- Company Announcement Date:
- June 14, 2021
- FDA Publish Date:
- June 14, 2021
- Product Type:
- Food & Beverages
- Reason for Announcement:
Recall Reason Description
Products are not intended to be used as infant formula
- Company Name:
- Designed by Nature
- Brand Name:
Designed by Nature
- Product Description:
Goat Milk, Cow Milk, and Base Mix Formulas
DESIGNED BY NATURE of California is recalling our Goat’s Milk Powder, Cow’s Milk Powder and Base Milk Powder formulas with an expiration date between May 01, 2021 thru June 11, 2022. We intend to change our labeling to make it clear that these products are not intended to be used as infant formula.
There are no reports of injury or illness to date from the products.
We are advising parents and caregivers of infants 12 months and younger to not use these products because they are deficient in multiple nutrients required for infant formula, and the products have not been tested for the presence of Cronobacter, a pathogen that can be particularly dangerous to infants and is required testing for powdered infant formula.
The Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as “a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk” (FFDCA 201(z)). FDA regulations define infants as persons not more than 12 months old
All infant formulas sold in the United States must meet the requirements of the Infant Formula Act (section 412 of the Food, Drug, and Cosmetic Act)
Designed by Nature formulas are not intended or approved for infants.
Designed by Nature products are purchased only online at www.designed-by-nature.com and shipped directly to consumers. Each pouch has a label on the bottom with a lot number and expiration date.
If you purchased Designed by Nature formula for your infant (0-12months) you can email [email protected] for refund and recall instructions or if you have any other questions.