Shaving Soap is regulated as a Cosmetic according to the FDA in the U.S.

Discussion in 'Lye-Based Soap Forum' started by earlene, Apr 28, 2019.

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  1. Apr 28, 2019 #1

    earlene

    earlene

    earlene

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    There are many U.S. soapmakers here at SMF who already know this, but for those who keep arguing that it isn't true, here is one link to a discussion about it less than 4 years ago, in which a response from the FDA confirmed the question:

    https://www.soapmakingforum.com/thr...tions-re-ingredients.49159/page-2#post-459051

    Above letter was referenced again the following year when the question came up again:
    https://www.soapmakingforum.com/thr...-products-safety-act.53917/page-2#post-512951

    It has been discussed at length on several threads including:https://www.soapmakingforum.com/thr...regulations-re-ingredients.49159/#post-458526


    Anyway, it seemed that the old argument has come up again, so thought I'd point this out with the references to back it up.

    If anyone in the U.S. wants to argue that fact, I suggest y'all contact Mr. Wright, the FDA agent who clearly informed our SMF member, new12soap that (and I quote)

    "Shaving soaps are regulated as cosmetics."

    His contact information is in the link above. I am sure he would be willing to confirm what the rest of us already know. If he doesn't work there anymore, there is bound to be another FDA agent willing to confirm this fact.
     
    Last edited: Apr 28, 2019
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  2. Apr 28, 2019 #2

    Andrew

    Andrew

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    To meet the definition of soap in FDA’s regulations, a product has to meet three conditions:

    1. What it’s made of: To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.
    2. What ingredients cause its cleaning action: To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. You still can use the word “soap” on the label.
    3. How it's intended to be used: To be regulated as soap, it must be labeled and marketed only for use as soap. If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. Or, if the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug. You still can use the word “soap” on the label.
    The only thing a shaving soap does is make a slick, stable lather. Probably the most important part of packaging/labeling/websites is that no reputable shaving soap maker will market the shaving product with words such as 'moisturizing' or to treat certain diseases. The lather is slick. The lather has great glide and cushion. It all is about the lather.

    Shaving soaps that we would make actually meet all three conditions listed above but are actually true soaps which by 2018 (years after these threads) the FDA specifically does not regulate.

    I think it is also very important to know that the FDA lets companies label detergent products as soap while at the same time not actually meeting the regulations of the term. I think this is somewhat confusing for consumers and makers alike. You can have a shaving soap that under FDA regulations is allowed to be called a soap, but in fact regulated by the FDA as a cosmetic.

    Some examples:
    Eczema Soap is a cosmetic since it is marketed to cure a skin issue
    Gillette Shaving Cream is a cosmetic since it is not a true soap
    Current true shave soaps with medical claims are regulated as cosmetics.
     
  3. Apr 28, 2019 #3

    earlene

    earlene

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    Okay, since you won't write to Mr. Wright to ask if his statement still holds true, as I am sure that it does, I wrote to him myself. I will post his answer when it arrives. But I doubt he will have changed his stance on this matter.

    Here again, is his previous response to new12soap:

    From: "Wright, Shontell" <Shontell.Wright@fda.hhs.gov>
    Date: October 9, 2014, 11:14:43 AM EDT
    To: (xxxx)
    Subject: RE: VCRP Question

    Dear (xxxx),

    Shaving soaps are regulated as cosmetics.

    The intended use of a shaving soap is aid the process of shaving similar to a shaving cream or foam. Shaving products are intended to smooth the face by lubricating the skin which allows a gentler shave.

    For your information in the United States, products are regulated according to their intended use. FDA determines intended use by the way in which a product is marketed as a whole, not on a word or phrase taken out of context. Intended use may be established in a number of ways. Among them are--

    • Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. As noted above, certain claims may cause a product to be considered a drug even if the product is marketed as if it were a cosmetic.

    • Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.

    • Ingredients that may cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use.

    Consider the following definitions to determine the regulatory status of a product according to the intended use:

    • The term "cosmetic" means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap.

    • The term "drug" means articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals.

    Drugs and cosmetics are regulated differently. For example, drugs are subject to premarket approval by FDA and drug manufacturers are required to register their manufacturing facilities with FDA. Please direct questions about drugs to FDA's Center for Drug Evaluation and Research (CDER). You can contact CDER's Division of Drug Information, Small Business Assistance, directly at CDERSmallBusiness@fda.hhs.gov. Or, you may contact CDER's Division of Drug Information with general drug-related inquiries at druginfo@fda.hhs.gov. For more information on drug registration, see “Drug Registration and Listing System (DRLS & eDRLS)” at http://www.fda.gov/Drugs/GuidanceCo...mation/DrugRegistrationandListing/default.htm and “Electronic Drug Registration and Listing Instructions” at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm177328.htm.

    If, after reviewing this information, you still have questions, please let me know. I will be glad to help.

    Best regards,

    Shontell Wright
    VCRP Staff
    <image001.png>


    So there it is, spelled out directly from the FDA (Bolding added).[/QUOTE]

    Regardless of shaving soap meeting all three criteria as a true soap, it is still a cosmetic soap per the regulations as stated by Mr Wright at the FDA.

    The INTENT of shaving soap is not to clean the face (or the legs, or the underarms or whatever other part of the body one chooses to shave). The INTENT is to provide a smooth shave and IMPROVE one's appearance. The INTENT of shaving soap is to be provide a comfortable shaving surface and prevent cuts and nicks. The INTENT of shaving soap lather is to coat the face during shaving providing protection and lubrication for the razor. A soap CAN be a soap AND a cosmetic. A soap can also be a soap AND a drug. Just because it is a soap does not preclude it from being both a cosmetic (even a cosmetic AND a drug) while it is still a soap.

    Also from the FDA:

    If a product

    • consists of detergents, or
    • primarily of alkali salts of fatty acids, and
    • is intended not only for cleansing but also for other cosmetic uses,
    it is regulated as a cosmetic.

    Shaving is a cosmetic use of soap; it is not only for cleansing. This is indisputable, yet you keep disputing this fact. I don't understand why.

    (red highlights added by me)

    Alright, you say it *isn't a cosmetic* and then you say **it is**? What's your stance? Has it changed since yesterday?

    No, Eczema Soap is regulated as a DRUG since curing a disease makes it a drug.

    No, Gillette Shaving Cream is regulated as a cosmetic BECAUSE it is INTENDED for cosmetic use (to make the user more attractive, etc.)

    No, shave soaps with medical claims are regulated as drugs AND cosmetics, not just cosmetics.
     
    Last edited by a moderator: Apr 28, 2019
  4. Apr 28, 2019 #4

    SaltedFig

    SaltedFig

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    The FDA have a page titled "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
    Found here: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap

    The page includes a lot of the text that was in that letter are on that FDA page (I'm guessing they get this question, a lot! :)).

    The page also includes links to the relevant federal laws and the Consumer Product Safety Commission website (the definition of soap is regulated by the CPSC in America, according to the FDA website).
     
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