r determine that an ingredient is generally recognized as safe (GRAS) and maintain trade secrets information on that ingredient?The answer to this question may be more perplexing than Congress originally intended when it created the GRAS exemption to food additives in 1958. At that time, food ingredients were more simple and processing less obscure. But, today, many food manufacturers rely upon expensive technology and science to formulate their products.
And, as food has become more complicated, the balance between trade secrets and public disclosure has become more complicated. On one hand, manufacturers must maintain trade secrets to protect their investments. On the other hand, consumers want to know what ingredients are in food products, as well as how those ingredients are made.
Now, as groups such as the Center for Food Safety and the Natural Resources Defense Council turn the spotlight on the GRAS process, the balance between trade secrets and public disclosure for food ingredients may become increasingly relevant.
Public Availability is Key to GRAS Determinations
Not all food ingredients make it to market the same way. Most notably, the U.S. Food and Drug Administration (FDA) must review and approve food additives. In contrast, FDA does not have to review or approve GRAS substances, although FDA does have a voluntary GRAS notification process.
So, before a manufacturer adds an ingredient to its product, it first determines whether the substance is GRAS — in other words, it makes a “GRAS determination.” And the key difference between food additives and GRAS ingredients is the availability of safety information; their safety standards are the same.
“Ingredients added to food must be safe for use in food,” explained a FDA spokeswoman to Food Safety News. “The difference lies in the availability of the safety information; for the use of an ingredient to be GRAS, the safety information must be publicly available and there must be consensus among food safety experts.”
Thus, publicly available safety information is key to GRAS determinations.
Trade Secrets Limit Voluntary GRAS Notifications
Although public availability is key to GRAS determinations, some manufacturers maintain trade secrets on GRAS ingredients.
For instance, Robert McQuate, CEO of GRAS Associates, LLC, a food ingredient-consulting firm, says that about half of his clients do not voluntarily submit their GRAS determinations to FDA for review. GRAS information submitted to FDA becomes publicly available, he explains, so the main reason his clients do not submit GRAS determinations is to protect their trade secrets.
“Confidentially is a significant issue, especially for smaller or medium-sized companies that are particularly sensitive to competition,” McQuate adds.
What are Appropriate Trade Secrets for GRAS Ingredients?
GRAS determinations are premised on public availability, yet some manufacturers still have trade secrets for certain GRAS ingredients. This somewhat paradoxical outcome may be attributed to the nature of the trade secret — that is, whether a trade secret is appropriate for a GRAS ingredient may depend upon whether the trade secret relates to the process of creating the ingredient or the actual ingredient itself.
“The process is not what goes into the food. What matters is what becomes a component of the food. How you get there, that in itself is not something that is subject to the GRAS review,” says Mark Itzkoff, an attorney at Olsson Frank and Weeda who represents food manufacturers and other food interests.
But another explanation for trade secrets on GRAS substances may be that some manufacturers are adding ingredients as GRAS instead of as food additives.
“Food additive petition allows you to submit confidential information and to be able to keep it confidential,” explained Tom Neltner, who researches and publishes studies on the GRAS process with the Natural Resources Defense Council. “If people don’t know what it really is, it can’t be generally recognized.”
FDA’s Clarification
In an email exchange, a FDA spokeswoman clarified that a manufacturer may be able to make a GRAS determination and maintain non-critical trade secrets information for that substance:
“If the company’s trade secret information is critical to its GRAS determination, then the use of the ingredient is not eligible to be GRAS. . . . If the company’s trade secret information is not critical to its GRAS determination, then the use of the substance may be considered eligible for GRAS,” the FDA spokeswoman explained (italics and bold are her own).
Additionally, she clarified that if trade secret information is critical, then the manufacturer has the option to submit the substance for review as a food additive, which has trade secrets protections:
“Trade secret, confidential commercial or financial information submitted as part of a food additive petition is not available for public disclosure.”
