Food and Drug Admin Updates GRAS Panel Burden Estimates

If you’ve ever worked on a GRAS project (Generally Recognized as Safe), you know there are two parallel universes:
(1) the scientific one, full of toxicology, exposure, and literature searches, and (2) the paperwork one, where everything you do
becomes a “burden hour.” In 2025, the Food and Drug Administration (FDA) updated its GRAS panel burden estimatesthe
official accounting of how much time the GRAS process typically takes across reporting, recordkeeping, and third-party disclosures.
Translation: FDA recalculated the “how long does this take, really?” math.

This isn’t FDA trying to make your day harder. It’s a normal part of the Paperwork Reduction Act processan ongoing
requirement for federal agencies to justify information collections and estimate the time and effort involved. Still, these updates
matter because they shape expectations for compliance teams, consultants, and companies deciding whether to convene a GRAS panel,
prepare a GRAS notice, or tighten internal documentation before anyone says, “We’re goodthis is GRAS.”

First, a quick GRAS refresher (without the nap)

“GRAS” is the legal and scientific concept that a substance can be used in food without going through the food additive
approval process when qualified experts generally recognize it as safe under the intended conditions of use.
In practice, companies may:

• Self-determine GRAS status (often called “self-affirmed GRAS”) based on a documented evaluation, sometimes with an expert panel.
• Submit a voluntary GRAS notice to FDA, asking the agency to review the basis for the GRAS conclusion.

A GRAS panel is one common way to support the “general recognition” piece, especially for newer ingredients or novel
manufacturing methods where you want a clear, defensible story: qualified experts reviewed the evidence, addressed uncertainties,
and agreed the use is safe.

What “burden estimates” actually mean (and why OMB cares)

When FDA asks industry or third parties to create, maintain, or submit certain information, the agency must estimate how much time
it takes. Those estimates are reviewed by the Office of Management and Budget (OMB). Think of it as a federally mandated reality check:
if the government expects documentation, it has to publicly estimate the effort involvedand update those estimates when the world changes.

For GRAS panels, “burden” usually shows up in three buckets:

• Reporting: time to prepare and submit a GRAS notice (if you choose to notify FDA).
• Recordkeeping: time to create and maintain required or recommended documentation (like a written GRAS panel policy).
• Third-party disclosures: time spent by potential panel members providing conflict-of-interest and related information to the GRAS proponent.

The 2025 update: what changed in the numbers

FDA’s updated estimates connect closely to best-practice expectations for GRAS panels and to observed submission patterns in recent years.
Here’s the high-level picture of the revised burden estimates.

1) Reporting burden: preparing GRAS notices (human food and animal food)

FDA’s updated reporting estimates assume an average of 170 hours per GRAS notice. That’s not 170 hours of typing the
words “This is safe” and calling it a day. It reflects the full effort of building a coherent, reviewable package: identity and specifications,
manufacturing description, intended use levels, dietary exposure, safety narrative, supporting studies, and documentation that the conclusion
is generally recognized among qualified experts.

One of the headline changes in 2025 was a decrease in the estimated number of animal food/feed GRAS notice submitters
compared with prior assumptions. FDA tied that adjustment to observed submissions over a recent multi-year period, which lowered the
total burden hours for that category.

2) Recordkeeping burden: written GRAS panel policies and applying them

If a GRAS panel is the jury, the written policy is the rulebook: who qualifies, what conflicts must be disclosed, how bias is managed,
what materials are reviewed, how deliberations are conducted, and how the panel’s conclusion is documented.

The 2025 burden update included a notable recalibration: FDA reduced the estimated time associated with maintaining
written GRAS panel policies. The logic is practicalmany organizations already created baseline policies, so the continuing effort is more
about keeping them current than drafting them from scratch every time.

In plain terms: FDA is signaling that it expects written policies to exist and be maintained, but it’s acknowledging that the heaviest lift
often happens up front. The ongoing burden is more about updates, version control, and consistent application.

3) Third-party disclosure burden: what panel members must provide

A GRAS panel works best when it’s credible to outsidersFDA reviewers, customers, auditors, or that one stakeholder who always asks,
“But who paid the experts?” That’s why disclosures matter. The 2025 estimates included a third-party disclosure burden tied to
potential panel members providing information to the GRAS proponent.

The big idea: independence and transparency aren’t “nice to have” accessories. They’re part of what makes the conclusion “generally recognized”
rather than “generally convenient.”

Why the update matters (even if you never plan to submit a GRAS notice)

You might be thinking, “We don’t notify FDA, so why should we care?” Because burden estimates shape the compliance climate. They influence how
regulators describe the process, how auditors evaluate readiness, and how internal teams budget time and resources. They also function as a signal:
FDA expects structured panel governance when a panel is used to support a GRAS conclusion.

