A Radicle: FDA cGMP project - labels and language
I have a question regarding common vs. Latin names.
"- list plants by common name and include the part (root, rhizome, leaf, seed, flower, etc...)"
It is my understanding that the reasoning is not to try to hide information from the consumer. For example, listing Camellia sinensis, which is less recognizable than Green Tea, and not mentioning that it contains caffeine.
Latin names are also acceptable, I believe, so long as they are used consistently. I know herbalists have a preference for the binomial nomenclature because it is more specific. There is more than one Skullcap. There is more than one Sage. (At the AHG conference, I asked you to specify which Goat's Rue you meant: Galega or Peganum.)
Just for amusement, this FDA letter has a hilarious product ingredient panel: http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/medicationhealthfraud/ucm355955.htm
Sheila - good point. I think you can mix-n-match botanical names with common, too - as evidenced by the above label, where we call it Echinacea and not coneflower. Specifying the binomial is indeed a good idea (though it can take up more space). Is it E. purpurea or angustifolia (purpurea in our case)?
The regulation says this:
" Source ingredients shall be identified in accordance with 101.4 (i.e., shall be listed by common or usual name, and the listing of botanicals shall specify the part of the plant from which the ingredient is derived) regardless of whether they are listed in an ingredient statement or in the nutrition label."21CFR101.36
My understanding is that unfortunately we must use common names always. While regs imply that binomials are optional, recent actions by AG offices points to a need to also specify binomial to species level. (Case in point is multiple species of Harpagophytum sold as Devil's Claw.) By this dictum we must follow Herbs of Commerce, or at minimum be prepared to show compendial reference to multiple species being used interchangeably under the same common name, if there is any variance. Or so we've been advised by counsel.
Linden, it does seem to be going towards binomials being a necessary addition - though the regulation doesn't specify that for now. My take on your comment is that the common name (whatever that is - viz. echinacea) should always be listed, and that the Latin binomial, while not required now, may soon become required.
Thanks so much for this Guido. I do have a question for you, though. I know you may not have the answer, but I figure it won't hurt to ask. So, I know that most of this info is in regards to what you can say on your product label, but what about what you say in a product description? Does that count as the label? What about what you say in a blog post? If you post about how herbs work or what a remedy can be used for, you'd most likely be making health claims, but if you didn't link to the products in your shop, would you still be out of compliance? I'm still trying to figure all of this out, and I really appreciate you, and Urban Moonshine, sharing how it's working for you.
you can't say anything that isn't an accepted structure/function claim in any product description, either. Including on a website. Or social media page. Or testimonial. If you're posting on a blog, that is a different story, although if the blog is a company blog, you will probably eventually run afoul of FDA. Some say 2-clicks is the rule - meaning, if the info is on a site two clicks away from the product web page, it's ok. This is really arbitrary, I don't think it has been tested yet.