Was there something wrong with the preservative? Should I sue?

GabyD

OK, I know that I have a thread on this already, but I wanted to start a new thread to gauge your opinions. I acquired a sample of Microcare SB and made some samples of skin cream using 1% MSB. They were fine and passed PET. I then bought a 25 kg pail of MSB and scaled up. Unfortunately, the cream containing this new batch of preservative burnt the skin. I contacted the manufacturers who suggested I add the MSB at the aqueous stage. I did this, all fine, no burning. However, I've gone back after 2 weeks and every single jar of cream is full of mould!

At this stage, I am seriously considering suing the manufacturers. There must be a problem with the preservative first by burning the skin and secondly by allowing the cream to go mouldy. Here is my formulation, I would welcome your views on whether you think there could be a problem with the batch of preservative I bought.  I have since changed the formula, but I am stuck with 60 kg of mouldy cream and have lost two contracts because of it.  Thanks in advance for your help and advice.

INGREDIENTS (%):
Water - 64.4
Aloe Vera Powder 0.5
Solagum Tara - 0.3
Coconut Oil - 18
Olyvoyl Emulsifier - 3.8
Shea Butter - 8
Floraesters K100 - 2
Vegelane - 1
Soya Lecithin - 0.5
Microcare SB - 1
Lavender EO - 0.5
Citric Acid to pH 5.8.

Pharma

If you have some Microcare SB left, you could have it analysed. Do you have the analysis certificates of the old and new batches?

If you're unlucky, your fist batch simply hadn't contact with the resistant mould now thriving in your product.

Your product is prone to spoilage, only using benzoate/sorbate is a tightrope walk.

BTW what is olyvoyl emulsifier? Your LOI would be more useful (to me) if it were proper INCI names.

And suing people because it was probably you who messed up... did you actually negotiate/talk to the manufacturer? See, using a pH 5.8 for your preservative blend is playing with fire. Benzoic and sorbic acid are also known irritants. Furthermore, sorbic acid is heat sensitive and scaling up usually increases cool down time and hence there's a higher possibility for sorbic acid to degrade in bigger batches.

Perry

One major problem I see is that Microcare SB is a mix of sodium benzoate and potassium sorbate. They are much less effective when the pH is greater than 5.0.

If I were the ingredient supplier, that would be the first thing I would say.

ozgirl

It is also possible that when you have scaled up you have also used a different batch of one of your raw materials and it is contaminated. You are using a number of natural materials (aloe vera, solagum tara and soy lecithin) which are all prone to microbial contamination. 

You will probably find a clause in the sales contract that they are not responsible for how you use the product or something similar.

The best you could possibly hope for is for the manufacturer/supplier of the preservative to take back the unused product and refund you but even this is probably unlikely.

Microformulation

Also, did you conduct PET/Challenge Testing of your product through a third-party lab? Was the Formulation tested in its final form or did you make changes after PET testing? Not to be skeptical, but I would not have sent this preservative at that pH for testing and wonder how it may have passed.

GabyD

It was the manufacturers who told me to get the pH to 5.8. Previously it was 3.65-3.95 and they claimed this was the reason for the skin burning (it wasn't).  

The emulsifier is Olivoyl Hydrolyzed Wheat Protein, Cetearyl Alcohol, Glyceryl Oleate, Glyceryl Stearate, Potassium Hydroxide, Potassium Sorbate, Sodium Benzoate.

Yes, we did the PET through a respected lab in the UK.

GabyD

So it could be the Aloe Vera, Tara Gum or Lecithin causing the mould. I can take out Aloe Vera and Lecithin and I might be able to switch to Xanthan Gum.

Any ideas why the MSB was causing burning to the skin previously? 

I need to get to the bottom of this.  The loss for me is >$100k and we are a small business so pretty devastating really.

MarkBroussard

@GabyD:

The problem with the skin burning is most likely from the Potassium Sorbate causing a flushing reaction.  This is common in many people with product containing Potassium Sorbate.

The problem with the preservation is that you are at the very upper limit on the effectiveness of this preservative combination (max 6.0, but really more around 5.0) and with Lecithin and Aloe Vera in your formula you are inadequately preserved against yeast/mold.  Also note that you do not have a chelating agent in your formula which would help with preservation.  I would have suspected you would have failed the PCT.

No offense, but it appears that the problem is not the preservative per-se, but the choice of preservative and a formula that is inadequately preserved given the ingredients.

I don't think you have much of a case regarding filing suit against the manufacturer of the preservative.

