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Cosmetic Claims and Required Approval

Recently there has been some discussion online (in a Facebook Group) as a result of a report of a conversation with someone from the FDA. The report was that this FDA representative said that if you wanted to use the word “moisturizing” to describe a soap, then your recipe would need to be submitted and evaluated for its composition of moisturizing properties. This FDA person also said that the term “lip balm” is regulated by the FDA as a drug.

I have absolutely no reason doubt that the person reporting this conversation reported it accurately. She was, in fact, doing her due dilligence in checking with the FDA to understand the rules and regulations.

The problem is that FDA staff are human, and may not be completely versed in all the applicable regulations when confronted with a question from the public. I doubt they intentionally give out wrong information, but it’s happened in the past, I expect it will happen in the future, and it’s likely that it happened in this instance. It’s generally better to understand the regulations by referring to the actual regulations, or at least to the written material the FDA provides as it has been vetted and double checked for accuracy.

So, here are a few documents to take a look at when evaluating the accuracy of the information provided by someone at the FDA in this case:

FDA Sends Warning Letters to Two Essential Oil MLMs

FDA.jgpI have posted numerous times, including here and here, about FDA warning letters concerning “drug claims” used for supposedly cosmetic products.  After those posts went up, I had a number of people tell me about several national companies selling essential oils that were making all sorts of claims, and asking why they could get away with it.  Apparently, they can’t (and rightfully so).

Updated Info on FDA site

The FDA recently updated several pages on their website that have to do with cosmetics. The regulations haven’t changed, but it appears that they are continuing in their trend to making them more understandable (although it is still a bit difficult to find things when you need them). Here’s a brief overview of some of the pages that have been updated:

Quest for the Perfect Pickle and GMP

2014-08-19-picklesThis last week has been shaped by the bounty from our garden. When the tomatoes, peas, beans, zucchini and cucumbers are ripe, they get picked NOW … it’s not something that can be put off for a day or two.

Of course, having the picked vegetables means that you have to do something with them before they go bad – so I’ve been prepping and canning lots of pickles and making zucchini bread for the freezer.

Pickles – well, this MANY pickles, anyway – are new. I decided to try several different recipes and then keep track of which ones are good, better, best (or really bad). Casting about for a way to keep track of it, I realized that it’s just one piece of good manufacturing practices .. and I already know how to do that!

Calculating Percentages for Blended Ingredients

calculatorIngredients are supposed to be listed in the ingredient declaration in “descending order of predominance”. In other words, the ingredient at the highest percentage (by weight) goes first, then then next highest, etc. Ingredients that are present at less than 1% can be listed in any order following the ingredients present at 1% or greater.

When a blended ingredient is used, all the component ingredients in it must be listed separately in the ingredient declaration, correctly placed in the descending order of predominance based on the component ingredient’s percentage of the entire formula.

So, how do you figure that out? Actually, it’s simple math, and not too hard when you know the formulas. Here’s an example:

Monday Mailbag – August 4, 2014


In this Monday Mailbag we have questions concerning the size of the net weight wording, getting started with GMP, handling incidental ingredients, INCI names and website software.

What are the size requirements for the net weight?

The size of the text for the net weight is dependent upon the size of the principal display panel. If the PDP is less than 5 square inches, height of the net contents must be at least 1/16”. If the PDP is 5 – 25 square inches, the net contents must be at least 1/8” high.

For most cosmetics and soaps, the PDP will be between 5 and 25 so the text of the net contents should be 1/8” high. If the text is in lower case or upper and lower case (i.e. “fl. Oz.” or “Fl. Oz.”), the height is measured by the height of a lowercase “o”. If the text is in only uppercase, it is measured by the height of the uppercase “L”. net-contents-spacing In addition, the text should be separated above and below by the space of an upper case “N” and on the sides by the width of three upper case “N’s”, as you can see in the image above.

Labeling Regulations – Don’t Know vs. Don’t Care


I’ve been discussing, writing, and lecturing on the subject of soap and cosmetic labeling for nearly 10 years now. During that time I’ve discovered that people who are making handcrafted soap and cosmetics seem fall into categories when it comes to knowing and following the regulations.

As with all things, how a person deals with knowing or not knowing a subject, can say a lot about him or her.

Monday Mailbag – Smoothies, Trade Secrets, Essential Oils and Links to Regulations


More interesting questions from readers this week. Smoothies in soap, trade secrets, essential oils, links to regulations and more. Please feel free to email me your questions to hello@mariegale.com!

If you make soap and use a smoothie (i.e. Green Machine or Bolthouse Farms Green Goodness) as water replacement, how would you label it? These products sometimes have about twenty items in them.

The answer depends on what you are doing with the soap and how you are marketing. If you aren’t SELLING the soap, then you don’t have to do anything. If you ARE selling, there are a couple of possibilities.

Getting UPC Codes on Your Labels


One of the things that you often see on soap and cosmetic labels are bar codes. They are not required by regulation, but can make a big difference in where and how your products can be sold.

Many of the large stores or chains use UPCs on all their products – both at the point of sale when the customer actually buys the product, but also for inventory, stocking, purchasing and more. If you are looking to get into the wholesale market – especially if you want to wholesale to large stores or chains – bar codes may be an important part of of your package label.