Products claim for treatment of conditions

[Iluminada]

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.

 

[navigator9]

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.

 

[lsg]

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

 

[pamielynn]

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.

 

[welsh black]

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.

 

[grayceworks]

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:

• 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.

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

 

[pamielynn]

"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!

 

[Soapsense]

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 :-(

 

[navigator9]

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.

 

[pamielynn]

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.

 

[Iluminada]

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.

 

[Dorymae]

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.

 

[The Efficacious Gentleman]

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.

 

[Cindy2428]

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....."

 

[The Efficacious Gentleman]

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

FDA website says this:



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:


etc etc

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

 

[Dorymae]

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.

 

[AutumnBreezeSoaps]

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.

 

[Susie]

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.

 

[grayceworks]

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:

• Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. .....etc etc
• 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.
  ......etc etc

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
21 CFR 1.3(a)

The FD&C Act defines in sec. 201(m) "labeling" to mean "all labels and other written, printed or graphic matter on or accompanying such article."

This includes labels, inserts, risers, display packs, leaflets, promotional literature or any other written or printed information distributed with a product.

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/

 

[pamielynn]

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