For years, companies introducing a new food ingredient in the US have had a genuine choice. They could decide on their own that a substance is generally recognized as safe, known as self-affirmed GRAS, or they could send their evidence to FDA through the GRAS notification program and ask it to review the conclusion. Both are legal today.
That choice is now under threat, because FDA proposed in August 2026 to make notification mandatory. So the question isn't only "which route suits us?" but also "which route will still be available?" This article walks through the trade-offs and the factors that should drive the decision. If you want the background on how a GRAS review works, start with our guide towhat actually happens in a GRAS review.
Self-affirmed GRAS. The company, usually with the help of qualified experts, concludes that its substance is generally recognized as safe for its intended use. It keeps the supporting evidence on file and doesn't submit anything to FDA.
FDA notification. The company submits the same kind of evidence to FDA in a formal notice. FDA reviews it and responds with a letter, most commonly either saying it has no questions or saying the notice doesn't provide a sufficient basis for the conclusion.
The science behind both routes should be equally rigorous. What differs is who looks at it, how it's received, and what it costs.
Speed and flexibility. You decide when to finish and don't wait for a regulator's review.
Lower direct cost. You avoid the effort of preparing a formal submission, though a sound expert evaluation still costs real money.
Control over information. Nothing is submitted, so less of your detail is made public.
A sensible option for lower-risk situations. For well-understood substances with a long history of safe use, many companies have relied on it.
No regulatory review. The conclusion hasn't been checked by FDA, so any weakness may only surface later.
Commercial resistance. Retailers, big customers and partners increasingly ask for FDA's response letter and may be reluctant to accept a company's own conclusion.
Risk if the position is challenged. FDA can question a self-determined conclusion after the product is already on the market, which can be far more disruptive than discovering a problem before launch.
An uncertain future. If the proposed rule is finalized, the route would end for new substances, so a plan built on it may need rework.
An independent review. FDA looks at the evidence and raises questions, which often improves the quality of the final package.
A response letter customers recognize. A "no questions" letter is not approval, but it's a credible reference point in sales and supplier conversations.
A public record. FDA's inventory of responses gives others something concrete to point to.
Alignment with where regulation is heading. Preparing to the standard of a notice puts you in a stronger position if notification becomes mandatory.
Time. Under current rules FDA aims to respond within about 180 days, with a possible extension, and reviews have often taken longer in practice.
Effort. A notice needs a complete, well-organized dossier, and FDA's questions can mean extra work.
Visibility. The notice and FDA's response appear in a public inventory, so you should plan around what you're comfortable having on record.
An uncertain outcome. FDA may conclude that the notice doesn't provide a sufficient basis, which can set a project back.
How novel is the substance? A new substance, a new manufacturing process or a significant increase in use makes a stronger case for notification than a long-established one.
How strong and complete is the safety evidence? If the data has gaps, you want to know before launch, not after.
What do your customers expect? If your main buyers require an FDA letter, the decision is largely made for you.
What's your exposure to risk? A substance used at high levels in widely consumed foods carries more consequences if something goes wrong.
What's your timeline? If speed to market is critical and the evidence is strong, self-determination may be tempting, but weigh that against the risks above.
Where will you sell? GRAS is a US concept. A GRAS conclusion doesn't carry over to other countries, which have their own approval systems for new ingredients and food contact substances. If you plan to sell internationally, the wider picture matters, and ourGlobal Regulations for Food Contact Substances and Materials course shows how differently major markets approach this.
GRAS is mainly about ingredients added to food. Substances in packaging and equipment usually follow a different route, either food contact notification or the food additive regulations. If your question is about packaging, our article onfood contact notification vs. food contact substance regulations is the better starting point, because choosing the wrong route is a common early mistake. In August 2026, FDA proposed converting the voluntary notification program into a mandatory one. As described in law firm summaries of the proposal:
Notification would be required for substances introduced for use in food, unless an exemption applies.
The self-affirmed pathway would end for those substances.
FDA would have 45 days to decide whether to file a submission, then 180 days to evaluate it, with up to two 90-day extensions.
Exemptions are expected to include substances already covered by an FDA regulation, an earlier "no questions" letter, and certain other established FDA reviews.
If finalized, the rule would take effect 60 days after publication, with an 18-month compliance period.
It's a proposal, not a final rule, and details could change. The treatment of substances already on the market is a point to check carefully as the rulemaking develops.
Treat your documentation as if it will be reviewed. Even if you choose self-determination today, build the file to the standard of a notice. That keeps your options open and protects you if the rules change.
Inventory your current self-determined conclusions. Separate those covered by an FDA letter or regulation from those that rely only on your own conclusion.
Ask suppliers on what basis they claim GRAS status, and request the supporting evidence.
Plan for change. If you have new ingredients in development, consider whether to notify FDA now instead of relying on a route that may close.
Stay current. Our guide totracking food packaging regulatory changes describes a routine you can apply to regulatory news in general.
Treating self-affirmed GRAS as "no review needed." It means no FDA review, not no scrutiny.
Assuming a "no questions" letter is approval. It isn't.
Choosing a route only on cost or speed. Customer acceptance and risk matter as much.
Assuming a US GRAS conclusion works abroad. It doesn't.
Ignoring the proposal. Plans built on a route that may close need a backup.
The right route depends on the substance, the evidence, your customers and your markets, and it's worth taking advice before you commit. Whichever you choose, building the evidence file properly is what protects you.
To see how approval systems compare across the US, EU, China and other markets, explore ourGlobal Regulations for Food Contact Substances and Materials course.
