# What are health claims?



## Crocoturtle

Is there a definitive list of words that are considered health claims or cosmetic claims?


Part of my business model is developing signature soaps for small  businesses such as I made a soap for a local beekeeper using their honey  and beeswax that they sell with their products. 
For the most part I avoid the issue by just saying <fragrance> soap
I have a client who runs a karate school and wants to call the product  "Chi Invigorating Soap." Is "invigorating" a claim? Is there a list  somewhere of what words you can and can't use? 		

If there is such a list or we can make one, can we make it a sticky?


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## Soapsense

I bought a soap that used Kelp from Maine, It said "Toning Bar" is Toning a health or cosmetic claim?


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## Genny

Invigorating would not be a health/drug claim.
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm

It is a drug if 
"as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]."

If you imply in any way that your product or any of the ingredients in it can heal/treat/prevent a disease or illness such as eczema, diaper rash, acne, cancer, cold sore, arthritis, PMS, migraines, etc.  then you've got a drug.  Selling drugs without proper approval is illegal, unless you are doctor or pharmacist.

Canada has a nice list of what words you can use.  I'll go see if I can find them.


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## Genny

Alrighty, I found the list of Acceptable and Unacceptable wordings/claims you can say about cosmetics:
http://www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmet/index-eng.php#a2  (you have to scroll 1/2 way down the page)

Like I said, it's from Health Canada, but it's similar to what the FDA allows accept a little more strict and better explained.

Also, giving brochures or having links to what the ingredients in your products are known to help, is still implying that your product can do whatever you're trying to imply.  Having customer testimonials that contain unacceptable claims is also against FDA regulations.


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## Genny

Soapsense said:


> I bought a soap that used Kelp from Maine, It said "Toning Bar" is Toning a health or cosmetic claim?



Cosmetic claim.


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## melstan775

Genny said:


> Cosmetic claim.



Can you make cosmetic claims about soaps and body washes? Like "Invigorating coffee body wash will wake you up!"   kind of stuff?


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## Genny

melstan775 said:


> Can you make cosmetic claims about soaps and body washes? Like "Invigorating coffee body wash will wake you up!"   kind of stuff?



As long as you abide by the cosmetic labeling regulations, which you would have to anyways for body washes.


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## Crocoturtle

melstan775 said:


> Can you make cosmetic claims about soaps and body washes? Like "Invigorating coffee body wash will wake you up!"   kind of stuff?


per that Canadian link "invigorates skin" is ok "wakes you up" is not.


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## Genny

Crocoturtle said:


> per that Canadian link "invigorates skin" is ok "wakes you up" is not.



Ooh, good catch.


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## melstan775

Crocoturtle said:


> per that Canadian link "invigorates skin" is ok "wakes you up" is not.



I"m glad I'm not in Canada for this one.  I am in the US, and while people here sometimes go overboard with expectations, with cosmetics I find people are realistic. "It's just soap," "It's just shampoo," etc. And the "claims" are fun anyway, and what gets you excited about a product. Who doesn't love a fun bottle of shower juice?


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## RocknRoll

This was very informative, thanks everyone


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## AngelMomma

I'm pretty sure you aren't supposed to make claims like this one.  This person has product out at 2 different flea markets in my area.  Rediculous,


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## Genny

Actually, since it just says that it makes you "look" younger, then it's okay.  Now had it said that it makes the skin younger, then it wouldn't have been okay.  "Look" was the key word.
Looking through the description, I don't see anything else either. 

Now does it actually make you look younger, who knows?  That's all in the eye of the beholder.


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## RocknRoll

Im currently working on the back side label for my facial soap using activated charcoal (which I love) and im wondering if I can put something like " activated charcoal gently removes inpurities from your skin while asorbing/removing excess oil." just a though as Im figuring on what wordage to use... or would this even be irrelevant because isnt that what "soap" is supposed to do lol! I just want to express the qualities of activated charcoal without claiming it to be a "drug".


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## AngelMomma

Genny said:


> Actually, since it just says that it makes you "look" younger, then it's okay.  Now had it said that it makes the skin younger, then it wouldn't have been okay.  "Look" was the key word.
> Looking through the description, I don't see anything else either.
> 
> Now does it actually make you look younger, who knows?  That's all in the eye of the beholder.


