What is Trade Secret Labeling & How to Achieve it?
A trade secret is defined as “any formula, pattern, device or compilation which is used in one’s business and which gives one an opportunity to obtain an advantage over competitors who do not know or use it.”
Cosmetics that are promoted in retail shops must bear an ingredient list as specified by the FPLA act for fair packaging. However, as determined by law, this list must not be taken to make a company reveal their trade secrets.
The Code of Federal Regulations, in part 701.3 offers us an example: Any ingredients that belong in the fragrance and flavor category are not required to be listed separately on product labels because they may constitute “trade secrets”. Note that if you want to advance to a trade secret label, the FDA enables this status only once.
How to achiev
e a “trade secret” status for your product?
First you have to give the composition and raw ingredient formation declaration to FDA VCTP body with the “FDA2512” form called the Cosmetic Product Ingredient Statement.
You have to submit to the FDA the details required to assess the factual and juridical bases that consist the trade secret status for the ingredient under evaluation. You will need to specify:
- The degree of which your ingredient is acknowledged both within and outside your business and the steps you have performed to secure this information as well as the ease these details could be recognized or copied.
- The ingredients worth to your business or the competition, in case they know it. along with the trial and costs necessary for its development.
You will typically get a response of your status within 180 days, by the FDA.
Contact us here for more information, CosmeReg is your Cosmetic Regulatory Consulting partner.
