Regulatory Open Forum

 View Only

  • 1.  Classification of electrolytes

    Posted 13-Nov-2014 11:47
    Hello All,

    I need some guidance regarding classification of electrolytes (for example: Pedialyte). Does FDA consider this as a dietary supplement or a beverage?

    Appreciate your help on this.


    Thanks,
    Mehul

    -------------------------------------------
    Mehul Govani
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
    -------------------------------------------


  • 2.  RE: Classification of electrolytes

    Posted 14-Nov-2014 09:51
    Mehul,

    Pedialyte is an oral re-hydration solution and is classified as a medical food. The statutory definition of a medical food can be found at 21 CFR 101.9(j)(8)

    There is a useful guidance here: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm054048.htm

    David

    -------------------------------------------
    David Jensen
    Regulatory Associate
    Durham NC
    United States
    -------------------------------------------


    Original Message


  • 3.  RE: Classification of electrolytes

    Posted 14-Nov-2014 14:46
    Thanks David. As per the definition of medical food, it is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

    I dont think electrolytes require supervision of a physician. Do they?


    Thanks,
    Mehul

    -------------------------------------------
    Mehul Govani
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
    -------------------------------------------


    Original Message


  • 4.  RE: Classification of electrolytes

    Posted 15-Nov-2014 12:01
    Dear Mehul and David,
    I can not comment on what the FDA says. (Web site temporality unavailable to me). However, as a Pediatric Nephrologist, I can say that it would not normally be given to healthy children or adults. It is used mainly for oral hydration of infants and small children who have diarrhea or other causes for abnormal fluid and electrolyte loss for whom intravenous fluid replacement is not indicated.  It is readily available at least in the US and easily administered to sick children. 

    Carl
    -------------------------------------------
    Carl Trygstad
    Executive Consultant
    SFJ-Pharmaceutical Group
    Del Mar CA
    United States
    -------------------------------------------


    Original Message


  • 5.  RE: Classification of electrolytes

    Posted 17-Nov-2014 09:43
    Thank you for your input Carl.

    -------------------------------------------
    Mehul Govani
    Regulatory Specialist
    PL Developments
    Westbury NY
    United States
    -------------------------------------------


    Original Message