GabyD

Thanks Mark. 

GabyD

OK, so given your advice, I will do this:

- Switch to a different preservative (Benzyl Alcohol in this case)
- Ditch the Aloe Vera
- Ditch the Soya Lecithin
- Bring the pH down to <5.

Is that looking better? Thanks.

GabyD

Oh, also:

- Add Naticide 0.6%.

MarkBroussard

@GabyD:

I think those changes will go a long way towards solving your problem.  Perhaps you should submit samples of your new formula to more than one lab to ensure the PCT results are all positive.

When you submitted your samples to the lab with a pH of 5.8 and Benzoate/Sorbate as the sole preservative, it should have raised some eyebrows.

GabyD

Sorry Mark, just to clarify, when we did the PET the pH for all our products was between 3.65-3.95. It was only when we had the burning problem with the SB that the manufacturers told us the pH was too low and that we should raise it to 5.8. At which point the mould appeared.

GabyD

I still don’t understand why we didn’t have the burning problem with the sample, only with the full pail. And it was bad. I am happy to PM some pictures if anybody is interested.

Pharma

How comes, no offence but a serious question @GabyD, that someone who develops and produces cosmetics for third parties doesn't know the basics.

At least to me this issue seems to have a higher priority than itchy skin.

GabyD

Pharma, I don’t produce cosmetics for third parties. I make it and sell it.

GabyD

... and sure, it's a bigger issue, but both are issues that need addressing. Which is why I am here seeking help. If you have any constructive advice with regard to these issues, I would be very open to hearing it. 

MarkBroussard

@GabyD

I see ... so you did a PCT with the product at a pH of 3.9, but then raised the pH to 5.8, but did not do another PCT.  So, you actually did not pass a PCT at pH 5.8? ... that makes more sense.

Gaby, you really should have a professional chemist advise you to make sure that all is in order before you make your next scale-up batch.  You are unfortunately learning the hard way from some mistakes on issues that are the most fundamental basics ... You must always run a PCT on a sample of the product that you are actually going to manufacture.  If you run a PCT, but then make a change to the formula, particularly adjusting the pH up, you need to run another PCT to verify that the revised formula passes PCT.

Perry

GabyD said:

I still don’t understand why we didn’t have the burning problem with the sample, only with the full pail. And it was bad. I am happy to PM some pictures if anybody is interested.

The burning sensation is likely caused by sorbic acid.  (See page 26 of this safety report 0 https://pdfs.semanticscholar.org/bbbe/1de833dfb7ebaf3959eaace0762e9b9ffb9b.pdf )

When the product has a pH of 3.9 you actually had more sorbic acid in the formula than the potassium sorbate. When you raised the pH to 5.8 you shifted the equilibrium so you had more potassium sorbate and less active sorbic acid. You reduced the irritation potential but also reduced the effectiveness of the ingredient as a preservative.

GabyD

Thanks Mark and Perry. That all makes sense. The formula was done by a professional chemist. I then employed another chemist when the first chemist when AWOL (another story!). I have also been in constant contact with one of the preservative manufacturer's senior chemists. So this whole process has been managed by people far more experienced than me. 

However, it seems that neither really understood what was going on. For that reason, I am very grateful to this site.

MarkBroussard

@GabyD

In that case, let me rephrase my advice to you ... have a competent professional chemist review everything before you scale up your next batch.

Were your chemist consultants aware that you were scaling-up without running a PCT on the sample at pH 5.8?  That's the only reasonable scenario that makes sense, because all of this is very basic.

That you were going to have preservation problems popped right out upon first reviewing your list of ingredients.

Pharma

GabyD said:

...I contacted the manufacturers who suggested I add the MSB at the aqueous stage...

...If you have any constructive advice...

...Benzyl Alcohol... ...Naticide 0.6%...

First of all, I wasn't going to insult you (well, probably I did but it wasn't my intention). See, I'm supposed to be very intelligent and what I do is giving free hugs waiting for good karma to kick in whilst you may not know as much but make good money from it. Who's now the smarter one of us? My question was probably more a rhetorical one to the universe...

Now back to topic: Do I understand you right that you first added MSB to the oil phase and did a PCT, everything was fine and you scaled up but now people got skin burn. At that point you changed to adding it to the aqueous phase and raised pH, trading in skin burn for mould?

Your solution is now benzyl alcohol and Naticide? BA requires a low pH and is only useful against bacteria. Naticide requires also a low pH and seems (from hearsay on the internet, not personal experience or anything) to be poor against mould but great in irritating skin.