 
Really?!  I am surprised that someone could claim that. I would think that they would have to prove it first. Huh!  Thats why threads like this are useful.


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## thefarmerdaughter

Rock&Royalty said:


> Im currently working on the back side label for my facial soap using activated charcoal (which I love) and im wondering if I can put something like " activated charcoal gently removes inpurities from your skin while asorbing/removing excess oil." just a though as Im figuring on what wordage to use... or would this even be irrelevant because isnt that what "soap" is supposed to do lol! I just want to express the qualities of activated charcoal without claiming it to be a "drug".



Well, according to the link Genny provided you could say;
Cleans acne-prone skin
Purifies skin by removing dirt
Cleanses oily skin

Personally, and this is just my opinion, when/if I start selling there wont be any claims on any of my soaps.


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## paillo

Genny said:


> Alrighty, I found the list of Acceptable and Unacceptable wordings/claims you can say about cosmetics:
> http://www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmet/index-eng.php#a2  (you have to scroll 1/2 way down the page)
> 
> Like I said, it's from Health Canada, but it's similar to what the FDA allows accept a little more strict and better explained.
> 
> Also, giving brochures or having links to what the ingredients in your products are known to help, is still implying that your product can do whatever you're trying to imply.  Having customer testimonials that contain unacceptable claims is also against FDA regulations.



Extremely helpful, Genny, I'm gonna have to rethink my website and placards. Sad because I think I'd be in a tiny minority in not extolling the known benefits of ingredients. I wouldn't add to my label, but I sure would elsewhere.

Another point: As a consumer, unless I'm pretty educated about ingredients, I WANT to know the documented benefits of particular ingredients. I feel like I, as the soapmaker, have done considerable research on ingredients and have, as honestly as possible, boiled them down for the consumer's benefit. I don't want my buyers to have to research every ingredient. 

How totally frustrating and confusing this issue remains.


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## Genny

thefarmerdaughter said:


> Well, according to the link Genny provided you could say;
> Cleans acne-prone skin
> Purifies skin by removing dirt
> Cleanses oily skin
> 
> Personally, and this is just my opinion, when/if I start selling there wont be any claims on any of my soaps.



Don't mention acne or blemishes and honestly I wouldn't even mention oily skin.


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## Genny

paillo said:


> Extremely helpful, Genny, I'm gonna have to rethink my website and placards. Sad because I think I'd be in a tiny minority in not extolling the known benefits of ingredients. I wouldn't add to my label, but I sure would elsewhere.



There are a lot of us out there that just say "My soap cleans".  Probably a lot more than people think, because we see so many people that list the "health" benefits of their ingredients.  I believe that there are some ingredients in my products that could help some skin conditions, but I don't say anything about it because I'm not a doctor.

 I'm going to be honest. I don't see much of a difference between B & B'ers who choose to sell what are considered OTC drugs and Marijuana dealers.  That might offend some people, but we're not doctors, we shouldn't be pretending to be doctors and we don't know the full background of our customers & their health problems. 

I feel very strongly about this due to a B & B'er who decided that they were a doctor and could cure my grandfather of his chronic cough.  They told him to just keep using a salve they sold him.  When he wasn't getting better, they told him that it might take longer for it to work.  Not once did they suggest going to a doctor.  You might think that he should have known better, but when told that a $5 product could get rid of something as opposed to paying $100's to get rid of something, a lot of people are going to choose the $5 product.  Well eventually he got so bad that my uncle fought with him to get him to the hospital.  By that time it was too late.  He had lung cancer which had spread to almost his entire body.  He was dead in less than a year.


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## gratia

Yes, there is a fine line we are walking.  There is a soap lady at my market who makes Pine Tar soap and claims to clear acne.  She told me in not so many words that she "polices" other soap makers and likes to let them know that they don't know what they are doing.  Well I made it quite clear that I know what I am doing and then looked at her brochure and she is making these claims.  I am not the soap police and let her dig her own grave if you will.

I would just be careful and leave out words like "helps" "clears" "cures" "gets rid of" etc...

