# Labels with Drug Claims



## christinak (Mar 13, 2013)

Active Ingredient: (Calendula) Cosmetic Ingredients: (Olive Oil, Beeswax)

Is this all I would have to do for the ingredients for a salve that boasts the medicinal properties of calendula?

I've read a bazillion posts on a trillion websites, inc. FDA...labeling is sort of a pain


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## christinak (Mar 13, 2013)

I forgot to mention that it's an infusion of calendula IN the olive oil....


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## melstan775 (Mar 13, 2013)

What is the claim you are making?


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## christinak (Mar 13, 2013)

Healing Salve....sorry, lol


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## melstan775 (Mar 13, 2013)

Check the panels of an aspirin container for drug labeling requirements, and copy.  Label as a drug labels, and you'll be golden.


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## christinak (Mar 13, 2013)

Thanks!  I've been reading the FDA site and it seems that the only diff between cosmetic and drug are the "active ingredient" portion.  I am assuming the active ingredient is the one attached to the claim in a cause/effect kinda way


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## sistrum (Mar 13, 2013)

You should probably check more that just labeling requirements if you planing on making a product with claims that puts it in the "drug" category.


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## christinak (Mar 13, 2013)

Thanks sistrum, what do you suggest?  It is so weird that it's such a simple recipe...so much hooplah around it!  What other checking are you referring to?


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## christinak (Mar 13, 2013)

Is it possible to not call it healing but include a description of what calendula is good for...like on a hangtag?  Would that bring it back down to cosmetic category?


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## Genny (Mar 13, 2013)

christinak said:


> Thanks!  I've been reading the FDA site and it seems that the only diff between cosmetic and drug are the "active ingredient" portion.  I am assuming the active ingredient is the one attached to the claim in a cause/effect kinda way



You can't just label it as a drug.  Drugs have to be tested and receive premarket approval from the FDA.  Also, all drug manufacturers have to adhere GMP guidelines during manufacturing.

http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM2007005.htm
http://www.fda.gov/Drugs/GuidanceCo...ion/DrugRegistrationandListing/ucm2007058.htm


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## Genny (Mar 13, 2013)

christinak said:


> Is it possible to not call it healing but include a description of what calendula is good for...like on a hangtag?  Would that bring it back down to cosmetic category?



No.  If you imply in any way that any ingredient in your product can heal, treat, prevent any disease or affect the structure or any function of the body (human or animal), then your product becomes a drug.

You can't give handouts with what the ingredients do, you can't direct them to websites that will tell them what the ingredients do and by putting "Active ingredient" on your label, you are implying that it treats something.


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## paillo (Mar 13, 2013)

Also, one of the first questions my insurance agency (RLI) asked me was whether I made any medical claims on my products. If so, they would not have insured me.


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## green soap (Mar 13, 2013)

christinak said:


> Is it possible to not call it healing but include a description of what calendula is good for...like on a hangtag?  Would that bring it back down to cosmetic category?



Do not call it healing.  If it is a cosmetic, you have to follow the FDA labeling guidelines, this is not hard at all.  If it is a drug (healing claims) then you have to PAY the FDA to test it for you.  This would close many of us down (it would close me down at least).  

'Calendula salve' or something like that would work well.  You can have information on the side (signs, brochures...) describing the use of calendula and calendula infusions over the years.  Still, be careful about medical claim even on signs that are not on the product.   

Another suggestion is to look at the way Burt's bees label their products.  They are wonderful and healing, but I believe they are not labeled as drugs.  For example, their "hand salve' has as a description '...protective hand salve......specially formulated to deeply penetrate skin....."  no health claims anywhere.  They have comfrey root extract in there, a well known healing herb, but no health claims about it.  

It is an exercise in semantics more than anything else.


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## AlchemyandAshes (Mar 13, 2013)

