No pre-market approval is required for cosmetic retinol serums (retinol, retinyl palmitate, retinal) in the US. However, under MoCRA, your contract manufacturer must register their facility with the FDA, you need a responsible person on file, and safety substantiation records must be maintained. Avoid drug claims in your marketing copy. Tretinoin (retinoic acid) is an Rx drug and cannot be sold OTC.
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