“Label” vs. “Labeling”

Is there a difference between the “label” and the “labeling” when it comes to soap and cosmetic labels? YES. (Well, mostly.)

The FDA defines “label” and “labeling” for food, drugs and cosmetic products. The FTC defines “label” for consumer commodities other than food drugs and cosmetics. Most states have regulations that define “label” and “labeling” for food drugs and cosmetics. The Uniform Packaging and Labeling Regulation (adopted by most states) defines “label” for consumer commodities excluding food, drugs and cosmetics.

Federal – FDA Regulations

The FDA regulations define both the “label” and the “labeling”.  Since this is an FDA regulation, it applies to foods, drugs, cosmetics and medical devices.

Label (FDA)

 Label means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.1

label So the label is what is actually affixed to or printed on the package and/or container containing the product.

Labeling (FDA)

Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce.2

labelingSo when you talk about the labeling of a product, you are discussing all of the material that goes with a product while it out there in the market (technically called “in commerce”) or being held for sale or delivery.  That could include printed brochures, signage, informational handouts, website copy or even Facebook text.  The FDA has even cited content metatags and keywords on websites as part of the information about a product.

Note that advertisements that do not “go with” a product are not considered part of the labeling.  Actually, advertisements, even for cosmetics, are regulated by the Federal Trade Commission, not the FDA.

Federal – FTC Regulations

The FTC regulations define “label” but not labeling. The definition is very similar to the FDA definition.

Label (FTC)

The term label means any written, printed, or graphic matter affixed to or appearing upon any consumer commodity or affixed to or appearing upon a package containing any consumer commodity;3

The definition goes on to say that it excludes inspector’s tags, non-promotional matter attached, or the written, printed or graphic material on containers or wrappers of commodities sold or distributed to industrial or institutional users.

NOTE: the definition of “consumer commodity” in the FTC regulations is any product or commodity that is customarily distributed through retail sales for consumption by individuals for personal care or in the household. The FTC definition specifically discludes  food, drugs cosmetics or devices which are covered by the FDA4.

When you are speaking of soap that is exempt from the definition of a cosmetic, it is regulated by the FTC and this is the definition of “label” that applies.

State Regulations

For cosmetics, most states have either adopted the federal Food Drug and Cosmetic Act and the resultant regulations directly or have written their own version which is the same (or very similar to) the federal laws and regs.

For consumer commodities other than food, drugs, cosmetics and devices, most states have directly adopted the Uniform Packaging and Labeling Regulations (UPLR)  or have regulations in place that are very similar to the UPLR.

Label (UPLR)

Label. – Any written, printed, or graphic matter affixed to, applied to, attached to, blown into, formed, molded into, embossed on, or appearing upon or adjacent to a consumer commodity, or a package containing any consumer commodity, for purposes of branding, identifying, or giving any information with respect to the commodity or to the contents of the package, except that an inspector’s tag or other non-promotional matter affixed to or appearing upon a consumer commodity shall not be considered a label requiring the repetition of label information required by this regulation.5

How does this apply?

While most of the details about how to label your products apply to the “label”, you also have to be aware of what you are saying in your “labeling” to make sure you don’t inadvertently change the nature of your product.

For example, you have a lotion that you sell.  The label contains only the basic required information – the identity of the product, the net contents and your name/address.  Because it is a lotion, it is a cosmetic, it also requires the ingredient declaration.  However, on a sign in your craft fair booth, you say “cures acne”. That sign is part of your labeling, and you have now made a medical (drug) claim for your product, which makes it an unapproved new drug.

Another example is a soap that meets all the requirements to be exempt from the definition of a cosmetic; it is identified as soap, it only claims to clean and it is made with lye, water and oils.  The label has the basic information and says it is “soap,” but the description on your website where someone would purchase the soap says that it is “moisturizing and gently exfoliating”.  Those are cosmetic claims, so your soap has now become a cosmetic.  (That’s okay, but you would need to make sure it is correctly labeled as a cosmetic.)

Be aware of both the label AND the labeling of your product.

References   [ + ]

Comments

  1. Thank you so much for all you do for the industry. Is there anywhere I can get an on line class for labeling and packaging.

    1. Author

      You’re welcome!

      I don’t know of any online classes at this time … hopefully I’ll have time to put something together for the labeling in the not-too-distant future!

  2. Hello there,
    I am looking for more articles about what CANNOT be on a label. I have a soap company that sends a letter about the Environment to a government official with each purchase and I’d like to include a blurb about it on the back f the label. Do you have links or articles on what CANNOT be included? I see lots of info on what must be included but not for my situation. Thank you so much!

    1. Author

      As far as I know, the only things that CAN’T be on a label are false or misleading statements, or statements that are in violation of existing regulations (ie claiming that the product is “made in the USA” without meeting the Made in the USA Standard). If the company sends a letter to the government about environmental issues with each purchase, I don’t know of any reason why you couldn’t stqte that on the label … but you should have some sort of proof or backup in case anyone accuses you of making false statements.

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