Helping you undersand 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 that 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 your 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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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?
Key Words to Know Nomenclature The words and terminology specific to a particular subject or area of study. Botanical Related to plants: a part of a plant. INCI International Nomenclature of Cosmetic Ingredients. The International Nomenclature of Cosmetic Ingredients is a list of the standardized and internationally accepted names (called “INCI Names”) that should be […]
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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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Making Cosmetics in Alabama
Alabama Code AL Code § 20-1-50 to 57 (2019) covers cosmetics. It’s pretty brief. The definition of a cosmetic is the same as the federal law and regulations, as are the definitions of adulterated and misbranded. The State Board of Agriculture and Industries is responsible for setting standards of “purity and quality.” Essentially, it is a violation to have or sell adulterated or misbranded […]
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Making Cosmetics in Pennsylvania
Pennsylvania has requirements for cosmetic manufacturers, including registration.
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Finally My Labeling eClass is Available!
For all the people who have asked me to put together an actual eClass, I am so excited announce that my eClass is now (finally!) available to one and all at The Nova Studio! It’s been months in the making and I’m extremely proud of the finished product. Rather than do one long lecture-type video, […]
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Label Review – Trader Joe’s Foam Soap (Video)
Let’s check out the package and label of a bottle of Trader Joe’s Botanical Bounty Foaming Hand Soap!
MORE RESOURCES
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 of 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 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..
Books
