Labeling

[jessiecms]

Hi! My partner and I have a book on labeling bath & body and it says you can't use phrases like "skin pampering," "moisturizing," or "good for acne." I've seen many people on etsy post phrases like that, but then have a FDA disclaimer. We are so confused. How do we sell soap if we can't describe what it does?

 

[The Efficacious Gentleman]

According the FDA, soap only cleans. Anything more than that and it is a cosmetic and then different rules apply.

 

[lionprincess00]

You can't use acne, eczema, and other medical claims without potential fda problems. those sellers are playing with fire. One call to the fda and they could be investigated and eventually shut down. Unless you have tested, submittied, and been approved by the fda for selling a drug, you can't sell with these claims.

Now. You CAN use cosmetic claims like moisturizing and such, and it's labels need to be inci names in proper order and is regulated by the fda. It's considered a cosmetic and you needs proper cosmetic labeling.

If you claim nothing other than SOAP on the front, then it's just soap and doesn't need specialized labeling. it's no longer regulated by the fda, but is in fact regulated by the consumer product safety commission (cpsc). I will try to post links in a second.

Fda cosmetic drug and soap definition.
http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm

Labeling cosmetics per fda standards.
Good info in case you are making lotions.
http://www.fda.gov/Cosmetics/Labeling/default.htm

Finally, some cosmetic claim examples.
Cosmetic claims can include the ability of the soap or detergent to cleanse, beautify, promote attractiveness or alter appearance.

And from what I gather, soap needs no ingredients list per the cpsc. Most write plain terms like coconut oil etc, though many write the plain term and parentheses in the inci name. So your best bet, label the fda cosmetic way (and you can make cosmetic claims), but no drug claims at all.

 

[new12soap]

As I understand it, and if you read down to the examples of ingredients labeling in that link that lionprincess posted, you do not in fact list the ingredients using INCI names. You must list them with their commonly accepted names.

 

[DeeAnna]

I agree with New12soap about the FDA requiring common names, not INCI, for a cosmetic ingredients list in the US. That is different than Canada and elsewhere. See: http://blog.mariegale.com/botanical-names-ingredient-declarations/

Other than that, LionPrincess did a lovely job of summarizing the requirements. Well done!!!

 

[Dorymae]

One thing. You can label your products as an over the counter drug if you follow the form the FDA has already approved. (forgot what it is called...mono something I think) This does not require you to do expensive testing and what not. Only NEW drugs are treated in that way. For an over the counter already tested type you simply register with the FDA and must follow best manufacturing practices.

It is more involved than cosmetics and I know most people don't want to even think about it but it can be done successfully and legally.

 

[girlishcharm2004]

One thing. You can label your products as an over the counter drug if you follow the form the FDA has already approved. (forgot what it is called...mono something I think)

Monographs?

 

[pamielynn]

One thing. You can label your products as an over the counter drug if you follow the form the FDA has already approved. (forgot what it is called...mono something I think) This does not require you to do expensive testing and what not. Only NEW drugs are treated in that way. For an over the counter already tested type you simply register with the FDA and must follow best manufacturing practices.

It is more involved than cosmetics and I know most people don't want to even think about it but it can be done successfully and legally.

But how would one determine their dosage levels for things like lotion or balms, if you're going for OTC labeling?

 

[Dorymae]

Monographs?

Yes thank you -

But how would one determine their dosage levels for things like lotion or balms, if you're going for OTC labeling?

The safe levels are already established as percentages, and some things do not require a safe level at all. This only applies to active ingredients which need to be listed separately from the inactive. For lip balms the safe level is "apply as needed" for example. Take a look at some of the monographs that are established and you'll get the idea.

 

[lsg]

I believe that you can list your ingredients using INCI names, if the common name follows in parentheses. I always list my ingredients this way.

 

[DeeAnna]

In the US, it's the other way around per the FDA. The common name should be the primary name. Include the INCI name as the secondary, if you wish to include it.

"...common names are required, and when used as a secondary listing, Latin names are accepted. Although the “INCI name” (which usually means the Latin name) is commonly thought to be required, it isn’t – it’s optional....

