CU comments regarding the FDA’s proposed voluntary notification procedure for GRAS substances


Comments of Consumers Union on
Food and Drug Administration (FDA)
Proposed rule on Substances Generally Recognized as Safe; Reopening Comment Period
Docket No. FDA—1997—N—0020
Prepared by Michael Hansen, Ph.D.
Senior Scientist
March 28, 2011

Consumers Union (CU) welcomes the opportunity to comment on FDA’s proposal to replace the voluntary petition process to affirm the generally recognized as safe (GRAS) status for substances used in human and animal feed with a voluntary notification policy. CU opposes this change because we think that this policy is weaker in terms of protecting food safety than the voluntary GRAS affirmation petition that it is replacing. However, if FDA continues forward with this change, we believe that they should finalize their 1997 proposed rule that lays out their framework and criteria for the voluntary notification policy for GRAS substances. In addition, FDA should seek authority from Congress to require companies to inform FDA of all GRAS determinations made by the company. FDA should also consider engineered nanomaterials to be new materials with unfamiliar properties or a significant new use of a material. Existing GRAS determinations for macroscale materials should not be considered valid for versions made with engineered nanomaterials.
In general, we believe that the FDA should ensure the safety of all substances added to food. In the case of GRAS substances, companies, at a minimum, should be required to notify FDA of any GRAS determinations they make. At present, the FDA does not have statutory authority to require that companies even inform them of any GRAS determinations that they make. Consequently, companies can make their own determination that a substance is GRAS, not tell the FDA of that decision, and then start adding that substance into food and selling it to consumers. We believe that this system allows for potentially dangerous substances to enter the food supply, without FDA’s knowledge or supervision.
For the full comments, click here.