Gluten-free certification and labeling: the FDA rule comes first

FDA gluten-free labeling: what the rule requires

Gluten-free certification and the gluten-free label claim are two different things. The claim is governed by federal law. FDA issued its final rule on August 5, 2013, and it now sits at 21 CFR 101.91. The claim is a voluntary claim: you may use it, and nothing forces you to. Once you print it, the food has to meet the rule.

The rule covers FDA-regulated packaged foods, including dietary supplements. It does not cover foods whose labeling USDA or the Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates. USDA generally regulates the labeling of meats, poultry, and certain egg products, and TTB covers most alcoholic beverages, including all distilled spirits. A food that carries the claim and fails the rule is deemed misbranded under federal law.

The table sets out the gluten free labeling requirements a small maker needs to know before printing a label.

Grains and ingredients that rule out a gluten-free claim

The limit is only half of the rule. FDA also looks at what you put into the food. According to FDA, a gluten-free food cannot be intentionally made with any amount of a gluten-containing grain, even if the finished food tests under 20 ppm. A recipe with a spoonful of wheat flour cannot be labeled gluten-free even if a lab test comes back low.

• Wheat in any form, including spelt, plus rye and barley. The rule names them as wheat, rye, barley, or their crossbred hybrids like triticale.
• Flour, bran, or other ingredients made from those grains that were not processed to remove gluten.
• Malt ingredients: FDA says malt-derived ingredients such as malt extract and malt syrup cannot be used in a gluten-free food, and the same applies to malt vinegar, which is fermented from barley malt and not processed to remove gluten.
• Regular soy sauce: in general, soy sauce made from soybeans and wheat cannot carry the claim or go into a gluten-free food. FDA allows soy sauce made without wheat or any other gluten-containing grain.
• Oats are allowed. FDA says oats do not have to be certified to be labeled gluten-free, but oats labeled gluten-free must contain less than 20 ppm gluten. Buying oats sold as gluten-free is one way to meet that limit.

Wheat starch is a common example that confuses people. It is made from wheat, but it has been processed to remove gluten, so the rule allows an ingredient processed to remove gluten, such as wheat starch, only if the food stays under 20 ppm. Using it also triggers the wheat statement described next.

How the claim sits with the wheat allergen line

FDA lists the major food allergens as milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame, so federal allergen rules apply to any food that contains wheat. You declare it either in the ingredient list, as in “flour (wheat)”, or in a separate statement such as “Contains wheat, milk, and soy.”. These rules reach retail and food-service businesses that package, label and offer food, for example a bakery that packages and labels its own goods.

If a food lists wheat and also says gluten-free, the rule asks for one more thing. The label needs an asterisk (or other symbol) right after the word “wheat”, pointing to this sentence near 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 label breaks the rule even if the food tests clean.

An advisory line about your kitchen is a separate matter. FDA allows it: an advisory statement such as “made in a facility that also processes wheat” may sit next to a gluten-free claim if it is truthful. The food still has to meet the full gluten-free rule.

Cross-contact in a home kitchen and on cottage food labels

Cross-contact is the main risk for a small maker. FDA notes that shared equipment used for foods with and without gluten could cause gluten cross-contact. In a home kitchen that means the same mixer, cutting boards, sifters, toaster and oven trays, and flour dust in the air from a wheat bake earlier in the day.

In a shared kitchen, one way to manage this is to separate by time and by tool: gluten-free batches first after a full clean, dedicated pans and utensils, sealed storage, and ingredients bought as gluten-free. FDA does not require testing, but it lists the tools makers use to stay under the limit: in-house testing, a third-party lab, supplier certificates of gluten analysis, or a third-party certification program. Keep supplier statements and any test results with your batch notes.

Cottage food labels add their own state lines. California, for example, requires “Made in a Home Kitchen” in 12-point type on the principal display panel, and its health department says cottage food products must be labeled under both state and federal rules. The gluten-free definition itself is federal: states and cities may not set a different definition for the gluten-free claim. Whether a cottage food law lets you sell a particular item, where you may sell it and what else goes on the label varies by state, and some cities and counties add their own rules. Check your state program before you print.

GFCO certification and other gluten-free certification programs

Certification is a private program that checks your products against its own standard and lets you print its mark. GFCO says its program not a requirement for gluten-free product labeling, and the Gluten-Free Food Program says certification and logos are not required for gluten-free products. Both set a tighter limit than the FDA rule and both publish some pricing.

GFCO is a program of the Gluten Intolerance Group (GIG), a 501c3 non-profit. Its certification is based on a review of all submitted products and their ingredients, plus facility audits, to an 80 point Standard. Under GFCO rules, every manufacturing facility must be registered before an application is accepted, and each plant is audited at least once per year. Its certification body is accredited to ISO 17065. The Gluten-Free Food Program (GFFP) says its certification involves an inspection of the company's systems and gluten testing.

GFCO sets its annual fee by company size, product risk and number of plants. A business with 10 - 49 employees pays from $2,180 a year to $4,240 a year for 1-5 plants. GFCO assigns the risk level only after a completed certification application and product list, and GFFP says its cost depends on the size and complexity of the company and the number of products, so treat these as starting points.

When retail buyers ask for certification

Selling at a farmers market, from a website or through a local cafe, the FDA rule is the legal baseline: a correct label and records that back it up. A customer with celiac disease may ask how you avoid cross-contact, so have a clear answer ready.

A grocery buyer or distributor may want proof beyond your label, since they cannot audit your kitchen themselves. GFFP puts its own view this way: retailers often favor certified gluten-free products. If a buyer names a specific program, ask which one before you apply, since the marks are not interchangeable.

Certification also means opening your production site to an auditor. GFCO says every manufacturing facility must be registered before an application is accepted, and it audits each plant at least once per year. Ask the program whether a home kitchen run under a cottage food permit can qualify before you pay for an application.

How to put a gluten-free claim on your label

These steps follow the FDA rule. They apply whether or not you later certify.

1. Check every ingredient

   Confirm no ingredient is or comes from wheat, rye, barley, or their crossbred hybrids like triticale, unless it was processed to remove gluten. Watch for malt, regular soy sauce and plain oats.

2. Get supplier statements

   Ask each supplier whether the ingredient is gluten-free and how it is handled, and request a certificate of gluten analysis where one is available.

3. Control cross-contact

   Clean before gluten-free batches, use dedicated tools where you can, and store gluten-free ingredients sealed and apart.

4. Decide on testing

   Testing is optional under the rule, but you are responsible for staying below 20 ppm gluten. A lab test on a finished batch gives you evidence if a customer or inspector asks.

5. Write the label

   Use one of the allowed wordings, declare wheat if present with the required statement, and add any state cottage food lines.

6. Keep records and re-check

   Keep recipes, supplier statements and test results. Re-check the rule and your suppliers on a set schedule, for example twice a year.

Where Nation fits

Questions about gluten-free certification and labeling