Helping you understand soap and cosmetic regulations — in plain English.
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
Latest blog articles
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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
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
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
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”
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
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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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
How do you figure out the ingrfeedient declaration in a hybrid soap?
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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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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..
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