It looks like, obviously, that your main issue is mould. Hence, you need something strong against mould. I have the impression you're going full natural. Therefore, the best I could find against mould (again, not based on personal experience) are p-anisic acid (low pH required) and Cosphaderm Magnolia Extract 98.

GabyD

OK, just to clarify some of the detail, this is what happened...

Dec 2017:
I undertook a Cosmetic Chemistry course with a view to launching my own skincare range. I have a science degree and an MBA and a background in retail. 

May 2018:
I approached a cosmetic chemist "Carol" and asked her to formulate an organic palm oil-free emulsion for me. She is well-qualified and teaches this subject. She came up with the recipe above with Microcare DB as the only preservative. We made the samples and ran PET and Stability. It passed. 

July 2018:
I received an order for a large quantity of skin cream, based on this formula. Unfortunately, the client did not want MDB so we switched to Potassium Sorbate & Sodium Benzoate. Ran PET & Stability again. All good. 

Sep 2018:
I was unable to find a manufacturer to make the cream within a time frame and at an MOQ that worked for me, so I decided to grow upon my limited knowledge and make it myself. By now, Carol the Chemist had started ghosting me and to this day I have no idea why. She ignored my increasingly desperate emails and then phonecalls, however I noticed she still posted on Instagram so was obviously fine. I have since discovered that she has form for this kind of behaviour. 

Feb 2019:
I received another large order based on the original samples we sent out. I now had two very large orders to fulfill.

March 2019:
I retained the services of another cosmetic chemist "Rachel" to review our formulas and formulate some more products for us. She advised that as we were using Potassium Sorbate and Sodium Benzoate, that we should switch to Microcare SB as it is basically the same. We got samples from the manufacturers and all was fine. The pH at this time was 3.65-3.95, as advised by Carol.

April 2019:
Bought a 25 kg pail of MSB. As the samples had been fine we proceeded to scale up to 60 kg. From that batch, we experienced the skin burning. I approached the manufacturers who told me to bring the pH up to 5.8. We did. All looked good, so made another 60 kg.  All went mouldy.

July 2019:
The company who placed the second order have pulled out and the company who placed the first order are now demanding their deposit back. Right now, I need a miracle.

I just want to add that I am hugely grateful for the support and expertise on this forum and I hope that my experiences can help others.

Gaby

MarkBroussard

@GabyD

So, the bottom line is:  You adjusted the pH to 5.8, but never ran a PCT on the product that was adjusted to pH 5.8?

GabyD

@Mark, I was advised by a Senior Chemist at the Manufacturers that it would be completely fine. I trusted them.

Microformulation

Not to be defeatist, but you likely will have to write-off any loss to life experience.

Perry

Thanks for the rundown @GabyD. Very interesting. It is a useful lesson for future product formulators & marketers. 

A few lesson I take from this...

1.  Always run stability (including PET) tests on the final formula & the first production run!

2.  Unless you have a lot of experience and knowledge, stick with parabens and formaldehyde donors. These preservatives are tried-and-true & also safe.

3.  Don't let your client dictate your preservative system without transferring the risk of microbial failure onto them.

4.  Be weary of cosmetic formulators or other "experts" who are good on Instagram. They likely spend more time on social media than on keeping up with formulating.

GabyD

Thanks Perry. I have learned A LOT from this experience. I just need to find a way to come out of it. I am not sure what to do now. The first company, the one who demanded we use a natural preservative, are asking for their money back. They paid a $10k deposit. I have spent $16k on formulators, ingredients, etc. I just don't know what to do.

MarkBroussard

@GabyD:

It does not appear that you have any options other than to refund the money.  Ultimately, the manufacturer of a product is solely responsible for ensuring their products meet the expectations of the end client and is safe for use by consumers.  Since you did the manufacturing yourself, that would be you.

It's a tough lesson to learn, but you simply have to run PCT on all products that go to manufacturing.  I'm sure the supplier of the preservative thought a pH of 5.8 would be fine and told you so in good faith, but they should also have suggested you run a PCT or at a minimum a microbial plate test prior to shipping any product to customers and/or you should have known to take this precaution on your own.

I'll add to Perry's list:

(5) Don't ever put Lecithin in a product unless you have absolutely no choice.

MarkBroussard

This is also a very good lesson for people who do not have the technical background and/or manufacturing experience who think they can make commercial batches of product on their own.

