Lotion Testing/Safety

[cmzaha]

This is an edited version of a pm I recently sent and a couple of good standing members thought I should post it. I will mention no names but I am including some thoughts on lotion safety which I am frankly paranoid about due to immune issues and as we probably all know, my severe eczema issues. Just an example of what can happen, I was on antibiotics for 2 weeks due to a bite on my leg that kept getting worse and at 3 months it is no where near healed. Infection is gone thank goodness. Any bacteria can cause such issues with my skin. Back to the somewhat edited pm

While I do not usually go this far as to send a pm about sometime I see a seller post (edited from original) here goes
made me do this...

Sellers really do need to revisit all the claims you make when selling products. (edited)
First big issue is people with severe allergies/ eczema can actually die from reactions and you cannot claim that your soap/lotions will cure eczema, acne and any other claims, which will actually put you in the area of selling drugs. You do not know the persons allergies. Also soap is a wash-off product to get you clean and really cannot help much of anything. We may all add in additives but they are for label appeal not cure-all.

As for GM lotions with added organic matter such as infused oils, oats etc You cannot be sure they are safe without lab testing. Most sellers do not want to go to the expense of having challenge testing done but even sending out for a plate count is better than nothing. GM is one of the hardest lotions to preserve and now throw in a nice food item for the buggies, you are really asking for trouble down the road. Preservative systems, many times, require more than one preservative and I find certain preservatives available to us just do not cut it as a stand alone preservative. No matter what your choice of preservative is, it needs to be tested for safety. Do you know if it grows bacteria or mold in 1 month, 3 months or will last a year? Nope not without challenge testing

A few months ago I had a lady come to my booth questioning my lotions and how I know they are safe. We chatted and bit and I told her they are lab challenged tested, her comment was, thank-you. Upon chatting more I asked her if she worked in a test lab, no she did not but her husband is a
Microbiologist. We had a fairly long conversation and I told her I understood why she did not want to purchase a lotion. Darn I might have received free testing...

All sellers need to make sure their insurance is up to date and covers your products. FYI cosmetic insurance, or most insurance does Not cover Mold and we live in a world of litigation and attorneys love cases.

I use a 3 step testing for lotions:
1. I use test kits from LotionCrafter knowing they are not 100% accurate I go to step 2 if it comes out clear
2. Send out for a plate count if this comes out at safe levels I go for step 3
3. Send out to a lab for challenge testing

With my own skin problems I would not even use my own lotion before it is tested. I will also note I never never purchase lotions from handmade sellers. I do admit I do not send out every batch but usually once a year, because my 2 main lotions have come back safe for over 7 yrs. I also carefully watch temps at market because containers can become to hot in the summer and result in killing the preservative system, so only testers go on display and I rotate them in and out of the cooler. It would be like reheating your lotion to pour it into a bottle, and you reheat over the temp restriction of the preservative.

Hope this helps some of you and sorry this is so long winded

 

[ulrurunaturals]

This is an edited version of a pm I recently sent and a couple of good standing members thought I should post it. I will mention no names but I am including some thoughts on lotion safety which I am frankly paranoid about due to immune issues and as we probably all know, my severe eczema issues. Just an example of what can happen, I was on antibiotics for 2 weeks due to a bite on my leg that kept getting worse and at 3 months it is no where near healed. Infection is gone thank goodness. Any bacteria can cause such issues with my skin. Back to the somewhat edited pm

While I do not usually go this far as to send a pm about sometime I see a seller post (edited from original) here goes
View attachment 32349 made me do this...

Sellers really do need to revisit all the claims you make when selling products. (edited)
First big issue is people with severe allergies/ eczema can actually die from reactions and you cannot claim that your soap/lotions will cure eczema, acne and any other claims, which will actually put you in the area of selling drugs. You do not know the persons allergies. Also soap is a wash-off product to get you clean and really cannot help much of anything. We may all add in additives but they are for label appeal not cure-all.