My question is-Is there a way to get your soap tested to be able to make claims and if so is it expensive or just not worth it?  She also has a shop but I don't think that means much right?

Sorry for rambling and no intention of high jacking.


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## Soapsense

I noticed a lot of suppliers of the ingredients put in their descriptions the word "known"  as "known to help acne prown skin."


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## thefarmerdaughter

Genny,
I'm sorry that happened to your grandfather. I'm sure he's not the only one, and that's unfortunate. 
I agree with everything in your post above. I'm trained as a nurse, and even though we are medical professionals, the phrase "You need to speak with your Dr. about X" is drilled into us. (or it should be) It's the reason I'm leery about putting claims on soaps or lotions. And it's the response I plan on using, if I'm ever in that situation.


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## Genny

gratia said:


> My question is-Is there a way to get your soap tested to be able to make claims and if so is it expensive or just not worth it?  She also has a shop but I don't think that means much right?



You absolutely can get your products tested.  
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM2007005.htm

You have to make sure that you are following all GMP regulations as well
http://www.fda.gov/Cosmetics/Guidan...PGuidelinesInspectionChecklist/ucm2005190.htm

I have heard that it is incredibly expensive.


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## Genny

Soapsense said:


> I noticed a lot of suppliers of the ingredients put in their descriptions the word "known"  as "known to help acne prown skin."



They're trying to skirt around the regulations.  I've seen many soapers say that it's okay.  It's not.

I can't remember which B & B biz got caught by the FDA for doing this, but it did happen not too long ago.  

It's still implying that the ingredients in your product can help acne, which is the same thing as saying your product will help acne.


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## Genny

thefarmerdaughter said:


> Genny,
> I'm sorry that happened to your grandfather. I'm sure he's not the only one, and that's unfortunate.
> I agree with everything in your post above. I'm trained as a nurse, and even though we are medical professionals, the phrase "You need to speak with your Dr. about X" is drilled into us. (or it should be) It's the reason I'm leery about putting claims on soaps or lotions. And it's the response I plan on using, if I'm ever in that situation.



Yeah, sometimes I get a little crazed about it. 
I guess I just don't understand why people fight it so much.  Makes me wonder what other kinds of laws they have no problem breaking. :think:


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## paillo

We really need someone from the FDA here to explain it all.

So here's another question. I often pull descriptions of ingredients from my reputable suppliers and summarize. How is it OK for them to describe the benefits of an ingredient and not OK for us? Because of the use, e.g. soapmaking may alter the properties of an ingredient? Could an aromatherapist, using one straight essential oil, get away with a description because there is no chemical reaction? But maybe there would be with different bodies. The more I think about this the more conflicted I get...


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## paillo

So anyone got any FDA connections? If not I have colleagues who might be able to find someone who might help us. Admins, is it possible to have something like a live Q&A via teleconference or other, with questions that are clearly laid out ahead of time? Personally, I think we have questions we can't answer and need someone -- a real person -- or better/more clear regulations to help us navigate this swamp. And personally I don't like the FDA regs, suspect they haven't updated in forever, due to lack of funding and staff.


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## melstan775

Now this is interesting. One of my posts seems to have disappeared. Genny,. I had offered my condolences on your grandfather's passing, and also commented that your story was poignant and made it's point.


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## melstan775

paillo said:


> So anyone got any FDA connections? If not I have colleagues who might be able to find someone who might help us. Admins, is it possible to have something like a live Q&A via teleconference or other, with questions that are clearly laid out ahead of time? Personally, I think we have questions we can't answer and need someone -- a real person -- or better/more clear regulations to help us navigate this swamp. And personally I don't like the FDA regs, suspect they haven't updated in forever, due to lack of funding and staff.



I agree.  Those regs are way out of date.  But lately, when the government updates something, it hurts independent business only.  

For example, the FCC regulation update a couple years ago mandated that bloggers must disclose when they are given a freebie for review.  But news companies did not have to follow the same regulation. This means, Good Morning America does a product review, they don't have to tell you it was given to them for free, nor do they disclose what they get for the kickback when the product's sales go up. 

