Warning on "cosmetic" soap lables question...

[Gryfonmoon]

If you read the regs, they will detail them better than I can here, but one such warning found in the regs is:


§ 740.10 Warning: "If the cosmetic product contains an ingredient for which adequate substantiation of safety has not been obtained a warning must be placed on the PDP like "Warning —The safety of this product has not been determined".

Okay, so if I'm understanding this properly, it's a particular ingredient or ingredient(s) IN my product I would need to warn about, not the product as a whole (meaning my hypothetical rectumless lip balm doesn't need to be officially tested)?

Also, thanks for the link Here's hoping my brain can comprehend the legalese.

 

[Kersten]

Well, not exactly, that was just an example. It's best to read the manual, which isn't really as cumbersome a read as I thought it would be. This is what the *summary* on warning section states (more details are given within the manual):

Label Warnings
Cosmetics which may be hazardous to consumers when misused must bear appropriate label warnings and adequate directions for safe use. The statements must be prominent and conspicuous. Some cosmetics must bear label warnings or cautions prescribed by regulation (21 CFR 740). Cosmetics in self-pressurized containers (aerosol products), feminine deodorant sprays, and children's bubble bath products are examples of products requiring such statements.

"Although the FD&C Act does not require that cosmetic manufacturers or marketers test their products for safety, the FDA strongly urges cosmetic manufacturers to conduct whatever toxicological or other tests are appropriate to substantiate the safety of their cosmetics. If the safety of a cosmetic is not adequately substantiated, the product may be considered misbranded and may be subject to regulatory action unless the label bears the following statement: Warning--The safety of this product has not been determined. Sec. 21 CFR 740.10."

 

[Kersten]

Btw, you crack me up!!! I think you would be safe not testing the rectum lip balm for safety, as long as you included the warning bwahahahaa

 

[melstan775]

Okay, so if I'm understanding this properly, it's a particular ingredient or ingredient(s) IN my product I would need to warn about, not the product as a whole (meaning my hypothetical rectumless lip balm doesn't need to be officially tested)?

Also, thanks for the link Here's hoping my brain can comprehend the legalese.

But some people put sodium hydroxide on their labels. Technically, it's correct, but lye within itself is dangerous. So doesn't taking the route of labeling soap as made with "water, sodium hydroxide, (insert favorite) oil, and glycerin," technically violate the added warning requirement?

And for that matter, if you put "lavender soap calms and refreshes," is that a cosmetic claim or a drug one? I would think drug since the claim is physical not just cosmetic. So you have to have an active ingredient panel too. This is so confusing!

 

[Kersten]

Here is another section of interest within the manual:

A cosmetic is considered misbranded if its safety has not adequately been substantiated, and it does not bear the following conspicuous statement on the PDP:

Warning - The safety of this product has not been determined.

The safety of a cosmetic may be considered adequately substantiated if experts qualified by scientific training and experience can reasonably conclude from the available toxicological and other test data, chemical composition, and other pertinent information that the product is not injurious to consumers under conditions of customary use and reasonably foreseeable conditions of misuse.

The safety of a cosmetic can adequately be substantiated by:

a. Reliance on available toxicological test data on its ingredients and on similar products, and

b. Performance of additional toxicological and other testing appropriate in the light of the existing data.

Even if the safety of each ingredient has been substantiated, there usually still is at least some toxicological testing needed with the formulated product to assure adequate safety substantiation.

 

[RocknRoll]

I've decided Im just going to go with labeling my soap as a cosmetic. Im going to include a back label which will have the ingredient list, a short little statement about the soap with contact info and warnings. That will free up more space on the front too without having to cram everything onto one side. If dove can get away with all their "claims" then i think it will be ok for me to make such claims as "moisturizing" and the like. As long as I follow all the guidlines I will be in compliance. In the end it comes down to really wanting to highlite the benefits of the ingredients i've added. I pay good money to add things like cocoa butter, shea butter and goats milk and I want people to know they add benefits. thats just me, please correct me if I'm wrong. i guess it's a risk I'm wiling to take as long as I feel all bases have been covered. Thank you for all the advice!

 

[RocknRoll]

But some people put sodium hydroxide on their labels. Technically, it's correct, but lye within itself is dangerous. So doesn't taking the route of labeling soap as made with "water, sodium hydroxide, (insert favorite) oil, and glycerin," technically violate the added warning requirement?

And for that matter, if you put "lavender soap calms and refreshes," is that a cosmetic claim or a drug one? I would think drug since the claim is physical not just cosmetic. So you have to have an active ingredient panel too. This is so confusing!

Right!? *rolls:crazy: eyes*

 

[RocknRoll]

Here is another section of interest within the manual:

A cosmetic is considered misbranded if its safety has not adequately been substantiated, and it does not bear the following conspicuous statement on the PDP:

Warning - The safety of this product has not been determined.

The safety of a cosmetic may be considered adequately substantiated if experts qualified by scientific training and experience can reasonably conclude from the available toxicological and other test data, chemical composition, and other pertinent information that the product is not injurious to consumers under conditions of customary use and reasonably foreseeable conditions of misuse.

The safety of a cosmetic can adequately be substantiated by:

a. Reliance on available toxicological test data on its ingredients and on similar products, and

b. Performance of additional toxicological and other testing appropriate in the light of the existing data.

Even if the safety of each ingredient has been substantiated, there usually still is at least some toxicological testing needed with the formulated product to assure adequate safety substantiation.

Wow, ya, i really wish they would provide us with example labels for cosmetic soaps.

 

[paillo]

Not to belabor my earlier point, but how often would you sell soap if you can't accompany it with a placard or website description (maybe much longer and more explanatory)?

I always put longer descriptions of the skin benefits of my soap (e.g. moisturizing ingredient, exfoliating ingredient, detox ingredient and history, uses) on my website, along with warnings for pregnant women, children, those with allergies. For markets and shops I have a shorter but still descriptive placard in front of the rows of soap. A brochure would be a great idea too. This allows people to read more and ask questions, and eliminates the sticky issue of cosmetic vs. soap labeling.

Sigh... in light of Genny's post on health claims, this may be not be the way to go either -- or still possible with very careful wording.

 

[Soapsense]

Maybe you could use "The safety of this product has been determined by my own toungue" lol
If I am interpretting correctly, the above post on testing says that if your ingredients are tested by your supplier that counts?