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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MoCRA Facility Registration & Product Listing Reports
On March 13th, 2025, the FDA announced the number of cosmetic facility registrations and cosmetic product listings that had been completed under MoCRA in the last year.
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BOI – Geez, Now it’s OFF!
Beneficial Ownership Information — On, off, on, off, on, now OFF (and probably for good).
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Labeling Book 2025 Edition Live on Amazon!!
Soap and Cosmetic Labeling 4th edition (2025) is LIVE on Amazon!
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Update on BOI Filing – It’s On Again
Another court decision – reporting Beneficial Ownership Information with the US Treasury is BACK ON.
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Soap, Cosmetics and Food Allergens
The FDA issued final guidance on food allergens. What does it mean for soap and cosmetic makers?
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Cosmetic Regulations Under Trump
Donald Trump was sworn in as the 47th President yesterday (January 20th, 2025). Some of the actions he took yesterday may affect cosmetic regulations.
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5 Steps to Avoid Social Media Disaster
Social media can be a great tool for your business, but it can also spell disaster – both legally and for your reputation.
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Happy New Year!
Happy New Year 2025! Positive manifestation: This year is going to be the best year ever!
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FinCEN BOI – File or Not?
The on-again off-again nature of the Corporate Transparency Act makes it a little uncertain whether you HAVE TO file your BOI (Beneficial Ownership Information) or not. Right now, not.
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Testing for Products Containing Talc
On December 27, 2024, the FDA issued proposed regulations that all cosmetic products containing talc must be tested for the presence of asbestos.
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Eyeshadow and MoCRA
If you make eye shadow, you are not qualified for the small business exemption. That means facility registration, product listing, and good manufacturing practices apply.
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FDA Regulatory Agenda – Fall 2024
The Fall 2024 Unified Agenda of Regulatory Actions is out. The FDA updated the timetable for issuing MoCRA regulations.
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