However, Mommy Blogger who was sent a new diaper bag for review has to tell you, "by the way, I'm reviewing this because I got it for free,"  or "so and so company sent me this to review, and if you click my affiliate link, I will get a little something for that, even though that doesn't affect your purchase price."

 If Mommy Blogger fails to have a disclosure on her site, she will face a fine. Good Morning America can continue to plug away with no disclosures and no penalties, even though the practice of reviewing a product is the same. 

so while I am in favor of updating regulations, I'm only in favor of it if it's not a classist thing.  

For the record, if you make health claims, it just means you have to register your product to the FDA and make sure you have an active ingredient portion on your label, like Clearsil, et al does. I'm not sure, however, what that means in terms of your soaping lab. Since drug companies test on animals a lot, does it mean soapers who make drug claims have to get a cage of white mice? I spose that's really the issue, isn't it, is what regs go with what wording? So complicated. Boo.


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## thefarmerdaughter

I think there is a huge difference between explaining why an ingredient was chosen for use in a product/ giving a description of ingredients VS making claims. The FDA may not agree with me, lol. 
Providing legit info to your customers, that could be found for free.... How can the FDA police that?


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## Genny

thefarmerdaughter said:


> .
> Providing legit info to your customers, that could be found for free.... How can the FDA police that?



By pretending to be a customer or by someone who knows the laws turning you in.  There are people out there that turn in B & B'ers who "provide" info on ingredients.  I've heard them talk about it.

I have turned in one B & B maker to the FDA.  But, it was a product that was given to me by a friend to use on my child.  The product was not preserved and the makers website & labels were drug claim city.  The product was a diaper rash cream that contained oils, eo's, lanolin and aloe.  Had they left the aloe out, it would have been fine.  When I opened it after having it for only 2 weeks, there was mold on the surface.  They also listed this cream as being great for c-section incisions.  Could you imagine if someone used it on a C-section incision and ended up infecting themselves because of it?
Before turning the person in I actually contacted them and let them know what happened.  They immediately blamed me and claimed that I mishandled it in someway.  I turned them in to the FDA.  About a month later, their shop on Etsy was taken down.  I have noticed an eerily similar site on Etsy though that I think may be them, just renamed & such.


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## Genny

paillo said:


> So here's another question. I often pull descriptions of ingredients from my reputable suppliers and summarize. How is it OK for them to describe the benefits of an ingredient and not OK for us? Because of the use, e.g. soapmaking may alter the properties of an ingredient? Could an aromatherapist, using one straight essential oil, get away with a description because there is no chemical reaction? But maybe there would be with different bodies. The more I think about this the more conflicted I get...



I wondered about that once & I asked a supplier.  I seriously wish I would have saved the email.  But it had something to do with the fact that they are suppliers of the ingredients, while we put together the final product.
I have no idea if that's true or not though.


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## Genny

I just wanted to mention quick that it's the sellers that make the claims and such that will hurt all of us B & B'ers in the end.  They're the reason we'll be paying high registration fees and will have prove that we're complying with GMP regulations, it will be very similar to Florida's regulations for making and selling cosmetics.


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## Crocoturtle

Genny said:


> By pretending to be a customer or by someone who knows the laws turning you in.  There are people out there that turn in B & B'ers who "provide" info on ingredients.  I've heard them talk about it.
> 
> I have turned in one B & B maker to the FDA.  But, it was a product that was given to me by a friend to use on my child.  The product was not preserved and the makers website & labels were drug claim city.  The product was a diaper rash cream that contained oils, eo's, lanolin and aloe.  Had they left the aloe out, it would have been fine.



I'm curious what you think about my aromatherapy balms. They are just carrier oils, EOs and beeswax. I tell people what part of the body they are for and tell them that they are aromatherapy. I don't claim that it will cure anything but people ask me to make them all the time. I definitely would never suggest someone use aromatherapy of any kind for a condition that hasn't been seen by a doctor. 
It's a huge thing here that everyone I know is drinking elderberry syrup. The lady who makes it will call her different blends like "skin blend" or "baby blend" and it's supposed to help allergies and boost immune system. But she also has a statement "not intended to treat or diagnose any disease" and gets away with selling it as a food rather than a drug. Where do you draw the line.


