FDA Alert on Homemade Infant Formula from Plug Heist Trap House EST. 2017
U.S. Food and Drug Administration
UNITED STATES - (News Release)
Audience
Parents and caregivers of infants who consume infant formula
Product
Product: Infant Formula from Plug Heist Trap House EST. 2017
Distribution: The product was sold through the firm’s Facebook page, “Stephanie PlugHeist Payton.”
Purpose
The FDA advises parents and caregivers of infants to stop using homemade infant formula from Plug Heist Trap House. The manufacturer was marketing this product as an infant formula with no product labeling and did not submit the required pre-market notification to the FDA. Homemade infant formulas have not been evaluated by the FDA for safety and may lack nutrients vital to an infant’s growth.
Summary of Problem and Scope
The FDA has determined that this product was not manufactured in compliance with infant formula regulations, was not tested to determine if it meets the nutritional requirements for infant formula, has the potential to cause nutrient deficiencies in infants, and may be contaminated with harmful bacteria.
FDA Actions
The FDA conducted an investigation earlier this week at the location of the firm, a home residence. The firm committed to no longer manufacturing and selling the product.
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.
