On August 2, 2013, the U.S. FDA finally made a ruling about how and when food can be labeled gluten free (for Canada see here). This is welcome news for those who have been watching and waiting. It will create some uniformity in the packaging of food and make labels easier to read. This will help people with celiac disease determine which of the countless new food offerings are actually gluten free.
If you are new to the celiac disease community, you may not know that people have expecting a ruling by the FDA to formally declare its requirements for labeling gluten-free food for many years. In 2004, the “Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)” was implemented to help standard food labeling to protect people with both food allergies and significant intolerances such as celiac disease. The Act stated:
“SEC. 206. GLUTEN LABELING. Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall issue a proposed rule to define, and permit use of, the term ‘‘gluten-free’’ on the labeling of foods. Not later than 4 years after the date of enactment of this Act, the Secretary shall issue a final rule to define, and permit use of, the term ‘‘gluten-free’’ on the labeling of foods.”
By 2008, while guidelines were proposed, they were not enacted. In 2011, the proposed guidelines were reopened to allow for comments within a 60 day period. That time period passed. The FDA just announced the final guidelines, 5 years after they were supposed to be in place.
The guidelines are essentially the same as those proposed in 2007 and restated in 2008, which suggested the gluten-free label could be used if the food did not contain any of the ingredients below:
- an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
- an ingredient derived from these grains and that has not been processed to remove gluten
- an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
- 20 ppm or more gluten
The regulations now state:
The final rule defines the term “gluten-free” to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food).
The regulations are essentially the same as what was proposed in the past. By in large they are in agreement with similar regulations in other countries.
For example, the Codex Alimentaris, established by the World Health Organization (WHO) and the Food and Agricultural Organization of the United Nations (FAO), uses the level of 20 ppm which is the same as 20 mg/kg as the cut-off level to define gluten-free food. This level was chosen because most available tests cannot detect levels lower than this.
The difference is that in some countries, including many in Europe and Canada, a gluten-free food can have 20 ppm or less of gluten, while in the United States it must be less than 20 ppm.
Oats were a food source under debate as to gluten content. They can be labeled gluten free if they contain less than 20 ppm of gluten. During the prolonged period of FDA review, studies have been done that seem to indicate oats handled in a gluten-free facility are safe already.
It is unclear whether or not there are a substantial number of products that would hit the 20 ppm level exactly and be labeled gluten free in Canada, for example, but could not be so labeled in the United States.
With the growth of the gluten-free market, more and more companies are making gluten-free products. It is estimated that as many as 30% of people are now trying to eliminate or limit the gluten in their diet. Only about 1% of the population actually has celiac disease, and most of these people have not received the diagnosis.
The strict limits are important only for people with actual celiac disease. Studies have shown that people who actually have celiac disease can tolerate food with less than 20 ppm of gluten, which is another reason for the selection of this level for labeling.
Going back to the practical effects of the ruling, the FDA has given companies a year to meet these requirements. It is anticipated that many products already meet the guidelines. However, they are voluntary.
People with celiac disease have many more options than they did in the past. The gluten-free fad means that more companies make gluten-free food. Since most people buying it do not have celiac disease, the labels are not critical for them. But people with CD must read labels carefully. Once these regulations have been fully implemented, gluten-free food should be clearly labeled and easier to choose. There are already more products than ever, and the availability of gluten-free products is not expected to decrease because of the labeling regulations.
Anyone who wants an even stricter definition of gluten-free food can try and find products certified by the Gluten Intolerance Group, which contains the Gluten-Free Certification Organization (GFCO). This organization checks foods down to 10 ppm of gluten. It is not yet clear whether or not the new ruling will affect their practices. The FDA has said that it will continue to allow this designation along with FDA-approved gluten-free labeling.
Food Labeling; Gluten-Free Labeling of Foods (A Rule by the Food and Drug Administration on 8/5/2013)