Does the FDA regulate home remedies/herbal remedies and things of that sort?

[Arkisaeo]

I live in PA and I've contacted the FDA directly a few times about this, but (of course) all I got was indirect answers.
All the research I've done online seems to have mixed answers about whether or not the FDA regulates herbal remedies and what is considered a "dietary supplement".

I'm a big supporter of using home remedies, herbal remedies, and so forth. I've made liniments, poultices, infusions, etc. and used them to treat a variety of issues (joint pain, shin splints, small cuts/scrapes, etc.).

They contain very basic ingredients, like herbs (dried or fresh), olive oil, water, beeswax--things of that nature.
Most (if not all) of the remedies would be applied externally.

I'd like to sell some of these things either online or at a local farmers market.

Would I need FDA approval to do that?
Would I need any particular permit or license?
Would the product labels need specific info?

In addition to the home/herbal remedies, the same question would also apply to homemade herbal shampoo, soap, face wash, aromatherapy blends--would those fall under their cosmetic regulations or would they be exempt?

Thanks.

 

[OHRoadwarrior]

Generally, the FDA avoids dietary supplement regulation. That does not mean they do engage in enforcement actions. You also have FTC issues and liability issues to deal with.

 

[Arkisaeo]

Generally, the FDA avoids dietary supplement regulation. That does not mean they do engage in enforcement actions. You also have FTC issues and liability issues to deal with.

But would the products even be considered a "dietary supplement"?

I use these remedies at home with no problem (obviously), I'd just like to know what I'd have to do to be able to sell them at local farmers markets and such places.
Do I need to register for permits, licenses, insurance and all that?
Or do I just need to slap a label on the product listing ingredients, usage directions, warnings, etc.?

 

[AnonUserName]

But would the products even be considered a "dietary supplement"?

I use these remedies at home with no problem (obviously), I'd just like to know what I'd have to do to be able to sell them at local farmers markets and such places.
Do I need to register for permits, licenses, insurance and all that?
Or do I just need to slap a label on the product listing ingredients, usage directions, warnings, etc.?

Info about PA sellers and business license and requirements.
http://businessnameusa.com/Sellers%20Permit/Pennsylvania.htm#.UhoBeie9KK0
http://businessnameusa.com/BusinessLicense.aspx

Info about FDA and alternate medicine, herbal supplements
http://www.fda.gov/ohrms/dockets/98fr/06d-0480-gld0001.pdf
http://www.fda.gov/Food/DietarySupplements/default.htm
http://healing.about.com/od/homeopathy/a/homeopathy_fact_4.htm

It would be wise to list all ingredients and warnings as well as carry liability insurance even if your state doesn't require it.

 

[ecmst12]

You would also need to be very careful about making any claims that your products treat medical conditions.

 

[Arkisaeo]

You would also need to be very careful about making any claims that your products treat medical conditions.

Does that apply to specific conditions or also general symptoms?

ex.: is there a difference between saying "this remedy treats arthritis" or "this remedy will ease/decrease joint pain", or would that be considered the same thing, even though the first quote directly targets a specific issue (arthritis) and the second quote only targets one symptom (which could relate to any number of issues)?

 

[Proserpina]

Does that apply to specific conditions or also general symptoms?

ex.: is there a difference between saying "this remedy treats arthritis" or "this remedy will ease/decrease joint pain", or would that be considered the same thing, even though the first quote directly targets a specific issue (arthritis) and the second quote only targets one symptom (which could relate to any number of issues)?

You specifically CANNOT include either statement.

You can use "may ease arthritis pain". But you cannot make claims that your supplements will diagnose or treat anything at all.

 

[Arkisaeo]

Thanks for clarifying.

What about things like "may be used as an anti-inflammatory" or "may be used as an astringent" (or would that wording also need changed?)?

 

[Proserpina]

Thanks for clarifying.

What about things like "may be used as an anti-inflammatory" or "may be used as an astringent" (or would that wording also need changed?)?

I strongly suggest that you speak to an attorney.

You can get into such a mess when it comes to the FDA, FTC etc., and nobody here can really talk you through the entire process.

 

[ecmst12]

I would not put ANY claims about usages on the package at all, and be careful what you name the products too. Just list the ingredients. But you can't call it anti inflamatory, pain reliever, anything like that since you have no testing to back it up.