The short answer
Flour, pasta, noodles and gluten-free products are regular foods for FDA: the facility needs food facility registration with a U.S. Agent, each shipment needs Prior Notice, and the U.S. importer needs an FSVP. What makes this category different is that many of these products have federal standards of identity — legal recipes behind names like “enriched flour”, “macaroni”, “spaghetti” and “egg noodles” — plus strict rules on wheat and egg allergens and the gluten-free claim.
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1. Standards of identity: the name must match the recipe
| Product | Rule | What it means |
|---|---|---|
| Flours (wheat flour, whole wheat flour, enriched flour, durum flour…) | 21 CFR part 137 | Each named flour must meet its standard; “enriched” flour must contain the required added nutrients at the levels set in the standard |
| Macaroni products (macaroni, spaghetti, vermicelli…) | 21 CFR part 139 | Made from the permitted wheat ingredients; shape names have size rules |
| Noodles and egg noodles | 21 CFR 139.150 | Must contain at least 5.5% egg solids (dry basis) |
| Enriched macaroni and noodle products | 21 CFR part 139 | Required added nutrients if labeled “enriched” |
If your product does not meet the standard — for example a wheat “noodle” with no egg, or a rice or bean pasta — do not use the standardized name alone. Use an accurate descriptive name such as “wheat flour pasta”, “rice noodles” or “chickpea pasta”.
2. Allergens
- Wheat must be declared as “wheat” — “gluten”, “semolina” or “durum” alone are not enough unless “wheat” also appears (for example “semolina (wheat)” or “Contains: wheat”).
- Egg must be declared in egg pasta and noodles.
- Soy, milk and sesame often appear in flavored pasta, noodle seasonings and gluten-free blends.
See the 9 major food allergens.
3. Gluten-free products
- “Gluten-free” requires the food to meet FDA’s definition, including less than 20 ppm gluten (21 CFR 101.91).
- Rice, corn, chickpea, lentil and buckwheat pastas are not automatically gluten-free — cross-contact in a mill or pasta line that also runs wheat is the main risk.
- Test finished lots with a validated method and keep the records. Fermented or hydrolyzed ingredients need extra records.
More detail: gluten-free, organic and non-GMO claims.
4. Food safety points
- Raw flour is not ready-to-eat. It can carry pathogens such as E. coli and Salmonella. Products like cookie dough mixes need clear cooking instructions.
- Mycotoxins such as DON (vomitoxin) in wheat — FDA’s October 2026 draft guidance on chemical hazards uses a bakery controlling DON in wheat flour as an example. See FDA’s chemical hazards guidance.
- Insects and filth in stored grain and flour — a classic FDA refusal charge.
- Pesticide residues in grains, tested against U.S. tolerances.
Example: durum pasta from Italy and rice noodles from Vietnam
An Italian pasta maker can call its product “spaghetti” if it meets the macaroni product standard, and declare “durum wheat semolina” with “Contains: wheat”. A Vietnamese rice noodle maker should not use “egg noodles” or “spaghetti”; “rice noodles” is accurate. If it adds “gluten-free”, it must test below 20 ppm and control cross-contact with any wheat lines. Both need FDA facility registration, Prior Notice and an importer with an FSVP.
Checklist
- 1Register the facilityFDA food facility registration with a U.S. Agent.
- 2Check the nameStandardized name only if the product meets the standard; otherwise a descriptive name.
- 3Declare allergensWheat and egg in the right words.
- 4Gluten-free only with proofUnder 20 ppm, with test records.
- 5Prior Notice and FSVPFor every shipment and every importer.
FDA food facility registration with U.S. Agent from $300. Standard label review with Nutrition Facts $550. Prior Notice $15 per shipment.
Frequently asked questions
Can I call my eggless noodles “noodles” in the US?
The standardized name “noodles” (and “egg noodles”) requires at least 5.5% egg solids under 21 CFR 139.150. Eggless products should use an accurate descriptive name such as “wheat noodles” or “rice noodles”.
Is semolina an allergen declaration?
Not on its own. Wheat must be named, for example “semolina (wheat)” or in a “Contains: wheat” statement.
Is rice pasta automatically gluten-free?
No. It can be labeled gluten-free only if the finished product meets FDA’s definition, including less than 20 ppm gluten, which usually means controlling cross-contact and testing.
Does pasta need Nutrition Facts?
Yes, unless an exemption applies — see the small business exemption.
Sources
- 21 CFR part 139 — Macaroni and noodle products
- 21 CFR part 137 — Cereal flours and related products
- Federal Register — Gluten-free labeling of fermented or hydrolyzed foods (2020; references the 2013 rule)
- Covington — FDA chemical hazards draft guidance (October 2026; DON in wheat flour example)
Standards and rules checked on November 11, 2026. This article is general information, not legal advice.