Regulatory Moment


Did you know FDA does not approve cosmetic products before they come to market? 

By definition the term, “cosmetic” includes all ingredients used to manufacture a product.  One exception is colorants which fall under 21 CFR Part 74, “Listing of Color Additives Subject to Certification”.  Colorants are designated by the format, “FD&C XXX#” or “D&CXXX#”, where X is the color of the product.  For example, Yellow 42 is batch tested and approved by the FDA, prior to being placed on the market. Any colorant not approved or tested by FDA are considered adulterated (21 USC 361).

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