Confusion regarding MHRA

[mandaschn]

Hi lovelies! I want to create a soap product aimed at pregnant women and babies, but after reading about it, I'm scared to use certain terms.
For example, if I were to create a soap with ginger essence and claim ginger is good for nausea, am I going to fall under the Medical Product? It sounds silly as the ginger will obviously not prevent the nausea, but the wording might insinuate some sort of treatment to it... Same if I were to put ingredients that are good for circulation, or stretch marks.

 

[soap newb]

If I were making a baby soap I'd skip all the additives except clay, salt and sugar. No added fragrances or colorants (except what you can get from different colored clays, but you can still get a lovely natural scent with an oil formulation of 25% shea butter. Something like 35% Coconut, 25% Olive, 15% Soy and 25% Shea. That'd be super gentle, smell good, and you'd have nothing to be worried about.
For all soap it's completely verboten to make any medical claims. Here's the FDA's page on the rules, good luck!

 

[artemis]

Also, some essential oils are not safe for pregnant women. This information can be easily found online, but here is a link to get you started:

https://www.morelandobgyn.com/blog/essential-oils-and-pregnancy-safety

 

[DeeAnna]

All of the purported benefits you list would turn your soap into a medicinal product in the US. The FDA in the US requires claims to be substantiated -- in other words you need to be able to show there's valid proof that supports your claims.

I don't know what the law is in the UK or EU, but I suspect you're not allowed to make these claims without proof either. Have you been working with an assessor in the UK to validate your products? If no, probably need to look into that before you go further with these plans.

 

[Obsidian]

If I were making a baby soap I'd skip all the additives except clay, salt and sugar. No added fragrances or colorants (except what you can get from different colored clays, but you can still get a lovely natural scent with an oil formulation of 25% shea butter. Something like 35% Coconut, 25% Olive, 15% Soy and 25% Shea. That'd be super gentle, smell good, and you'd have nothing to be worried about.
For all soap it's completely verboten to make any medical claims. Here's the FDA's page on the rules, good luck!

35% coconut is far from gentle, I can't use near that much, can't imagine how harsh it would be for a baby

 

[cmzaha]

If I were making a baby soap I'd skip all the additives except clay, salt and sugar. No added fragrances or colorants (except what you can get from different colored clays, but you can still get a lovely natural scent with an oil formulation of 25% shea butter. Something like 35% Coconut, 25% Olive, 15% Soy and 25% Shea. That'd be super gentle, smell good, and you'd have nothing to be worried about.
For all soap it's completely verboten to make any medical claims. Here's the FDA's page on the rules, good luck!

As Obsidian mentioned I would not even consider your recipe a gentle bar of soap. That amount of CO would destroy my skin as it would produce a much too cleansing bar of soap. "Soap" is not even recommended for babies a nice syndet or good m&p bar base is gentler for babies than soap. I prefer my bars to have CO no higher than 17%.

As for the original point of this post, any description stating your soap will do something other than cleanse will put it over the edge of a drug.

 

[NewlyCreative]

As you pointed out ginger in soap wouldn’t help nausea since they would not eat the soap so that right there comes off more deceptive than silly to me (personally). …. Also (not sure what ginger essence is precisely) ginger is not something you’d want anywhere near sensitive parts of your body, it would sting!

Probably best to stay away from marketing anything for babies. Their skin is so fragile and sensitive that it’s the one demographic (I’d personally) stay away from.

Pregnant women are pretty much like all other women when it comes to soap

 

[soap newb]

35% coconut is far from gentle, I can't use near that much, can't imagine how harsh it would be for a baby

Soapcalc will show a very moisturizing bar with that recipe. My experience at 35% is lots of gentle lather that doesn't dry if I don't use the soap more that a couple of times a day, which is where most folks are anyway. Like with everything, it's all about the dose.
Thinking more about it, if I were labeling a bar as super gentle baby soap I'd adjust the coconut down. Still, 35% CO used a couple of times a day fine for most.

 

[AliOop]

Still, 35% CO used a couple of times a day fine for most.

Sorry, I must respectfully disagree with you there. Men in general seem to tolerate higher amounts of coconut oil, as do many people in tropical countries where there is more sweating. But most women I know cannot use much over 20% without severe dryness. Older folks and those with common medical conditions such as eczema, psoriasis, and T1 or T2 diabetes also need far, far less -sometimes none at all.

 

[soap newb]

I appreciate the feedback. All we can do is what our experience tells us. My recipe is 37% CO and I get zero feedback on drying, but taking into account your 10k+ contributions here maybe it's time for me to come up with a more gentle, lower CO formulation that's labeled as such. I appreciate the dialogue.

 

[AliOop]

I appreciate the feedback. All we can do is what our experience tells us. My recipe is 37% CO and I get zero feedback on drying, but taking into account your 10k+ contributions here maybe it's time for me to come up with a more gentle, lower CO formulation that's labeled as such. I appreciate the dialogue.

