Your Ingredients Aren't GRAS - Maybe They're EAFUS?
As our clients in the food business know, or should know, GRAS is the acronym for Generally Recognized As Safe. When an ingredient has an FDA GRAS affirmation, it can used in a food without any peril that the FDA might find the food to be adulterated or unsafe. More commonly, this is called a “safe harbor.” Some GRAS affirmations allow unrestricted use of an ingredient and others may limit an ingredient’s use to certain foods and/or certain amounts.
An ingredient does not have to be FDA GRAS affirmed to be used in food. It can be self-affirmed, meaning that the company using the ingredient in its product has sufficient evidence to demonstrate that its use of the ingredient is safe.
EAFUS is a list of about 3,000 ingredients maintained by the FDA and stands for Everything Added to Food in the United States. The list can be seen at http://www.cfsan.fda.gov/~dms/eafus.html. When you peruse the list you’ll notice that some of the ingredients have cross-references to the Code of Federal Regulations (“CFR”). These are the ingredients that have one or more FDA GRAS affirmations. The other ingredients do not have a cross-reference to the CFR’s. These ingredients do not have an FDA GRAS affirmation. However, you can still be use them in your food products if you have sufficient evidence to demonstrate that your use of the ingredient does not present a danger to the public health. But, you do this at your own risk. There is no safe harbor to protect you from the FDA or those ever pesky public interest groups and plaintiffs’ lawyers.
A final note on FDA GRAS affirmed ingredients. In some cases, when the FDA imposes a restriction on the use of a GRAS affirmed ingredient, the limitation is an absolute restriction and not merely a safe harbor limitation. If the GRAS affirmation contains an absolute restriction and you violate it, then your food product will be adulterated.