So, before talking about how to develop a lotion (or other water based product), let's take a look behind the scenes.
FDA and cosmetic oversight
A lot goes into making a lotion. In spite of what you may have read elsewhere, the FDA DOES regulate the cosmetics industry.
HOWEVER, the FDA does NOT regulate the cosmetics industry in the same way it does pharmaceutical companies, … and, for all of you who like variety, this is a good thing (assuming that YOU the consumer take on the responsibility of doing your homework).
So, what’s the difference?
Let’s start out with a couple definitions.
Pharmaceutical or drug?
I use these terms (pharmaceutical and drug) interchangeably below... 'nough said :)
Cosmetics throughout this post is a comprehensive term including skincare products, deodorants, body washes, and the more traditional cosmetics – blush, foundation, lipstick.
Basically, you can think of a cosmetic as ANYTHING you put on your skin with the exception of:
- anti-bacterial soaps
- a drug (think Differin, Retin-A, any topical treatment that has a little box that says "Active Ingredient(s)" whether or not you need a doctor's prescription to purchase)
- sunscreens. When I say sunscreen, I mean any topical formula that claims an SPF rating on the label.
- One more exception is cosmetics that use over a certain percentage of certain ingredients (like more than 10% alpha hydroxy acids - AHAs)
Well, the categorization mostly has to do with what the company claims the product will do. A company can't claim SPF 30 without additional testing to back this claim and without listing the concentration of the active ingredient. The same goes with an anti-bacterial claim.
But, the categorization also has to do with consumer protection... let's look at AHA for instance.
The Cosmetic Ingredient Review (CIR) board has conducted extensive testing on AHAs and pretty much every other ingredient used in cosmetics (I'm sure there are exceptions, but I know of none).
Based on the results of these CIR tests, FDA has set a limit on acceptable maximum percentage of AHA in cosmetic products.
In contrast to cosmetics, drugs - Require Pre-approval and FDA can move in of its own authority if companies don't comply (pharma industry creed: Comply or die. How do I know? My day job is in pharma :)
For any drug you can buy, the pharmaceutical company HAD to get pre-approval from the FDA before launch. This involves a whole litany of things that cosmetic consumers hate:
- Animal testing – REQUIRED for pharmaceuticals
- Long lead times before launch – Clinical trials and gates to evaluate product performance at different phases of clinical trials (this translates to very long launch times… just think if you had to wait a decade for a new skincare product or a new blush, lipstick, eyeliner, etc. to come to store shelves), and then think about how much your skincare products would cost if only 10% of the products entering these trials were approved by the FDA to market1,2.
- High prices – The two bullets above are two of the reasons why drugs cost so much
Cosmetics (including skincare products) - No pre-approval required
Cosmetics do NOT require pre-approval by the FDA before launch.
Also, FDA’s jurisdiction is not as far reaching as it is with pharmaceutical companies:
- FDA can issue mandatory recalls of drugs and foods
- FDA can request that cosmetic companies conduct voluntary recalls of cosmetics
However, FDA still has the ability to shut down cosmetic manufacture and distribution if they deem it necessary by going through the Department of Justice (DOJ).
AND, there are still codes of federal regulation (CFR) for cosmetics.
- the authority to inspect cosmetic companies
- can request that a cosmetic company conduct a voluntary recall if necessary (as I already mentioned)
- the ability (by going through the DOJ) to potentially shut down cosmetic companies that market products that exhibit microbial contamination or otherwise are out of compliance with regulations (or don't issue a voluntary recall upon request)
FDA guidelines for cosmetics include:
- Label requirements - If you’ve ever wondered why the ingredients are written the way they are, well, there are guidelines to help avoid ambiguity and give the consumer an idea of ingredient concentration3.
- Net weight or volume
- Other labeling requirements3
- Manufacturing conditions – example: Cosmetics MUST be manufactured in an environment that prevents adulteration or contamination of the product
- Microbial load - Products are free from microbial contamination both at the time of manufacture and also over the shelf-life of the product
Can a skincare company make products without following FDA guidelines?
