Helping you understand soap and cosmetic regulations — in plain English.
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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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Rubbing Alcohol
The term “rubbing alcohol” originally referred to alcohols that were applied to the body rather than drinking them as a beverage. Especially during Prohibition, when consumable alcohol was illegal, the distinction was very important.1 The Alcohol and Tobacco Tax and Trade Bureau (TTB) and the United States Pharmocapeia (USP) define two different formulas for rubbing […]
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Isopropyl Alcohol (Isopropanol)
Isopropyl alcohol (also called 2-propanol or isopropanol) is a colorless, clear, flammable liquid with a strong and recognizable odor. It is made from propylene (also called propene) which comes from petroleum. Isopropyl alcohol is often also referred to as “rubbing alcohol” although it is not the only type of rubbing alcohol. Isopropyl alcohol is highly poisonous […]
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Ethyl Alcohol (Ethanol)
When used in the naming of a cosmetic ingredient, “alcohol” is the proper INCI name for ethyl alcohol (ethanol). Ethyl alcohol—also called grain alcohol—is the consumable kind of alcohol. It’s naturally produced by the fermentation of sugars, from which we get all sorts of alcoholic beverages; beers, wines, and hard liquors. It can also be […]
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Talc
As an ingredient in cosmetics, talc has been under scrutiny for some years now. I’ve recently done a survey of the current information about talc, and here’s what I found out. Talc was originally used as “talcum powder”—the original body or baby powder. Now it has many uses in cosmetics and other personal care products; […]
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Made in the USA
If you want to make the claim that a product is “Made in the USA” you must comply with the Federal Trade Commission’s “Made in the USA” policy.
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Making Cosmetics in Ohio
Ohio is one of the several states that have additional requirements for cosmetic makers.
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The Importance of Good Manufacturing Practices
Sometimes it’s easy to think that keeping in Good Manufacturing Practices when making cosmetics is just a good idea—a “suggestion” rather than a “rule.” I suppose that idea is reinforced by the fact that cosmetic GMP isn’t actually in the regulations, it’s a “guidance.” Events of the past several months have shown that GMP failures […]
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What is INCI?
The INCI is a list of the standardized and internationally accepted names of ingredients which should be used in the ingredient declaration …,. mostly.
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FDA Policy Change on Hand Sanitizers
On October 12th, 2021, the FDA announced they are withdrawing their temporary policies allowing manufacturers who were not drug manufacturers to produce certain alcohol-based hand sanitizers. Background In the US (and elsewhere) hand sanitizers are classified as drugs—usually over-the-counter drugs. They must be manufactured by approved drug manufacturers in facilities that are registered, inspected, and […]
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FDA Warning Letters 2021
I’ve been receiving a lot notices of FDA warning letters, so I reviewed the last 106 warning letters (60 days) to see what sort of warnings they have been sending out lately. Here’s the breakdown of the types of products cited (in descending order). Unapproved New Drugs Warning letters concerning cosmetics are usually found under […]
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Ingredient Declarations for Soap (US Only)
Is an ingredient declaration required on your soaps? Let’s take a look!
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Florida – 2021-Changes to Cosmetic Manufacturers Law
The laws for cosmetic manufacturers in Florida have been updated and now include a small business exemption!
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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 – $125 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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