I appreciate the dialogue, as well! You are spot on about experience; if your target market likes your soap, no need to change. Don't fix what isn't broken, right? But it can be nice to have options that might draw other customers, too.

I should have been more specific that since the OP was asking specifically about soap for babies, I'd typically recommend 100% lard, 100% OO, or a 50-50 blend of those two. Even though the calculator will show 0 for cleansing, it is still soap and will still clean the skin, but will not remove as much of the natural skin oils. That is very important for babies (once their skin is mature enough to tolerate any soap at all).

Since soaps without the bubbly oils like CO and PKO won't lather easily, I normally add some sugar (honey, sorbitol, goat milk, etc.) The effects of that won't show in the calculator numbers, but it will definitely make the soap lather more easily, and also make the bubbles a bit larger and looser.

 

[ScentimentallyYours]

If I were making a baby soap I'd skip all the additives except clay, salt and sugar. No added fragrances or colorants (except what you can get from different colored clays, but you can still get a lovely natural scent with an oil formulation of 25% shea butter. Something like 35% Coconut, 25% Olive, 15% Soy and 25% Shea. That'd be super gentle, smell good, and you'd have nothing to be worried about.
For all soap it's completely verboten to make any medical claims. Here's the FDA's page on the rules, good luck!

Here is a profile of the recipe when plugged into soapmakingfriend.com:

You can see the harsh effect of coconut oil in the red cleansing bar in the graph.

For comparison (and fun), check out J&J’s Baby Soap formulas, even though the percentages of oil aren’t shown. They vary the ingredients and additives from country to country.
Baby Soap Bar USA
Baby Soap Bar Australia
Baby Soap Bar South Africa

Keep in mind that these are extruded bars with an opportunity to add ingredients to correct the pH. We can’t do that with our soaps. All of the bars include at least one ingredient as a preservative.

Customers who do not like the bar soap complain in reviews that it burns the babies eyes! Maybe that’s why I don’t see melt and pour soap bases offered for babies? Consumers want an extremely gentle and tear free baby bath product. Imagine that!!!

 

[Christa10]

Once you've settled on a recipe that you think is gentle enough, maybe you could give it a name that would make it appealing to your target audience, rather than making claims about what it does. "Gentle Soap for Sensitive Skin" or "Mamas and Babies" or something that would allude to a gentle soap. I make a version of Zany's Castille - whose recipe I got here (thank you Zany), which I named after my grandson (he's now 2), to indicate who might be interested in using it. Lots of women are attracted to it because they say they have very sensitive skin, so marketing is key, but I don't make claims about anything remotely medicinal.

 

[soap newb]

Here is a profile of the recipe when plugged into soapmakingfriend.com:

View attachment 73477
You can see the harsh effect of coconut oil in the red cleansing bar in the graph.

For comparison (and fun), check out J&J’s Baby Soap formulas, even though the percentages of oil aren’t shown. They vary the ingredients and additives from country to country.
Baby Soap Bar USA
Baby Soap Bar Australia
Baby Soap Bar South Africa

Keep in mind that these are extruded bars with an opportunity to add ingredients to correct the pH. We can’t do that with our soaps. All of the bars include at least one ingredient as a preservative.

Customers who do not like the bar soap complain in reviews that it burns the babies eyes! Maybe that’s why I don’t see melt and pour soap bases offered for babies? Consumers want an extremely gentle and tear free baby bath product. Imagine that!!!

I really appreciate the feedback here. The high shea butter soap is just a way to get some nice smell into it without fragrance, but you have to use undeodorized of course. I get the hard bubbly vs creamy moisturizing dilema we're all facing, it's a bit of a zero sum game, you can never have all of both. If I had a company goal it would be to sell the best all natural soap for the lowest price to the most people, but there's so many different kind of people! So I need to investigate another more gentle formula/product line.
My additives in amount to 15% of a batch, color, fragrance, salts, sugars and clays, and I'm pretty happy with what what they're doing for me, but again, refer to my forum handle. I'm at 3% clay, 2.5% sugars and 2.5% salts, plus fragrance and color. Six different bars all the same formula except color/fragrance.
The soaping books I have are apolitical on the bubbly/moisturizing controversy, you do you in other words. Most popular youtube channels preach bubbles. I'm literally in my first week of sales, fab feedback from samples and label appeal and I'm now $100 better off, but this drying thing has me concerned.
My recipe is 37% CO, 33% OO, 20% palm (strongly considering a switch to soybean) 5% cocoa butter and 5% castor. I've torn my hair out over figuring great additive dispersion techniques and best temps and it's paid off, my soaps are beautifully pastel and homogeneous, but do you think that formula is too drying for a customer base of gift shops, vacation rentals and organic food stores? Hard and bubbly or moisturizing and creamy... gah!

