Marie Gale

Hi, I’m Marie Gale.

Helping People Understand What’s Required.

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 my personal quest to understand soap and cosmetic labeling for my own products has grown into a deep understanding of the many regulations that handcrafted soap and cosmetic 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

Choose the right solution to fit your needs


DIY with Blog Articles & Videos

FREE

This blog has much of the basic information you need to get your labels right and comply with other regulations. Here are some pages to get you started:

If you are wondering about requirements in your state, check the State Agencies page. You can also search by subject for related articles and videos.

DIY with Books

$9.99 – $34.95

My books contain the details you need to correctly label your soaps and cosmetics and folllow the laws and regulations applicable to handcrafted soap and cosmetics. All are available from Amazon.com – just click the images below!

Complying with MoCRA by Marie Gale
Soap and Cosmetic Labeling cover
Navigating the Rules and Regs book by Marie Gale
Good Manufacturing Practices cover
300 years of Natural Soap and Cosmetic Recipes cover

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..

  • An Almond Doesn’t Lactate

    An Almond Doesn’t Lactate

    Last month, pointing out that “almonds don’t lactate,” FDA Commissioner Scott Gottlieb announced that the FDA will soon issue a new guidance on the use of the term “milk.” Currently cow’s milk is defined as: Directly from the regulations: “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more […]

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  • Are Your Color Additives Legal?

    Are Your Color Additives Legal?

    Color additives are a major concern for the FDA. Using an unapproved color additive can cause your product to be adulterated (and illegal).

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  • If One, Then All?

    If One, Then All?

    “If you put one ingredient on your soap label, you have to list them all” is an idea is being bandied around a lot lately. But is it true? As with most questions about legal stuff and regulations, yes… and no. Cosmetics If the product is a cosmetic, then the answer is a resounding YES. […]

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  • Natural Colorants, More

    Natural Colorants, More

    Since my last post about natural colorants I’ve gotten some questions about using ingredients that change the color of the soap or cosmetic, where that really wasn’t the point of the ingredient. Lets review the definitions. I’m just including the important bits, and bolding the really important bits. Color Additive Any material that is capable […]

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  • Natural Colorants for Soap & Cosmetics

    Natural Colorants for Soap & Cosmetics

    For most people making and selling handcrafted soap and/or cosmetics “natural colorants” means ingredients such as herbs and spices that will change the color of your product. If you do a Google search for “natural colorants” you will find articles, posts, messages, books, webinars, and much more detailing the many ways you can make beautiful and […]

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  • Trade Secrets

    Trade Secrets

    You’ve developed the perfect product and you want to keep the formulation secret. Can you hide some of the ingredients? Well, yes and no. Key Word to Know Trade Secret Any formula, pattern, device, or compilation of information which is used in one’s business and which gives one an opportunity to obtain an advantage over […]

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  • Looking for Product Drug Claims

    Looking for Product Drug Claims

    When we talk about “drug claims” we are actually talking about the statements that tell the consumer that a product is intended to be used to diagnose, mitigate, treat, or prevent disease or to change the structure or function of the body. How does the Food and Drug Administration (FDA) determine the intended use of […]

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  • 10 Ways to Improve Your Quality Control

    10 Ways to Improve Your Quality Control

    “Quality control” is all about finding each little thing you can do to maintain control over the quality of your products. Here are 10 things you can do to improve your quality control.

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  • Anti-Aging, Rejuvenating, and Repairing Claims

    Anti-Aging, Rejuvenating, and Repairing Claims

    In 1988, the FDA issued Import Alert 66-38 titled “Skin Care Products Labeled as Anti-Aging Creams” which clearly stated that exaggerated ‘anti aging’ claims could cause a product to be an unapproved new drug. Import Alert 66-38 was the basis for understanding restrictions on cosmetic claims like anti-aging, rejuvenating and repairing. That Import Alert was […]

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  • Color Additives for In-Bath Products

    Color Additives for In-Bath Products

    The FDA regulates color additives and their use. For cosmetics, the FDA has a list of color additives permitted for use in cosmetics and each color additive has specifications on how it may be used: In-Bath Products “In-bath products” include cosmetic products such as bath oil, bubble bath, bath fizzies, or bath bombs—many of which are […]

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  • Street Address – Your Choices

    Street Address – Your Choices

    Even though the requirements for the street address on the label are pretty clear cut, it still seems to be an issue for those working out of their homes.

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  • “Love” Isn’t an Ingredient

    “Love” Isn’t an Ingredient

    The FDA has finally stated, clearly and definitely, that “love” isn’t an ingredient—at least in granola. Recently the news and social media have been filled with articles about the FDA’s recent warning letter to a bakery in Concord, Massachusetts, in which they were cited for (amongst other things), including “love” which is “not a common […]

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