A substance added to food needs a food additive regulation or a GRAS conclusion for its use, and supplement ingredients follow a different route
This page explains the two U.S. routes for food ingredients, what a GRAS conclusion requires, how FDA's August 2026 proposal would change GRAS notification, and why color additives and supplement ingredients sit outside GRAS. Educational, not legal advice.
Status. EUTECNIQ Sciences is a company in formation. It has prepared no GRAS notices or food additive petitions. GRAS evidence work described here is proposed; studies would be run by qualified external laboratories, and expert panels would be independent.
Academy and related: the legal status of excipients (Course 12) · CFR atlas
FDA had no questions about 1,071 of the 1,317 closed GRAS notices; most of the rest closed at the notifier's request
Data table
| Year | No questions | Ceased at notifier's request | No basis | Total |
|---|---|---|---|---|
| 1998 | 4 | 2 | 0 | 6 |
| 1999 | 11 | 3 | 6 | 20 |
| 2000 | 18 | 3 | 3 | 24 |
| 2001 | 23 | 3 | 2 | 28 |
| 2002 | 21 | 5 | 5 | 31 |
| 2003 | 22 | 0 | 0 | 22 |
| 2004 | 20 | 4 | 0 | 24 |
| 2005 | 12 | 6 | 0 | 18 |
| 2006 | 26 | 3 | 0 | 29 |
| 2007 | 17 | 2 | 0 | 19 |
| 2008 | 19 | 9 | 0 | 28 |
| 2009 | 38 | 7 | 0 | 45 |
| 2010 | 38 | 10 | 0 | 48 |
| 2011 | 33 | 8 | 1 | 42 |
| 2012 | 41 | 9 | 0 | 50 |
| 2013 | 28 | 6 | 0 | 34 |
| 2014 | 50 | 7 | 0 | 57 |
| 2015 | 53 | 10 | 0 | 63 |
| 2016 | 56 | 18 | 0 | 74 |
| 2017 | 39 | 15 | 0 | 54 |
| 2018 | 69 | 7 | 0 | 76 |
| 2019 | 55 | 10 | 0 | 65 |
| 2020 | 48 | 11 | 0 | 59 |
| 2021 | 57 | 13 | 0 | 70 |
| 2022 | 37 | 15 | 0 | 52 |
| 2023 | 75 | 10 | 0 | 85 |
| 2024 | 47 | 17 | 0 | 64 |
| 2025 | 61 | 10 | 2 | 73 |
| 2026 | 53 | 3 | 1 | 57 |
| Total | 1071 | 226 | 20 | 1317 |
A “no questions” letter is FDA's view of the notifier's conclusion for the stated use; it is not an approval.
A food additive needs an FDA regulation before use; a GRAS use does not, because GRAS substances fall outside the food-additive definition
Text version of the decision path
Food additive petition
Any person may petition FDA to issue a food additive regulation. FDA responds by order, either denying the petition or issuing a regulation that prescribes the conditions of safe use. A food additive used outside such a regulation is deemed unsafe.
Statute RequirementGenerally recognized as safe (GRAS)
A substance whose intended use is generally recognized by qualified experts as safe is not a food additive for that use. Its maker may conclude GRAS status independently and may notify FDA under 21 CFR Part 170, Subpart E.
Final regulation RequirementThe food-additive definition also excludes pesticide chemicals, color additives, substances with a sanction granted before September 6, 1958, new animal drugs, and ingredients in or intended for dietary supplements (21 U.S.C. 321(s)(1)–(6)).
Explanation, details and sources
Both routes are tied to the intended conditions of use. In FDA's words, “the conditions of intended use of a substance, rather than the substance itself, are eligible for GRAS status.”
GRAS by scientific procedures needs a food additive's quantity and quality of evidence, and the evidence must be generally available
The routes differ in who reviews the evidence and how widely it is known. The amount of evidence required is the same.
Text version of the requirements
- Who
Experts qualified by scientific training and experience
General recognition “may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food.” 21 CFR 170.30(a)
- Basis
Scientific procedures, or common use in food before 1958
Any substance not in common food use before January 1, 1958 can become GRAS only through scientific procedures. Pre-1958 use outside the United States must be documented and corroborated by a second, independent source. 21 CFR 170.30(a), (c)
- Standard
Reasonable certainty of no harm, known throughout the scientific community
GRAS “requires common knowledge throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that there is reasonable certainty that the substance is not harmful under the conditions of its intended use.” 21 CFR 170.30(a)
- Quantity
The same evidence as a food additive approval
GRAS through scientific procedures “shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive.” 21 CFR 170.30(b)
- Availability
Ordinarily published data, corroborated by unpublished data
It rests on generally available and accepted data, information or methods, “which ordinarily are published,” and may be corroborated by unpublished data. 21 CFR 170.30(b)
A GRAS notice has seven parts 21 CFR 170.225–170.255
Text version of the seven parts
- Signed statements and certification§ 170.225
- Identity, manufacture, specifications, technical effect§ 170.230
- Dietary exposure§ 170.235
- Self-limiting levels of use§ 170.240
- Common use in food before 1958§ 170.245
- Narrative§ 170.250
- List of supporting data and information§ 170.255
GRAS notification is voluntary today; FDA proposed on August 11, 2026 to make it mandatory, and comments close December 9, 2026
Text version of both figures
Voluntary notice, FDA letter within 180 days
- “Any person may notify FDA” of a GRAS conclusion (§ 170.205).