And even if you choose self-affirmed GRAS, documentation is the thing you’re going to wish you had when:

• a retailer asks for substantiation and conflict-of-interest safeguards,
• an insurer wants to see risk controls,
• a competitor challenges your ingredient claims,
• or new science appears and you need to show you have an updating process.

What FDA “best practices” imply for your GRAS panel workflow

FDA’s GRAS panel best practices focus heavily on bias management, balanced expertise, and transparent procedures.
In real projects, that translates into practical, buildable steps:

Build a written GRAS panel policy that’s more than a one-pager

A strong policy usually answers:

• Selection criteria: what expertise is required (toxicology, exposure, chemistry, microbiology, allergenicitydepending on the ingredient).
• Conflicts and disclosures: what must be disclosed (financial ties, consulting arrangements, research funding, prior positions, advocacy).
• How conflicts are handled: exclusion, mitigation steps, or documented rationale for why a disclosed item is not disqualifying.
• Compensation rules: payment that is not contingent on a “yes” outcome.
• Evidence standards: how the panel evaluates study quality, relevance, and general availability of the evidence.
• Deliberation and documentation: how conclusions are reached and recorded (including dissent, if any).
• Records: retention and version control so you can prove what was reviewed when.

Decide what you’re proving (and to whom)

GRAS isn’t just “safe.” It’s “safe under the conditions of intended use” and “generally recognized” by qualified experts.
Your scope statement should be specific enough that the safety narrative doesn’t drift:

• What is the ingredient (identity/specs)?
• How is it made (process, controls, impurities)?
• Who will consume it (general population, children, special diets)?
• How much will they get (use levels, exposure estimates, cumulative intake)?
• What endpoints matter (toxicity, allergenicity, microbiological safety, contaminants, pharmacologic effects)?

Use the burden numbers as a planning tool, not a performance review

The reporting estimate (170 hours per notice) is an average. Your actual time can vary wildly based on:
ingredient novelty, quality of the study package, whether exposure modeling is complex, and whether the manufacturing story is stable.
A practical approach is to treat the FDA estimates as a baseline for budgeting and staffing, then add a “reality multiplier” based on the project:

• Low complexity (well-characterized ingredient, abundant public data): you might stay near the baseline.
• Medium complexity (some proprietary data, moderate exposure modeling): expect more iteration and internal reviews.
• High complexity (novel process, limited public literature, sensitive population): plan for deeper analysis and more panel back-and-forth.

Specific example: how “170 hours” can disappear in a blink

Imagine a company wants to market a new plant-derived sweetener extract. A simplified (and very human) time breakdown might look like this:

• Ingredient identity/specs + impurities story: 20–35 hours (and more if manufacturing is still evolving).
• Intended use + exposure estimate: 20–40 hours (depending on how many food categories and populations are involved).
• Literature search + study quality assessment: 40–60 hours (more if endpoints are disputed or data are inconsistent).
• Safety narrative + margin of safety reasoning: 25–40 hours.
• Panel convening + disclosures + report drafting: 30–60 hours (varies with the policy maturity and coordination needs).

Add internal legal review, formatting, and the inevitable “Can we re-run that intake estimate using the updated market forecast?” and
you’re not looking at 170 hours anymoreyou’re looking at 170 hours before lunch.

Zooming out: GRAS transparency is under a brighter spotlight

While the 2025 update is focused on burden estimates, it lands in a broader national conversation about GRAS transparency and oversight.
GRAS has long been praised for efficiency and criticized for the potential conflicts that can arise when safety determinations are industry-led.
That tension has prompted public scrutiny over the yearsfrom government reports to academic analysis and mainstream coverage.

The practical takeaway for companies is not panicit’s preparedness. If you’re going to rely on GRAS (with or without notification),
the credibility of your process matters more than ever. Written policies, clean disclosures, and disciplined recordkeeping aren’t just
“checklist items.” They’re your proof that the decision was made thoughtfully and could withstand questions later.

What should companies do now?

1) Treat your written GRAS panel policy like a living document

FDA’s updated recordkeeping estimate assumes maintenance, not constant reinvention. That’s a hint: build a strong baseline policy,
then update it intentionallynew disclosure categories, new data integrity expectations, improved documentation practices.

2) Standardize disclosures so panelists aren’t reinventing the wheel

If your disclosure process is clunky, you’ll feel every one of those estimated hours. A standardized disclosure packet (with clear
definitions and examples) reduces friction and improves consistency.

