USFDA CFSAN Cosmetics New Update on "Trade Secret" Ingredient

FDA requires cosmetics to have an “ingredient declaration,” a list of all the product’s ingredients. FDA requires this labeling under the Fair Packaging and Labeling Act (FPLA). This law is intended to make sure consumers have information they can use to compare the value of different products and make informed choices.

But according to the FPLA, regulations for this list of ingredients must not be used to force a company to disclose “trade secrets” (FPLA, section 1454(c)(3)).

For example, fragrance and flavor ingredients do not need to be listed individually on cosmetic labels, because they are the ingredients most likely to be “trade secrets.” Instead, they may be listed simply as “fragrance” or “flavor” (Title 21, Code of Federal Regulations (CFR), Part 701.3(a)).

To request “trade secret” status for any other ingredient, a cosmetic company needs to follow a process detailed in the cosmetic regulations.

How to Request Trade Secret Status for a Cosmetic Ingredient?

You will need to start by submitting your cosmetic formulation or raw material composition statement to FDA’s Voluntary Cosmetic Registration Program (VCRP) using Form FDA 2512 (Cosmetic Product Ingredient Statement). No fees are required for this type of request.

How Long It Takes for FDA to Review “Trade Secret” Requests

Review time varies. You will receive at least an interim response within 180 days, but not necessarily a final decision at that time. For the one request granted in the last twenty years, our complete review process took about one year.

What About Patenting an Ingredient?

You can choose either to request trade secret status for a cosmetic ingredient from FDA or to apply for a patent from the U.S. Patent and Trademark Office (USPTO). You cannot have both. To learn more, see the USPTO’s information under “Patents.”

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