When a potential client tells me they are intending to "self-manufacture" the products I develop for them as opposed to working through a contract manufacturer, I immediately turn down the business.

All it takes is one or two experiences with this and any chemist can tell you ... the amount of the chemists' time & energy that gets burnt up with incessant questions and frantic phone calls from such a client makes it such that you could never even come out financially break-even on this kind of arrangement, much less make a profit.

Microformulation

MarkBroussard said:

When a potential client tells me they are intending to "self-manufacture" the products I develop for them as opposed to working through a contract manufacturer, I immediately turn down the business.

I agree 100%.

GabyD

Sadly Mark, I think you're right. Given that I have invested everything I had into this business I probably have no choice but to sell up. 

Thanks for all your help, I wish I had found this site earlier.

GabyD

@Mark, I would agree with you in theory. I think you are in the US where things are better.  I am in Australia where getting anything done is a nightmare.  I have been let down so many times which is why I ended up doing it myself!

GabyD

I have an update: the manufacturers of the preservative have invited me in for a meeting to talk about a way forward. They have offered their services to get the formula right, which is very generous of them. At last, I see some light at the end of the tunnel. With their expertise, I should have a product that is safe.

By the way, this...

(5) Don't ever put Lecithin in a product unless you have absolutely no choice.

... has to be the best advice I have ever received.  Just highlighting it in case it helps anyone else.  I will let you know how I get on at the manufacturers.  Thanks for all your help and support, it is much appreciated.

Just to add, please go easy on small businesses such as mine.  We don't all have big budgets to outsource everything.  We are just doing our best, some of us to support a family, as I am.  

crillz

Hmm, I've personally never been a fan of lecithin, but the boss has it in nearly all his formulations at 0.5-1% that I make.

ngarayeva001

This is really heartbreaking to read this. I am just shocked that you paid to professional formulators for this formula. When I just saw it, I thought it's a hobbyist formula from Etsy... I really wish you don't have to sell your business and manage to get out of it. Good luck.

GabyD

ngarayeva001 Thanks, that's very kind of you to say. Is the formula really that bad ?

MarkBroussard

@GabyD:

The formula is generic ... it's not really a moisturizer and it does not appear to be designed to have any particular effect.  So, yes, it kind of does look like a homecrafter's formula on Etsy.  What specifically are you intending this formula to be marketed as ... a moisturizer, a body cream?

The good news is that you were able to get two customers to buy it, so don't fret too much about it.  But, you might want to consider adding some functional ingredients unless your intention all along was to make a basic body cream, in which case you're fine with the formula as is. 

Gunther

I don't think you can sue the preservative manufacturers
I doubt you can even get your money back, since the product wasn't defective, just improperly used.

Next time do some challenge testing.
Better yet, check preservative MICs Minimum Inhibitory Concentrations and you'll see that they are almost guaranteed to fail challenge testing, unless you use huge amounts of them.

You can try parabens below the EU limits (methylparaben 0.4%, propylparaben 0.14%) used at 75-90% of that limits and they work so much better.
I still have to see a single product to fail challenge testing with that (but we don't add natural or hard to preserve products)
Add some EDTA 0.1% if you want.
Paraben scaremongers can GTHO Get The Hell Out.

ngarayeva001

@Gunther, I agree with you, and the first thing that comes to my mind when I see such formulas is to say "please just add bloody parabens!!". But in many cases it's not an option because the client won't pay for it.

Belassi

I would advise anyone looking for a "natural" type preservative system and can afford to buy a 25Kg pail to take a look at Spectrastat by Inolex. We changed from parabens to that, three years or more ago, and have samples in pots still on the shelf from that time with no apparent preservative issues. I've recently been experimenting with KEM NAT and so far have had no issues with that either; and I have a LOT of organic material in our creams and gels, some are 50% aloe vera for instance.

Betterusername

Hi Gaby. Hope you found a way forward, how stressful for you. I’ve also worked with a chemist who started going AWOL after the first few months. I would be promised new samples in the post but 3 months later, no samples and no response. Plenty of Instagram and blog posts though. Repeat about 4 x. I’m wondering if we have the same “Carol”. It’s cost me thousands more to get the formulation finished & passing tests via the manufacturers lab and it’s still not passing challenge tests. Process has taken 2 years so far and has put huge strain on my family as we took out a loan for r&d with no return so far and increasing costs. I realise this isn’t the same scale as yours but your story sounds familiar. 

GabyD

Hi @Betterusername, I am sorry to hear that you've had the same bad luck as us with formulators. It is soul destroying, isn't it?

