Regulatory Open Forum

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  • 1.  Wellness coaching regulations

    This message was posted by a user wishing to remain anonymous
    Posted 07-Sep-2018 13:01
    This message was posted by a user wishing to remain anonymous

    ​​I'm looking for information on rules and regulations pertaining to providing wellness recommendations for dietary supplements and meals that would be based upon individual diagnostic data from blood or urine IVDs, or wearable devices.  Any thoughts, or experience shared would be most welcome.


  • 2.  RE: Wellness coaching regulations

    Posted 07-Sep-2018 13:48
    Could you provide more context? Are these "recommendations" part of a user manual? Will they accompany a therapeutic product- drug, device or combination device? or accompany a dietary supplement not indented to treat any condition?

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    Vidyalakshmi Jayaraman
    RA Specialist
    Marlborough MA
    United States
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