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## Genny

Well here's what the FDA says about aromatherapy products:
http://www.fda.gov/cosmetics/productandingredientsafety/productinformation/ucm127054.htm

What are you exactly saying about what & why they should use your balm?

As far as the elderberry syrup, I honestly have no idea how that goes, because I don't know much about the Food part of the FDA.  Although yogurt companies, orange juice companies and milk companies say a lot about the different things that they can help with.  So maybe it's okay?


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## 2lilboots

Reminds you of elixirs of olden days that would cure all that ailed you.


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## Crocoturtle

Genny said:


> Well here's what the FDA says about aromatherapy products:
> http://www.fda.gov/cosmetics/productandingredientsafety/productinformation/ucm127054.htm
> 
> What are you exactly saying about what & why they should use your balm?
> 
> As far as the elderberry syrup, I honestly have no idea how that goes, because I don't know much about the Food part of the FDA.  Although yogurt companies, orange juice companies and milk companies say a lot about the different things that they can help with.  So maybe it's okay?



I guess it's more of an informal thing. I haven't sold any balms in retail or made them ahead of time. The one that most people ask me for is one that has peppermint, rosemary and eucalyptus and people use it for headache. They know I know about EOs and they ask me to make them something. I'm not a health care provider so I can give my friends advice, legally. It's tricky. If I just call it a lotion, I can package it as a cosmetic. Other stuff that people ask me to make like "home made vapo rub" IDK, it's pretty blatant that it's a drug. I think it's best if I keep that as more people paying me for the service of mixing it up rather than selling it as a premade product.


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## thefarmerdaughter

Genny said:


> By pretending to be a customer or by someone who knows the laws turning you in.  There are people out there that turn in B & B'ers who "provide" info on ingredients.  I've heard them talk about it



So if a customer asks, "why did you use cocoa butter?" or "can you tell me about cocoa butter?"  How does one answer that. 

It's like the law doesn't distinguish between someone lying, by making false claims, and an honest B&ber who wants to provide info.


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## Genny

thefarmerdaughter said:


> So if a customer asks, "why did you use cocoa butter?" or "can you tell me about cocoa butter?"  How does one answer that.



If someone asks me why I use cocoa butter in my soap, and as long as I'm labeling my soaps under cosmetic regulations, I would say, "It helps with a nice stable lather, it helps provide a harder bar of soap and it contains conditioning properties."

If I'm not labeling them under cosmetic regulations, I'd leave out the part about conditioning properties.


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## Kansas Farm Girl

A year or so ago I read that there was new legislation in Washington that, if passed, would require much more from us. The only thing I found today on it was an old post (2008) on Soap queen
http://www.soapqueen.com/business/the-law-with-unintended-consequences-2/
"In a nutshell, the FDA Globalization Act of 2008, is designed to impose  stringent monitoring, manufacturing and reporting requirements on all  products under FDA purview. The “Cosmetics” portion of the bill is  actually very small (1/64th of the entire bill) in relation to the “Food” portion. None the less, the implications for small, home based crafters and cosmetic manufacturers, is concerning."

has anyone heard if this was shot down or still on the table? I know it was long after 2008 that I heard about it, and it was still active then. In searching google for FDA Globalization Act the latest entry I can find is from Jun 2009. I know I heard about it after that because I didn't start soaping until later, and when I heard about it I had been for awhile.


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## Genny

Is it this http://personalcaretruth.com/2012/04/hr-4395-cosmetic-safety-amendments-act-of-2012/
If so, then it's still on the table.


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## Kansas Farm Girl

It doesn't mention soap, but you never know how they would interpret the GMP portion and if they make sure they continue the soap exemption.


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## Robert

Crocoturtle said:


> Is there a definitive list of words that are considered health claims or cosmetic claims?


There are some for which the precedent is that they are, and some for which the precedent is that they're not, and everything else is a "maybe".  And by "precedent" I don't even mean anything as solid as a court decision!

I have a friend who makes money advising makers and marketers of dietary supplements on this issue.