I make salves and tinctures, and only list them as a "salve" or "tincture". I list all (every!) ingredients with INCI labeling - I don't list "active ingredients". I don't list what ailment it's for, and any of its "healing" properties. 
http://www.etsy.com/listing/108139631/dandelion-clover-nettle-salve-with-tea?
I leave it up to the consumer to research and decide what they want to use it for. Most folks looking for a Calendula salve will know what it's used for. Herbalism takes research, but it is all about being able to take care of yourself. Supplying a product for people to do with as they please (as they will do anyway), _*as long as the are informed of the ingredients*_, shouldn't require the FDA's approval, *in my opinion.*
It's a touchy subject with herbal products, with lots of grey area.
There are tons of Etsy sellers (as well as other internet sites) with all kinds of claims listed. How they get away with it, I'll never know. I guarantee they have not been registered and lab tested. I guess the FDA is busy with bigger fish. There is a section on the FDA website that states if there is any implied use (for curative properties) or if the product is publicly associated and used as a drug, it should be labeled with an active ingredient. This is where things get a bit sticky for me. 
Is that the only requirement- an active ingredient? 
What about registering the product and intended use with the FDA? 
Lab testing for safety and efficacy?
How do all these supplement/diet companies get away with their outrageous claims?
Salves, ointments, balms, tinctures and the like are most likely associated with "healing" (think Neosporin ointment). However, my salves could be used as a cuticle conditioner (cosmetic), skin barrier for hair color (cosmetic), moisturizer (cosmetic), used on heels and feet for moisturizing and exfoliation (cosmetic), essential oils can be used as fragrance (cosmetic)...so it gets to be a bit of a "grey area". Tinctures and Extracts can be used for "spiritual" or "ritual" purposes (or as a cosmetic fragrance like Vanilla extract), so that takes care of those, as the FDA doesn't regulate those, unless I'm stating an internal (healing drug) or cosmetic use.

I would be interested to hear how others handle this situation...


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## christinak (Mar 13, 2013)

Thank you everybody for your input.  I have learned some things that I was wondering about!  Especially to you, Shawnee; those are all points I was implying from my short post 

I thought just saying the name of an herb made it a drug, that's why I was trying to figure out what I could do.  I have been making infused salves for so long and would love to sell them but didn't know if it was possible.  I know so many people sell them online but I am the kind of person that gets caught if I do one thing out of step   Im kinda gunshy when it comes to breaking any rules.

There is a clear section in the FDA that does say if there is an implied use or if it's publicly associated and used as a drug that you just need the proper label (active ingredient).  I'd say that herbs would fall under that category.  It says nothing about having to test and approve each product.


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## AlchemyandAshes (Mar 13, 2013)

This is a good reference to the dilemma of not putting the claim on the label, but using brochures and such to promote the products intended purpose/claim:


> Claims made in advertising but not on product labeling are regulated by the Federal Trade Commission, although advertising claims can be used to establish a product's intended use.


http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm127054.htm


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## VanessaP (Mar 13, 2013)

Even using brochures and other promotional material for the products' intended purpose can classify it as a drug.

http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm



> How is a product's intended use established?
> 
> Intended use may be established in a number of ways. The following are some examples:
> 
> ...


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## AlchemyandAshes (Mar 13, 2013)

VanessaP said:


> Even using brochures and other promotional material for the products' intended purpose can classify it as a drug.
> 
> http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm



To clarify, I think it's stating that if your labeling indicates your product is a "cosmetic", but your marketing insinuates medical claims, the FDA can use your marketing information as "intended use" and would consider your product a "drug", which has many more regulations and requirements than a cosmetic. Lots of supplements (especially diet products) use this method...the product will just state the ingredients, but the marketing and advertising will lead you to believe the product acts as a drug (heals, cures, etc). Seems like that violates the FDA laws...so how do they continue to "get away with it"? There must be some legal loophole that they use...
I contacted an accomplished and successful (and very educated) herbal product manufacturer in California asking her how this effects her products (tinctures, ointments, etc...I would consider her claims "herbal medicine")...her products are so creative and awesome, I just wonder what her situation is regarding this. Hopefully she gets back to me and I can share her "real world" information instead of an FDA reply directing me back to their guidelines page...


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## jcandleattic (Mar 13, 2013)

AlchemyandAshes said:


> I contacted an accomplished and successful (and very educated) herbal product manufacturer in California asking her how this effects her products (tinctures, ointments, etc...I would consider her claims "herbal medicine")...her products are so creative and awesome, I just wonder what her situation is regarding this. Hopefully she gets back to me and I can share her "real world" information instead of an FDA reply directing me back to their guidelines page...



And hopefully if she is making any claims, she IS following FDA R&R's... 
Doing something the right way, and having real world experience are not always synonymous unfortunately...


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## new12soap (Mar 13, 2013)

Genny said:


> You can't just label it as a drug.  Drugs have to be tested and receive premarket approval from the FDA.  Also, all drug manufacturers have to adhere GMP guidelines during manufacturing.
> 
> http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm
> http://www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM2007005.htm
> http://www.fda.gov/Drugs/GuidanceCo...ion/DrugRegistrationandListing/ucm2007058.htm


 
This.

