In a new rule, RIN: 0910-AJ02, steps are purportedly being taken to amend GRAS regulations. I at present, what these new modifications will be have not been announced. All that has been announced at present is that there will be changes to these regulations, foods already recognized by GRAS will be exempt from these changes, and the FDA can reply with a “No Questions” letter. Depending on the changes enacted, this could be big news.

In addition to substances actually recognized as food, the new rules could affect food packaging as well or any other added substances. At this stage though, there is too little information to make any solid determinations about what will happen. Before anything is enacted, there will be a time period where the new guidelines will be released and the public can comment on the proposed guidelines.

For those who don’t know, GRAS is an acronym standing for Generally Recognized as Safe. There have been many iterations of the GRAS designation over the years. However, when most people are talking about the designation, they are talking about the 1997 iteration.

Previous iterations still placed most work on the FDA, and it was an intense process. Reviews could take 72 months (6 years). In addition to being time inefficient, such a process is resource intense. In order to alleviate this strain, a 1997 addition allowed for companies, under certain circumstances, to self-declare that an ingredient is GRAS. In accordance with that, food companies are given the latitude to determine whether they would like to report the ingredients to the FDA along with any associated safety data concerning the ingredient in question. They are encouraged to do so, but they do not have to. When people talk about the GRAS loophole, they are typically referring to the ability for companies to surreptitiously add ingredients that they have determined to be GRAS. In short, the loophole allows the addition of ingredients that the FDA is unaware of, in unknown quantities.

While the 1997 rule is not illegal, it has been found to not be conducive to maintaining the health of the American public. Additionally, these gaps have placed the onus on individual states to regulate the addition of potentially harmful ingredients to the food supply. For example, California recently passed legislation to ban the addition of the compound potassium bromate. Lastly, the FDA has proven reluctant to revoke GRAS designations from compounds. Changes to GRAS designation could prove beneficial. Only time will tell.