Here are some of the basics of labeling and the questions that frequently come up about the basic labeling.
What goes on the FRONT panel?
There are two items that MUST go on the front panel of any product that is sold to consumers. Whether the product is a soap or a cosmetic, these items are required:
- Identity. What is the product? (soap, lotion, bubble bath, etc).
- Net Quantity of Contents. How much actual product is there? In both US (oz, pounds, pints, etc) AND metric (ml, grams, liters, kilos).
The Name and Brand of the product are commonly placed on the front panel, but are not required.
FOR COSMETICS, the name may not include the name of one ingredient if there are two or more ingredients in the product. FOR SOAP, the identity of the product may not include the name of one ingredient, unless that ingredient is present at a “substantial or significantly effective amount”. See blog post, Using an Ingredient Name in a Product Name for a more detailed discussion.
The Net Quantity of Contents should be in a large enough text size (usually 1/8″ high, measuring the lower case “o”) and be placed parallel to the bottom of the package, in the bottom 30%.
Of course, other marketing type information can also go on the front panel of the package!
What goes on the BACK or SIDE panels?
For all products:
- The name and address of the responsible party.
- Directions for safe use (if applicable)
Additionally, for cosmetics:
- The declaration of ingredients.
- Any required warning statements.
Again, you can use the side and back panels for additional marketing text touting the wonderfulness of your products and why a consumer should buy them. Remember not to use any claims that could be construed as “drug” claims (see blog posts FDA Cracking Down on Cosmetic Product Claims and More on Product Claims for more info).
Is SOAP exempted from the label requirements?
No. If it is a “true soap” (made from oil and lye), AND the only claim is that it cleanses AND it is only called “soap,” it is exempted from the FDA cosmetic regulations (but not the basic consumer commodity labeling requirements).
If it is exempted from the FDA cosmetic labeling regulations, an ingredient listing is not required. That doesn’t mean you can’t put an ingredient listing on the package, but it is not required, and isn’t regulated by the FDA rules for cosmetic ingredient declarations. See blog post Ingredient Labels for Soap for more info.
Name and Address:
What is required for the NAME and ADDRESS?
The address must include the full street address, city, state and zip code. IF the name used on the label is listed in a CURRENT phone or city directory (print or online) and the street address is included, the street address may be omitted from the label (but the city, state and zip code are still required).
In the end of 2014, the FDA responded to a petition by the Handcrafted Soap and Cosmetic Guild and stated that an online directory would be suitable as a “current phone or city directory”. See the blog post for the whole story.
Additionally, the FTC is in the process of updating their regulations for online listings for the street address. Their proposal will change to regulations for the name/address on SOAP (and all other non-cosmetic items) to read:
(c) The statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is listed in a readily accessible, widely published, and publicly available resource, including but not limited to a printed directory, electronic database, or Web site.1
Can a PO Box be used instead of a physical address?
No. An actual physical address is required.
Can a Mailbox Service (like UPS or Mailboxes Etc) be used?
No. The address needs to be the “place where business is conducted.” Obviously, you aren’t sitting in Kinko’s or the UPS store carrying out your business activities.
How should ingredients be identified (named) in the ingredient declaration?
Generally, ingredients should be identified by the name listed in the Cosmetic Ingredient Dictionary EXCEPT that botanical ingredients should be listed by their common name.
The regulations say 2 things: first, the Fair Packaging and Labeling Act, which is the basis of the labeling regulations that the FDA has issued, says that the COMMON NAME should be used. Then in another place, the regulations list out the places from which the names of ingredients should taken – first on the list is the Cosmetic Ingredient Dictionary, 2nd Edition and last on the list is the “common name” if the ingredient is not listed in any of the sources.
When the regulations were written, the Cosmetic Ingredient Dictionary 2nd Edition listed botanical ingredients with their COMMON NAME.
Later editions of the Cosmetic Ingredient Dictionary, published by the Personal Care Products Council, used Latin names for botanicals which the FDA DID NOT APPROVE. But, people went ahead and used them anyway, since that is what the regulations for Europe (and Canada?) require.
For quite a while it was unclear what the FDA wanted, since the regulations seemed contradictory and the FDA hadn’t published (or at least made easily findable) their responses to the newer editions of the CID (starting in 1996).
Within the past 18 months, the FDA has published several web pages as a video which very clearly state that the COMMON NAME IS REQUIRED, but that they will allow the Latin name as a secondary name (in parenthesis).
Also note that trade names should not be used in the ingredient declaration. The manufacturer of the product should be able to provide you with the component ingredients so they can be correctly placed in the ingredient declaration.
In what order should ingredients be listed?
Ingredients should be listed in descending order of predominance (based on their percentage, by weight, in the product).
Blended ingredients used in the product (such as pre-made bases or preservatives) must have their component ingredients listed in the ingredient declaration based on the percentage of use in the entire formula.
There are a few exceptions:
- Fragrances may be listed as “fragrance” without identifying all the component ingredients in the fragrance blend.
- Ingredients that are present at less than 1% may be listed in any order after the ingredients present at 1% or greater.
- Color additives (which must be on the FDA list of approved color additives), may be listed after all other ingredients (regardless of the percentage at which they are used).
- Incidental ingredients, “trade secrets,” and alternative ingredients have special methods of being listed (or not) in the ingredient declaration. See the FDA website, the labeling regulations or the book Soap and Cosmetic Labeling for details.
Does every essential oil have to be listed?
Well, yes and no.
If you consider that they are individual ingredients, then yes, they do need to be individually listed.
However, if you are using them as a fragrance, you can use the term “fragrance” as an all-inclusive description of the essential oil blend.
Keep in mind that if you choose to use “fragrance” on your ingredient list, you always have the option to explain to the customer (on an informational panel) that you are using only essential oils and/or list them if you want. That’s “marketing,” not an ingredient declaration.
How should lye be listed?
Use the full chemical name “sodium hydroxide” or “potassium hydroxide.”
What about “Organic”?
IF you are registered with the National Organic Program, you are subject to all of the requirements for that program.
If you are not registered with the NOP, you cannot use the NOP symbol on your products. Current court cases and statements by FDA and other government officials indicate that the term “organic” is NOT regulated for cosmetic products. See blog post What About “Organic” Cosmetics for more info.
Ethically, you should consider your use of the term “Organic” – particularly on the front panel of your label – in light of the regulations that apply to registered products.
In any event, there is nothing whatsoever wrong with identifying organic ingredients in your ingredient list and even listing the percentage of organic ingredients in the final product, although that is probably best stated on an informational panel, rather than the front (principal) display panel.
How about selling “naked” soap?
Whether the product is “naked” or labeled, it is your responsiblity to provide the consumer with the necessary information to make an informed decision for their purchase. Therefore, you should still provide, in some fashion or another, all the information typcially required on any package (identity of the product, net weight, name/address and any necessary directions for safe use).
Most important would be the net weight, so the consumer can fairly compare the cost and value based on the price.
If the soap classed as a cosmetic (based on the way it’s made or the claims you make about it), then you must also provide the ingredient declaration.
Last updated October 31, 2015
|↑1||16 CFR 500.5(d)|