirmed illnesses and two infant deaths.

As a result of the recall, Abbott Laboratories has faced a growing number of contaminated baby formula lawsuits claiming the manufacturer failed to use reasonable care screening its powdered formula for bacteria, which exposed their children to a risk of serious and potentially life-threatening blood infections.

That recall of Similac, Alimentum and EleCare also contributed to a growing infant formula shortage in the U.S., which has caused the FDA to relax some rules regarding the import and sale of infant formula, to increase the available supply for parents. However, Mother’s Touch Formula did not go through that process, according to the agency.

The American Academy of Pediatrics has a webpage devoted to giving parents tips on what to do if they are affected by the infant formula shortage. The organization strongly recommends against trying to make your own formula at home or attempting to “water down” existing formula to make it last longer.

Parents can also contact their local Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) office for more assistance.

Similac Formula NEC Lawsuits

In addition to facing Salmonella and Cronobacter infection lawsuits over the distribution of contaminated formula, Abbott Laboratories is also facing a number of Similac NEC lawsuits brought by families of premature infants who developed a severe and life-threatening gastrointestinal illness after being fed the products in the NICU, known as necrotizing enterocolitis (NEC).

In recent years, a number of studies have highlighted a link between baby formula and NEC for preterm infants, resulting in sudden intestinal perforations that allow bacteria to leak through, causing abdominal infections and intestinal tissue to die off. Common symptoms of NEC include swollen, red or tender belly, difficulty feeding, constipation, dark or bloody stools, body temperature changes, green vomit,  apnea, bradycardia (slowed heart rate) and hypotension (low blood pressure), among others. If not fatal, often times NEC survivors experience long term side effects from surgery to remove dead bowels, resulting in a lifetime of bowel complications.

According to allegations, Abbott Laboratories withheld warnings and information from parents and medical providers for decades, placing desire for profit before consumer safety. Similar claims are also being pursued against Mead Johnson in Enfamil NEC lawsuits brought by families of babies who received this competing cow’s milk formula instead of breast milk.