- FDA files the notice, or explains why not, and responds by letter within 180 days of filing; it may extend that timeframe by 90 days (§ 170.265(b)(1)).
- A notifier may ask FDA to cease evaluating a notice before FDA responds.
- The usual favorable outcome is a “no questions” letter, which is not an FDA approval.
Mandatory GRAS notices (91 FR 51834)
- Would “require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS.”
- Exceptions include uses with an existing “no questions” letter and substances listed or affirmed in FDA's regulations.
- A time-limited streamlined submission for substances already in commerce.
- Not notifying would be “a factor in its prioritization of food substances for post-market review.”
- Proposed timing: effective 60 days after a final rule; compliance 18 months after that.
Sources: 21 CFR 170.205, 170.260, 170.265 (eCFR); Federal Register, Substances Generally Recognized as Safe, proposed rule, 91 FR 51834–51881 (Aug 11, 2026; docket FDA-2025-N-3262; RIN 0910-AJ02), Summary and Sections V and VII; HHS press release, Mar 10, 2025.
Explanation, details and sources
As of October 22, 2026, a company may still conclude GRAS status on its own and market the substance without notifying FDA. The proposal would change that only if finalized.
The proposal would define a “no questions” letter and states that such a letter is “neither an affirmation by FDA that the notified substance is GRAS for its intended conditions of use … nor a published finding” under the color additive provisions. EUTECNIQ would never describe a GRAS conclusion or an FDA letter as an FDA approval.
Searching the inventory shows which botanical substances have already been notified, and what FDA said
A prior notice covers its own notifier's substance, specifications and intended use; a new supplier or use needs its own GRAS basis.
Ingredients in dietary supplements cannot be GRAS for that use; their pathway is the new dietary ingredient notification
The FD&C Act excludes dietary-supplement ingredients from the food-additive definition, and GRAS is an exception within that definition.
“As such categories are excepted from the definition of ‘food additive’ in section 201(s) of the FD&C Act, they are not eligible for classification as GRAS under the GRAS provision included in the definition of ‘food additive’ (see proposed § 170.205(c)).”
Text version: GRAS compared with NDI notification
| Aspect | GRAS (conventional food use) | NDI notification (dietary supplement use) |
|---|---|---|
| Legal basis | Exclusion from the food-additive definition, § 201(s); 21 CFR 170.30 | FD&C Act § 413; 21 CFR 190.6 |
| Safety standard | General recognition of reasonable certainty of no harm under the intended conditions of use | History of use or other evidence that the supplement “will reasonably be expected to be safe” |
| Who must know the evidence | Qualified experts generally, from ordinarily published data | The notifier, who submits it to FDA |
| Submission to FDA | Voluntary notice today; mandatory under the August 2026 proposal | Required at least 75 days before marketing unless § 413(a)(1) applies |
| FDA timeline | Response within 180 days of filing, extendable by 90 | No marketing for 75 days after filing; FDA aims to respond within that period |
| Favorable outcome | “No questions” letter; not an approval | Acknowledgement without objection; not an approval |
| Public disclosure | FDA lists filed notices and publishes its letters; other contents are disclosable under 21 CFR Part 20 from the day FDA receives the notice (§ 170.275) | Public after 90 days, minus trade secrets and confidential commercial information |
Explanation, details and sources
Presence in the food supply in a form not chemically altered can, separately, decide whether a supplement ingredient needs an NDIN (§ 413(a)(1)). See NDIN strategy and dossiers.
A botanical extract used to impart color is a color additive for that use, and needs FDA listing before it is used
Color additives have their own premarket approval system in every product category FDA regulates. GRAS does not apply to them.
Text version of the decision
A color additive includes a dye or pigment “extracted, isolated, or otherwise derived … from a vegetable, animal, mineral, or other source” that can impart color to a food, drug, cosmetic or the human body (21 U.S.C. 321(t)).
StatuteA color additive is deemed unsafe for a use in food, drugs, devices or cosmetics unless a regulation lists it for that use and it is batch-certified or exempt from certification (21 U.S.C. 379e(a)). Listings are in 21 CFR Parts 73 and 74.
Statute RegulationColor additives are excluded from the food-additive definition (§ 201(s)(3)), so, as FDA's August 2026 proposal restates, they are not eligible for GRAS classification.
StatuteEUTECNIQ proposes to build GRAS evidence packages for botanical food ingredients, with independent experts reviewing the conclusion
The work would follow the seven-part notice structure whether or not the client notifies FDA, so the file is ready if notification becomes mandatory.
Text version of the figure
- Define the intended conditions of use and the technical effect
- Build identity, manufacturing and specification data
- Estimate dietary exposure across the proposed food uses
- Plan and oversee external safety studies to fill gaps
- Draft the narrative and the notice
- Run toxicology studies at contract research organizations
- Sit on an independent expert panel, where the client uses one
- Give legal opinions on pathway, color-additive status and labeling
- Any GRAS notice filed or “no questions” letter received
- That GRAS status covers supplement, cosmetic or non-U.S. uses
- That a GRAS conclusion is an FDA approval
Moving a botanical ingredient into foods or beverages?
The intended use decides the route. EUTECNIQ welcomes early conversations about evidence planning, while it is in formation.