My problem is I love the soap and I've just started selling it, literally my first deliveries this last week. I'm at 37% CO, 33% OO, 20% PO and evenly split 10% cocoa and castor. Then +15% of oils for additives; fragrance, color, 3% clay and 2.5% both salts and sugars. Gorgeous creamy lather and bar feel, and for me no drying. In your opinion, is that a drying bar for a typical person who washes their hands 2x/day and grabs a shower? I know there's no "typical person," maybe let's call it the 80% range from the middle of the bell curve.
Regardless, I'm pretty sure I need a more moisturizing line that's labeled as such.

 

[soap newb]

Forgot about citric, another 2% for 17% total additives

 

[ScentimentallyYours]

I really appreciate the feedback here. The high shea butter soap is just a way to get some nice smell into it without fragrance, but you have to use undeodorized of course. I get the hard bubbly vs creamy moisturizing dilema we're all facing, it's a bit of a zero sum game, you can never have all of both. If I had a company goal it would be to sell the best all natural soap for the lowest price to the most people, but there's so many different kind of people! So I need to investigate another more gentle formula/product line.
My additives in amount to 15% of a batch, color, fragrance, salts, sugars and clays, and I'm pretty happy with what what they're doing for me, but again, refer to my forum handle. I'm at 3% clay, 2.5% sugars and 2.5% salts, plus fragrance and color. Six different bars all the same formula except color/fragrance.
The soaping books I have are apolitical on the bubbly/moisturizing controversy, you do you in other words. Most popular youtube channels preach bubbles. I'm literally in my first week of sales, fab feedback from samples and label appeal and I'm now $100 better off, but this drying thing has me concerned.
My recipe is 37% CO, 33% OO, 20% palm (strongly considering a switch to soybean) 5% cocoa butter and 5% castor. I've torn my hair out over figuring great additive dispersion techniques and best temps and it's paid off, my soaps are beautifully pastel and homogeneous, but do you think that formula is too drying for a customer base of gift shops, vacation rentals and organic food stores? Hard and bubbly or moisturizing and creamy... gah!

My problem is I love the soap and I've just started selling it, literally my first deliveries this last week. I'm at 37% CO, 33% OO, 20% PO and evenly split 10% cocoa and castor. Then +15% of oils for additives; fragrance, color, 3% clay and 2.5% both salts and sugars. Gorgeous creamy lather and bar feel, and for me no drying. In your opinion, is that a drying bar for a typical person who washes their hands 2x/day and grabs a shower? I know there's no "typical person," maybe let's call it the 80% range from the middle of the bell curve.
Regardless, I'm pretty sure I need a more moisturizing line that's labeled as such.

In my opinion, it’s a much harsher bar than we may wish to use on most skin. Consider that the high cleansing numbers mean that not only will high CO soap strip off dirt and grease, it will strip off natural oils, and the Microbiome needed to protect our skin. Once I give a soap away, I have no idea how it will be used once the person gets at home. Is the formula I use some thing I would be comfortable with a person using the soap on their private parts? (I don’t recall seeing re-moisturizing lotions for that! ) On young children? On the other hand, it could be a hand soap for the workingman (or woman) who can use a heavy duty hand cream afterwards.

Everyone on the forum has a collection of books on soapmaking, some good, some written at a time when not as much information was available to the boutique soap maker. I still go back to them for creative reference. For creating my basic soap recipe, however, I go to Kevin Dunn‘s book, Scientific Soapmaking. He sets forth a series of experiments to test different oils for soap properties and includes other information such as how to avoid dreaded orange spots.

My other references begin with doing a search for a key word here on the forum, such as the search I did on bubbles that landed me on this thread. I have an extensive collection of bookmarks from the forum now, which you can do by tapping the bookmark icon above any post you find really valuable. We are blessed to have @DeeAnna to explain soap chemistry, and you should check out her website!

For liquid oils, I try to make sure they are high in oleic acid so they are less prone to becoming rancid in the bottle or eventually in the soap itself. Oil high in linoleic acid can contribute to DOS, the dreaded orange spots. (No, they are not considered a desirable design element!) The formula I plan to use today to make soap for my sister uses high oleic sunflower oil. Some of your books may have charts with the fatty acid profiles of various oils. Or you can check out one of the soap making website pages such as this one. Then check your formula in one of the online soap calculators such as soapmakingfriend.com or soapcalc.net. You can see formulas from other people in the recipe database, such as my latest trial on Duck Soap or on Franklin’s Crown Soap, which you can also read about in the forum here. (Yes, in addition to tried and true I like to experiment to satisfy my curiosity.)

Wishing you luck with your new soap venture!

