Gluten Free Labeling

What about Gluten and Medications?

Learn about the Citizens' Petition to label gluten in medications, FDA docket item FDA-2015-P-5081, at Celiac Support Group's 12/29/15 blog post, Citizens' Petition To Label Gluten In Medications (link: Remember that your comments make a difference.  The comment period ends June 27, 2016.  To comment, enter the docket number in the search field at

In a separate effort to label gluten in medications, the Gluten In Medications Disclosure Act of 2015 was referred to a committee on 9/29/15.  Its progress through Congress can be tracked here:

What about Gluten and Foods?

How does the FDA define gluten-free for gluten-free labeling? Can a gluten-free labeled product be made in a facility that processes wheat? More...

Terms that might, or might not, appear on product labels:

“Contains wheat,” or “wheat” is language that's been required under Food Allergen Labeling and Consumer Protection Act (FALCPA) since 2006, whenever wheat is used as a product ingredient. FALCPA was passed to inform people who have allergic responses to wheat and seven other allergens. (Remember, Celiac Disease and the other gluten-related disorders are not allergies). Barley and rye ingredients are not required to be disclosed under FALCPA because they are not among the top eight allergens.

“Made in a facility (or on equipment) that processes wheat.” This is a voluntary advisory statement by manufacturers, allowed under FALCPA. This voluntary disclosure provides additional information to people who are so severely allergic to wheat that they might react to small amounts in a product, even when wheat is not an ingredient. Because barley and rye are not among the top eight allergens, this statement isn't used for them.

“Gluten-free ingredients.” No law covers this statement, which may be made for marketing or other purposes. It means only that wheat, rye, and barley are not used as ingredients in a product. The statement does not mean the product is gluten-free.

“Gluten-free.” This voluntary label under FDA final rule, Gluten-Free Labeling of Foods, effective in August 2014, is discussed more fully below.

None of the above. The absence of any of these declarations indicates only three things. Wheat is not present as a product ingredient. Barley or rye may be present as ingredients. Gluten (whether from wheat, rye or barley) may be present, even if no gluten grain is listed among the ingredients.

FDA Gluten-Free Labeling of Foods Final Rule.

The FDA published its Gluten-Free Labeling of Foods final rule in August 2013. The rule takes effect on August 5, 2014. Labeling a food product as “gluten-free” is voluntary. 

The FDA provides answers to 36 frequently asked questions about the gluten-free labeling rule at the FDA website (; search for Questions and Answers: Gluten-Free Food Labeling Final Rule).

A product displaying a “gluten-free” voluntary label will not contain, as an ingredient, any gluten grain, any gluten-grain product derivative not processed to remove gluten (like flour), or any gluten-grain product derivative processed to remove gluten (like wheat starch) if its presence results in 20 or more ppm gluten in the final product.

A product displaying a “gluten-free” voluntary label must contain less than 20 ppm gluten.

The “gluten-free” voluntary label can be used on products that are “naturally” gluten free.

Gluten free grains may experience cross-contact with gluten-containing grains during production. This is allowed under the U.S. Grain Standards. The “gluten-free” voluntary label may be used for these gluten free grains, as long as the cross-contact results in less than 20 ppm gluten.

It’s possible under the FDA Final Rule for a product to have both a voluntary “gluten-free” label and a voluntary advisory label (like ”made in a factory that also processes wheat products”). 

The Final Rule applies to foods only, including supplements, but not to drug products (whether or not prescription).  See also Gluten in Drugs - Action Steps Needed.

As a service, Celiac Support Group can arrange for Celiac Support Group Participants to purchase individual Glutentox Home test kits at Celiac Support Group's cost. These kits are designed to test for gluten at 5 ppm or 20 ppm, depending on personal needs, using the G12 antibody testing method developed in Spain. For more information about this product, visit here.  For more on how the G12 antibody testing has been used to distinguish among oat cultivars' potential immunogenicity for celiacs, see here.  Please contact us for more information about this service. 

Contact us for more information about Gluten Free Labeling.