I had another bad experience with a contract manufacturer before I went to "Carol."  I paid them $3k to make a tan for us. They made a great sample, however they had used one wrong essential ingredient so I asked for another sample. Months went by. The chemist ignored all my communications. Then out of the blue after 6 or 7 months I got an email from the company telling me that the chemist had left the company but not to worry - they had employed another genius chemist by the name of T.S. (preserving her anonymity here). They told me she had years of experience and would look after our case.

I went straight onto Linkedin and found her, but discovered that she was in fact just an admin person who they had promoted to Head Chemist. She hadn't even been to university, let alone got any kind of chemistry degree.

So for those of you who question why unqualified people like myself end up doing our own formulating, this is why. I am sure things are better in the US. Alas, some of us are in the backwaters of countries like Australia where it is impossible to get anything done properly.

MarkBroussard

@Betterusername, @GabyD:

Why do you not just hire competent, professional chemist(s) who are members of the Society Of Cosmetic Chemists?

You have to be credentialed to be accepted into SCC, so an organization has already done the credential screening for you ... SCC memberships does not mean the individual will be a talented chemist or have great business ethics, but at least you know they are an actual chemist.

Many of us service clients on a global basis and the only real drawbacks are the time/expense of shipping samples through customs and time differentials for communications.  But, other than that ... it makes no difference what country you are located in.  Now, having your product manufactured is another matter as you will want to do that in-country.

I'm curious if this "Carol" is an actual chemist or a poser?

MarkBroussard

Here you go:

https://ascc.com.au/

GabyD

@MarkBroussard I just wish I had found this website 2 years ago. “Carol” is a qualified chemist. She also teaches several cosmetic chemistry courses and is a member of several professional organisations here in Australia.

Before “Carol”, I was using another formulator, Rita, who had come highly recommended. I asked her to make us a foaming tan (this was before we went organic and palm oil-free). She made it within a few days and it was great! It sold out very quickly so I asked her to make some more. She told me I had to drive to her lab to deliver some DHA for the tan. It was the first day of my new (day) job, but I risked it to take the DHA to her. That was the last I heard from her. I called and emailed, left messages through mutual contacts... nothing. I didn’t even get my DHA back.

And before her there was Diane. Again, very keen. Long career with L’Oreal. I found her details on a professional website. After the initial few emails we arranged to meet. She didn’t turn up. Full of apologies, arranged to meet again, but didn’t turn up and I never heard from her again.

Betterusername

Pretty sure Carol is an actual chemist and member of SCC. Formulations were good, was really happy with all the science, however professionalism and communication not so much. If she doesn’t like what you’re asking for as a client, she seems more likely to make an unflattering public post about it than have a conversation with you directly. It’s all quite problematic and having only worked in a collaborative, professional environment, not something I knew how to navigate at all. Before Carol I almost hired someone who’s visible online and a member of the SCC and associated with a well known chemist. Turns out she’d faked her experience so that wouldn’t have gone well either. The problem is that people don’t generally name their chemists/labs, there’s no reviews or anything so no accountability. My manufacturer are brilliant so far which is a saving grace and I have recommendations for others who I’m looking forward to working with. I’m sure all you on here are wonderful though, we seem to have had bad luck.

Betterusername

Also, based on what @GabyD is saying and her region, I suspect my Carol and hers may well be the same.

MarkBroussard

Pity ... sorry to hear you both had this bad experience.  

Perry

This is one of the reasons I have a hard time recommending formulators or even contract manufacturers. 

Providing a service like formulation requires more than knowledge of how to formulate. It also requires some interpersonal skills, business skills and ethics.  Just because someone can whip up a good formulation, doesn't mean they'll do a good job for everyone.

I'd still recommend working with a formulator who has a science background over one who doesn't. But that's never a guarantee.

Pharma

Having a science background certainly helps understanding why things happen or don't work out but cosmetic chemistry is most of all an empirical science, not an exact one. Having a degree in chemistry, pharmacy or whatever doesn't make you a good formulator, let alone a good business man/woman (and, I speak from experience, it's more likely to drive someone socially incompetent). There is no official degree or qualification for cosmetic chemists, it's "just" a job/skill people have and that's very hard to judge at a distance. These days, it's often the ones with the most prominent internet presence  who get the most attention but that tells you only one thing and one thing only: They're hanging out too much on the internet and might not have the time for formulating (reminds me that I should spend more time with my mortar and pestle ).