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Keeping your recipe a secret
By Saper Law | March 9, 2008
Saper Law counsels many clients in the food and beverage industry as they bring their products to market. One of the main challenges faced by these businesses is the need to comply with Food and Drug Administration rules of disclosure without revealing secret recipes. The following article provides answers to many frequently asked questions.
Do I have to disclose the ingredients and processes of my recipe to the F.D.A? Yes, you must fully comply with all F.D.A requirements.
The F.D.A. needs to know the ingredients and processes of your recipe. Depending on your particular circumstances, the F.D.A. may also require you to register your food production and food storage facilities as well. The above listing of requirements is not an exhaustive listing.
Why does the F.D.A. need to know all of my information?
As a matter of public policy, the food supply needs to be well-regulated for the safety of United States citizens. The food needs to be non-hazardous to human health and prepared in hygienic conditions. Also, the F.D.A. may need to counter potential terrorist threats to the food supply. For instance, if federal agents become aware of a potential threat to a certain food item, federal agents need to be informed of the facilities that produce and store that food item.
Lastly, you should always be willing to reveal the ingredients of your recipe because your potential customers may be allergic to certain foods. You can avoid a great deal of potential harm by adhering to good business practices.
If the F.D.A. gets all of my information, how is my recipe protected?
The F.D.A. is very experienced in protecting recipes. All of the well-known American brands from Campbell’s to Coca-Cola have disclosed their ingredients and processes to the F.D.A. Furthermore, the ingredients of their recipes are listed for customer review in accordance with F.D.A. labeling requirements.Though your ingredients must be revealed to the customer in accordance with labeling requirements, you do not have to reveal the specific amounts of each ingredient. Furthermore, if a third party asks the F.D.A. to disclose the processes of your recipe, the third party will receive a redacted (edited) version of your file. The relevant portions of your processes will be blacked-out, and the third party will not be able to discover the processes of your recipe. Referring to the Code of Federal Regulations, 21 C.F.R. 20 states:
“If a record contains both disclosable and nondisclosable information, the nondisclosable information will be deleted and the remaining record will be disclosed unless the two are so inextricably intertwined that it is not feasible to separate them or release of the disclosable information would compromise or impinge upon the nondisclosable portion of the record.”
I have seen that the F.D.A. has specific trade secret provisions. What are those provisions used for?Indeed, the F.D.A. has specific trade secret provisions. Referring to the Code of Federal Regulations, 21 C.F.R. 20 states:”(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process . . .(c) Data and information submitted or divulged to the Food and Drug Administration which fall within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure.”
The majority of food recipes are not protected using these specific trade secret provisions. The F.D.A. uses these specific trade secret provisions for more complex compositions (such as pharmaceutical products). The specific trade secret provisions may also be used when there are complicated patent issues within the production process. Therefore, unless your recipe uses complicated, bio-engineered ingredients, you probably will not be using the specific trade secret provisions.
I have more questions. Where do I go for more information?This article is meant to provide a general overview how the F.D.A. deals with secret recipes and trade secrets. To address your specific circumstances, you should seek further information and consultation. The F.D.A. has compiled information on its website: http://www.fda.gov. Also, feel free to contact Saper Law. Our skilled professionals will effectively and efficiently help you through any matters which arise.
Topics: Small Business, Trade Secrets |
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