Running away from home in our new RV is turning out to be a little more complicated than one would think. So many things to consider and take care of. The biggest issue is getting rid of all our STUFF, since it won’t fit in the RV! The good news is that we’re making progress. The bad news … lots more progress to be made!
I get notices when the FDA sends out warning letters and it seemed like there has been an increase in warnings to cosmetic companies for drug claims. So I checked. Yes – there definitely has been an increase. One would guess that the FDA is looking a little more carefully at the claims being made. So far in 2015, there have been 5 warning letters on the subject of drug claims made for cosmetic products. That’s more than any year from 2005 until now (except for 2012 which had 11 warning letters for the whole year).
So, what sort of claims are these companies making for their products?
There has been considerable discussion about various aspects of the bill and what its effects will be. Several people have asked me for my take on the bill, so I’ve gone through the bill in detail . (What a process!) My comments about it and what it might mean are detailed below.
Last month, Jere and I announced to family our intention to get an RV and “run away from home,” living and working on the road as we travel around the US seeing the sights and visiting friends and family.
Yesterday it became a lot more REAL. I actually drove our new (to us) RV. Actually, it wasn’t as hard as I thought it would be, although I did nearly take out part of our fence on the narrow section of our driveway.
I was just informed that our ranch, of which I have been the Operations Manager for 12 years, has been awarded the Private Landowner Stewardship Award by the Oregon Chapter of the Wildlife Society! The award is one of two civic recognitions they give out annually. From their website:
“Private Landowner Stewardship Award
“This civic award recognizes private landowners for implementing positive wildlife conservation programs or actions on their land in conjunction with their commercial operation.”
The FDA has said that the “common name”1 is required for cosmetic ingredients.
But what does that mean, exactly?
Let me tell you the story of the Cosmetic Ingredient Dictionary and INCI names.
Once upon a time …
Back in the 1970’s, a book called the Cosmetic Ingredient Dictionary (CID) was published by the Cosmetic Toiletries and Fragrance Association, a US trade association for the cosmetic industry. The CID listed the acceptable (“common”), human understandable, names for cosmetic ingredients. Since it was a US publication, the plant-based (botanical) ingredients were listed by their common English names.
We all know that the Fair Packaging and Labeling Act requires that all consumer products (including cosmetics) have the identity of the product and the net contents on the front, the name and address of the manufacturer somewhere on the label. Cosmetics also require the ingredients to be listed.
Here’s a question that has come up more than once: How do stores that carry unwrapped products in bins with just signs get away with it?
The Federal Trade Commission is looking to update their regulations under the Fair Packaging and Labeling Act, and “modernize the place-of-business listing requirement.” These are the regulations that apply to “true soap” that is exempt from the FDA definition of a cosmetic. The proposed change would amend 16 CFR 500.5(c) to read:
(c) The statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is listed in a readily accessible, widely published, and publicly available resource, including but not limited to a printed directory, electronic database, or Web site.
This is very good news for everyone who makes true soap or other consumer commodities. Comments are being accepted until March 30, 2015.
The FDA continues to update their website, clarifying and making things more understandable. I love the new articles as they are very clear and easy to understand (as well as many of them being targetted to small and emerging business). The only thing is that they are a little hard to find … I still can’t figure out the categorization and menu system!
Here’s a list of some of the more helpful pages, directly linked so they are easier to find:
Well, it’s finally happened. I’m OUT OF STOCK on the 2nd Edition of the book (2010)!
The 2015 updated 3rd Edition (I’m calling it the “purple edition”) is almost finished. I’m on the final round of edits and updates. In a way, it’s good that the project was delayed a bit because now I’ll be able to include information about the FDA’s response to the HSCG’s PO Box Petition.
At the moment, it looks like the book will be winging its way to the printer sometime near the end of January, and I’ll have books in stock around the end of February.
Cost of this edition is the same ($24.95 with free shipping in the US), but orders placed before the book is back in stock will get a 20% discount (reducing the price to $20.00).
The FDA denied the HSCG’s PO Box petition, but it did provide some clarification that a “current phone or city directory” includes ONLINE directories as well as printed directories. This is VERY GOOD NEWS!
Jackie Thompson’s long awaited book, Liquid Soapmaking, is finally here – and more than worth the wait.
For those who make handcrafted soap bars, transitioning to making liquid soap can be daunting. While the chemistry is essentially the same, when it comes to the finished product, opaque bar soap is much more forgiving than liquid soap that should be completely clear and of the right consistency. Jackie has researched (for years) and has managed to capture all you need to know about liquid soapmaking in just 207 pages!
I admit, I’ve made liquid soap. I also admit that while it turned out “okay” as soap (I mean, it didn’t harm anyone and it did lather and clean) – it wasn’t what I’d call “great.” Certainly not anything I’d be willing to package and sell to a customer. The thing is, I never knew exactly what the problem was, or how to fix it. I didn’t know enough about advanced soap chemistry, how the chemical qualitities of various oils affect liquid soap, and the effects of different additives. Without that understanding, it’s not surprising that I gave up on making liquid soap.
Jackie’s book changed that. After reading it, I became inspired (again) to make liquid soap.
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:
I 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). Continue reading FDA Sends Warning Letters to Two Essential Oil MLMs
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: Continue reading Updated Info on FDA site
This 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! Continue reading Quest for the Perfect Pickle and GMP
It’s been a quiet week, this week. Must be summer; it’s such a temptation to get out there and enjoy the wonderful weaterh! Personally, I’ve been working in the garden and canning, drying and freezing produce for the pantry!
Ingredients 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:
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”.
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.
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 firstname.lastname@example.org!
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.
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.
One of the things I love about the handcrafted soap and cosmetic industry is how so many people are willing to share and help others. I’m a member of a number of Facebook groups covering different aspects of soap and cosmetics and I am always inspired by the amount of care that the members have for have for each other. Whether it’s advice about how to accomplish something, suggested resources or just a pat on the back for a job well done, these are generally friends you can count on.
In brief, the questions for this week are:
Licensing needed for bath and body products containing wine or beer?
“100% natural” with fragrance oils?
Essential oils as inert ingredients in bug repellent?
When we talk about soap and cosmetic labeling, very often the discussion is about the regulations and the requirements. It’s true that the package label must contain very specific elements, but what about the rest of the label content? What about the “labeling,” defined as the materials and text that goes with the product (like promotional materials and website content)?
On your actual product labels and in your accompanying materials, you have many, many opportunities to present your product and your business to your customers and the world. Just because you can’t say that your soap cures eczema or reduces acne, doesn’t mean you can’t say plenty of other good things about the product and the company.