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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 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

  • 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

    The FDA’s 1988 Import Alert regarding Anti Aging Creams was withdrawn at the end of 2017. What does that mean?

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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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  • Minimum Risk Pesticides

    Minimum Risk Pesticides

    The EPA website has been updated since the last time I looked at it. It still wasn’t too easy to find the Minimum Risk Pesticides page, but once I found it, I discovered it was much clearer and easier to understand than before the updates. Of course, the information and regulations haven’t changed, but it […]

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  • FTC updates business address requirements

    FTC updates business address requirements

    The Federal Trade Commission (“FTC”) has issued the final rule for updating some aspects of their labeling regulations, including the requirements for the business name and address. Note that these revised regulations will apply to non-cosmetic items, including to soap that is exempt from the definition of a cosmetic (see Soap, the Chameleon). The updated regulation […]

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  • Understanding the Net Contents

    Understanding the Net Contents

    Close to HALF of the labels I see don’t include the net weight. The net weight of the product isn’t just a good idea.  It is a key piece of information that is required on every product.

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  • Another FDA Warning Letter

    Another FDA Warning Letter

    The FDA just (July 2017) published a warning letter to a cosmetic manufacturer in St. Louis. Once again, the FDA reviewed the website and cited drug claims: “…the claims on your website establish that the products are drugs under the … Food Drug and Cosmetic Act … because they are intended for use in the […]

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  • FDA “Discretionary Enforcement”

    FDA “Discretionary Enforcement”

    Last March (2017), I sent a Freedom of Information Request to the FDA, asking for details on any decisions they had made to use “discretionary enforcement” on some regulations. It seems that there are some labeling regulations which the FDA has apparently decided not to enforce, but they haven’t really said anything publicly. That may […]

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  • More About “Natural” Claims

    More About “Natural” Claims

    The FDA doesn’t regulate the term “natural” for cosmetics, but the FTC has taken action against deceptive claims of “all natural” cosmetics under their authority over “deceptive practices.” Who Has Authority? When it comes to cosmetic products, their safety and labeling, the FDA has authority. But as an interesting historical note, when the Food Drug […]

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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..