More on “Lip Balm”

http://www.dreamstime.com/stock-images-homemade-lip-balm-image18359584Last year I wrote a post, “Drug Claims and Lip Balm” which discussed the use of the phrase “lip balm” as the identity of a product.  Unlike “lipstick” or “lip gloss,” the specific term “lip balm” is cited in the over-the-counter drug monograph for “skin protectants” as one of the approved ways to identify a skin protectant (which is a drug). The issue came up again recently on a newly updated FDA webpage, Cosmetic Export Certificates.  On that page, which is essentially a FAQ about how to get a cosmetic export certificate, lip balm was mentioned in one of the questions, “Is my product really a cosmetic under the law?”The answer to which was:

Many personal care products are actually drugs under U.S. law, such as products with claims of–

… Skin and lip balm

Clarification from the FDA

I immediately sent the following to the FDA for clarification:
I am seeking some clarification on the use of the term “lip balm” as used to identify a product. 21 CFR 347:50, Labeling of skin protectant drug products, specifies the use of the term “lip balm” as one way in which skin protectants used on lips may be identified. Within the handcrafted soap and cosmetic industry, the term “lip balm” has become a generic term used to identify lip products that are intended only to moisturize (and sometimes color) the lips. The ingredients in these products are generally a combination of food grade hard and soft oils, a wax (typically beeswax, but sometimes other food grade waxes), and optionally a flavor and/or color.  Such manufacturers do not make claims that the product is a “skin protectant”, nor do they include sunscreen or other active ingredients. … Clarification from the FDA on whether the use of the term “lip balm” is allowed to identify lip products other than those that are claimed to be skin protectants would be of great assistance to the handcrafted cosmetic community. If you could provide answers to the following questions, it would be greatly appreciated:

Is the use of the term “lip balm” RESTRICTED in use to only identify skin protectant products?

In other words, does the use of the term “lip balm” cause the product to be considered skin protectant, even if no skin protectant claims are made and the product, by virtue of actual claims would otherwise be considered a cosmetic?

It took a few weeks to get an answer. The response I received back from the FDA was:
These types of products would be considered cosmetics granted they were not making drug claims (as in claiming to diagnose or treat any type of disease).
So, apparently it IS okay to use the term “lip balm” to describe a product, so long as there is no claim that it will diagnose or treat any type of disease. Keep in mind that “chapped lips” is a “disease” in the eyes of the FDA, so preventing or treating chapped lips would be a (drug) claim to diagnose, treat or prevent a disease, making the product an unapproved drug. On the flip side, a claim that your lip balm product “improves appearance” would be only a cosmetic claim, and keep it in the cosmetic product category.

Keep in mind …

The information I’ve provided here is what I received from the FDA. It was not worded as an “official opinion” of the FDA, and I have no idea what side-check the data went through before being sent to me. I want to believe that all the information received in any form of communication from any FDA staff is always accurate, but my experience tells me that there have been times that FDA staff haven’t been totally correct.  So take the information with a (small) grain of salt and be watchful in how you use the term “lip balm” to describe any lip product.

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Comments (11)

  • comment_avatar

    Lisa Farrell

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    Good Gracious! And thanks for the heads up and good work , always appreciated !

    Reply

  • comment_avatar

    lLisa Farrell

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    I just realized I have a question:) Can you still say balm at all, as in foot balm? or cuticle balm?

    Reply

    • comment_avatar

      MarieGale

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      I did some searching and couldn’t find anything within the regulations or on the FDA site that restricts the use of the term “balm” except for the places where it’s used as “lip balm”.

      I also checked the definition of “balm” at http://www.yourdictionary.com, http://www.definitions.com and King James Bible Dictionary. Among the various definitions are several that refer to “healing or soothing,” and some refer to “treatment”, but other definitions include “a pleasing aromatic fragrance,” “anything healing or soothing, esp. to the mind or temper,” and several other similar definitions.

      Based on the definitions for “balm,” it could be used to identify either a drug OR a cosmetic – so it comes back to the intended use of the product. If the intended use is to treat, cure, mitigate or prevent disease, or to alter the function or structure of the body, then it would be a drug. If it is applied to the human body to improve appearance or beautify then it’s a cosmetic.

      A “foot balm” that is intended to make the feet smoother, softer and more attractive (and maybe smell good) would be a cosmetic. A “foot balm” that is intended to prevent or cure cracked, dry feet or that is promoted as anti-fungal would be a drug.

      Reply

  • comment_avatar

    Vee

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    Hello how are you?
    My lip balm has cocoa butter in it, is this considered a drug according to the fda? Thanks for your amazing website and I just ordered your book!! :D

    Thanks in Advance

    Reply

    • comment_avatar

      MarieGale

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      Cocoa butter is cocoa butter. It’s a common ingredient in cosmetics.

      There IS a monograph for using cocoa butter at 50% – 100% as an active ingredient for a skin or lip protectant. Using it at that rate and claiming the product actually PROTECTS the skin or lips causes the product to be a drug. In order to be marketed as such it would need to follow the regulations for Skin Protectant Drug Products for Over-The-Counter Human Use, covered in 21 CFR 347, AND the manufacturer would need to be registered with the FDA as a drug manufacturer and follow all the required good manufacturing guidelines for drug manufacture (which are in regulation).

      Reply

  • comment_avatar

    Hilary

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    Hello Marie,

    Thank you for posting all of your wonderful research. It can be so confusing searching through the FDA’s website pages. I was wondering about lip balms that are designed to ease cold sores. What can I say on the label? Medicated? Sooth cold sores? Any suggestions would be greatly appreciated. I own you labeling book and am purchasing your GMP book now. Thanks!

    Reply

    • comment_avatar

      MarieGale

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      Hi Hilary,

      Cold sores are a “disease” and are caused by the “function and structure of the body”. Anything that claims to treat cold sores would be claiming to modify the function or structure of the body or to cure, mitigate, or prevent the disease of cold sores. Either way, those would be drug claims, and would very likely make the product a “new unapproved drug” in the eyes of the FDA.

      Remember, it has to do with the INTENT of the product. Any product with the INTENT to treat, cure mitigate or prevent disease is a drug (which, of course, requires FDA approval in most cases, as well as an approved drug manufacturing facility). Products with the intent to make a person more attractive or beautiful or to alter the APPEARANCE (not the function or structure) of the body is a cosmetic and doesn’t require FDA approval.

      Be very careful marketing or making claims for a product that is intended to treat cold sores.

      Marie

      Reply

    • comment_avatar

      Marie Gale

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      There are a couple of places where the FDA uses “lip protectant” (including the term “lip balm”) as an example of a cosmetic that is also a drug. I contacted the FDA last year about that, and was told that the term “lip balm” may be used for cosmetics and it is NOT considered a drug just by the use of the name alone. I don’t think the updates to the FDA website changes that.

      Reply

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