No, GRAS Isn’t Just About Vinegar

It gets repeated as an article of faith: The generally recognized as safe (GRAS) exception to the definition of “food additive” in section 201(s) of the FD&C Act was intended to encompass only common food ingredients such as vinegar and salt.

Not so fast. Just a few months after passage of the 1958 Food Additives Amendment, FDA published a proposed rule [that included the following text:

121.100 Substances that are generally recognized as safe. It is impractical to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as safe for their intended use. In addition, the following lists include some substances that, when used for the purposes indicated, in accordance with good food manufacturing practice, are regarded by the Commissioner as generally recognized as safe for such uses.

The proposed rule went on to list over 200(!) substances categorized by uses that included buffers, neutralizing agents, preservatives, sequestrants, antimycotics, antioxidants, sweeteners, nutrients, stabilizers, and emulsifying agents. The nature of those substances and the range of their uses may come as a surprise to those who’ve only been exposed to the party line.

It seems doubtful that Congress would have been completely unaware of the uses of such substances in food at the time the ’58 amendment was being debated. Further – and as was noted by our friend Stuart Pape at FDLI’s recent Food and Dietary Supplement Safety and Regulation Conference – it makes little sense that Congress would have provided the option of demonstrating GRAS status through scientific procedures if the GRAS exception was intended to encompass only to common food ingredients. In that instance, the option of demonstrating GRAS based on common use in food prior to ’58 would have sufficed.

By all means, let’s have a robust debate over the future of GRAS. Let’s see if we can do it without resorting to distortions of the historical record.