As for GM lotions with added organic matter such as infused oils, oats etc You cannot be sure they are safe without lab testing. Most sellers do not want to go to the expense of having challenge testing done but even sending out for a plate count is better than nothing. GM is one of the hardest lotions to preserve and now throw in a nice food item for the buggies, you are really asking for trouble down the road. Preservative systems, many times, require more than one preservative and I find certain preservatives available to us just do not cut it as a stand alone preservative. No matter what your choice of preservative is, it needs to be tested for safety. Do you know if it grows bacteria or mold in 1 month, 3 months or will last a year? Nope not without challenge testing

A few months ago I had a lady come to my booth questioning my lotions and how I know they are safe. We chatted and bit and I told her they are lab challenged tested, her comment was, thank-you. Upon chatting more I asked her if she worked in a test lab, no she did not but her husband is a
Microbiologist. We had a fairly long conversation and I told her I understood why she did not want to purchase a lotion. Darn I might have received free testing...

All sellers need to make sure their insurance is up to date and covers your products. FYI cosmetic insurance, or most insurance does Not cover Mold and we live in a world of litigation and attorneys love cases.

I use a 3 step testing for lotions:
1. I use test kits from LotionCrafter knowing they are not 100% accurate I go to step 2 if it comes out clear
2. Send out for a plate count if this comes out at safe levels I go for step 3
3. Send out to a lab for challenge testing

With my own skin problems I would not even use my own lotion before it is tested. I will also note I never never purchase lotions from handmade sellers. I do admit I do not send out every batch but usually once a year, because my 2 main lotions have come back safe for over 7 yrs. I also carefully watch temps at market because containers can become to hot in the summer in kill preservatives, so only testers go on display and I rotate them in and out of the cooler.

Hope this helps some of you and sorry this is so long winded

Very informative I for one do not make any claims. All I'd like to know is a some good advice to make my lotions more heat stable. Also that's why for some it's a great ideah to find a good base lotion.

 

[cmzaha]

I forgot to mention that using a premade base lotion does not leave much room for additives, especially botanicals. It is better to check with the manufacturer to find out the percentage of additives and what type are safe to use. Extracts are safe many times to use in pre-made base but again check on it.

I have a lotion that is made with an infused oil that in a year of testing and tweaking I have not been able to get it properly preserved. At 2 months it always failed. I will probably go back to it sometime after the holidays. It just may be an infusion that will not work

 

[SaltedFig]

A few months ago I had a lady come to my booth questioning my lotions and how I know they are safe. We chatted and bit and I told her they are lab challenged tested, her comment was, thank-you. Upon chatting more I asked her if she worked in a test lab, no she did not but her husband is a Microbiologist. We had a fairly long conversation and I told her I understood why she did not want to purchase a lotion. Darn I might have received free testing...

Why did she stop and then not want to purchase a lotion (after finding out about your lotion preservatives)?

I use a 3 step testing for lotions:
1. I use test kits from LotionCrafter knowing they are not 100% accurate I go to step 2 if it comes out clear
2. Send out for a plate count if this comes out at safe levels I go for step 3
3. Send out to a lab for challenge testing

Are the plate counts and challenge tests specific to skin products, or are they the same tests as used for food?

(The test sequence/order is great, thanks)

 

[DeeAnna]

Hear, hear, Carolyn. Well said! Thank you for sharing your perspective and experience.

A translation for those who might not know:
GM => goat milk

 

[amd]

Why did she stop and then not want to purchase a lotion (after finding out about your lotion preservatives)?

I can't answer for Carolyn or her customer, but I will throw in my perspective as someone who has tried shopping for handcrafted lotions: I've run into too many sellers who don't even know what testing is or why they should do it, or for that matter, that they need preservatives. Much like a soap customer might purchase one bad soap and have a distrust of soapmakers, I have the same mistrust of lotion makers. I ask makers a lot of questions and even if they answer them perfectly, I'm still not likely to buy.

 

[Misschief]

And Carolyn's post is the reason I will not make creams or lotions for anyone but myself and my daughter. I have been asked and have explained my reasons. Once explained, most people understand.

 

[cmzaha]

Why did she stop and then not want to purchase a lotion (after finding out about your lotion preservatives)?



Are the plate counts and challenge tests specific to skin products, or are they the same tests as used for food?

(The test sequence/order is great, thanks)

I really do not think she purchases any handmade lotions, she was stopping to see if I could prove their safety. I offered to email her the labs results but she did tell me she believed me. That was nice if she truly did. Who knows.

I can not answer about the food question. I send to a lab that does cosmetic testing, but may very well that they test other products.

