FDA Advises Parents and Caregivers Not To Buy Or Give Mother’s Touch Formula To Infants
September 21, 2022
On September 16, 2022, Mother’s Touch initiated a voluntary recall of its Mother’s Touch Baby Formula because the product did not conform to the FDA's infant formula standards. The below information was provided by Mother’s Touch to the affected retail consignees where the recalled product was available for purchase by consumers. The recall notice will be posted in a prominent location at the following three locations:
- Scenic Ridge Foods in Loganton, PA 17747
- Hillside Bulk Foods in Gap, PA 17527
- Creekside Foods in Kinzers, PA 17535
While Mother’s Touch is advising consumers in their notice that parents and caregivers who have unused containers of Mother’s Touch Baby Formula should return them to the store where they were purchased, FDA continues to recommend that consumers who have purchased this product discontinue use and throw it away.
September 6, 2022
- Parents and caregivers of infants who consume infant formula
- Product: Mother’s Touch Formula
- Distribution: The product is sold at local markets in Kinzers, Loganton, and Gap, PA and was available for purchase directly from Mother’s Touch website.
The FDA advises parents and caregivers not to buy or give Mother’s Touch Formula to infants under their care. The product is being marketed as an infant formula without the required pre-market notification to the FDA, and it does not meet infant formula nutrient requirements for seven nutrients.
Summary of Problem and Scope
The FDA has determined that Mother’s Touch Formula is not manufactured in compliance with the FDA’s infant formula regulations. The infant formula product is not tested to determine if it meets the nutrient requirements for infant formula, and contains label claims for seven nutrients that do not meet the nutrient requirements for infant formula such that consumption of this formula has the potential to cause nutrient deficiencies or toxicity in infants. In addition, the product was not fully tested for the presence of potentially harmful bacteria such as Cronobacter.
The FDA advises parents and caregivers not to buy or give Mother’s Touch Formula to infants under their care because we have determined that this brand of infant formula is being marketed without pre-market notification to the FDA and has not been properly tested for the presence of potentially harmful bacteria. Additionally, nutrient label claims on the product label showed the product to contain nutrient amounts below the minimum levels required for protein, linoleic acid, calcium, sodium, potassium, and chloride; and above the maximum level allowed for iron.
The FDA has not granted enforcement discretion for this product under the “Infant Formula Enforcement Discretion Policy: Guidance for Industry” issued in May 2022.
Recommendations for Consumers
Parents and caregivers of infants who have purchased this product should discontinue use and throw it away.
Parents and caregivers of infants who have used this product and are concerned about the health of their child should contact their health care provider.
To report a complaint or adverse event (illness or serious allergic reaction), you can:
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
Visit www.fda.gov/fcic for additional consumer and industry assistance.