Labeling herbal extracts in topical products
For herbalists making herb-infused oils, salves, creams, and related products, the question of how to properly label extracts often arises. These herbal products generally fall into the regulatory category of cosmetics (more about that here). In the ingredient listing of cosmetics, all ingredients are meant to be listed in order of predominance by weight.
But when you add calendula flowers and plantain leaf into oil to extract their herbal goodness, how do you label that properly?
FDA doesn’t have any guidance that’s easy to find, so I asked them and got a reply from FDA’s Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN). Note that the reply is labeled for use only by the inquirer and “does not constitute an advisory opinion.” So, I’m posting as a courtesy to clients who may also have this question.
Q: What is the proper way to list an infused ingredient in a cosmetic product? For example, if calendula flowers are infused into olive oil, strained out, and then the olive oil is added as an ingredient in an herbal cream, how may the ingredient be listed? Is it “Olive oil infused with calendula flower”? Or is it “Olive oil” and “Calendula extract” as separate ingredients?
A: Thank you for your inquiry regarding how to list an infused ingredient in a cosmetic product.
FDA regulates cosmetics under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and, if marketed on a retail basis to consumers, the Fair Packaging and Labeling Act (FPLA).
Under the FPLA, FDA requires an ingredient declaration for cosmetics marketed on a retail basis to consumers. Each ingredient in a cosmetic product must be listed in the ingredient statement in descending order of predominance. While ingredients used solely for flavor or fragrance may be identified simply as “Flavor” or “Fragrance,” other ingredients must be identified individually. Therefore, the components of “Olive oil infused with calendula flower” must be declared separately in descending order of predominance. Ingredients present at a concentration not exceeding 1% may be listed in any order after the listing of the ingredients present at more than 1% in descending order of predominance [Title 21, Code of Federal Regulations (CFR), part 701.3(f)(2)].
The declaration of ingredients must contain the common or usual names of the cosmetic ingredients as required in 21 CFR 701.3(c). “Olive oil” is an acceptable ingredient name. However, “Calendula extract” should be declared as “Calendula flower extract” since the extract is derived from the flowers of the calendula plant rather than the whole plant.
[end of FDA reply]
So, if you want to be fully compliant, the ingredients get listed separately. Indeed it’s impossible to know just how much calendula and plantain extract is in there, but it’s likely that they are less than 1% by weight, and so can be listed towards the end with other ingredients that are less than 1%.