# Products claim for treatment of conditions



## Iluminada (May 9, 2014)

Since we are not technically allowed to make claims on our products (such as dead sea salt treats psoriasis, sunflower for dry skin and etc) does anyone know if there is a company that offers some kind of display showing different properties of different products. I figure I can make some myself and quote the source of the information but seems like it would look better coming from an outside source. I am thinking maybe an company that sells herbs may have this.

To make myself clearer, I am making some products out of Dead Sea Salt. I would like to have a sign by my products describing the benefits without necessarily making claim (since I am not allowed without testing) that my product cures or treats the condition. I would also like to include that information on my website. Maybe a section that describes the different properties of each ingredient.

I so hope i am making sense here.


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## navigator9 (May 9, 2014)

I understand what you're saying, but even though you don't actually make any claims on the label, I would think, that if you have the information that says some ingredient you're using helps with some medical condition on your display, or on your website, it's technically the same thing. Again, I don't know the legalities, just guessing.


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## lsg (May 9, 2014)

I agree, you have to be very careful of any claims made on the label, with handout or brochures.


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## pamielynn (May 9, 2014)

You're not supposed to insinuate that the ingredients in your products do anything, and having a sign that says "Dead Sea Salt does such-n-such" and then having a product with Dead Sea Salt in it, insinuates that your product will have the same "healing" powers. It is technically misleading the consumer.


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## welsh black (May 10, 2014)

What if you had customer comment book that it helped (in their opinion)their skin issue or dry skin ect. Are you allowed to put other peoples reaction to your products?  Just a thought.


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## grayceworks (May 10, 2014)

*FDA website* says this: 



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



Also, *another part of the FDA lists some companies and products that incorrectly attributed drug claims to their cosmetics, and what exactly they needed to fix on their labels.*  

for example *this warning letter shows* that they include consumer testimonials about what conditions it helped qualify as "drug claims" about a product.  It says: 


> Your web site also contains disease claims in the form of personal testimonials about your ******* product, including:



etc etc


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## pamielynn (May 10, 2014)

"Perception"!! That was the word I was looking for in my brain last night. Ugh. I hate getting old. 

If a customer thinks that a lavender soap will help with their insomnia, that's fine. If you agree with them, have a sign that says lavender helps with insomnia, put it on your label, anything at all that will encourage them to believe it - I think you are potentially in troubled waters. Now, of course, we see people doing this all the time. I see products with "before and after" products, or with the FDA warnings - and nothing seems to happen to them. There are soapmakers all over the place making completely outrageous claims about their soaps - I don't care what they do, but I think it makes the rest of us look bad.

And I liken the danger to the IRS - they may never find you. But then again, it's easier for them to penalize a small company who can't afford big, mouthy lawyers. It's just safer to stay away from "claims", IMHO.

grayceworks, thank you for the links!


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## Soapsense (May 10, 2014)

On another note, by naming a soap, "Facial Bar" is that making a claim or is it okay?  Noticed some soaps in our gift shop that say this, some have the ingredients and some don't :-(


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## navigator9 (May 10, 2014)

Soapsense said:


> On another note, by naming a soap, "Facial Bar" is that making a claim or is it okay?  Noticed some soaps in our gift shop that say this, some have the ingredients and some don't :-(



I believe that, although this sounds innocent, it's also a claim of sorts. Making a soap for any specific purpose, other than just to clean, is a claim.


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## pamielynn (May 10, 2014)

No, "facial bar" is not a claim. "acne reducing facial bar" is a claim. You can have "body bar", "facial bar", "butt bar". Maybe your "facial bar" has less cleansing oils than the "butt bar". As long as you're just talking about cleansing properties, I think you're ok. But I could be wrong.


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## Iluminada (May 11, 2014)

*Thank you*

Thank you for all the responses. I knew one person that only sold herbs and he had an herb book that you could look through and you would pick which ones you wanted. But, from what everyone is saying, I guess that may not be okay either. Oh well, it was a try.


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## Dorymae (Jun 24, 2014)

Please someone point out if I am wrong but I believe the rule is you can in a separate brochure or sign state what an ingredient is known for but you may not state that your product is good for.

Example you may say in a brochure or sign:

Lavender    known for calming properties

Citrus oils   known for uplifting qualities

Tea tree    known for antiseptic properties

But you may not say your soap has calming properties or that it has uplifting qualities etc.


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## The Efficacious Gentleman (Jun 24, 2014)

From the links in the Graceworks thread, I think that even this is too far.  As was said, if you sell a soap with lavender EO and the customer thinks "oh, that will help me to get off to sleep at night" then it is their own connection made.  If you in any shape or form in what you do talk about the effects that ingredients in your products could have, other than cleaning stuff, you are in cosmetic territory.


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## Cindy2428 (Jun 24, 2014)

Just my 2 cents, but if you included an empirical statement about the soap only functioning as a cleanser followed by "anecdotal reports suggest lavender....."


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## The Efficacious Gentleman (Jun 24, 2014)

I'll just bring this here, because she wrote it really well.............



grayceworks said:


> *FDA website* says this:
> 
> 
> 
> ...



It's on page 1 of this thread, for the whole post from Graceworks


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## Dorymae (Jun 25, 2014)

I believe what I read had said something to the effect of the traditional benefits of ingredients can not be anywhere on the packaging and further if you made a brochure you could not include it with the purchase.  If however they are kept separately and you make no claim that your product contains the properties because it contains the ingredients then you are safe. (This is for US only I have no idea of EU regulations)

I agree though this is a very iffy and grey area.  I think if I were to even think of doing this I would have an attorney look it over first.

