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Problems With FDA Food Additive Approval Process

By Jim Chen at al.

When I first began teaching food law, I was rather astonished to discover the process that the FDA has for approving the overwhelming number of food additives used in our processed foods. Let me rephrase that - I was astonished by the lack of a cohesive approval process. I wrote about FDA's non-approval system in my article, Reconnecting Consumers and Producers.

The Food Drug & Cosmetic Act requires pre-market approval for new food additives and states that no additive should be approved without a showing that its specified use will be safe. 21 U.S.C. sec. 348.

However, two huge categories of ingredients are excepted from the definition of "food additive." These exceptions are "prior approved substances," i.e., substances in common use prior to 1958 and ingredients that are "generally regarded as safe" or GRAS. Food companies initially had to submit scientific information to the FDA and wait for the agency to affirm GRAS status. Since 1997, however, the FDA has operated under a proposed rule that allows companies to self-determine that a new ingredient is safe and then to voluntarily notify FDA of its use. FDA can either affirm the GRAS status (a process that may take years) or simply not question it. 62 Fed. Reg. 18,938 (proposed Apr. 17, 1997) (to be codified at 21 C.F.R. pts. 170, 184, 186, and 570).

The GAO shares my concern with the workings of the GRAS process. In a recently released report, Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) it finds:

FDA?s oversight process does not help ensure the safety of all new GRAS determinations. FDA only reviews those GRAS determinations that companies submit to the agency?s voluntary notification program?the agency generally does not have information about other GRAS determinations companies have made because companies are not required to inform FDA of them. Furthermore, FDA has not taken certain steps that could help ensure the safety of GRAS determinations, particularly those about which the agency has not been notified. FDA has not issued guidance to companies on how to document their GRAS determinations or monitored companies to ensure that they have conducted GRAS determinations appropriately. Lastly, FDA has yet to issue a final regulation for its 1997 proposed rule that sets forth the framework and criteria for the voluntary notification program, potentially detracting from the program?s credibility.

Full post as published by Agricultural Law on March 07, 2010 (boomark / email).