Of course there are a lot of people that do it, and a lot of people get away with it.  That doesn't make it right, and it doesn't make it legal. I'm sorry, but it isn't a "grey area" IMO. The FDA is very clear about what constitutes a drug and how they have to be handled and labeled if selling to the public. The "real world information" that someone is getting away with it is anecdotal at best. What you (the OP and PP) or anyone else chooses to risk is your business, but encouraging others to disregard the regulations is IMO irresponsible.


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## AlchemyandAshes (Mar 13, 2013)

new12soap said:


> This.
> 
> Of course there are a lot of people that do it, and a lot of people get away with it.  That doesn't make it right, and it doesn't make it legal. I'm sorry, but it isn't a "grey area" IMO. The FDA is very clear about what constitutes a drug and how they have to be handled and labeled if selling to the public. The "real world information" that someone is getting away with it is anecdotal at best. What you (the OP and PP) or anyone else chooses to risk is your business, but encouraging others to disregard the regulations is IMO irresponsible.


I am absolutely NOT encouraging others to disregard the FDA regulations, and neither do I do it myself. I am also not insinuating that because others do it and get away with it that it is right. If I wasn't clear, then at least let me clarify that point.

My "grey area" comment is regarding making an herbal product and selling it WITHOUT MAKING ANY MEDICAL CLAIMS either on the label or in marketing. Just making and selling a Calendula Salve and selling it as Calendula Salve - is that considered a drug? Calendula Salve can certainly be used for cosmetic purposes (to moisturize dry skin on heels, for example), but it can certainly be used as an "herbal medicine" also (as a treatment for eczema)...so where does it fall in the FDA categories? Is it only a drug if marketed or labeled that way? If there are no claims made on it's use, either in label or marketing, but it's labeled with the INCI ingredients, is it now a cosmetic? That's the grey area for me. I linked the FDA's stance on labeling/marketing and intended use so that  any question about using brochures/flyers to give "medical" information about a product while  not labeling your product it as a drug would still be against regulation. 

As for the herbalist I contacted - I have no idea of her circumstances, and would not just assume she's not complying with FDA regulations, or that she is. I was only stating that she is an educated and successful  business woman in this particular arena, and can possibly share her knowledge or information regarding this topic. It's certainly possible that she's flying in the face of danger, using medical claims, and could care less what the FDA says. I don't know, which is why I contacted her instead of making assumptions. I'm hoping that she has dealt with the FDA regarding her products and can shed a little light. And while she may not be an FDA official, she may have dealt with this exact circumstance and can speak from her experience.

If you had read my previous posts, you would see that I am simply "questioning out loud", stating my opinion and my experience. I am not irresponsible with my labeling or marketing (feel free to check out my Etsy store, FB page, or website), nor encouraging others to be - though I may be encouraging others to think for themselves and ask questions, not just take something found on the internet or forum as fact. Saying that someone finds a loophole and gets away with some illegal activity and wondering how is NOT encouraging others to do so, nor is it stating it's morally or ethically right. It's more a matter of questioning why something hasn't been done about it - if I have to follow strict guidelines, they should, too.


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## AlchemyandAshes (Mar 13, 2013)

jcandleattic said:


> Doing something the right way, and having real world experience are not always synonymous unfortunately...



I totally agree with this statement. 

I have no idea if the herbalist I contacted is following FDA guidelines or her specific labeling requirements. I did not mean to infer that she is following or not following FDA R&R, just that she sells herbal products with medical claims. She may very well have FDA clearance for her products. She may not. I'm awaiting her answer to hopefully share some pertinent information to this topic from someone who sells this type of product.

I'll share her reply either way. I'm assuming if she does not follow FDA regulations, she may not want to reply and "incriminate" herself...however, she's all over the internet, so if she was trying to "hide", I think they would have "found" her by now...


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## jcandleattic (Mar 13, 2013)

AlchemyandAshes said:


> My "grey area" comment is regarding making an herbal product and selling it WITHOUT MAKING ANY MEDICAL CLAIMS either on the label or in marketing. Just making and selling a Calendula Salve and selling it as Calendula Salve - is that considered a drug? Calendula Salve can certainly be used for cosmetic purposes (to moisturize dry skin on heels, for example), but it can certainly be used as an "herbal medicine" also (as a treatment for eczema)...so where does it fall in the FDA categories? Is it only a drug if marketed or labeled that way? If there are no claims made on it's use, either in label or marketing, but it's labeled with the INCI ingredients, is it now a cosmetic? That's the grey area for me.



If it is labeled as Calendula Salve and that is ALL that is said about it, and only the name of the product, and said name is not a claim (like say the name was Healing Beautifying Calendula Salve would be) then, no, it is not a drug or cosmetic, but will still need to be labeled per regulations for the product that it is (lotion, soap, etc.) 
Just because there are herbs or what not in it, doesn't automatically make it a medicinal or cosmetic product. It is the claims being made that will differentiate that in most cases. But like everything else there are exceptions to these rules, which is why there are published and updated FDA R&R's.


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## AlchemyandAshes (Mar 13, 2013)

jcandleattic said:


> If it is labeled as Calendula Salve and that is ALL that is said about it, and only the name of the product, and said name is not a claim (like say the name was Healing Beautifying Calendula Salve would be) then, no, it is not a drug or cosmetic, but will still need to be labeled per regulations for the product that it is (lotion, soap, etc.)
> Just because there are herbs or what not in it, doesn't automatically make it a medicinal or cosmetic product. It is the claims being made that will differentiate that in most cases. But like everything else there are exceptions to these rules, which is why there are published and updated FDA R&R's.


That would be my interpretation of that rule, also...which is why my salves are just labeled as "salve", not "healing" or "bug bite salve" or "acne salve" or any other drug claim - although I think "beautifying" would be a cosmetic claim. I list the ingredients with INCI labeling as you would a cosmetic.

But what about the FDA statement about what a consumer intends to use it for or associates it's use with - "implied use"? Consumer A may think it would be great for her cuticles. Consumer B may think it would be useful for her psoriasis. Consumer C has no idea what a salve is in the first place  ...LOL


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## jcandleattic (Mar 13, 2013)

AlchemyandAshes said:


> But what about the FDA statement about what a consumer intends to use it for or associates it's use with - "implied use"? Consumer A may think it would be great for her cuticles. Consumer B may think it would be useful for her psoriasis. Consumer C has no idea what a salve is in the first place  ...LOL



you can't do anything about what they THINK it's good for. All you can do is if they ask if it's good for your cuticles, or psoriasis, or yada yada yada, all you should reply with is, "that is not it's intended use" and go from there. If they ask what a salve is, be honest. It's a topical product much like lotion only thicker (or whatever) just be very clear that you are not telling them that it can DO anything other than be rubbed onto their skin. Like with soap all you can really 100% get away with is saying is "you can use it to wash yourself with"


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## AlchemyandAshes (Mar 13, 2013)

This is the FDA statement that causes me to wonder:



> Intended use may be established in a number of ways. The following are some examples:
> 
> *Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials.*  Certain claims may cause a product to be considered a drug, even if the  product is marketed as if it were a cosmetic. Such claims establish the  product as a drug because the intended use is to treat or prevent  disease or otherwise affect the structure or functions of the human  body. Some examples are claims that products will restore hair growth,  reduce cellulite, treat varicose veins, increase or decrease the  production of melanin (pigment) in the skin, or regenerate cells.
> 
> ...


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## jcandleattic (Mar 13, 2013)

AlchemyandAshes said:


> This is the FDA statement that causes me to wonder:



A product will only HAVE that reputation of implied usage if you have made claims in the past and established that reputation for your products.  (as it says in the very large print you attached) 
I really don't know how to make it more clear than the FDA has, and I'm sorry you are confused. 
I have been doing this a very long time and am very familiar with the FDA R&R - there is no need to shout them at me. I was only trying to help you.


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## AlchemyandAshes (Mar 13, 2013)

jcandleattic said:


> A product will only HAVE that reputation of implied usage if you have made claims in the past and established that reputation for your products.  (as it says in the very large print you attached)
> I really don't know how to make it more clear than the FDA has, and I'm sorry you are confused.
> I have been doing this a very long time and am very familiar with the FDA R&R - there is no need to shout them at me. I was only trying to help you.


Sorry, I didn't mean to shout - I was trying to highlight the part that wasn't clear to me...will go back and fix that. 
Just trying to emphasize that part that has me wondering - not the whole quote.
I haven't made any claims on my products. My question is if that statement meant an implied use that the public associates with a TYPE of product (not my particular product), like an herbal salve. If most people associate herbal salves with "medicine", is it considered a drug?

And thank you for your assistance. I apologize if my red bold type came across as shouting.

P.S. The black bolding is from the FDA website, not my own doing.


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## christinak (Mar 13, 2013)

My my, well thanks for the help   I think you've all made it very clear that as long as no claims are made on the label or on any brochures that you can pretty much sell what you want and to be on the safe side, label it as a cosmetic.  Is there a hard and fast list to the terminology that can be used before crossing a line into the world of drugs?

I also think it's clear (and common sense) that "implied use" is something that is mostly common use across the board, such as aspirin is for headaches.  I'm not going to stand on a soapbox (no pun intended) and rant about how I believe government is too involved anyway....and how there's wayyyyy too much "netiquette" now-a-days....but I'm new to this forum and the first thing I thought of when I got here was how refreshing it is to be a part of something with really nice people.  I hope that doesn't change.  Everyone here is just helping eachother out.  Nobody is getting loud or cocky or yelling...we're typing...and nothing is implied.  People will always perceive words differently or out of context, it's best to let things roll off your back.

The herbalist in question over the last few posts probably knows more about herbs than any lab coat at the FDA does.  The only reason to put one over the other is to not land in jail.

Thanks EVERYONE for your input and keep up the good work!


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## AlchemyandAshes (Mar 13, 2013)

christinak said:


> Thanks EVERYONE for your input and keep up the good work!



Hey! Quit shouting at EVERYONE! :eh:

Bwahahaha! Just kidding! :razz:


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## christinak (Mar 13, 2013)

lololol!!!!!!!!


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## Parke Co. Grapevine (Apr 2, 2013)

*more labeling Qs, and pine tar Q*

I too, have searched online and read here and read there, and ... it all can become quite confusing. 

I found the FDA's definition of soap, of course, and this . . .
_"Products that meet this definition of soap are regulated by the Consumer Product Safety Commission   (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC..."_

But could not find anything at the CPSC website about rules and regs or labeling for soap. Rather, the best I could discern is that true 'soap' - like what we make - is an '*unregulated product*.'  So... no rules for labeling as long it is only 'soap' and not presented as anything else?

We once stayed at a local statepark Inn. The guest soap was boxed and presented as an 'all-natural body cleansing exfoliant' or some such wording. No ingredient label anywhere. We used it and found it to be extremely similar to your basic unscented Walmart bath bar. The lack of labeling info irritated me.

I have sometimes looked at homemade soaps sold by others with very 'skimpy' labeling, IMO. My sister (in another state) claimed that the soaps she buys at her neighborhood soaper were *not* lye soaps because 'lye' was not on the ingredient label ... after sharing a not-well-received brief chemistry lesson, I suggested she just go ask her soapmaker about making soap and using lye. She did :wink:

On our labels, I intentionally call it 'soap' and give a condensed version of our CP recipe and method, and the statement _(no lye remains in the final product.)_ Then I add, "also contains:..."  and I list the unsaponifiables or things that I *hope* do not saponify - FOs, EOs, exfoliants, waxes, etc. Things I add at trace. I really want to give the customer accurate information, but clearly state that this is a SOAP.

But Pine Tar . . .  is our most demanded and best-selling soap. We label it Pine Tar soap. period. We have never used it for anything but soap (though our sons did have good results controlling athletic fungus with it, lol).  It's our customer who will say, "I've been looking everywhere for this for my psioriasis...!"   Then, I found this statement at the National Psoriasis Foundation: _"Two active ingredients, salicylic acid and *tar*, are approved by the FDA as treatments for psoriasis."  _

Noone in our household has psoriasis. We did not know this until our customers told us. Our first customer, who requested pine tar soap, was a lil old lady who remembered always using it as a child and wanted some. Then others bought it. And then we had a crowd . . . it is our #1 item that we cannot keep in stock. Hubby is now retired, we need the income, we are launching our hobby soap business into something fulltime. On my labels, I state the percentage of pine tar in the recipe but no medical claims.

So, there we are with the 'perceived' medical use of our soap, that *we* never intended. I've heard horror stories about this or that soaper who did make cosmetic/medical claims on their soaps, were hit with big fines. But I also see so many others doing it, for years apparently, and like one of you said ... the FDA has 'bigger fish' to worry about?  Just looking for input, thanks to all.

(and I agree with Christinak ... labeling becomes a 'pain'


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## Genny (Apr 3, 2013)

Well soap is unregulated by the FDA, but there are still labeling regulations for it since it's a consumable commodity.  
http://www.mariegale.com/soap-cosmetic-labeling/quick-labeling-faq

If you put pine tar in your soap, it does not make it a drug.  Now, if you call your soap, Pine Tar Soap, then you may have problems.  I honestly would just rename them so I didn't have to deal with the hassle & potential legal problems.

