Regulatory Open Forum

Hi All, 

I first have to say thank you to all the helpful members of the RAPS community. It is an invaluable resource for me.

I know how to base claims for an OTC product using the FDA 1983 notice but how can you determine claims for a Homeopathic OTC product? 

Specifically, I am trying to determine what claims I can make for a topical with 5% Arnica. I do not currently have access to hpus. Does anyone know if the HPUS has claim and concentration guidance? Any other helpful links or ideas would be greatly appreciated. 

Hi Anon

Five percent sounds more like an active ingredient than a homeopathic dilution?

You may already have seen the draft guidances on herbal and homeopathic products:

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

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

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-products-labeled-homeopathic-guidance-fda-staff-and-industry

Hi All, 

I first have to say thank you to all the helpful members of the RAPS community. It is an invaluable resource for me.

I know how to base claims for an OTC product using the FDA 1983 notice but how can you determine claims for a Homeopathic OTC product? 

Specifically, I am trying to determine what claims I can make for a topical with 5% Arnica. I do not currently have access to hpus. Does anyone know if the HPUS has claim and concentration guidance? Any other helpful links or ideas would be greatly appreciated.