ETA: The lady also remembed the seller that used to advertise "Preservative Free" products including lotions. I reiterated that I would never consider selling such a product. I preserve liquid and cream soaps

 

[DeeAnna]

It's not just the fairs and farmer markets where one can find "iffy" lotions and other B&B products. Our local "whole foods" type store apparently doesn't ask their suppliers to do product safety testing. Some of the lotions and other B&B products in their personal care department don't contain any emulsifier (for those products that need them) nor preservative.

 

[cmzaha]

That is very true DeeAnna

 

[Saponificarian]

I totally understand why @amd would not buy hand made lotion,I wouldn’t either. it is too risky because people just slap oils and butter together with some emulsifier and there you have a lotion! Most don’t even observe GMP.

 

[SaltedFig]

Carolyn, have you ever thought of trying your hand at running your own plate counts?

It's not terribly hard, and the medium is pretty easy to come by too - just thinking it might save you costs at one step along the way, before you send it out for documented lab tests.

 

[cmzaha]

Carolyn, have you ever thought of trying your hand at running your own plate counts?

It's not terribly hard, and the medium is pretty easy to come by too - just thinking it might save you costs at one step along the way, before you send it out for documented lab tests.

I have been looking into it and I do find the medium is easy to come by. I actually have been waiting until I buy the granddaughter a decent microscope, not a toy one. Thankyou for the reminder I was thinking I would buy one for her this Christmas. She would love it if I did the plate counts

 

[loriag]

Just want to say thank you for sharing your story and thoughts.

 

[Cellador]

I love making lotions... I would love to sell them someday but am paranoid about the bugs. I think I'd have to have tested just for my own peace of mind. Good advice, Carolyn.

 

[Vandam]

Good advice and great article. I make lotion for my daughters and myself. Recently I had a bottle go bad on me. This bottle travelled to Mexico with me this summer and then sat in my bag. My other bottle of the same lotion is fine, it didn't get to go to Mx. It was super hot and humid there in July! You just never know what conditions people will expose your lotions to so I am so glad I never sell any. 3 daughters keep me happily making enough.

 

[paradisi]

I have been looking into it and I do find the medium is easy to come by. I actually have been waiting until I buy the granddaughter a decent microscope, not a toy one. Thankyou for the reminder I was thinking I would buy one for her this Christmas. She would love it if I did the plate counts

Unless you're an MD, or a certified microbiologist, and performing plate counts in a licensed laboratory, I would be surprised if doing so did not void your insurance. Relying on untrained, unlicensed diy reading of home-kit tests for something that could endanger others? No insurance company I know of would get within miles of insuring you. And someone bringing suit would have a huge thing to wave at the court.

Untrained home crafters just aren't competent to read such tests--that's half the reason the home check kits aren't reliable--even if the media are perfect and the instructions & incubation great--and that's doubtful--, Susan P. Homemaker reading and recognizing what's growing? No way.

For your own information, as a record keeping item, sure, but let the professionals do what they know how to do.

 

[dndlyon]

I've worked as a University research microbiologist for 4 years and a corporate R&D microbiologist for 16 years. I am a food microbiologist, but the micro principles (what makes them grow, persist, or die) are the same with respect to cosmetics and food. I only mention this to lend a bit of credibility to what I'm about to post as I'm a bit new around here (lots of lurking, not much posting).

Regarding products and what we call "microbiological shelf-life":
It has been said above, so just putting in my 2 cents of agreement - people producing cosmetics for sale should be doing challenge testing (at normal and "likely abuse" conditions). If you can't afford challenge testing, then you aren't ready to provide this product for sale to consumers. While cosmetics are not food, people can get just as sick from contaminated products. For example, contaminated lotion rubbed over a cut can lead to a septic infection (bacteria in the blood) in some people.

While cosmetic regulations do not spell out challenge testing specifically, they do include verbiage stating that manufacturer's must retain records that prove shelf-life. This can be scientific literature that indicates bugs won't grow in the product, a risk assessment based on science that defines the risks, experience with your formula, and/or challenge studies if scientific literature doesn't exist. If an issue occurs, these records would be reviewed by "subject matter experts" that work for the regulatory body (FDA in the US, for example). You'll have to defend your risk assessment against experts, so you want to be sure you have the right science behind it and understand how the science relates to your formulation. I'm not saying you can't do this at home, but there's a learning curve.