Edit to say I'm going to look and see if I can find this article, it wasn't recent but I'm going to see if I can find it.


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## AutumnBreezeSoaps (Jul 12, 2014)

I'm still wrapping my head around how much there is to learn about soaps before you even begin to think about selling it. Sure glad I found you guys!!!  I had NO clue about this.  Thanks for the great thread   This is helpful to us newbies.


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## Susie (Jul 12, 2014)

OK, I have been looking at articles for a few days now, and I *think* you could get away with the following.  NOTE:  I am not an attorney or anyone specializing in product labeling, but I have driven myself crazy trying to see how this could be done, and this is the best I can come up with.

If you made some sort of pamphlet that was titled something like:  

Herbal Traditions:  American Folk Uses of Herbs  

It very carefully needs to not say that there is any medical evidence whatsoever to the use of the herbs.  Use language such as "salves of jewelweed were often used by the early colonists to relieve the itching of poison ivy or oak"  

This will take quite a bit of research on your part, as you still need it to be as accurate as possible to avoid other problems.  Have it somewhere on your table, available, but NOT handed out to any customer.


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## grayceworks (Jul 12, 2014)

Dorymae said:


> I believe what I read had said something to the effect of the traditional benefits of ingredients can not be anywhere on the packaging and further if you made a brochure you could not include it with the purchase.  If however they are kept separately and you make no claim that your product contains the properties because it contains the ingredients then you are safe.




*FDA website* says this: 



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




*MORE EXAMPLES:*

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm310937.htm

This company had articles on their website talking about what herbal ingredients like aloe are known for. The FDA says that this is a bad thing because it becomes associated with their products containing aloe, and therefore becomes a drug claim. Their website also tries the approach of saying "this ingredient has been traditionally known for...." and FDA says this also is a no-no.

On their step-by-step labelling guide, it mentions this:
http://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126444.htm




> *Labeling*
> All labels and other written, printed or graphic material on or accompanying a product in interstate commerce or held for sale
> 
> Sec. 201(m), FD&C Act
> ...



MORE LABEL STUFF:
I also found this little FAQ for home businesses, which addresses some labelling stuff. Including what to list for specific ingrediemts. Also, on the topic of labelling, Says no PO Boxes yet, but says you can use a main place of business instead of a manufacturing address, which could be helpful... 
http://www.fda.gov/Cosmetics/ResourcesForYou/Industry/ucm388736.htm#11

The above article is one recent update on the FDA website.

More updates, and some discussion are listed all in one place on Marie Gale's site for easy reference:
http://blog.mariegale.com/fda-cosmetic-website-updated/

And something else interesting I found on Marie Gale's site, mentions that you cannot use an ingredient as part of the name on the label if there is more than one ingredient in a product. So one cannot say Oatmeal Soap as tje name of the product. But they could say MyName Soap and then separately say -with Oatmeal.  Hmm. That messes with the naming ideas for some of MY soaps! Sigh
http://blog.mariegale.com/using-ingredient-name-in-product-name/


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## pamielynn (Jul 12, 2014)

Ok, but on Marie Gale's label examples, it says the lotion is "deeply moisturizing". Doesn't that make it a "drug" since the inference is that the lotion will penetrate the epidermis and change the structure of the skin from "dry" to "moisturized"?? Or can you moisturize without affecting the skin structure? Stupid FDA and FTC - making our lives miserable, ha ha.

So we're saying that a "Honey & Oatmeal" soap is wrongly labeled? Is the perception that the bar contains ONLY honey and oatmeal that somehow magically mushed together and became a bar of soap?

Seriously, this is why I drink


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## grayceworks (Jul 12, 2014)

Also, the FDA isn't even allowing citing of established research or studies to support claims elsewhere in one's literature or websites. They're even examining what people say about their stuff in other places besides their direct advertising and labelling, such as blogs, facebook posts, invoices etc.

Because those claims would be supporting its use as a drug, not a cosmetic. It's not that the claims are wrong, it's that it makes it no longer a cosmetic, but a drug. 
http://blog.mariegale.com/fda-cracking-down-on-cosmetic-product-claims/

You'd have to jump thru the hoops to get it approved as a drug unless it's already established as one of their 'monograph' drugs like some sunscreens or acne products, which would be labelled as drugs, not cosmetics.



And more on product claims

http://blog.mariegale.com/more-on-product-claims/


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## grayceworks (Jul 12, 2014)

pamielynn said:


> Ok, but on Marie Gale's label examples, it says the lotion is "deeply moisturizing". Doesn't that make it a "drug" since the inference is that the lotion will penetrate the epidermis and change the structure of the skin from "dry" to "moisturized"?? Or can you moisturize without affecting the skin structure? Stupid FDA and FTC - making our lives miserable, ha ha.
> 
> So we're saying that a "Honey & Oatmeal" soap is wrongly labeled? Is the perception that the bar contains ONLY honey and oatmeal that somehow magically mushed together and became a bar of soap?
> 
> Seriously, this is why I drink



Yeah, that's the perception according to them. For the reasons stated in her example about the 'shea butter' her friend got in a pump bottle lol.

From what I read on her site, moisturizing is cosmetic. It's adding moisture, changing external physical properties but not changing how the skin functions physiologically, ie, it's not making the skin make more moisture. Also, one can say soothing, but not healing, for example.


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