Generally Recognized As Safe (GRAS) is a regulatory designation for food ingredients that are considered safe by expert consensus under intended use. The U.S. Food and Drug Administration (FDA) currently allows two pathways to GRAS status: self-affirmation and FDA notification. However, recent developments indicate the FDA may eliminate the self-affirmation option in favor of stricter oversight.
This report compares self-affirmed vs. FDA-notified GRAS, explains why the FDA is moving to end self-affirmed GRAS, and outlines what this means for food and beverage companies. It also highlights BeyondMushrooms – a line of mushroom extracts with FDA-notified GRAS status – as a smart solution for brands needing compliant, high-quality ingredients.
Under the law, if an ingredient’s safety is “generally recognized” by qualified experts and published science, it is exempt from FDA pre-approval. The key difference between GRAS pathways is who reviews and knows about the safety determination:
In summary, a self-affirmed GRAS determination stays within the company’s files, whereas an FDA-notified GRAS determination is shared with regulators and the public. Both pathways are legal, but they carry very different levels of oversight and transparency. Table 1 below highlights the key differences:
Table 1: Comparing Self-Affirmed vs. FDA-Notified GRAS
| Aspect | Self-Affirmed GRAS | FDA-Notified GRAS |
| FDA Involvement | None required – company does its own GRAS review | FDA reviews the GRAS notice and related data |
| Public Disclosure | Not required (kept internal to company) | GRAS notice and FDA’s response are public |
| Safety Review Outcome | Company’s expert panel concludes “safe” | FDA issues “no questions” letter if agreed |
| Regulatory Assurance | Relies on company’s diligence (loophole risk) | FDA oversight provides added confidence |
The FDA is now poised to close the “self-affirmation” loophole. On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the FDA to explore rulemaking that eliminates the self-affirmed GRAS pathway. The reason is simple: safety and transparency.
“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” said Secretary Kennedy.
“Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”
In other words, regulators are concerned that under self-affirmation, ingredients can enter foods without any FDA knowledge or review. FDA currently “strongly encourages” companies to use the notification program, and has reviewed 1,000+ GRAS notices (about 75 per year), which are all catalogued in a public inventory. But because notification is optional, many substances may have been self-certified as safe behind closed doors. A 2010 Government Accountability Office (GAO) report flagged this issue, and a decade later experts noted that the FDA “has chosen to remain uninformed about food substances self-determined as GRAS by manufacturers.”. Even when the FDA finalized updates to the GRAS rule in 2016, it did not require companies to submit self-GRAS substances or create a master list of all GRAS ingredients in use. This gap means FDA cannot fully ensure the safety of the food supply if it doesn’t even know what additives are being used.
The push to eliminate self-affirmation is a response to these longstanding concerns. By mandating FDA notification, every new GRAS ingredient would face some level of FDA oversight and public disclosure before use. Kennedy emphasized that this step will help “ensure that ingredients being introduced into foods are safe” and bolster consumer confidence. HHS and FDA are even considering working with Congress on legislation to “completely close the GRAS loophole”, indicating a strong commitment to reform.
Companies currently formulating with self-affirmed GRAS ingredients face a critical decision point. If your product relies on an ingredient that only you (or your supplier) have deemed GRAS without FDA input, you should begin strategizing now:
Bottom line: Brands using self-affirmed GRAS ingredients should act now. Conduct an audit of your ingredient GRAS statuses, engage with suppliers about their GRAS plans, and consider reformulating with FDA-notified GRAS ingredients where possible. This will future-proof your products in anticipation of the new rule.
For companies formulating with functional mushroom ingredients (a popular category for wellness beverages, supplements, and foods), BeyondMushrooms offers a timely solution. BeyondMushrooms is a line of mushroom extract ingredients that have already gone through the FDA’s GRAS Notification process – in fact, they are the world’s only FDA-notified GRAS mushroom extracts available today. This unique status means that their safety has been thoroughly vetted and acknowledged by the FDA at the highest level, eliminating the uncertainties associated with self-affirmed ingredients. In a landscape where self-affirmed GRAS is on the way out, using BeyondMushrooms allows brands to seamlessly comply with upcoming rules and confidently innovate with mushrooms.
Beyond just regulatory peace of mind, BeyondMushrooms brings significant formulation advantages that make it an attractive choice for product developers:
By leveraging BeyondMushrooms, companies not only align with the anticipated FDA rules but also gain a superior ingredient that can make their products better. It’s a rare win-win for compliance and innovation: you avoid regulatory headaches and simultaneously improve product performance.
The FDA’s expected elimination of the self-affirmed GRAS pathway marks a new era of transparency and oversight in food ingredient safety. Brands should begin adapting now by prioritizing ingredients that come with FDA-notified GRAS status or equivalent regulatory review. In practical terms, this means working closely with suppliers, reformulating where necessary, and choosing proven ingredients like BeyondMushrooms that have already met the highest safety standards. Not only will this proactive approach keep you ahead of regulations, but it will also strengthen the trust consumers place in your products.
As the industry transitions, staying informed is crucial. Keep an eye on FDA’s rulemaking progress and be ready to pivot as guidelines evolve. By understanding the difference between self-affirmed and FDA-reviewed GRAS and acting accordingly, food and beverage companies can ensure both regulatory compliance and consumer confidence in every ingredient they use. The bottom line: safety and transparency are becoming non-negotiable – and embracing them now will set your brand up for lasting success.