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Medical Food, Baby Formula – FDA Approved? Pt 7

Medical Food, Baby Formula – FDA Approved? Pt 7

It is not uncommon for people to take notice on product labels, company websites, commercials promoting a new product or treatment or hear some marketers saying the word’s “FDA approved!” What does that even mean and is it really FDA approved? How can you know for sure what the US Food and Drug Administration approves? This article focuses on medical food and infant formula. And subsequent articles will look at how the FDA regulates products and what it does and doesn’t approve.

FDA does not approve medical food

A medical food can be defined as a food used for the dietary management of a disease or health condition. Such disease or condition may require special nutrient needs provided by the medical food. For example, food used by persons with phenylketonuria, a genetic disorder; such food would be termed as medical food. A person with such a disorder may require foods that are free from amino acid phenylalanine. That being said, a medical food must be used under the supervision of a physician. Medical foods do not include products such as meal replacements or diet shakes. Or products used for the management of diseases like diabetes which can be managed through modification of the normal diet.

Medical foods do not undergo premarket approval by the FDA. However, medical food companies must comply with other requirements. These requirements include:

  • Good manufacturing practices
  • Registration of food facilities

Additionally, medical foods do not have to include nutrition information on their labels. However, any claims in their labelling must be truthful and not misleading.

FDA does not approve infant formula

While FDA does not approve infant formulas before they are marketed, manufacturers are subject to the FDA’s regulatory oversight.

Manufacturers must ensure that the infant formula complies with federal nutrient requirements. In addition, they must register with the FDA and provide a notification to the FDA before marketing a new formula.

Each year the FDA conducts inspections of all facilities manufacturing infant formula and collect and analyse product samples. In addition, the FDA also inspects new facilities. However, if it is determined that an infant formula presents a risk to human health, the manufacturer must conduct a recall.




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