This is a guest blog post by Richard Perlmutter, MS
GRAS is the acronym for Generally Recognized as Safe. This is a designation for some food ingredients when they are used as intended. These ingredients are regarded as safe based on:
1) extensive prior use, or
2) assessments made by experts with knowledge of food ingredients and their potential hazards.
Until 1997, the agency reviewed industry food ingredient safety determinations. When found to be valid, the FDA affirmed the GRAS status of these ingredients. Beginning in 1998 the FDA has been guided by interim proposed regulations of its own creation that allow food companies to self-determine the GRAS status of food ingredients.
The FDA no longer performs these reviews. The Agency indicated that it made the change because it lacked sufficient resources to continue doing them.
Currently, a food company does not need FDA consent to designate a food ingredient (along with its intended use) as GRAS. Also, a food company is not required to inform the FDA when it has done so. This means that some food ingredients are used in some applications that the FDA knows nothing about.
Organizations that promote public health have been critical of the FDA over this lack of oversight and concern. This criticism is beginning to bring change.
In August, the Grocery Manufacturers Association (GMA), a trade group representing the largest food and beverage manufacturers, announced it will establish a GRAS database.
“The database will list information on all GRAS assessments conducted by the food industry.”
The sentence in quotes is taken from the Association’s press release on the subject. I do not know how the organization can make such a sweeping statement since all of the food industry does not have membership in the GMA.
The database will not be made public; but it will be made available to the FDA and to other parties that have a legitimate interest in its content. To quote the GMA press release a second time:
“GMA is establishing a program to ensure the FDA has increased visibility to the ingredients that are assessed as GRAS by members of the food industry.”
The Association will also develop procedures and standards to be used in making GRAS assessments. It is affiliating with Michigan State University to establish the Center for Research and Ingredients Safety to assist with this work.
A so-called watchdog group is also promoting change. The Center for Food Safety (CFS) is compelling the FDA to bring finality to its 1997 seventeen year old proposed regulation concerning GRAS notifications. In October, the CFS and the FDA agreed in US District Court to a legally binding Consent Decree. This was the outcome of a February 2014 CFS initiated Complaint for Declaratory and Injunctive Relief against the FDA for not following the procedures for rulemaking as required by the Administrative Procedures Act.
The FDA consented to publish its final rule regarding “Substances Generally Recognized as Safe” in the Federal Register no later than August 31, 2016. In the Complaint, CFS wanted the FDA to perform food ingredient safety reviews as it had prior to 1998. But the court did not uphold this demand. The Consent Decree does not require that the FDA make any changes in its current procedures that cover industry self-determination of GRAS status.
The American public believes that the FDA checks the safety of food ingredients and their usage. But in many cases the Agency does not perform these functions. Consumer trust in food and food ingredients is of paramount importance to both producers and consumers. The FDA needs to do what is necessary to insure that this trust is not diminished.
Richard Perlmutter is the owner of Abington Nutrition Services LLC which prepares nutrition labeling for products manufactured by food and beverage companies. He also takes an interest in seeing that government nutrition policy is in line with nutritional science.