Sure, but at their own risk (think criminally liable – yeah, nobody wants to be on the wrong side of that).
So, that brings us to the title of this post – what exactly goes into developing a lotion for sale?
- Prep the work area.
- Sanitize the area.
- Clear ALL equipment, ingredients, etc. that are not related to the batch you’re about to make.
- Make the lotion.
- This requires recording the weight of all ingredients added (order of addition is also important)
- Noting temperatures before and after combining oil and water phases
- Recording mixing conditions and times
- Recording all other processing (vacuum degassing, when preservative is added, etc.)
- Set the lotion up for stability testing.
- Real time testing – At the very least, stability testing at room temperature should be conducted over the anticipated shelf-life of the product (one to two to three years).
- Accelerated testing – freeze/thaw cycles or elevated storage conditions can serve to get a quick idea of whether or not a product will hold up long term.
- Once the product passes stability testing (or before if you’ve got deep pockets and some assurance it’s going to pass stability) conduct A/PET testing.
What’s A/PET testing?
A/PET stands for anti-microbial preservative efficacy testing (usually it’s either labeled antimicrobial efficacy testing (AET) or preservative efficacy testing (PET), but I've hung out around a bunch of topical pharmaceutical formulation scientists in the past decade, and they all call it APET cause it’s just easier to say).
A/PET is a US Pharmocopeia (USP) compendial method, and USP chapter 51 (aka USP<51>) describes how this test should be conducted, appropriate measuring intervals, and passing criteria.
A/PET should be performed on EVERY new formulation offered for sale to ensure the preservative concentration is sufficient to protect the product from microbial contamination.
Why is it necessary to conduct A/PET on EVERY new formulation?
Because each formulation has a different composition of oil to water. And, many preservatives have a stronger affinity (aka like) for oil than for water.
So, what does formulation composition have to do with preservation?
Well, that’s WAY too big a topic for this blog post, so we’ll talk more about that in the future. But, this basically means that less preservative is available for preservative efficacy than the amount of preservative actually added to the product (especially true for a lotion or cream but the principal applies to oil free serums also).
Because EVERY single formulation has a different composition of oil soluble and water soluble ingredients, EVERY SINGLE formulation has a different amount of preservative available in the water phase to kill the bacteria (or yeast or mold).
- EACH batch of lotion should be tested for microbial contamination before offering it for sale… yep, that’s right, cosmetic companies doing it right conduct this test (commonly known as an APC – aerobic plate count) prior to selling any products from the batch.
These are just a few of the things cosmetic companies need to do to comply with FDA guidelines.
Of course, I’m sure you’re asking yourself what’s the big deal about A/PET and conducting APC testing on every single batch?
Well, none of us want to be using the contaminated products shown below on our faces.
The perfect segue into a future blog post on preservatives 😊
So, I know what you're asking... can I just use a skincare product that is water free so it doesn't require a preservative?
Sure, if you're lucky enough to never break out and you're one of those people fortunate enough to live in a humid environment or have the perfect genes where your face seems to hydrate itself and you don't need to supplement with extra ingredients to protect transepidermal water loss (TEWL) aside from what your fabulous skin already makes.
But, for the rest of us, a good lotion or cream or serum (I'm using serum in the traditional meaning here - oil free serum) helps our skin look and feel its best. So, for those of you who are like me, head on over to our shop to find the PERFECT lightweight lotion or oil free serum to hydrate your skin.
1Report suggests drug-approval rate now just 1-in-10 by | May 25, 2016 | https://www.amplion.com/inthenews/report-suggests-drug-approval-rate-now-just-1-in-10
About the Author
Brandy Searcy is an outdoor girl who loves hiking, gardening, bird-watching, and body boarding. Her innate curiosity means she's constantly researching something, and she's likely sharing what she's learned here on the blog.
Nearly obsessive about her skincare, she started developing products to pack with her on day hikes and soon realized her backpacking friends were searching for a portable skincare routine as well, and that's how Rain Organica started.
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