FDA Cosmetic Website Updated

FDA.jgpThe FDA recently updated the Cosmetic section of their website and added some new pages that clarify regulations, particularly for small manufacturers of soap and cosmetics. Some of the most commonly asked questions are very clearly answered in FAQ format.

When you go to the FDA Cosmetics home page (from the FDA home page, click the “Cosmetics” tab), you’ll see that the page has been reorganized.  At the moment, in the main image box, there is an announcement that the content has been reorganized and if you click that link it will take you their press release.  The link in the left-hand menu under “News and Events” has a link to What’s New in Cosmetics which lists out the new and some (but not all) of the changed content.

As an aside, I noticed that not only did they change the content, they have also changed the layout and the way the new pages function so they are mobile-friendly (that is, the layout changes when viewed on a table or mobile device to make it easier to read).

Small Businesses & Homemade Cosmetics: Fact Sheet

One of the new documents is the Small Businesses & Homemade Cosmetics: Fact Sheet.  Written in FAQ (Frequently Asked Questions) format, it does in fact address some of the most frequently asked questions about small cosmetic manufacturing and covers important subjects such as how cosmetics are regulated by the FDA, if any testing is required, registration, requirments for starting a business, and labeling.  Many of the answers also links to additional information on several different subjects.

Of interest, one of the questions is “Can I use a Post Office (P.O.) box or website for the address on the label?”  The answer is extremely clear … no.

Soap: Fact Sheet for Soap Makers

If you’ve had any difficulty understanding when “soap” is exempted from FDA regulation (and when it’s not), the new page Soap: Fact Sheet for Soap Makers clearly explains the criteria and includes some links to additional information.

Fragrances in Cosmetics

The new Fragrances in Cosmetics page is intended for both consumers and manufacturers.  It talks about how to tell if a fragrance product is regulated as a cosmetic and discusses the terms “essential oils” and “aromatherapy” and how they apply to cosmetic regulation.  Use of the term “fragrance” in the ingredient list is explained.

Labeling Section

The reorganization of the FDA Cosmetics website has created a section called Labeling, which has several sub-sections.

In the Labeling Regulations sub-section, you’ll find an Overview of Labeling Regulations which gives an excellent overview of the regulations (just like the title says).  The Summary of Labeling Requirements is a nice, concise summary of what the labeling requirements are, with a brief explanation of the fundamental information you should know.  The Labeling Regulations page gives links to each part of the Code of Federal Regulations that apply to labeling cosmetics; it makes the actual code much easier to find than it was before.

The Labeling Claims sub-section contains links to information about different claims and what the regulations are – or if they are not regulated terms.  There are articles on Alcohol Free, Cosmeceutical, Hypoallergenic, Aromatherapy and more.

The Cosmetic Labeling Guide has been included in the Labeling section.  It has been updated a bit, and reformatted in a way that makes it somewhat easier to read.  I didn’t find any major changes to what’s covered, but there were some minor changes that make it easier to understand.

Ingredient Names

Another new document, Ingredient Names,  clearly states how to determine  what names should be used to identify ingredients in a product.  The FDA makes it very clear that common or usual names must be used (not Latin or foreign language).

Cosmetic companies sometimes ask FDA about identifying botanicals only by their Latin names, identifying color additives only by the “CI” numbers used in the European Union, or using terms from other languages, such as “Aqua” and “Parfum” instead of “Water” and “Fragrance.” Under the FPLA, however, ingredients must be listed by their “common or usual names,” and FDA does not accept these alternatives as substitutes. But FDA does not object to their use in parentheses following the common or usual name in English (or Spanish, in Puerto Rico). [emphasis added]

Product Testing

The new page covering Product Testing answers the question about when product testing is recommended or required and how to support the safety of your cosmetic.  It’s excellent reading and contains links to additional information as well.

In Summary

It’s important to note that there have not been any changes to the regulations. However, it really looks like they have recognized that the handcrafted soap and cosmetics industry exists, and that we are different from the large, commercial manufacturers they typically dealt with in the past.

This reorganization of the FDA Cosmetics website pages makes it much easier to navigate around and to find information pertinent to making and labeling cosmetic products.  Most of the new pages are much needed and serve to clarify points that have often been confusing, especially for the handcrafted soap and cosmetic industry.

