In-Depth Analysis: The FDA Officially Explains the GRAS Reform System

On October 15, 2026, the FDA hosted an online webinar providing an official breakdown of its proposed GRAS (Generally Recognized as Safe) rules originally published on August 10.

The proposed rules transition the nearly 30-year-old Voluntary GRAS Notification system into a mandatory requirement. Unless an exemption applies, any entity introducing human or animal food substances into US under GRAS provisions must now notify the FDA of the basis for its safety conclusion. Crucially, the new rules do not establish a pre-market approval process. To ensure a smooth transition for existing ingredients, the FDA is offering a 1-year simplified submission pathway alongside an 18-month compliance grace period.

During this webinar, the FDA provided a detailed overview of the GRAS reform, covering the motivations for the reform, key changes in the proposed rule, transitional exemption policies for human food, and special provisions for animal feed. Below are the key compliance takeaways distilled by Group from the webinar.

1. Motivation for Reform: Three Major Regulatory Pain Points Exposed by the Voluntary System

Excessive regulatory blind spots: Of the more than 10,000 additives in U.S. foods, approximately 1,000 have never been submitted to the FDA via GRAS notification; they are placed on the market solely based on companies’ internal “Self-GRAS” determinations, leaving both the FDA and the public without adequate information.

Frequent safety issues: Some substances entered the market with insufficient safety data (e.g., crude stevia extract, Delta-8 THC, and Tara flour).

“Cease to evaluate” used as a fallback: After receiving inquiries from the FDA, companies could apply for “Cease to Evaluate”. Some companies, rather than addressing the concerns after withdrawing their notifications, instead brought the products to market directly under “Self-GRAS”.

The FDA reiterates two key legal principles: ① “Safety” is not an inherent property of a substance, but rather a determination based on specific intended conditions of use (food category and usage level); ② Whether through the food additive pathway or the GRAS pathway, substances must be supported by safety data meeting equivalent scientific standards; GRAS waives “pre-market approval,” but by no means exempts companies from the “burden of proof regarding safety”.

2. Key Changes in the Proposed Rule

From voluntary to mandatory: Amendments to 21 CFR Part 170 (Human Food) and Part 570 (Animal Food) require any entity introducing a substance into interstate commerce under the GRAS provision to submit a notification to the FDA along with the basis for its safety conclusion.

Compliance grace period: 18 months from the effective date of the final rule.

Link to postmarket review priority: GRAS remains a statutory exemption from pre-market approval; this rule establishes a mandatory notification and filing mechanism. If a substance is subsequently “cease to evaluate”, it will be deemed equivalent to “failure to fulfill the notification obligation”. Substances that have not been notified or have not received a “no question” letter will be prioritized for inspection.

3. Transitional Policy for Human Food Exemptions

4. Special Provisions for Animal Food

1. Standardization of terminology: “Animal food” replaces “pet food” and “animal feed” to align with Part 507.

2. No TOR or FCN: There is no regulatory threshold (TOR) exemption for animal food, nor is there a Food Contact Substance Notification (FCN) process.

3. Two exclusive exemptions: ① Evaluated through the FDA’s Animal Food Ingredient Consultation (AFIC) process, with a summary made public and no safety concerns raised by the FDA; ② Listed in Chapter 6 of the 2024 official AAFCO publication and used as defined, with no public objections raised by the FDA.

4. Simplified submission requirements: Submit to CVM via email within one year of the rule’s effective date; the target animal species must be specified; if used in food-producing animals, residue data in edible animal tissues must be included, and the applicant must possess data supporting human food safety.

5. Key Compliance Timeline & CIRS Recommendations

The process from public comment to formal implementation of the new rule is closely interlinked; companies must pay close attention to the following key milestones:

CIRS Group recommends that companies conduct self-inspections and upgrades according to the following workflow:

Current compliance assessment: For all ingredients in products currently on the market, systematically review the regulatory pathway for each one (FDA GRAS / Self-GRAS / NDI / Food Additive Petition / Color Additive Petition) and determine its compliance risk level under the new regulations.

GRAS data gap analysis: Conduct a completeness assessment for each ingredient, focusing on identity information, manufacturing processes, specifications, exposure assessments, and safety data.

Path selection and strategy design: Conduct a full-cost, full-lifecycle assessment of the options—“Continue with Self-GRAS”, “Transition to an FDA GRAS notification” , or “File an NDI”—and recommend the optimal path.

High-quality submission of FDA GRAS notifications: Secure compliance assets through FDA GRAS notifications proactively before the Self-GRAS designation is revoked.

What Can CIRS Do for You

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services, from regulatory compliance, laboratory testing, and R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists of 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 1 European Registered Toxicologist (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Reading

How to Legally Export New Food Ingredients to the US: FAQs on GRAS Notice

Summary of US FDA GRAS Status from July to October of 2026