FDA finally defines gluten free

February 26, 2014 Uma Pisharody, MD, FAAP

On August 5th, 2013, the U.S. Food and Drug Administration (FDA) at long last published a formal rule regulating the use of the term "gluten free" on foods and beverages.  Even though this came with a big sigh of relief to the millions of people with celiac disease living in the US, consumers should be aware that the law gives manufacturers one year to be in full compliance (and goes into effect August 5, 2014).

As we head into the final months before the law’s final compliance date, I thought I’d highlight a few other key points about this brand new law:

1. No symbols needed.  The law does not require or recommend manufacturers use any particular symbol or food label, but if a label should include any of the following phrases, compliance must be ensured:

  • "Gluten-free"
  • "Free of gluten"
  • "No gluten"
  • "Without gluten"

2.  It’s voluntary.  A manufacturer may produce gluten-free foods, but just choose not to label them as such.   

3.  “Gluten-free” does not mean “zero gluten”. The new law defines "gluten-free" to mean that a food contains less than 20 parts per million (20 ppm) of gluten.  (This tiny amount can be visualized as less than a tenth of a grain of salt on a slice of bread, and is acceptable as the standard for people with celiac disease).

4.  As with any rule, there are exceptions.  Although the FDA’s new regulation applies to all foods and beverages (including packaged foods, dietary supplements, fruits and vegetables, shelled eggs, and fish), there are a few notable exemptions.    



  • Restaurant menus:  Although packaged and labeled foods sold in cafeterias and restaurants must comply with the new law, restaurant menus do not.  People with celiac must remain diligent in asking about gluten-free options when eating out.
  • Meat, poultry, and certain egg products.  (These foods are regulated by the U.S. Department of Agriculture, not the FDA)
  • Most alcoholic beverages (These foods are regulated by the Alcohol and Tobacco Tax and Trade Bureau)



Remember, celiac disease affects an estimated 1/100 people worldwide, and it’s estimated that there are about 3 million people living with this disease in the U.S. alone.  If you want to read more about celiac disease itself, I’d recommend you start with this blog about celiac by my colleague Dr. Karlee Ausk. If you have more questions about the law itself, you may find this resource helpful.


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