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## Robert

Genny said:


> As long as you abide by the cosmetic labeling regulations, which you would have to anyways for body washes.


Unless (in the USA) the body wash is made of soap.


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## Robert

paillo said:


> We really need someone from the FDA here to explain it all.


But the next person from FDA might say something else.  Seriously, this is what keeps them and lawyers in gen'l in business.  If laws were simple enough, courts would be empty.

I'll give an example as to how finely the line can be drawn for shampoo.  Both Prell and Vidal Sassoon (at least) have been advertised as saying they remove dandruff flakes -- which of course they do -- and that's a cosmetic claim.  However, if they claimed to prevent or slow the reappearance of dandruff, that'd be a drug claim.  Removing the flakes from the skin and/or plastering the remaining ones down is deemed not to be affecting the structure of function of the body, but the production of dandruff is deemed to be a physiologic process.  That one's not actually that hard a line to draw biologically; "moisturizing" is a lot more arbitrary classif'n.

But having only cosmetic claims doesn't get you out of the woods in the USA (or vs. state att'ies gen'l).  There's still the FTC, which now says you have to have a good scientific reason for believing the claims you make.  This is becoming an issue for dietary supplements, and no reason to think it couldn't be for cosmetics.  They're no longer taking the existence of data on an isolated ingredient in a product as necessarily enough reason to think the whole product is effective in doing what that ingredient is supposed to make it do.


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## Robert

melstan775 said:


> I agree.  Those regs are way out of date.  But lately, when the government updates something, it hurts independent business only.
> 
> For example, the FCC regulation update a couple years ago mandated that bloggers must disclose when they are given a freebie for review.  But news companies did not have to follow the same regulation. This means, Good Morning America does a product review, they don't have to tell you it was given to them for free, nor do they disclose what they get for the kickback when the product's sales go up.


That's not true.  The reason the new reg didn't apply to them is that the old reg still did.  That's why you see or hear the anmt. at the end, "Promotional consideration provided by...."

Even scientific journals that assess page charges to authors have to include a disclaimer in the fine print explaining that for that reason, the article has to be labeled "Adverisement".


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## christinemm

*Difference between book or co claims & face to face seller*

Hi, I am new here and am reading this old but still interesting and relevant thread.

The issues here are similar to the herb world. Herbalists who make teas, foods, lotions, cremes, salves that have medicinal properties have these laws applied to their practice. 

One herbalist I know was discussing this conundrum. Even when there are studies validating that tea tree oil kills skin fungus she is not supposed to make that claim on her products she sells for that purpose. Clear as mud...

Meanwhile I heard a lecture this spring by an RN who is very interested in herbs and plants for healing and wellness. She explained it in a way that cleared it up for me, for the US government:

a book author can publish a book listing plants, oils or whatever as having been used to cure or help symptom X. These are considered historical discussions, especially when specifically framed "the Native Americans used sasparilla for ___
" and "Colonial settlers in the 1600s used X to cure back pain". Book authors are not giving medical advice they are sharing information to people they do not know or interact with. They are not meeting a person and hearing I have X medical problem what can I cure it with?

The nurse shared with us some medicinal qualities of herbs but kept saying I am not selling you a product or service and this is for your information only, so she was protected and not giving out medical advice. 

When a person knows someone and talks to them and says "I need something to help my acne" if the person answers them "use this soap" they are in the eyes of the US Government, giving out medical advice. Therefore the person is treating a person when they do not hold a medical license. This is because they met them and interacted with them. (The book author sold information in a book not having a "personal relationship" with the consumer.)

By the way the American Medical Association is behind all this. In America pharmacists cannot give medical advice or recommend treatments. My friend just got back from Italy and had a rash. The local friend she was visiting brought her to a pharmacy and she showed her arm to the pharmacist and he said "buy this drug and use it 3x a day" then sold her an OTC medication that in the USA is prescription only.

So if an herbalist or a soapmaker is at a farmer's market and selling a product that makes a health claim it is considered breaking the law, because they are giving out medical advice.

Herbalists who have training and run an herbalist practice can give out medical advice but they have to keep all kinds of records. One herbalist I buy things like tea and hand salve from just sent us a questionnaire that asked some of our medical history just in case anything she uses in her products may harm us in some way. 

