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Shampoo Surfactants
I’ve formulated a shampoo bar with sodium cocoyl isethionate as the only surfactant which I’m extremely happy with. I’d like to sell it in the future but am concerned that the sodium cocoyl isethionate is at a concentration of 70% in the bar and it has only been approved for safe use of up to a 50% concentration by the CIR. The reason they’ve only approved it in concentrations of up to 50% is because that’s the highest concentration that they tested. My question is, if I sell a bar that uses it at 70%, what happens exactly? Will they arrest me, break down my door, raid my shampoo bar supply, etc? I’m not exactly sure how the CIR works. I’m quite sure the bars are safe.
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2 Replies
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You have to be able to prove that your product is safe. If the CIR has shown that an ingredient is safe up to a certain percentage, you’ll be able to use that as evidence that your product should be safe. But if you use a higher level, then you’ll have to conduct product toxicology testing or you have to include the following warning on the label “Warning - The safety of this product has not been determined.”
What happens depends on how lucky you are. If you stay under the FDA radar then nothing will happen. More likely you’ll get a letter and a fine. You could also have your product confiscated and impounded. If you’re serious about building a legitimate brand / business, it’s not a good strategy.
Being “quite sure” that the bars are safe is not adequate proof that they are safe. You’ll need actual toxicology studies.
Perhaps worse than you getting in trouble with the FDA, one of your consumers might buy the product and have a reaction. This reaction might be to your product or maybe not, maybe they just say it’s your product. Then you’ll have to produce your product safety testing proof. Without this you won’t be able to prove that your products are safe and will likely lose in court. Your business and perhaps your own self could be bankrupted.
This doesn’t seem like a good idea to me.
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Thank you very much for that information. Would you happen to know how much toxicology tests usually cost? If I include “Warning - the safety of this product has not been determined,” is it possible to avoid liability in the scenario you presented?
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