I know that a lot of people think, "Who cares?  The FDA have bigger things to worry about, they won't come after little old me."  That doesn't make it okay.  Just because you don't get caught, doesn't make it okay.  Millions of people get away with stealing, abuse, rape, murder, etc, but it's still illegal and it doesn't make it okay.


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## paillo (Apr 3, 2013)

Wait, Genny, I don't understand. If you name it Pine Tar soap with no medical claims, how can this be a problem? What am I missing?


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## Genny (Apr 3, 2013)

paillo said:


> Wait, Genny, I don't understand. If you name it Pine Tar soap with no medical claims, how can this be a problem? What am I missing?



Because of consumer perception.  It's the same reason that if you make whipped shea butter, you have to call it something else, like Whipped Body Butter.  Or, if you make Tea Tree Soap, you have to call it something else.  




http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm

"How is a product's intended use established?

Intended use may be established in a number of ways. The following are some examples: 

Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for "essential oils."


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## Parke Co. Grapevine (Apr 4, 2013)

Sigh.  OK, so for awhile I was calling our pine tar soap, 'Grampa's Workday Soap' but then we decided to simplify things and changed to just Pine Tar Soap. Do you think the original title is better?

I read that aloe vera helps make a soap whiter, and mild and gentle. We also grow our own Aloe Vera and make (my own recipe of soap with

_fresh Aloe Vera, and a touch of EOs - Lavender, Tea Tree, Rosemary, Litsea. And a bit of Kaolin white clay. It smells very fresh and clean and is just wonderful to use. I have never given this soap any name except 

fresh Aloe Vera Soap 

 (cause my daughters actually sit and help me scrape aloe 'snot' for each recipe; we throw in plenty of tiny bits of green leafy stuff cause as it cures, it adds interesting beige-pink flecks in the soap.)  Do you see a problem with this one?_


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## SoapPapaw (Apr 4, 2013)

Can you say on the label, " Unscented Moisturizing Soap with Shea Butter" or " Unscented Soap with Shea Butter"? Then list Shea butter in the ingredients.


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## Genny (Apr 4, 2013)

SoapPapaw said:


> Can you say on the label, " Unscented Moisturizing Soap with Shea Butter" or " Unscented Soap with Shea Butter"? Then list Shea butter in the ingredients.



You can't put shea butter in the name of the soap, because of shea butter's widely known "healing properties" and what the potential customer will likely expect it to do. I know, it sounds stupid, because how can we control what a person expects something to do for them?  But unfortunately, it is what it is.
Also, unless you are following cosmetic labeling regulations, moisturizing can't be in the title or description either.


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## Genny (Apr 4, 2013)

Parke Co. Grapevine said:


> Sigh.  OK, so for awhile I was calling our pine tar soap, 'Grampa's Workday Soap' but then we decided to simplify things and changed to just Pine Tar Soap. Do you think the original title is better?



I'd change it back to Grampa's Workday Soap.

As far as the Aloe Soap, it is an incredibly well known plant around the world used for healing wounds and other skin ailments, so I'm going to assume it would fall into the "Customer perception" rule.
But, when I talked to a FDA officer, I only specifically addressed shea butter, pine tar, certain essential oils, milk, honey and oatmeal.  (Oatmeal, honey & milk are okay, by the way).  So you may want to contact them yourself to make sure.

Also, for people who are putting customer's testimonials on their websites that talk about helping cure, curing, healing, etc., you might find this interesting:
http://blog.mariegale.com/fda-cracking-down-on-cosmetic-product-claims/


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## christinak (Apr 4, 2013)

This is all very confusing.  It seems like making up whimsical names for soap is safer to do that calling it what it actually is.  To me it doesn't make sense that a soap cannot be called what it is if it's in the ingredients....WEIRD.


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## Parke Co. Grapevine (Apr 4, 2013)

I want to say Thank You, to everyone for this discussion so far. It is very, very helpful. I know Christinak, it all sounds weird. According to the FDA, we cannot just be simple and say what the soap is IF the customer is going to buy with preconceived notions about some item's healing or medicinal properties. ? Gives me some new research to do and new info to 'chew' on with hubby concerning any soap business activities.

Thanks again, esp. to Genny.


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## layserbrat (Apr 4, 2013)

I was just as confused until I got Marie Gale's book on labeling...it is written so the average person understands...well worth the money.