 

[soap newb]

In my opinion, it’s a much harsher bar than we may wish to use on most skin. Consider that the high cleansing numbers mean that not only will high CO soap strip off dirt and grease, it will strip off natural oils, and the Microbiome needed to protect our skin. Once I give a soap away, I have no idea how it will be used once the person gets at home. Is the formula I use some thing I would be comfortable with a person using the soap on their private parts? (I don’t recall seeing re-moisturizing lotions for that! ) On young children? On the other hand, it could be a hand soap for the workingman (or woman) who can use a heavy duty hand cream afterwards.

Everyone on the forum has a collection of books on soapmaking, some good, some written at a time when not as much information was available to the boutique soap maker. I still go back to them for creative reference. For creating my basic soap recipe, however, I go to Kevin Dunn‘s book, Scientific Soapmaking. He sets forth a series of experiments to test different oils for soap properties and includes other information such as how to avoid dreaded orange spots.

My other references begin with doing a search for a key word here on the forum, such as the search I did on bubbles that landed me on this thread. I have an extensive collection of bookmarks from the forum now, which you can do by tapping the bookmark icon above any post you find really valuable. We are blessed to have @DeeAnna to explain soap chemistry, and you should check out her website!

For liquid oils, I try to make sure they are high in oleic acid so they are less prone to becoming rancid in the bottle or eventually in the soap itself. Oil high in linoleic acid can contribute to DOS, the dreaded orange spots. (No, they are not considered a desirable design element!) The formula I plan to use today to make soap for my sister uses high oleic sunflower oil. Some of your books may have charts with the fatty acid profiles of various oils. Or you can check out one of the soap making website pages such as this one. Then check your formula in one of the online soap calculators such as soapmakingfriend.com or soapcalc.net. You can see formulas from other people in the recipe database, such as my latest trial on Duck Soap or on Franklin’s Crown Soap, which you can also read about in the forum here. (Yes, in addition to tried and true I like to experiment to satisfy my curiosity.)

Wishing you luck with your new soap venture!

Many thanks, ScentimentallyYours! Lots of info for me to go through here and I'm going to reformulate a batch under 20 in cleansing. I'll pass them around and see what folks think. Your comment on not knowing where the soap is going convinced me. I appreciate your feedback.

 

[Obsidian]

Keep in mind that soap cleans, it doesn't moisturize in any shape or form.

If you don't want soap that is drying, you need a low cleansing number. I like around 11 but my hubby can go much higher so I make him his own recipe.

 

[ScentimentallyYours]

@soap newb, for a starting point you might consider the formulation Kevin Dunn came up with for general testing in his book Scientific Soapmaking. Even though it doesn’t contain duck fat (unlike my most recent batch), he calls it Duckbar’s Delight. In Chapter 5, Multi-oil Soaps, he invented the term duck, defined as “that quantity of raw soap produced from a total of 1000 g of oil.” The result will yield approximately 10 bars of soap. He goes on to lead the reader through experiments to understand the effects of water loss during the cure and other considerations in developing your own signature bar.

The starting point for many of us here on the forum to develop a formula is 40-30-20-10. Easy to remember, right? That’s where I begin when tweaking a new recipe in a soap calculator. For example, to create 10 bars of soap I plug in:
40% olive oil (or similar) 400 g
30% palm oil (or similar) 300g
20% coconut oil (or similar) 200 g
10% castor oil (nothing similar!) 100 g

From there in the soap calculator, I swap out similar oil(s) within each category and see what the soap quality graph looks like until I get a soap profile I like. For example, I prefer tallow over lard, so I swap 30% tallow for the palm oil. If I want to use avocado oil, I could split the 40% by entering 30% olive oil and 10% avocado oil, then check the soap qualities in the graph. You can stay up all night running various scenarios and looking at graphs. (Go ahead, ask me how I know.) I find it much easier, faster and more accurate than making multiple batches of soap. This process also helps me avoid the trap of projecting my expectations of perceived benefit when testing new oils vs actual bar qualities.

The most significant benefit of soap calculators is that they automatically recalculate the amount of lye required every time I change or tweak oils in a formula.

Coming up with new recipes. . . Welcome to the rabbit hole!

 

[soap newb]

Really appreciate your feedback.

I whipped up a new batch today at:
30% CO
24% PO
5% CB
36% OO
5% Castor
I list them that way in my procedures spreadsheet because that's the oil order I work in, hard to liquid.
Soapcalc gives this recipe a 45 hardness, 20 Cleansing and 51 conditioning with 163 INS, a big change from my standing recipe. I'll let you know tomorrow how it comes out.
Until now my focus has been on getting consistent, beautiful homogenous bar of soap. With all the clays, salts and sugars that need to go into a batch, along with a chelator, colorants and fragrances, just coming up with a good procedure that actually works consistently is a battle. Changing recipes will be a breeze by comparison, until I run out of palm and switch to soy...