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
- FDA Basics Metrics: April 2013
- When and why was FDA formed?
- How does FDA provide information about drug products currently under review for approval by the agency?
- Why are some drugs available as both a prescription and an over-the-counter drug?
- What does FDA do?
- What Should I Do If I See Violations of FDA’s Tobacco Products Rules?
- FDA Center for Tobacco Products Inaugural Year and Looking Forward
- What are FDA’s Regulations for Flavored Tobacco?
- What are the new Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents?
- What will FDA do to curb tobacco use among children and adolescents?
- What are some of the key regulatory timelines associated with the tobacco control act?
- How does the regulation of tobacco products differ from FDA’s regulation of drugs or medical devices?
- Is FDA going to ban tobacco?
- What products are not considered to be tobacco products as defined by the tobacco control act?
- What products are considered to be tobacco products as defined by the tobacco control act?
- What is the main goal in regulating tobacco products?
- What are the priorities of the Center for Tobacco Products?
- Does FDA have the authority to regulate tobacco products?
- What does FDA inspect?
- How is FDA organized?
- What does FDA regulate?
- FDA Basic Video: Lawrence Deyton Discusses Tobacco (Video)
- What part of FDA regulates tobacco products?
- FDA Basics Metrics: March 2013
- Upcoming Webinar Tuesday, March 19th - Buyer Beware:The Risks and Dangers of Purchasing Drugs Online
How helpful was this information?