What should I know about infant formula?
FDA oversees manufacturers of infant formulas, and ensures that they comply with established nutritional requirements. However, it does not approve infant formulas before they can be marketed.
FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements. Infant formula manufacturers are required to register with FDA and provide the agency with a notification prior to marketing a new formula.
FDA monitors infant formula products as part of its responsibility and conducts yearly inspections of all facilities that manufacture infant formula, and collects and analyzes product samples. FDA also inspects new facilities. The agency is authorized to initiate a mandatory recall if it determines that an adulterated or misbranded infant formula presents a risk to human health.
Babies fed infant formulas do not need additional nutrients, unless they are being fed a low-iron formula.
Questions & Answers for Consumers Concerning Infant Formula
- Webinar: 20 Years Later – Returning to FDA to Regulate Tobacco
- What doesn’t FDA regulate? How do I contact the agencies that do?
- FDA Basics Metrics: October 2013
- FDA Basics Metrics: August 2013
- FDA Basics Metrics: September 2013
- FDA Webinar on Tattoos and Permanent Makeup
- FDA Basics Webinar August 19, 2013: Biological Products, Part 2: Biosimilar Biological Products
- FDA Basics Metrics : June 2013
- FDA Basics Metrics: July 2013
- July: CBER's Direct Recall Classification Program
- Webinar on FDA’s Safety Monitoring of Approved Vaccines
- What is the FDA doing to protect children from tobacco?
- Can you explain the approval process for animal drugs?
- Does FDA have any other food safety materials?
- FDA Basics Webinar, June 17, 2013: Biological Products: Part 1
- What is the difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?
- FDA Basics Metrics: July 2011
- FDA Basics Metrics: June 2011
- FDA Basics Metrics: May 2011
- FDA Basic Video: Dianne Murphy Discusses Effective and Proper Uses of Medicines and Devices in Children (Video)
- FDA Basics Metrics: March 2011
- FDA Basic Video: Terry Toigo Talks About Helping Patients and their Families (Video)
- What should I do if I have a serious reaction (side effect) to a cosmetic product?
- FDA Basics Webinar: Picnic Food Safety, How Safe is Your Picnic?
- FDA Basics Metrics: May 2013
How helpful was this information?