• On October 27, 2025, the New Jersey Senate introduced Bill S4748 which would in effect require that all self-determined GRAS conclusions, with the exception of those covering certain substances of natural biological origin and widely consumed prior to 1958, be filed with the state Department of Health, and ultimately published online. The Bill is identical to A4640, which was introduced to the New Jersey General Assembly last year.  
  • The objective of the bill seems to be to require that for each new use of a food ingredient based on self-determined GRAS status, food manufacturers would report that use to New Jersey’s Department of Health in an annual report. The language of the bill, however, would require some revisions. It currently references and incorporates the definition of “food additive” in the Federal Food, Drug, and Cosmetic Act without recognizing that GRAS substances are excluded from the “food additive” definition. The Bill exempts from notification (1) GRAS substances that have received a no questions letter from FDA, (2) any substances recognized in the federal regulations as prior sanctioned or GRAS, (3) any food contact substances subject to an effective food contact notification, (4) any substance “subject to regulation approving its intended use for food” (i.e., food additive regulation), (5) a “food ingredient of natural biological origin that has been widely consumed for its nutrient properties in the United States prior to January 1, 1958 without known detrimental effects, which is subject only to conventional processing as practiced prior to January 1, 1958, and for which no known safety hazard exists,” and (6) “any substance determined safe to be added to food by the commissioner” (of the New Jersey Health Department).
  • In terms of content, the requirements of the notification largely mirror FDA’s GRAS Notification requirements in 21 CFR part 170, subpart E, although it also requires inclusion of “any previous GRAS substance notices submitted to the Food and Drug Administration on the reported substance and any response from the agency.”
  • The Bill requires the notices to be published within 6 months. It permits redaction of trade secret information to the extent such information is not required the establish the GRAS status of the substance.
  • Manufacturers who “sell, distribute, or offer for sale [in New Jersey] any food that contains a new use of a food additive” for which a required notice has not been submitted to New Jersey’s Department of Health are subject to a penalty of up to $1,000 for a first offense, and up to $5,000 dollars for each subsequent offense, with each day constituting a separate violation.
  • The self-determined GRAS pathway has been in the hot seat as of late and there are proposals to require notification of all GRAS substances at the federal level. For example, Senator Marshall has proposed a bill to amend the FD&C Act and require reporting of GRAS substances, while FDA has indicated that it plans to a publish a proposed rule that would establish some form of mandatory GRAS Notification.