FDA Gluten Free Labeling Rules
What are the FDA rules for gluten-free food labels?
FDA's gluten-free labeling rule is 21 CFR 101.91. A food may say "gluten-free," "no gluten," "free of gluten" or "without gluten" only if it is made without gluten-containing grains (or ingredients from them that still contain gluten), and any gluten it can't avoid is below 20 ppm (below 20 mg gluten per kg of food).
Approach: I read the current eCFR text of 21 CFR Parts 100-169 (food labeling and food standards), all of § 101.91, and searched those parts for other gluten provisions.
Definitions (§ 101.91(a))
- Gluten-containing grain means wheat (any Triticum species), rye (any Secale species) or barley (any Hordeum species), or their crossbred hybrids, such as triticale [1][2][3][4].
- Gluten means the proteins that occur naturally in those grains and may harm people with celiac disease, such as prolamins and glutelins [5].
- "Gluten-free" has two parts [6]:
- The food either inherently contains no gluten [7], or it contains none of these [8]:
- a gluten-containing grain, such as spelt wheat [9];
- an ingredient from such a grain that has not been processed to remove gluten, such as wheat flour [10];
- an ingredient from such a grain that has been processed to remove gluten, such as wheat starch, if using it leaves 20 ppm or more gluten in the food [11].
- And any unavoidable gluten in the food is below 20 ppm [12].
- The food either inherently contains no gluten [7], or it contains none of these [8]:
Labeling requirements (§ 101.91(b))
- A food labeled "gluten-free" that doesn't meet the definition, or the records rules for fermented and hydrolyzed foods where they apply, "will be deemed misbranded" [13]. The same applies to "no gluten," "free of gluten" and "without gluten" [14].
- Wheat on the label: a gluten-free food may list "wheat" in the ingredients or carry a "Contains wheat" statement (required under 21 U.S.C. 343(w)(1)(A)). If it does, the word "wheat" must be followed by an asterisk or other symbol that points to this statement, placed close to the ingredient list: "The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods." Without it, the food is deemed misbranded [15].
How FDA checks compliance (§ 101.91(c))
- Testing: when FDA tests a food, it will use a scientifically valid method that can reliably detect and measure 20 ppm gluten in many food types, raw and cooked or baked [16].
- Fermented or hydrolyzed foods (no valid test method available): the manufacturer "must make and keep records" showing three things [17]:
- Foods with fermented or hydrolyzed ingredients: the manufacturer must keep the same kind of records showing those ingredients are gluten-free [21].
- Keeping records: they must be kept for at least 2 years after the food enters interstate commerce. They may be originals, true copies or electronic, and must be provided to FDA for examination and copying during an inspection if asked [22].
- Distilled foods: FDA will check compliance by confirming that no protein is present in the distilled component, using valid methods [23].
State laws (§ 101.91(d))
States and local governments may not set or keep any requirement for defining or using "gluten-free," "no gluten," "free of gluten" or "without gluten" that differs from this section [24]. State rules on these claims therefore can't depart from the federal rule.
Related provision
An ingredient made by hydrolyzing gluten has to name its source. For example, "hydrolyzed wheat gluten" is an acceptable name, while "hydrolyzed vegetable protein" and "hydrolyzed protein" are not (§ 102.22(a)) [25].
How do the rules differ from gluten-free certification?
The FDA rule is legally binding. Gluten-free certification is a voluntary private programme that FDA does not run, endorse or accredit. On a packaged food you may use a "gluten-free" claim under 21 CFR 101.91 with or without certification, and a certification logo is allowed on the label if it is truthful and not misleading. Being certified doesn't replace meeting the federal definition.
Approach: I searched the eCFR food labeling rules (21 CFR Parts 100-169) and FDA's Human Foods Program guidance catalogue, then opened FDA's gluten-free labeling page, its Small Entity Compliance Guide and its Q&A on the final rule. The datasets and FDA pages don't hold the standards of individual certification bodies (their thresholds, audits or testing schedules), so I haven't given figures for them.
Side-by-side
| Point | FDA rule (21 CFR 101.91) | Gluten-free certification |
|---|---|---|
| Legal status | A food carrying the claim that doesn't meet the definition "will be deemed misbranded" [13] | FDA "does not endorse, accredit, or recommend any particular third-party 'gluten-free' certification program" (FDA Q&A) |
| Is it required? | The claim itself is optional, but any food that uses it "must conform to our definition" (FDA Small Entity Compliance Guide) | Optional; FDA lists it as one quality-control option a manufacturer might choose (FDA Q&A) |
| Gluten limit | Any unavoidable gluten must be below 20 ppm [12] | Set by each programme; not in the sources I opened |
| Testing | "The regulation does not require manufacturers to test" ingredients or finished foods (FDA Q&A). When FDA itself tests, it uses a valid method that can detect 20 ppm [16] | Set by each programme |
| Records | Only fermented, hydrolyzed and distilled foods get specific treatment. Fermented or hydrolyzed foods, and foods with such ingredients, need records [17][21], kept for at least 2 years [22]. For distilled foods, FDA checks that no protein is present [23] | Programme audits and records are a private contract, not an FDA requirement |
| Who checks | FDA. It "does not have plans to authorize third-parties to inspect facilities" or to verify that foods meet the definition (FDA Q&A) | The certification body, under its own scheme |
| State rules | States may not set any requirement that differs from § 101.91 for these claims [24] | Private schemes aren't state law, so § 101.91(d) doesn't cover them |
What this means in practice
- A certification logo can sit next to the claim. FDA's Q&A says manufacturers "may include the logo of a 'gluten-free' certification program on their food labels, provided that its use is truthful and not misleading."
- A stricter private limit can go on the label. The rule "does not prohibit manufacturers from stating any truthful and non-misleading information," including "declaring the maximum amount of gluten the food may contain" (FDA Q&A). A lower limit claimed by a certifier can therefore appear, but the binding legal line is still below 20 ppm.
- Certification doesn't protect a product that fails the rule. If the food doesn't meet § 101.91(a)(3), it is misbranded whatever certificate it holds. The wheat asterisk statement in § 101.91(b)(3) still applies too [15].
- Oats: asked whether gluten-free oats must be certified, FDA answers "No," but oats labelled "gluten-free" "must contain less than 20 ppm gluten" (FDA Q&A).
- Other wording: statements such as "made with no gluten-containing ingredients" are allowed if they are truthful and not misleading (FDA Q&A).
- Restaurants: the rule covers packaged foods. FDA recommends that restaurants putting "gluten-free" on menus stay consistent with the FDA definition (FDA Q&A).
If you tell me which certification scheme you're looking at, I can check what its official documents say against § 101.91.
Sources: