Regulatory Open Forum

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  • 1.  Synthetic Antioxidants GRAS or approved food additives

    Posted 30-Jan-2013 13:35
    I am reviewing a potential product formulation containing the following:

    R-Lipoic Acid
    Acetyl-L-Carnitine Arginate
    L-Carnitine Tartrate

    Are these ingredients approved food additives or GRAS?

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    Dmims
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  • 2.  RE:Synthetic Antioxidants GRAS or approved food additives

    Posted 31-Jan-2013 11:13

    A quick search says those specific names are not on the list but for you, and future reference, the FDA GRAS list 1.) general 2.) food   links are below.

    1.)
    http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?filter=&sortColumn=&rpt=scogsListing

    2.)
    http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASSubstancesSCOGSDatabase/ucm084104.htm

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    Dawn Demko
    DIrector Q/RA
    Broomfield CO
    United States
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  • 3.  RE: Synthetic Antioxidants GRAS or approved food additives

    Posted 23-Feb-2016 11:25
    Edited by Amanda Roche 23-Feb-2016 11:26

    Hello Danah,

    If you need to do an in-depth analysis of a product and its ingredients to see if they are complaint, that is a service that my company offers and we would be happy to assist you. As you may know, ingredients that are determined GRAS in the U.S. are determined safe on the basis of both the specifications of the ingredient as well as the manufacturing process, and there are many limitations on GRAS substances (basically, there is no "one GRAS fits all"). You can read more on this topic in one of our recent newsletter articles, Limitations on GRAS Substances: Not All GRASes Were Created Equal

    Burdockgroup remove preview
    Limitations on GRAS Substances: Not All GRASes Were Created Equal
    The Food and Drug Administration (FDA) has made it abundantly clear on several occasions that there is no "blank check" to use a GRAS[1] substance in any food, at any level of use or for any purpose.
    View this on Burdockgroup >

    .

    Feel free to send me an email or give me a call to discuss your product.

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    Amanda Roche
    Marketing Coordinator
    Burdock Group
    (407)802-1400 EXT 170
    aroche@burdockgroup.com