A quick point on challenge testing:
I see a bit of confusion in both the food and cosmetic industry regarding what "challenge testing" actually means. For a test to truly be considered a "challenge test", a known population and type of bacteria (usually a cocktail of several types) is inoculated into the product. The product is monitored over time, and you get results that show you what happens to the bugs in the product over shelf-life (usually shelf-life + some extra time).

What I often see people call "challenge testing" is really a snapshot of current micro load in a product. I'd call this more of a "use test". If you are just taking plate counts (or other micro tests) over time or at time=zero (right after production), then you will get useful information. However, you can't assume the product is good if you never see counts - maybe the bugs that could grow never got into the product. You also can't predict how your consumer could contaminate the product.

When you do an actual challenge, you know when the contamination event occurred and how many microbes were involved so you can use the data to predict how your product will perform.

With respect to doing your own micro work:
I highly recommend against it. For lab test results to be acceptable to a regulatory body (FDA, etc), you need to have several things in place that may be cost prohibitive. These things also have their own learning curves. You'll need to put Good Lab Practices in place (similar to GMP). You'll need a control plan for all media you create (the stuff you grow the bugs on). This includes growing and maintaining bacterial cultures that you'll use on samples of every batch of media to prove the media was made correctly. You'll need some analytical equipment to confirm media meets standards, defined space with appropriate airflow to prevent contamination of media and test samples...and on and on.

And, even if you have all the equipment and extra space, you'll need to do a bit of research to figure out which tests you'll need, which media to use, what temperature and how long to incubate plates. Different bugs grow in different products and have different requirements for growth. A standard plate count is not always the right micro test.

(On a side note, you only need a microscope if you are going to try to figure out what type of bug you have using microscopic features. Plating methods are based on the idea that each individual colony makes a visible spot on the plate after some incubation time. Each of these spots is gazillions of microbes, but started from one colony so you can get a count without a microscope. But microscopes are super cool to play with - there are so many weird looking things in pond water that kids love to look at it!)

I'm working toward my own cosmetic business and won't be doing my own micro testing. I will probably design my own studies, but I'll pay an external lab to execute against my protocol.

In Summary:
I hope you aren't sleeping after all of that

A summary - Challenge testing is important in some cosmetic products, and you should outsource that stuff. Even a microbiologist starting a new business is going to outsource it.

I also hope it's useful info. It can get quite complicated, and I just want to be sure that if you are thinking about doing it yourself, you have an idea of what you might be getting yourself into in the long run. Kind of akin to all those "just because you made good soap this weekend doesn't mean you can start your business on Monday morning" posts

Also...I really geek out about microbiology.

 

[Livx]

Interesting. I wonder how lush does it. Most of their products are all natural such as face masks are out on display in the stores. All of their bathbombs are unwrapped for everyone to pick up and handle with unclean hands etc.

 

[SaltedFig]

I've worked as a University research microbiologist for 4 years and a corporate R&D microbiologist for 16 years. I am a food microbiologist, but the micro principles (what makes them grow, persist, or die) are the same with respect to cosmetics and food. I only mention this to lend a bit of credibility to what I'm about to post as I'm a bit new around here (lots of lurking, not much posting).

Regarding products and what we call "microbiological shelf-life":
It has been said above, so just putting in my 2 cents of agreement - people producing cosmetics for sale should be doing challenge testing (at normal and "likely abuse" conditions). If you can't afford challenge testing, then you aren't ready to provide this product for sale to consumers. While cosmetics are not food, people can get just as sick from contaminated products. For example, contaminated lotion rubbed over a cut can lead to a septic infection (bacteria in the blood) in some people.

While cosmetic regulations do not spell out challenge testing specifically, they do include verbiage stating that manufacturer's must retain records that prove shelf-life. This can be scientific literature that indicates bugs won't grow in the product, a risk assessment based on science that defines the risks, experience with your formula, and/or challenge studies if scientific literature doesn't exist. If an issue occurs, these records would be reviewed by "subject matter experts" that work for the regulatory body (FDA in the US, for example). You'll have to defend your risk assessment against experts, so you want to be sure you have the right science behind it and understand how the science relates to your formulation. I'm not saying you can't do this at home, but there's a learning curve.

