Cosmetics marketed on a retail basis to consumers must have an ingredient list. But under the law, this list cannot be used to make a company disclose “trade secrets.” What does this mean for cosmetic labeling?
The Legal Background
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
First, be aware that it’s unlikely that FDA will grant your request. We’ve received only a handful of trade secret requests in the last 20 years and have granted such a request only once. But if you decide to proceed, here’s how:
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).
You will need to disclose to FDA the information we need to evaluate the factual and legal grounds justifying trade secrecy for the ingredient in question. There are two key elements to address:
- The extent to which the ingredient is known, both outside and inside your company, and what you have done to protect that information, as well as how easily it could be identified or duplicated.
- The value of the identity of the ingredient to you or to your competitors, if they became aware of it, as well as the effort and expense involved in developing the ingredient.
FDA will not disclose this information while it is under review. If we grant your request for confidentiality, the information you provide will not be subject to release under the Freedom of Information Act. If we deny your request, we will return the information to you without retaining copies.
No fees are required for this type of request.
For details on the process for submitting a “trade secret” request and the type of information to provide, see the regulation, “Confidentiality of statements,” at 21 CFR 720.8.
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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