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## SoapPapaw (Apr 4, 2013)

Thank you all.
I reviewed the FDA rules - no label requirements for True or Pure Soap.
Cannot say, moisturizing, softening, healing, hydrating, or any other term that says the soap improves or changes the skin. If you do then it is a drug or cosmetic and follows rules for those products.

I reviewed MarieGales blog. I can say on the main label:
(company name) Papaw's Soap Works
(Tag line) Made the Old Fashioned Way
(Soap name) Papaw's Back Woods
(Somewhere separate from name) _With Pine Tar_

Or

(company name) Papaw's Soap Works
(Tag line) Made the Old Fashioned Way
(Soap name) Grandma's Back Porch
(Somewhere separate from name) _Contains 6% Shea Butter_

Or

(company name) Papaw's Soap Works
(Tag line) Made the Old Fashioned Way
(Soap name) Aunt Betty's Brew
(Somewhere separate from name) _Aloe and Vitamin E Enhanced_

I know I will get feed back.


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## christinak (Apr 4, 2013)

That seems ok to me, Frank.  You are not making any claims yet you're listing the ingredients.


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## SoapPapaw (Apr 4, 2013)

Also you can have Informational Panels on another part of the packaging like:

"Gets an A+ on moisturizing" - Sarah M

Or

"Get that Baby Softness your skin deserves"


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## la-rene (Apr 4, 2013)

I came across this one today... (I will paraphrase.)

I've heard that your products... (cure stuff)... 
The FDA prevents us from using the word cure... but we have hundreds of testimonies... have been so delighted with our products ... treating their conditions.... They go on to state how the healing of the oils is wonderful.... 

I have to say that it's really disheartening for anyone who is trying to do right to see a possible competitor selling really expensive stuff with impossible and FDA illegal claims all over the place on their very beautiful and compelling website.   

It seems to me that if you disregard FDA guidelines and tout your products' healing properties it's an unfair advantage in the popular, upscale,  handmade, no chemical, good for you, green product market.  Honestly, if I were an affluent soccer mom looking for the next best spa product for my and my babies skin, I would shop at the website of the people with these claims because that is what I want to hear.  I would not have done my research to know that Jane Soapmaker has the same stuff in there, but sells it $4 cheaper a bar.  

The bad thing is, I've seen so much of it lately!  Ugh!!


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## Genny (Apr 5, 2013)

SoapPapaw said:


> Also you can have Informational Panels on another part of the packaging like:
> 
> "Gets an A+ on moisturizing" - Sarah M
> 
> ...



The informational panel is for your ingredients, warning statement and name & address.


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## christinak (Apr 5, 2013)

Frank, I am pretty sure you cannot have any claims on your packaging...even testimonials.


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## SoapPapaw (Apr 5, 2013)

From the FAQ section om Marie Gale's blog
Start Quote
What else can go on a label?
You can put whatever you want on the informational panels (not the front) to tell about your product, how great it is and all that.  The informational panels are for providing information to the consumer.
End of Quote

So as long as it is not on the front you should be able to provide a panel that says, "how great it is and all that."

I think that could include a testimonial.


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## Genny (Apr 5, 2013)

SoapPapaw said:


> From the FAQ section om Marie Gale's blog
> Start Quote
> What else can go on a label?
> You can put whatever you want on the informational panels (not the front) to tell about your product, how great it is and all that.  The informational panels are for providing information to the consumer.
> End of Quote



I'd double check with the FDA or CPSC before doing that, just to be sure if I were you.  

Honestly, there's no way I could fit anything else on my informational panel.  It's hard enough fitting the ingredients, warning statement, address & my website on it and make sure my letters aren't too small.


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## MarieGale (Apr 30, 2013)

*Chiming in - help on labeling*

Thought I would chime in here and maybe help clear up a few points ... (trying to answer the various questions posted by different people)

First, when it comes to labeling and regulations, you have to remember that it is determined by what CLAIMS are made about the product.

For example, a soap can be:

a SOAP if the only claim is that it cleans (and it's a "true soap" made with lye and oil)
a COSMETIC, if there are claims that it promotes attractiveness or makes one more beautiful
a DRUG, if there is a claim that it treats, cures, mitigates a disease or physical condition
an INSECTICIDE, if there is a claim that it repels bugs
a FOOD, if it is intended to be eaten (not really applicable to soap, but there have been "edible cosmetics" --- which are treated as food.

