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  • 1.  Medical nutrition claims &

    Posted 01-Dec-2023 09:02

    Hi everyone,

    I would like to know if someone can help me understand

    If in ingredient mix that has been developed as a medical food and is considered an FSMP in the EU can be used in a health supplement product with the associated claims in the US?

    Kind regards,

    Julie



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    JULIE FAITG
    Dr
    Lausanne
    Switzerland
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  • 2.  RE: Medical nutrition claims &

    Posted 01-Dec-2023 14:20

    Hi Julie

    To begin, here's an overview of the kinds of claims that can go on dietary supplements:

    https://www.fda.gov/food/food-labeling-nutrition/label-claims-food-dietary-supplements

    And in case it applies, here's guidance on medical foods:

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



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Medical nutrition claims &

    Posted 03-Dec-2023 01:02

    Based on my understanding, I am new in this field; from https://www.fda.gov/food/food-labeling-nutrition/label-claims-conventional-foods-and-dietary-supplements, I think the answer is no. An ingredient mix developed as a medical food and classified as a Food for Special Medical Purposes (FSMP) in the EU cannot be marketed with the same claims as a health supplement product in the US. The FDA's regulations for health supplements do not allow claims that suggest they diagnose, treat, cure, or prevent diseases without substantial scientific evidence and such claims must not be misleading. Instead, health supplements in the US are limited to structure/function claims that detail the role of a nutrient or ingredient in affecting the body's standard structure or function, and they must carry a disclaimer clarifying that the FDA has not evaluated these claims, nor is the product intended to diagnose, treat, cure, or prevent any disease.



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    Shahrokh Ghobadloo
    M.Sc., Ph.D., M.B.A.
    Ottawa, ON
    Canada
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    Original Message


  • 4.  RE: Medical nutrition claims &

    Posted 13-Dec-2023 08:24

    Hallo Julie

    I would also add: Check that all the ingredients are allow in food supplements in US ( Are the gras, NDI?)

    Re claims, jus note Food supplements are intended for healthy population. While , Medical Foods have very specific requirements and target a specific population.

    regards

    Colette



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    Colette Shortt
    Weybridge
    United Kingdom
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    Original Message


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