Helping you understand soap and cosmetic regulations — in plain English.
Hi, I’m Marie Gale.
For over 15 years I’ve been researching and following the world of laws, regulations, standards and guidelines for the handcrafted soap and cosmetic industry. What started as a personal quest to understand soap and cosmetic labeling for my own products has grown into a deep understanding of the myriad of requirements that handcrafted soap and cosmetics makers are subject to.
My personal passion to assist others to understand and follow the labeling and other requirements grew out of all that research. If I had my way, no handcrafter would ever experience the stress and heartache of unwittingly running afoul of the the laws and regulations.
There is peace of mind in knowing that you are compliant with the applicable regulations. I’m here to help you achieve that stress-free relationship with your products and your business.
Whether you know it or not, you’ve been an invaluable resource for me throughout our years in business as I’ve relied on your many books whenever I have questions. I’ve recently purchased “Navigating the Rules & Regulations” and am going through it with tabs & a highlighter and am learning more than I ever expected. — Julia
Latest blog articles
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Ingredient Names From 1977 Still Good?
The Code of Federal Regulations specifies where to find the names by which cosmetic ingredients should be identified in the ingredient declaration on a cosmetic. First are any names “established by the Commissioner” (there are a few) and then the CTFA Cosmetic Ingredient Dictionary, Second Ed., 1977. After some searching, I was finally able to locate a copy of this elusive book ($200 from an…
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Ingredient Name in a Product Name
FDA regulations that prohibit the use of the name of one ingredient in the name of the product (if it has two or more ingredients)
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Getting Back in the Groove
They say that when you fall off a horse, the best thing is to get right back on. The rationale is that the longer you delay, the harder it is to overcome any fear you have from falling off in the first place. In other words, you lose your groove. Well, I can tell you from recent personal experience, the longer your out of the…
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More on “Lip Balm”
Last year (2012) I wrote a post (on “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…
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FDA Issues New Draft of Cosmetic Good Manufacturing Practices Guidelines
The FDA recently announced that they have issued a new draft guidance on good manufacturing practices for cosmetic products. This new draft is an update to the existing “Cosmetic Good Manufacturing Guidelines/Inspection Checklist“. According to the Introduction: “This document provides guidance to industry and other stakeholders on the FDA’s current thinking concerning what constitutes Good Manufacturing Practices (GMPs) for cosmetics.”
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Cosmetics – Is Testing Required?
In a nutshell, no, testing is not required. What is required is that you make sure your products are safe. Actually, the FDA (and most state) regulations require that you ensure that your product is not “adulterated or misbranded.” So what does that mean, exactly? The Food, Drug and Cosmetic Act (which is the law that gives the FDA authority over cosmetics) prohibits adulterated or…
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What About “Organic” Cosmetics?
Several people lately have asked me about using the term “organic” when it comes to cosmetics. Can cosmetics claim to be “organic? What about using the term “organic” in a product or company name? I did some research, and what I discovered was a little bit surprising. It seems that the FDA and the USDA don’t actually see eye-to-eye on the subject.
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More on Product Claims
The FDA continues to cite claims for ingredients and claims in referenced publications as claims for the product itself, as noted in my earlier post, FDA Cracking Down on Cosmetic Product Claims. A warning letter issued May 16th, 2013, to Matrix Health Products, is a good case in point. While the products are nutritional supplements, not cosmetics, what’s interesting is the peripheral materials that the FDA referenced…
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Soapmaker’s Handy Reference Guide
(Updated 2024: This guide is out of print and not currently available.) May 2013: Not one to rest on my laurels, I’ve produced another book for soapmakers (also for cosmetic makers, even though that’s not in the name). The Soapmaker’s Handy Reference Guide was released at the Handcrafted Soap & Cosmetic Guild’s 2013 Annual Conference last week and was very well received. This little book…
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Botanical Names in Ingredient Declarations
In the ingredient declaration for cosmetics, botanical ingredients should be listed by the common English name. Here’s why.
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Using an “FDA Disclaimer” on Cosmetics
Several people have asked me about FDA disclaimers they see on packaging, websites and promotional materials that say: “This statement has not been evaluated by the Food and Drug Administration. This products is not intended to diagnose, treat, cure or prevent any disease.” I’ve been asked if the same disclaimer can be used for claims made about cosmetics. The answer is “No!” The regulations for…
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Safe Cosmetics and Personal Care Products Act of 2013
On March 21st, 2013, Rep Jan Schakowsky (D-IL) introduced the Safe Cosmetics and Personal Care Products Act of 2103. The text is now available at govtrack.us. It has been referred to to the House Energy and Commerce Committee and the Committee on Education and the Workforce. This bill does contain provisions that will affect handcrafters and small businesses when it comes to labeling, reporting and…
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Membership
$37 per month
Affordable and easily accessible ongoing support through courses, coaching, regularly scheduled Zoom Q + A sessions, a private Facebook group, and more. You don’t just learn what the rules are—you learn how to apply them to your business and get help when and how you need it.
Label Review
$125 per label
If you want another set of (experienced) eyes on your label to make sure it meets all the requirements, a label review is a good choice. A label review checks your label against the pertinent regulations. You get a checklist showing if corrections are needed (or not), along with documentation to help you understand the requirements. Label reviews take about a week. Once your review is complete, you can send me the revised label and I’ll take a look to make sure everything is in order.
I wanted my labels to be as close to compliant as I could get them. I took advantage of your label review service and can’t thank you enough for your expert advice. It was money well spent! — N.M.
Consulting
$100 – $150 per hour
Consulting is the tailor-made solution to address whatever your concerns are with your labeling, GMP, MoCRA compliance, safety substantiation, and the like. Consulting can be as simple as just answering the questions you have by email, phone or online meeting, or it can cover reviewing all your labels, ingredient declarations, website copy, safety substantiation documentation, and good manufacturing practices. It’s your call – I’m here to help with what you need.
I speak on behalf of the entire team that we are all very appreciative of your work in helping us grow our brand. It is a big step for us, and you have been instrumental in making that a reality. Thank you for your help. — D.C..
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