Label Reading & the FDA

Covered:

• All FDA-regulated foods
• Dietary supplements (vitamins, minerals, herbs, amino acids)
• Imported food products that are subject to FDA regulations

Not Covered:

• Meat, poultry, and unshelled eggs (and any other products regulated by the USDA)
• Distilled spirits and wines that contain 7% or more alcohol by volume. These alcoholic beverages are regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB). The TTB states that alcohol beverages that are made from ingredients that do not contain gluten (such as wines fermented from grapes or other fruit and distilled spirits distilled from materials other than gluten-containing grains) may continue to make “gluten-free” claims. Products made from gluten-containing grains may be labeled with a statement that the product was “Processed,” “Treated,” or “Crafted” to remove gluten, if that claim is made together with a qualifying statement that warns the consumer that the gluten content of the product cannot be determined and that the product may contain gluten.
• Malted beverages made with malted barley or hops

A food product regulated by the FDA may be labeled gluten-free if:

• It is inherently gluten-free, meaning it does NOT contain wheat, rye, barley, or their crossbred hybrids like triticale (a gluten-containing grain) OR
• It does NOT contain an ingredient that is derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour) OR
• It does NOT contain an ingredient derived from a gluten-containing grain that has been processed to remove gluten (e.g., gluten-free wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food

Also, any unavoidable presence of gluten in the food (e.g., from cross contact) must be less than 20 ppm.

Yes. Food products that are naturally gluten-free, like bottled spring water or tomatoes, may be labeled gluten-free. However, this is not required.

Oats that contain less than 20 ppm of gluten may be labeled gluten-free. Oats do not need to be certified gluten-free by a third-party, but people with celiac disease should always choose oats that have a gluten-free label. Some people with celiac disease may have an immune reaction to the avenin in oats, a protein similar to gluten, even if labeled gluten-free. It is important to speak with your gastroenterologist or dietitian about whether you should include oats in your gluten-free diet.

No. The FDA has determined that consumers favor the label “gluten-free” to communicate that a food is free of gluten. Manufacturers are allowed to include a symbol (e.g., from a third-party certification) as long as it is truthful and not misleading.

No. Manufacturers are not required to test for the presence of gluten in ingredients or in the finished gluten-free-labeled food product. However, they are responsible for ensuring that the food product meets all labeling requirements. Manufacturers will need to determine how they will ensure this.

The FDA may perform food label reviews, follow-up on consumer and industry complaints, and analyze food samples. Consumers and manufacturers may report a complaint to an FDA Consumer Complaint Coordinator in the state where the food was purchased.

• Contact FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System. More information can be found on the FDA website.
• Consumers and manufacturers can also report any complaint they may have about an FDA-regulated food (e.g., potential misuse of gluten-free claims on food labels) to an FDA Consumer Complaint Coordinator for the state where the food was purchased. A list of FDA Consumer Complaint Coordinators is posted at FDA’s website. Reports should include:
  • the name, addresses, and phone numbers of persons affected and the person reporting the incident.
  • the doctor or hospital if emergency treatment was provided.
  • a clear description of the problem. Describe the product as completely as possible, including any codes or identifying marks on the label or container.
  • the name and address of the store where the product was purchased and the date of purchase.

The U.S. Food and Drug Administration defines “gluten-free” as foods containing less than 20 parts per million (ppm) of gluten. This threshold reflects the lowest level that can be consistently detected and enforced using current scientifically validated testing methods across a range of foods.

Although testing methods continue to improve, measuring gluten below 20 ppm remains difficult, especially in processed or complex products. The <20 ppm standard balances scientific capability with practical regulation.

Clinical data show that the vast majority of people with celiac disease improve on a gluten-free diet under this current standard, though individual sensitivity varies.

The Celiac Disease Foundation and The Society For The Study Of Celiac Disease supports the <20 ppm standard, which is consistent with international guidelines and current evidence.

Studies indicate that about 10 milligrams of gluten per day is unlikely to cause harm for most individuals with celiac disease. Total exposure depends on both the amount of gluten in foods and how much is consumed throughout the day.

The gluten-free labeling rule applies to packaged foods, which may be sold in some retail and food-service establishments, such as some carry-out restaurants. However, given the public health significance of “gluten-free” labeling, the FDA says that restaurants making a gluten-free claim on their menus should be consistent with the FDA’s definition.