3) Budget realistically for the science and the administration

The burden estimates underscore what experienced teams already know: the administrative side is real work. Plan for project management,
document control, and review cyclesnot just technical writing.

4) Decide early whether you’re notifying FDA

Notification can be valuable for transparency and risk management, but it also shapes how you structure the dossier and timelines.
Make the decision early so you don’t build a file that has to be reworked later.

Conclusion: the “burden” isn’t the enemysurprises are

FDA’s updated GRAS panel burden estimates are a reminder that credible safety conclusions require both strong science and disciplined governance.
The 2025 revisions adjust expectations in meaningful placesespecially around maintaining written GRAS panel policies and the projected volume of
animal food GRAS notices. For industry, the win is clarity: better forecasting, better staffing, and fewer last-minute scrambles.

If you want the shortest path through GRAS, don’t aim for “minimum effort.” Aim for “minimum rework.” That means clear scope,
a panel policy that actually runs the show, and documentation that can stand on its ownbecause someday, it might have to.

Real-World Experiences: What the GRAS Panel “Burden” Feels Like

Let’s talk about the human side of “burden estimates,” because numbers are tidy and real projects are… not. While every GRAS engagement is different,
there are some common experiences that pop up again and again for regulatory and R&D teams working with GRAS panelsespecially when the goal is to
align with FDA’s best-practice expectations.

The “We already have a policy” moment (followed by the “Wait… do we?” moment)

Many teams start confidently: “We have a panel policy.” Then someone asks for the last revision date, a clean disclosure form, and a description of how
conflicts are evaluated. Suddenly the policy is more of a polite suggestion than an operational document. This is where FDA’s reduced “maintenance burden”
estimate makes sense: once you’ve built a real policy framework, keeping it current can be manageable. But if your policy is thin, outdated, or undocumented,
the effort isn’t maintenanceit’s rebuilding.

Panelist disclosures: the paperwork nobody loves, but everybody needs

The most common friction point is disclosure collection. Not because experts are uncooperative, but because disclosure expectations can be fuzzy:
What counts as a conflict? How far back should financial relationships go? Does teaching a webinar for an ingredient trade group matter? What about
prior consulting for a competitor? The smoother projects are the ones where the proponent provides:

• a plain-English disclosure checklist,
• clear time windows (e.g., past 12–36 months),
• definitions with examples, and
• an explanation of how disclosures are used (screening vs. mitigation vs. documentation).

In practice, disclosures also become a scheduling tool. If a potential panelist has a major conflict, you want to know before you’ve built the agenda,
reserved meeting time, and drafted half the report. That’s why disclosure collection often feels like it’s “taking forever” even when it’s only a few hours
per personbecause it determines whether the panel is viable.

The literature search spiral (aka: “Congratulations, you found 1,842 abstracts”)

A classic experience: a team runs a broad search, pulls hundreds of papers, and then realizes many aren’t directly relevant to the ingredient identity,
dose range, or intended population. The best panels don’t just ask “Is there data?” They ask “Is there usable data?” That means filtering for:
appropriate endpoints, known composition, relevant exposure ranges, and study quality. This step can consume more time than expectedespecially when
the ingredient has multiple names, variable specifications, or older studies that don’t match modern manufacturing.

Drafting the panel report: where clarity beats cleverness

GRAS panel reports tend to go off the rails when they read like marketing copy or when they assume the reader already believes the conclusion.
Experienced teams learn to write like a friendly skeptic is in the room:

• State what’s known (and what’s not).
• Explain why uncertainties do not change the conclusion under the intended conditions of use.
• Show how exposure estimates connect to safety endpoints.
• Document dissent or questions, and how they were resolved.

Ironically, this approach often makes the process faster. When the report is transparent, panel meetings are more focused, and revision cycles shrink.
When the report is vague, everyone debates wording instead of substanceand those “burden hours” multiply like gremlins after midnight.

The “future you” test: can someone defend this file in two years?

One of the most useful mindset shifts is treating recordkeeping as a gift to future you. Teams change, vendors rotate, and new data emerges.
If your documentation is organizedpolicy versions, disclosures, meeting notes, literature search strategy, study tables, and final conclusionsthen updating
the GRAS determination later is realistic. If not, you’ll re-spend the same time (or more) recreating what happened, and you’ll still be stuck answering
the same question: “How did we get comfortable with this conclusion?”

That’s the real value behind FDA’s burden estimates: they don’t just measure effort. They hint at what a credible, repeatable GRAS process looks like in
the real world. And the projects that go best aren’t the ones with the fewest hoursthey’re the ones with the fewest surprises.