"...For botanicals, the name should be either as identified in the CTFA Cosmetic Ingredient Dictionary, Second Ed (1977) – which listed botanicals by their common English name – or if not listed there, the name generally recognized by consumers. Either way, the correct wording is the common name, which complies with the FPLA [Fair Packaging and Labeling Act] requirements...."

Source: http://blog.mariegale.com/botanical-names-ingredient-declarations/
Additional information from FDA: [ame]https://www.youtube.com/watch?v=akPq1tsbze0[/ame]

 

[cmzaha]

You can't use acne, eczema, and other medical claims without potential fda problems. those sellers are playing with fire. One call to the fda and they could be investigated and eventually shut down. Unless you have tested, submittied, and been approved by the fda for selling a drug, you can't sell with these claims.
Just a small note here. A call to FDA will really get no action unless you are fortunate to get a really agressive person on the other line, and I was never able to get one. But I can tell you they can find you if you sell a lot online line and do a lot of offers such as Groupon, etc. Yep they found us and yes we did pass, apparently, since we never heard back from them. We actually shipped an order to their address, no they did identify themselves. We checked the address

 

[Lindy]

In Canada you use true INCI, EU trivial and Botanical names only. You are not allowed to put the common name in parenthesis after the product name.

 

[coffeetime]

Lindy, our regs give me a headache. Last night I went online to look up what would be involved in selling a salve I'm making for my family. Oyivay! I would have to submit the equivalent of a thesis to have it considered under the traditional remedies category. I understand why they do this, but the process to get approval is a nightmare. I don't think I'll do it.

 

[lsg]

In the US, it's the other way around per the FDA. The common name should be the primary name. Include the INCI name as the secondary, if you wish to include it.

"...common names are required, and when used as a secondary listing, Latin names are accepted. Although the “INCI name” (which usually means the Latin name) is commonly thought to be required, it isn’t – it’s optional....

"...For botanicals, the name should be either as identified in the CTFA Cosmetic Ingredient Dictionary, Second Ed (1977) – which listed botanicals by their common English name – or if not listed there, the name generally recognized by consumers. Either way, the correct wording is the common name, which complies with the FPLA [Fair Packaging and Labeling Act] requirements...."

Source: http://blog.mariegale.com/botanical-names-ingredient-declarations/
Additional information from FDA: https://www.youtube.com/watch?v=akPq1tsbze0

Yes, you are right. Apparently that has changed since I last read Marie Gale's book on labeling. I checked her website and that is one of the things she has updated in her book.

http://www.mariegale.com/soap-and-cosmetic-labeling/soap-and-cosmetic-labeling-book-updates.html

 

[Lindy]

Lindy, our regs give me a headache. Last night I went online to look up what would be involved in selling a salve I'm making for my family. Oyivay! I would have to submit the equivalent of a thesis to have it considered under the traditional remedies category. I understand why they do this, but the process to get approval is a nightmare. I don't think I'll do it.

Canada is really strict about anything medicinal. I made a Bug Off for dogs made strictly with essential oils and they declared I had to take it through poison control. :roll:

 

[DeeAnna]

Ugh, lsg -- isn't that frustrating??? I wish the rules stayed more consistent!

 

[new12soap]

In Canada you use true INCI, EU trivial and Botanical names only. You are not allowed to put the common name in parenthesis after the product name.

Wait, you cannot use common names on your products at all??? So let's say I saw Caprylic/Capric Triglyceride on your label, if I didn't happen to know that is fractionated coconut oil, there is nothing on your label to tell me what it is? That seems, well, kind of anti-consumer to me, making it harder for the average customer to know what they are buying. :?

 

[DeeAnna]

I agree with you, New12Soap. INCI terminology is correct in the sense that it uniquely identifies a particular ingredient, but I doubt the average person with a decent education in any country will be able to translate many INCI names into common language. There is no way I'm going to remember that Citrus aurantiifolia is Lime when reading an ingredients list in the aisle of Walmart.

On the other hand, using common names can cause confusion too, since some totally unrelated botanicals share similar names. The bay in bay rum fragrance is Pimenta racemosa, the West Indian bay, not Laurus nobilis, the classic culinary bay laurel.

 

[Lindy]

In Canada you can't however in some of them the common name is used such as Cocos Nucifera (Coconut) Oil or with an essential oil the proper way of listing them is Citrus Aurantifolia (Lime) Oil so there is less confusion that you think.