Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Reg Community,

Is anyone familiar with the regulatory submission requirements for introducing a new infant formula, for example, one with no lactose?
We're interesting in learning about this for US, UK, and Germany. 

Many thanks for any information.

For the US, see FDA overview webpages:

https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/regulations-and-information-manufacture-and-distribution-infant-formula

https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/infant-formula-guidance-documents-regulatory-information

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Anne LeBlanc
United States
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Original Message:
Sent: 24-Jun-2022 10:53
From: Anonymous Member
Subject: Infant Formula

This message was posted by a user wishing to remain anonymous

Hello Reg Community,

Is anyone familiar with the regulatory submission requirements for introducing a new infant formula, for example, one with no lactose?
We're interesting in learning about this for US, UK, and Germany.

Many thanks for any information.