The FDA defines the LABEL as the information that is ON the product.  They define LABELING as the information that goes WITH a product (as in a brochure with the product, or information on a website about the product).  The FDA regulates LABELS and LABELING of foods, drugs and cosmetics.

The FDA has been cracking down lately on drug claims made for "cosmetic" items. In recent warning letters, they have cited information in brochures, on websites (including in explanations of ingredients and testimonials), facebook pages, and even meta data on a site's website.  See my blog post: FDA Cracking Down on Cosmetic Product Claims.

Note that making a claim about an INGREDIENT in a product is considered to be making a claim about the product itself.  So if the product contains tea tree oil, and you say that tea tree oil is "known to be an anti-fungal" - then you're considered to be making the claim that the product itself is anti-fungal (and so an "unapproved drug").

ADVERTISING, which is done separately from the product itself (ie TV, magazine, radio), is covered by a different federal agency.

ALL PRODUCTS require four things on the label:

Name of the product
Identity (what it is)
Net Weight
Name and address of responsible party.

Soap (if it's "true soap" and only claims to clean) isn't regulated by the FDA, but it still requires those 4 things on the label.  In that case, it's regulated by the Fair Trade Commission.

Cosmetics require those 4 items on the label, AND the ingredient list. 

Drugs require those 4 items, plus information about the active ingredients and a few other things. Drug

Foods require those 4 items, plus ingredients, plus nutritional facts.

There are two types of drugs ... drugs that require pre-approval from the FDA (usually prescription drugs that are "invented" by a company, tested and then proven to work ... and then approved by the FDA) and Over The Counter (OTC) drugs, that contain ingredients that are *already approved* for certain uses.

Even though, for example, tea tree oil is known to be anti-fungal, but it's not on the FDA approved list for OTC drugs.  There is a list of the ingredients that are approved for different uses, and each one has clearly defined usage levels and what claims can be made about it.  Those are called "Monographs".  You can't just add the "Active Ingredient" to the label and put it in the right form  - it has to have a monograph that is followed.  

Drug manufacturers (including OTC drugs) must be registered with the FDA and inspected, and are required to follow good manufacturing practices that are outlined in regulations (and are VERY detailed).  So even if you make an anti-bacterial product containing tryclosan and do it exactly per the monograph - you would then be a drug manufacturer and have to follow all THOSE regulations as well.

Food supplements, which are also regulated by the FDA, have some allowances for making nutritional claims that can be tied to healing or curing conditions caused by lack of a substance.  These allowances are very specific and for use only with nutritional supplements.  If you've ever seen that disclaimer, "This statement has not been evaluated by the Food and Drug Administration..." - it's part of what they are allowed to do.   See my blog post on Using an FDA Disclaimer on Cosmetics for more about that.

I hope this helps a bit. If you have any questions about any of these points, please comment and I will try to answer.  Or you can email me. There's also more information on my blog (blog.mariegale.com) or my website (www.mariegale.com).

Note that I'm getting ready for the Handcrafted Soap & Cosmetic Guild annual conference in Raleigh in a few weeks, so I may not be super-fast in responding.

Marie Gale


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## melstan775 (Apr 30, 2013)

Wow. That was a ton of information. Thank you Marie for taking the time.  Now I am so curious about this and other things. I will chew it over and try tO narrow down what I mean before I post. Have a great time at the conference!


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## Nevada (Apr 30, 2013)

Miscreants abound!

Search for "Tea Tree Soap" in Etsy, eBay and Amazon

Lemongrass and Tea Tree Oil Soap Bar 5 Ounces by Nubian Heritage
Paul Mitchell Tea Tree Body Bar Soap 5.3 oz. / 150 G by Paul Mitchell
PediFix FungaSoapLiquid with Tea Tree oil, 6 oz. by Pedifix
Dr. Bronner's Magic Soaps Pure-Castile Soap, All-One Hemp Tea Tree, 5-Ounce Bars (Pack of 6) by Dr. Bronner's Magic SoapsBar Soap-Tea Tree Therapy 1 Bar by Desert Essence
The Body Shop Tea Tree Body Wash, 8.4-Fluid Ounce by The Body Shop
Tea Tree Therapy Vegetable Base Soap with Tea Tree Oil -- 3.5 oz by Tea Tree Therapy  




Genny said:


> Because of consumer perception.  It's the same reason that if you make whipped shea butter, you have to call it something else, like Whipped Body Butter.  Or, if you make Tea Tree Soap, you have to call it something else.
> 
> 
> 
> ...


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