Kudos to the FDA for recognizing the need for change, and for doing so in a manner that will really assist those who are looking for the information they need to follow the existing regulations.

 

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Comments (6)

  • comment_avatar

    Pam

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    Thank you Marie for keeping us in the loop and updated. I found your article from Soaping101 facebook page.

    I read thru the regulations and come away with more questions! Isn’t that the way!
    As soap in it’s basic element is regulated by “Consumer Product Safety Commission” not the FDA do you have a link to their guidelines.

    “How are different “soap” products regulated?

    If your product meets the regulatory definition of soap, it’s regulated by the Consumer Product Safety Commission (CPSC), not by FDA. Please direct questions about requirements for these products to CPSC.

    If it’s a cosmetic, it’s regulated by FDA. ”

    Thank you.

    Pam

    Reply

    • comment_avatar

      Marie Gale

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      I went to the CPSC site and looked at the Regulations page. Since it’s not not listed there, the page says it would be an “unregulated product“. There are still some reporting requirements for “dangerous products” and “lawsuits”.

      I can’t see anywhere where being regulated (or not regulated) under the CPSC negates the need to follow the Fair Packaging and Labeling Act and the labeling regulations under its authority. Also applicable are any product labeling requirements at the state level, which usually are completely or mostly in accordance with the National Institutes of Standards and Technology (NIST) Handbook 130, which details suggested uniform laws for the states to use.

      In general, the basic regulations that apply to soap that is not a cosmetic are: name, product identity and net weight on the principal display panel and the name and address of the business on an informational panel. thos eare the same basics that are required on cosmetic packages (although cosmetics require a few other things), since all of the labeling for both cosmetics and non-cosmetic products have the foundation in the Fair Packaging and Labeling act.

      Reply

      • comment_avatar

        Pam

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        Thank you so much for clarifying that for me. I did find the site and I did read thru it looking for what I thought I wanted to see. I for one appreciate your knowledge base Marie and your interpretation of the site. Many warm and heartfelt thank you!

        Reply

  • comment_avatar

    Tracy

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    Thanks for posting this! For soap, they say, “Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin.” I guess Zum isn’t a soap, then!

    I think a lot of us try to stay just soap because the regulations are confusing and because we don’t want to use INCI nomenclature, because it gives a false impression that our products are chemical-laden (consumers don’t know that sodium cocoate is coconut oil). And ingredient vendors always give us the INCI terminology, giving the impression that we have to use INCI.

    I’m not quite sure how to make soap products stand out within the regulatory guidelines. Cleans better! ?

    What are the hurdles we’d have to clear to make claims like moisturizing or soothing? If we already label our soaps properly under CPSC rules, would the only difference be including FDA-proper ingredients lists? Or would we also have to stop using most of our botanical colorants?

    Reply

    • comment_avatar

      Marie Gale

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      Really, the only difference with labeling a “true soap” that only claims to clean (and is therefore exempted from FDA authority) and a “moisturizing soap” (which is a cosmetic and does come under the FDA) is the requirement of listing the ingredients.

      To clarify the ingredient declaration, it should be listed in descending order of predominance (with some possible exceptions) and use common names for the ingredients. So botanicals should be listed by their COMMON name; the Latin name MAY be included in parenthesis, but is not required. So the correct way to list Lavender essential oils is “Lavender essential oil” or “Lavender (Lavendula officinalis) essential oil”.

      Cosmetics do have restrictions on what can be added to the product with the specific intent to change the color. A “color additive” must be on the list of approved color additives for cosmetics. However, there is nothing wrong with adding an ingredient for some other purpose (consistence, texture, even just marketing) that also happens to change the color of the product. Powdered sage, for example, can add a nice clean scent to soap, and it has some nice marketing aspects (think “Herbal essence shampoo!), and it also happens to change the color of the soap. In that case it probably wouldn’t be a “color additive” … it’s an ingredient that happens to change the color of the soap.

      Reply

      • comment_avatar

        Tracy

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        THANK YOU!! The FDA website has always been clear as mud. I bought your book, but differentiating soap rules from cosmetic rules was still confusing. So I’ve tried to keep my nose clean by just marketing soap that cleans. And lose sales to soap makers (big AND small) whose soap will “cure” everything from acne to aging.

        Reply

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