A gluten-free diet is one that that does not contain the protein gluten. Gluten is found in grains such as wheat, barley and rye (sometimes in oats). Gluten causes inflammation in the small intestines of people with celiac disease. A gluten-free diet is required by patients with celiac disease (1% population) as it helps to control signs and symptoms and prevent complications.

Earlier in 2016, the FSSAI had notified the Food Safety and Standards (Food Products Standards and Food Additives) Second Amendment Regulations, 2016 relating to standards for gluten food and low gluten food. Correspondingly it made changes in Food Safety and Standards (Packaging and Labelling) Regulations, 2011 in packaging labels for gluten free and low gluten foods (rice, millets, ragi, oats, rye, barley, maize, wheat, pulses and legumes) specially processed to reduce gluten content to a level 20-100mg/kg.

Under these new regulations, FSSAI defined gluten-free food as food that consists of or is made of one or more ingredients containing rice, millets, ragi, pulses or legumes. A “gluten-free food” is one in which gluten levels are below 20 mg/kg. It also said that 

“A food which, by its nature, is suitable for use as part of a gluten free diet shall not be named as ‘special dietary’, “special dietetic” or any other equivalent term, however, such food may bear a statement on the label that ‘this food is by its nature gluten-free’.”

The Gluten-Free Food Labeling Final Rule issued by the US FDA in 2015 has defined "gluten-free" as meaning that the food either is inherently gluten free; or does not contain an ingredient that is:

• a gluten-containing grain (e.g., spelt wheat);
• derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or
• derived from a gluten-containing grain that has been processed to remove gluten (e.g., 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 must be less than 20 ppm. That is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with trace amounts of gluten without causing adverse health effects. 

Why didn’t FDA adopt zero ppm gluten rather than less than 20 ppm gluten as one of the criteria for a food labeled gluten-free?

FDA used an analytical methods-based approach to define the term gluten-free and adopted < 20 ppm gluten as one of the criteria for a food labeled gluten-free because the agency relies upon scientifically validated methods for enforcing its regulations. Analytical methods that are scientifically validated to reliably detect gluten at a level lower than 20 ppm are not currently available. In addition, some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of gluten in foods (including levels that are less than 20 ppm gluten) without causing adverse health effects. (https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm362880.htm) 

As per the FSSAI draft Food Safety and Standards (Labelling and Display) Regulations, 2018: The term “Gluten Free” shall be printed in the immediate proximity of the name of the product in the case of products described in regulation 2.14 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, namely ‘Gluten Free’.

The term “Low Gluten” shall be printed in the immediate proximity of the name of the product in the case of products described in regulation 2.15 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, namely: “Low Gluten”. The label shall carry a ‘warning’ that ‘the food labeled as Low Gluten may pose a risk for those with celiac disease.

But now the FSSAI has decided to take “Low gluten” label out of the regulation as in celiac disease no amount of gluten is safe. 

HCFI Recommendations

• The term “Low gluten foods” to be taken out of the label.
• Gluten free should instead be labeled as zero gluten (since the public perception is that gluten-free means some amount of gluten is allowed).
• Awareness should be created that ‘beer’ contains gluten and is harmful to gluten sensitive population. The harm reduction alternative is honey water wine, which has < 3% alcohol.
• There should be options for gluten-free foods in airlines and trains.
• In all parties, marriages and restaurants, there should be a provision for gluten free foods. Medical associations should pass a resolution to this effect on priority.
• Non-celiac wheat sensitive persons (up to 10% of the population) should be offered wheat-free food options.
• Wheat available in the market should also be labeled as high gluten wheat and low gluten wheat (both are harmful to celiac disease but low gluten wheat may have some solution for non-celiac wheat sensitive persons).

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA