Draft Formula Notification For Free

The FDA evaluates the safety of all packaging materials before they enter the market place, including material that may be used in infant formula packaging, such as baby bottles, bottle inserts, nipples, and any other products used to collect and store human milk.

The Access to Baby Formula Act will grant the U.S. Department of Agriculture (USDA) the authority to waive certain requirements so that vulnerable families can continue purchasing safe infant formula with their WIC benefits during extenuating circumstances, such as a public health emergency or supply chain disruption.

The new infant formula submission must include: 1) the product name and a description of the physical form, 2) an explanation of why it is a new infant formula, 3) the quantitative formulation of the infant formula, 4) a description of any reformulation of the formula or change in processing of the infant formula, 5)

No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.

Made with organic, grass-fed whole milk, ByHeart says its Whole Nutrition Infant Formula has been proven (through clinical trials) to aid in brain and eye development, immune support, easy digestion and nutrient absorption, improved gut health, less spit-up and less gas and even gets babies to sleep faster.

Why is there a shortage? Long-term economic pressures collided with a sudden supply shock. The long-term issues stem from the pandemic, which disrupted supply chains of myriad products -- including ingredients used in baby formula -- and caused labor shortages that are vexing many industries.

In 2019, ByHeart acquired and updated the manufacturing facility in Reading rather than using a contract manufacturer. ByHeart said the plant cost $40 million, including preventive food safety measures, to convert the plant from toddler food production to infant formula. The company has raised a total of $190 million.