Generally Recognized as Safe: Key Changes to FDA’s GRAS Notification Requirement Looming

Overview

The U.S. Food and Drug Administration (FDA) proposed a change to the Generally Recognized as Safe (GRAS) notification system for the first time in almost 30 years. The new proposed rule, unlike the current rule proposed in 1997 and finalized in 2016, makes GRAS notifications mandatory. The comment period for the proposed rule ends in only two months (December 9, 2026), and stakeholders should act promptly to submit comments before the deadline closes. Given the significance of the proposed changes for food manufacturers and suppliers, understanding the scope and implications of the rule is critical now — before it is finalized.

Typically, companies introducing food additives into interstate commerce must have premarket approval from FDA. Food substances that are GRAS, however, are excepted from this requirement and have been since 1958, when the Federal Food, Drug, and Cosmetic Act (FDCA) was enacted. The GRAS system has changed over the last seven decades, evolving from GRAS affirmation — which consumed considerable resources for FDA — to our current voluntary notification system. Under the current voluntary system, manufacturers can independently conclude a substance is GRAS without having that status confirmed by FDA. The purpose of the proposed rule, according to FDA, is to increase transparency in food production in the United States rather than to reform how FDA approves substances as GRAS.

Under the proposed rule, nothing about the threshold for GRAS would change, including what information manufacturers must submit to have a substance approved as GRAS. Likewise, there would still be no premarket approval requirement for GRAS substances. Manufacturers would be able to market existing and new substances as GRAS during the pendency of their GRAS notifications, though if post-market review reveals a substance is not GRAS, it would be deemed an unapproved food additive under Sections 402(a)(2)(C)(i) and 409 of the FDCA. For this reason, manufacturers should begin preparing the relevant information they would need for either full or streamlined GRAS notifications.

Current and New Obligations

There is no premarket approval requirement before manufacturers can market and use a food substance under the current or proposed regulations. However, a post-market determination that a substance is not GRAS can have severe consequences, including seizure, penalties, and injunctions pursuant to 21 C.F.R. §§ 302–04. Manufacturers would have 18 months from the date the rule takes effect to comply with the new notification requirements and should take care to do so given these potential consequences under the FDCA.

Timeline

The proposed regulation could extend by months the time manufacturers must wait for final determinations from FDA. The lifecycle of a GRAS notification generally goes through three stages: (1) initial review of the GRAS notification to determine if it can be filed; (2) substantive review of the GRAS notification to determine if the provided information and available data support a GRAS finding; and (3) determination by FDA. FDA may request more information during its review, which can delay its determination.

The initial review and determination of whether a GRAS notification qualifies for filing by FDA is expected, though not assured, to be complete within 45 days of receipt. While FDA would retain the current 180-day evaluation timeline and 90-day extension for its substantive review of whether the notified substance qualifies as GRAS, the agency is already accounting for possible delays in processing the influx of notifications. FDA proposes that it can invoke an additional 90-day extension for its substantive review.

In total, manufacturers could be facing 405 days — or more, if the initial filing determination surpasses 45 days — between filing a GRAS notification and a final determination by FDA of whether a substance is GRAS. Even though manufacturers’ obligation to notify would generally be satisfied once FDA accepts the GRAS notification for filing — assuming FDA does not request additional documentation — the additional time a substance is on the market without approval increases manufacturers’ potential exposure should FDA ultimately reject the GRAS designation.

Streamlined Notification and Exceptions

A major reprieve for manufacturers with prior, independently concluded GRAS substances is the streamlined GRAS notification offered under Subpart F of proposed sections 170.303 and 170.305. For one year after the rule takes effect, abbreviated notifications can be submitted with basic information about the notifier and information about the substance’s use in interstate commerce under the intended use that preceded the effective date of the proposed rule.

Section 170.205(b) of the proposed regulation also provides exceptions to the mandatory filing requirement, including where there is a “no questions letter” from FDA regarding the substance, the substance is already recognized as GRAS for its intended use by regulation, or the substance was widely consumed prior to 1958 and the processing has remained unchanged since then.

The exceptions and streamlined notification process would offer manufacturers a less burdensome path to complying with the proposed regulation while also alleviating some of the inevitable administrative burden should the proposed regulation take effect. However, manufacturers with substances currently on the market should keep in mind the 12-month time limit on the streamlined submission process, as after that point FDA would require a full GRAS notification.

Practical Effects

The biggest hurdle for manufacturers in complying with the proposed regulation would be gathering the relevant information needed to demonstrate that a substance should be GRAS. First, manufacturers would have to keep track of and account for the substances they use, especially those already on the market under an independent GRAS determination. Second, while exceptions to mandatory notification do exist, manufacturers hoping to take advantage of them would have to ensure that the substance in question qualifies for an exception, or they could risk a post-market determination that a substance is not GRAS and the consequences that follow. Third, manufacturers would be responsible for collecting and retaining more evidence to support GRAS determinations. Finally, manufacturers would have to weigh the risks and benefits of introducing a substance into interstate commerce before receiving confirmation from FDA that a substance is GRAS under the intended use.

Beyond the regulatory compliance burden, the proposed rule carries significant practical risks for manufacturers. A post-market determination that a substance is not GRAS would render it an unapproved food additive under the FDCA, potentially requiring manufacturers to pull affected products from the market entirely. Such a determination could also trigger FDA enforcement actions, including product seizures, warning letters, and injunctive relief. Perhaps more significantly, manufacturers could face civil litigation exposure from consumers, competitors, and downstream purchasers, including product liability claims, breach of warranty actions, and potential class action suits. Supply chain disruptions resulting from a forced market withdrawal could compound these risks, particularly for manufacturers whose products are widely distributed. Accordingly, manufacturers should proactively assess their GRAS substance portfolios and prioritize notification submissions to mitigate these risks well in advance of the compliance deadline.

Key Takeaways

• While the GRAS criteria are not changing, manufacturers' obligation to notify FDA is.
• The 45-day window between receipt by FDA and acceptance for filing is the most crucial window for manufacturers. During this period, FDA conducts an initial review to determine whether the notification is sufficiently complete to be accepted for filing. A manufacturer's notification obligation is not satisfied until FDA accepts the GRAS notification for filing, meaning that manufacturers bear the risk of any delay or deficiency during this initial review period.
• Manufacturers currently using independently determined GRAS substances should have the relevant information ready to submit a streamlined application within the 12 months after the rule takes effect. Manufacturers should proactively assess their GRAS substance portfolios and prioritize notification submissions well in advance of the compliance deadline. Beyond regulatory consequences, a post-market determination that a substance is not GRAS exposes manufacturers to significant commercial risks, including FDA enforcement actions, civil litigation from consumers and downstream purchasers, forced market withdrawal, and supply chain disruptions.