Original Post
September 6, 2022
Audience
- Parents and caregivers of infants who consume infant formula
Product
- 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.
Purpose
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.
FDA Actions
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.
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