New gluten-free requirements for food businesses

by | Dec 23, 2013

NCDA&CS food business specialist Annette Dunlap offers resources that agribusiness owners and food entrepreneurs can use to grow and manage their business. Annette is available for free one-on-one consultations and can assist business owners with financial and market planning through the agribusiness development section. She can be reached at


Gluten-free products have been available on the market for years to help the nearly 3 million Americans living with celiac disease. Today, more and more consumers are buying gluten-free products as part of their overall nutrition plan. This has led to a significant increase in products on the market that claim to be gluten-free. But, how can you tell if a product is really gluten-free?

In August 2013, the U.S. Food and Drug Administration issued a regulation that defines the term “gluten-free” for food labeling. The purpose of the rule is to standardize what “gluten-free” means on the food label. Companies wishing to make the gluten-free claim on their product will have until August 2014 to bring their label into compliance. After August 2014, a food that is labeled “gluten-free” but fails to meet the requirements of the regulation will be subject to regulatory action by the FDA.

Your decision to label your product “gluten-free” is voluntary. However, if you choose to label your product as “gluten-free,” you are accountable for using the claim in a truthful manner. You’re also required to comply with all regulations established and enforced by the FDA.

So what makes a product gluten-free?

According to the new regulation, if your product carries the label “gluten-free,” “no gluten,” “free of gluten” or “without gluten,” it must have contain less than 20 parts-per-million gluten. This is the lowest level that currently can be detected in foods using scientifically validated analytical methods.

The FDA has not outlined how frequently you have to test your product. In general, if you test your recipe and it meets the standard of less than 20 ppm of gluten, then you may continue to make the claim on your label. However, if you should change your formulation, or if you change suppliers, it is strongly advised that you retest your product.

Ultimately, the liability for the gluten-free claim rests with you, the manufacturer. Therefore, it is strongly advised that you have your formulation tested, even if your suppliers have given you copies of test results that show your product meets the gluten-free standard.

The new regulation does not outline requirements for food labeling. If you choose to make the gluten-free claim, you can place the claim anywhere on your food label, as long as it doesn’t interfere with mandatory labeling information and meets all regulatory requirements.

For more information on how the gluten-free rule applies to your food business, check out these resources: