Regulatory Open Forum

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  • 1.  Arnica Pain Relief

    This message was posted by a user wishing to remain anonymous
    Posted 11-Oct-2023 13:12
    This message was posted by a user wishing to remain anonymous

    I'm new to homeopathic products and wanted to ask the group about a claim question for a homeopathic OTC drug. 

    There are many articles and studies that support Arnica (topical application) for pain relief and an equal amount that are inconclusive. All studies support it as an anti-inflammatory which, by it's nature, supports pain relief. Also, Health Canada supports Arnica for Anti-inflammation and Pain Relief. 

    Does Arnica support a claim for Pain Relief? any helpful advice and links appreciated.  



  • 2.  RE: Arnica Pain Relief

    This message was posted by a user wishing to remain anonymous
    Posted 12-Oct-2023 09:03
    This message was posted by a user wishing to remain anonymous

    If you are using it at a concentration with measurable anti-inflammatory properties, it's not going to be in the traditional homeopathic category. Those are supposed to be diluted to the point where the substance is not physically active but metaphysically active in the inverse.

    https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/what-botanical-drug

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/complementary-and-alternative-medicine-products-and-their-regulation-food-and-drug-administration

     https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=172.510&SearchTerm=arnica%20montana

    https://www.fda.gov/drugs/information-drug-class/homeopathic-products

    https://www.ncbi.nlm.nih.gov/books/NBK589897/

    https://www.fda.gov/food/dietary-supplements