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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Net Contents Big Enough?
Most of the recent packaging I’ve seen DOES have the net contents on it. However, on almost all, it is way too small. Way. Too. Small.
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Hybrid Soap Ingredient List
Some stunning hybrid soap can be made by combining two different types of soaps into one artistic bar. The problem is, how do you figure out the ingredient declaration when you have a CP (cold process) soap with MP (melt & pour) soap embeds, or vice versa?
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What About Glitter?
Oooh, pretty! Shiny! Sparkles! Glitter! But can you put it in soap or cosmetics? The FDA regulates color additives that may be used in cosmetics, and “glitter” is not on the list of approved color additives. In fact, the FDA says that glitter is not an approved color additive. BUT, you can see glitter in all […]
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Soap: Cosmetic or Not?
Soap is a chameleon; it can be a cosmetic or something else, depending on what it is made of, what it’s used for, and what you claim it can do. In many cases, it is the CLAIM that determines what the product is, and that in turn determines which REGULATIONS or LAWS apply. Soap Can […]
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Lawsuits Over “Organic” Cosmetics
Babyganics is now the last in a long line of cosmetic companies sued for false advertising over organic-type claims. Last month (Sept 2016) there were two suits filed against Babyganics, one for falsely advertising and implying their products are organic and one by a mom who alleged that her toddler sustained chemical burns from Babyganics tear-free […]
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FDA Upping Their Game for Cosmetics
The FDA just updated their Warning Letters Address Drug Claims Made for Products Marketing as Cosmetics Claims page with yet more warning letters. That makes twenty-five warning letters issued so far in 2016. And of those, 18 were issued in just the last 3 months! Compare that to nine warning letters in 2015 and only […]
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Healing Claims for Ingredients
When you say that an product ingredient can heal, you are making the same claim for the product itself, so it becomes an unapproved new drug.
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Claims and Intended Use
When describing your product, keep in mind that the whole point of “claims” is that they are providing information to the consumer about the intended use. Technically it’s not the claim, but what the consumer perceives to be the intended use of the product, which determines whether it is a drug or cosmetic. If your […]
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What’s in a Name?
Once again we’re discussing ingredient names, but this time in the name or identity of the product, not in the ingredient declaration.
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Intended Use – Know Before You Go
It is the intended use of a product that determines what it is. Oddly enough, it can be the exact same product formulation, but it could be classed as different types of products depending on what you say is its intended use. What is it? This is a very important concept to understand: the intended use […]
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Brexit and Cosmetics
If you are following international news, you probably heard that Brexit was approved and Great Britain will be leaving the European Union. What does that have to do with cosmetics? Well, honestly, I don’t know all the ins and outs of how the process of their leaving the EU will work, but I was struck […]
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Toxic Substance Control Act Reform 2016
If you’re following chemical news, you may have heard that reforms of the Toxic Substance Control Act of 1976 were just signed into law by President Obama. In very, very brief summary, the revisions to the TSCA passed in 1976 include giving the EPA authority (and a mandate) to test and verify more chemicals for their […]
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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..
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