Marie Gale

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

  • Are You Helping Hackers?

    Are You Helping Hackers?

    Are you putting your personal accounts at risk? Lately I’ve seen a lot of quizzes and surveys in my Facebook feed. It scares me to see the amount of personal information that is being shared without thinking it through. You know those shared posts that have lists of questions so your friends can get to

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  • FDA Warning Letters Over CBD

    FDA Warning Letters Over CBD

    Three FDA warning letters issued in the past week have been concerning products containing CBD. Looks like they are starting enforcement activities in this area. All three of the warning letters (to PotNetwork Holdings, Advanced Spine and Pain, and Nutra Pure) cited similar violations. Drug Claims Claims that the product would treat or mitigate various

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  • Hemp Oil & Seeds

    Hemp Oil & Seeds

    As a follow-up to my previous post, What About CBD Oil?, I have been asked about the status of hemp oil and seeds. The FDA has approved hemp seed oil, hemp seed protein powder and hulled hemp seed as GRAS (generally recognized as safe) for use in food products. There should be no problem using

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  • What about CBD Oil?

    What about CBD Oil?

    CBD is short for cannabidiol, one of the many compounds found in the cannibis plant. It is non-intoxicating, but many claim it has significant physical benefits. “Hemp” and “marijuana” have been lumped into the same category since the 1937 Marijuana Tax Act and the 1970 Controlled Substances act. However, in December the 2018 Farm Bill

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  • For Members of the HSCG

    For Members of the HSCG

    I am very pleased to announce that I am now an official “HSCG Expert” and as such I have my very own entry in the Handcrafted Soap and Cosmetic Guild’s Expert Consultations page. You can find tons of information on soap and cosmetic labeling and good manufacturing practices. (With more to come!) In addition, I

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  • New Year’s Resolutions – Check Your Labels!

    New Year’s Resolutions – Check Your Labels!

    With every New Year come the New Year’s resolutions. Now’s the time to check your labels!

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  • Proposed FDA Survey: Allergens in Cosmetics

    Proposed FDA Survey: Allergens in Cosmetics

    Allergens in cosmetics have been an issue of growing concern. Food product regulations require the disclosure of certain allergens, even if only that the facility makes other products with the allergens in them (e.g., “this product was made in a facility that puts peanuts in other products”). Cosmetics don’t have those requirements. Concern for consumers has

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  • Certificate of Free Sale

    Certificate of Free Sale

    A Certificate of Free Sale is a document that provides proof that a product is being freely and legally sold without restriction. It is sometimes also called a “Certificate for Export” or “Certificate to Foreign Governments.” When Is a Certificate of Free Sale Needed? A Certificate of Free Sale is needed if you are exporting

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  • Why is Regulatory Compliance Important?

    Why is Regulatory Compliance Important?

    When looking at the minutiae of labeling a soap or cosmetic product, it’s easy to forget the big picture. Why are all these regulations in place? Why is it important to comply with them? Why Are There Regulations At All? In the USA, regulations are the rules that are put in place to implement the

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  • Blended Color Additives

    Blended Color Additives

    Color additives in cosmetics continue to be a difficult topic.  Blended cosmetics are especially problematic. Keeping your products legal requires diligence and an understanding of color additives and the regulations.

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  • Making Cosmetics in Nevada (Archived)

    Making Cosmetics in Nevada (Archived)

    Nevada is one of the states that requires cosmetic manufacturers to register, get inspected and pay fees.

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  • California Cosmetic Regulations Updated

    California Cosmetic Regulations Updated

    Two bills concerning cosmetic manufacturing in California have been working their way through the legislative process. California Governor Jerry Brown signed AB 2775 on Sept 14th, 2018, and SB 1249 went to the Governor on September 12th. What does it mean for handcrafted cosmetics? AB 2775 – Professional Cosmetic Labeling California AB-2775 requires that all cosmetics

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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..