The last I knew a few years ago, giving brochures as a separate piece of educational literature was okay. That is why the health food stores still have such brochures written by, printed by, and given to the store free by the vitamin and supplement manufacturers. I see them doing that today, so I question if the law changed and if we really cannot do that. Another example is read the amazon.com supplement product pages, they give a lot of medical claims, on the company websites they usually cite some research. I don't know if they can make the claims due to the research or what. I will say some of it is a stretch though, such as the study said X helped children with attention span then they make a more general claim that it can help everyone with attention span (or whatever).

I am using herbs and herbal infusions in my soaps. I think I am hog tied with telling the real benefits of some of these.

I am thinking about starting a small cottage business via etsy but am not sure I truly have time for it. I'm researching while I make batches of soaps with my own custom made recipes, I'm experimenting.

Thanks for this thread on the forum. This has been informative.


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## Robert

christinemm said:


> When a person knows someone and talks to them and says "I need something to help my acne" if the person answers them "use this soap" they are in the eyes of the US Government, giving out medical advice. Therefore the person is treating a person when they do not hold a medical license. This is because they met them and interacted with them. (The book author sold information in a book not having a "personal relationship" with the consumer.)


It's not the US gov't that's concerned with this, but the state gov't.  Even then, if the person is not getting paid by or soliciting business from the individual, the states don't consider it health practice.  And there are even ways around that in some states--for instance, the acceptance of a free will offering in the course of "faith healing", which was a loophole my friend Ralph found for NJ, where "faith healing" is defined without reference to religion.


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## christinemm

I saw this today, a soap and lotion seller online, look at these claims. I read the FDA page that was linked in another thread about labeling, this: 

http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/ucm126438.htm

and this seems suspect. http://www.essential-soaps.com/Night-Cream.html

But I am a newbie and what do I know? Also when selling on the Internet maybe I am confusing product descriptions on the site versus the label attached to the product? 

Confused, ChristineMM


Sent from my iPad using Soap Making


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## Kansas Farm Girl

If you go to that FDA link and down to this sentence: For additional information, refer to Is It a Cosmetic, a Drug, or Both? (Or Is It Soap)?
you find this:
*How is a product's intended use established?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.
*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." For example, a  fragrance marketed for promoting attractiveness is a cosmetic. But a  fragrance marketed with certain "aromatherapy" claims, such as  assertions that the scent will help the consumer sleep or quit smoking,  meets the definition of a drug because of its intended use. Similarly, a  massage oil that is simply intended to lubricate the skin and impart  fragrance is a cosmetic, but if the product is intended for a  therapeutic use, such as relieving muscle pain, it's a drug.
.........
Soaps are in a different category unless it is being marketed to do something else:


is intended not only for cleansing but also for other cosmetic uses,
it  is regulated as a cosmetic. Examples of cosmetic uses include making  the user more attractive, by acting as a deodorant, imparting fragrance  to the user, *or moisturizing the skin*.
......
This is from the same site
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm

My understanding is that you can make these types of claims IF you follow the Cosmetics rules and not the soap rules. Soap is regulated by the Consumer Product Safety Commission, not the FDA, as long as it meets the FDA definition of soap:
*How FDA defines "soap"*

*Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when
*




the  bulk of the nonvolatile matter in the product consists of an alkali  salt of fatty acids and the product's detergent properties are due to  the alkali-fatty acid compounds, and
the product is labeled, sold, and represented solely as soap [21 CFR 701.20].
...
is intended not only for cleansing but also to cure,  treat, or prevent disease, or to affect the structure or any function  of the human body,
it is regulated as a drug, or possibly  both a drug and a cosmetic. Examples include antibacterial cleansers and  cleansers that are also intended to treat acne.

If a product


is intended solely for cleansing the human body,
has the characteristics consumers generally associate with soap, and
does not consist primarily of alkali salts of fatty acids,
it may be identified in labeling as soap, but it is regulated as a cosmetic.

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.
.....
Long-winded, I know and it can be confusing. I don't sell my soap but I do put labels on it for my friends and just call it soap.


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