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Products not scientifically test must be label as such?


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I posted another question concerning label requirements for very small containers. When I was reading the information at


I came across the following.

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,


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.

Cosmetics With Unsubstaintiated Safety

Warning - The Safety of This Product Has Not Been Determined

21 CFR 740.10

Am I understanding this correctly, if our products have not been evaluated and toxicological testing completed on the formulated product we are suppose to have the warning label written above? I had assumed that the products were safe if each individual ingredient had been proven safe. I wasn't aware that the finished product had to be submitted for testing. I purchase B&B products(lotions, bath bombs) from craft fairs and farmer's markets made by individuals and I have never seen this on any label. Am I interpreting the above correctly?

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With the exception of soap everything that I make including lip balm has this warning on the label in red:

Warning the safety of this product has not been determined.

Friends and family are loving this product.

Those are the colors I use and I use the same size font for both statements. I am not a big time seller, but I want to be as correct as possible with my labeling.

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I think it is great that you are including the warning on your label. I haven't sold any of my B&B it has strickly been for my use. I am still surprised at how many items I have purchased from individuals and have never once seen this on any label.

Do you think having this warning on your products would hurt sales? To be honest, if I would have seen that on some of the items I have purchased I probably wouldn't have purchased them. JMO

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