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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What is a CONSUMER COMMODITY?
The labeling laws for items that ARE consumer commodities are different than items that ARE NOT consumer commodities. Knowing if a product is classed as a consumer commodity will help you determine whether certain laws or regulations apply. Key Words to Know Consumer A person who purchases goods or services. Commodity Something that is bought […]
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Frankincense: Not So Sustainable
Frankincense has been used for thousands of years as a medicine, as a perfume or incense, and in religious practices. It is harvested from various species of Boswellia trees, which are native to the Arabian Peninsula (Oman, Yemen) and northeastern Africa (Somalia, Ethiopia). The frankincense industry provides income to millions of people. The problem is […]
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FDA & Social Media
NOTE: This post is not specifically about handcrafted soap and cosmetics, but more about FDA enforcement generally. The Food Drug and Cosmetic Act defines the “label” as the written printed or graphic matter on the immediate container of a product and, and defines “labeling” as all written, printed, or graphic matter accompanying an article at […]
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FDA Site Update
If you’ve gone to the FDA website in the past week or so, you probably noticed that their website has been updated and now looks completely different. According to their website, they are changing over to a new “more modern” WCMS (Website Content Management System), the biggest benefit of which is that it will be […]
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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
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
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?
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
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!
With every New Year come the New Year’s resolutions. Besides the old standbys to lose weight, eat better, exercise more, and reduce stress, how about a new one this year? Review your product labels to make sure they are compliant with the regulations! Eliminate the stress you might have from wondering whether your products would get […]
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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
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 […]
MORE RESOURCES
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..
Books