A quick point on challenge testing:
I see a bit of confusion in both the food and cosmetic industry regarding what "challenge testing" actually means. For a test to truly be considered a "challenge test", a known population and type of bacteria (usually a cocktail of several types) is inoculated into the product. The product is monitored over time, and you get results that show you what happens to the bugs in the product over shelf-life (usually shelf-life + some extra time).

What I often see people call "challenge testing" is really a snapshot of current micro load in a product. I'd call this more of a "use test". If you are just taking plate counts (or other micro tests) over time or at time=zero (right after production), then you will get useful information. However, you can't assume the product is good if you never see counts - maybe the bugs that could grow never got into the product. You also can't predict how your consumer could contaminate the product.

When you do an actual challenge, you know when the contamination event occurred and how many microbes were involved so you can use the data to predict how your product will perform.

With respect to doing your own micro work:
I highly recommend against it. For lab test results to be acceptable to a regulatory body (FDA, etc), you need to have several things in place that may be cost prohibitive. These things also have their own learning curves. You'll need to put Good Lab Practices in place (similar to GMP). You'll need a control plan for all media you create (the stuff you grow the bugs on). This includes growing and maintaining bacterial cultures that you'll use on samples of every batch of media to prove the media was made correctly. You'll need some analytical equipment to confirm media meets standards, defined space with appropriate airflow to prevent contamination of media and test samples...and on and on.

And, even if you have all the equipment and extra space, you'll need to do a bit of research to figure out which tests you'll need, which media to use, what temperature and how long to incubate plates. Different bugs grow in different products and have different requirements for growth. A standard plate count is not always the right micro test.

(On a side note, you only need a microscope if you are going to try to figure out what type of bug you have using microscopic features. Plating methods are based on the idea that each individual colony makes a visible spot on the plate after some incubation time. Each of these spots is gazillions of microbes, but started from one colony so you can get a count without a microscope. But microscopes are super cool to play with - there are so many weird looking things in pond water that kids love to look at it!)

I'm working toward my own cosmetic business and won't be doing my own micro testing. I will probably design my own studies, but I'll pay an external lab to execute against my protocol.

In Summary:
I hope you aren't sleeping after all of that

A summary - Challenge testing is important in some cosmetic products, and you should outsource that stuff. Even a microbiologist starting a new business is going to outsource it.

I also hope it's useful info. It can get quite complicated, and I just want to be sure that if you are thinking about doing it yourself, you have an idea of what you might be getting yourself into in the long run. Kind of akin to all those "just because you made good soap this weekend doesn't mean you can start your business on Monday morning" posts

Also...I really geek out about microbiology.

Fabulous information! Thanks for taking the time to type this up

I totally agree that product challenge testing should be conducted by an accredited laboratory

What I often see people call "challenge testing" is really a snapshot of current micro load in a product. I'd call this more of a "use test". If you are just taking plate counts (or other micro tests) over time or at time=zero (right after production), then you will get useful information. However, you can't assume the product is good if you never see counts - maybe the bugs that could grow never got into the product. You also can't predict how your consumer could contaminate the product.

It was this part that I was suggesting to Carolyn to do herself, slipping it into the schedule (as per her first post). It is not a replacement for the final challenge test (I doubt anyone could wrestle cmzaha away from using challenge testing as the final product safety test anyway!), but an addendum to the checks done before the product is sent out for testing in the lab.

With respect to doing your own micro work:
I highly recommend against it. For lab test results to be acceptable to a regulatory body (FDA, etc), you need to have several things in place that may be cost prohibitive. ...

I understand that you have doubts, but I take the opinion that if a person has some ability to look for themselves, their understanding increases. A local college here taught the plate count technique in science this year, and all of the students did plate counts from swabs from around their own homes (that was interesting ): the process is not that hard, it's pretty cheap and gives good information.

The suggested plate check isn't meant for presentation to the FDA (or any regulatory body), or to be presented in evidence in any court of law.
The plate test suggestion is an informal, in-house preliminary test.

If it passes, then the product can go out for official lab testing - that's where in-house testing sits in the schedule.

I have been looking into it and I do find the medium is easy to come by. I actually have been waiting until I buy the granddaughter a decent microscope, not a toy one. Thankyou for the reminder I was thinking I would buy one for her this Christmas. She would love it if I did the plate counts

A real microscope for Christmas! Lucky girl!