In 2004, the U.S. Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) to require food manufacturers to clearly list any common foods or food groups that are known to cause allergic reactions on the product label (within or next to the ingredients section). This act was established to further protect those citizens who have allergies to the eight most common allergen-provoking foods: milk, wheat, soybeans, eggs, fish, Crustacean shellfish, peanuts and tree nuts. According to the FDA, it is these foods that account for 90 percent of all food allergies. The FALCPA kicked into effect on January 1, 2006 and has likely had a number of positive benefits for not only the majority of the estimated 15 million Americans who have food allergies, but also for those with food sensitivities.
But what about those who are allergic or sensitive to gluten, a complex protein-composite found in other grains besides wheat? This is, after all, a widespread issue going beyond those diagnosed with celiac disease. With estimations varying from 15-40 percent of the U.S. population suffering from some degree of gluten sensitivity, this is surely a food-labeling issue that the public should be concerned about. As a result of the FALCPA, the Secretary of the Department of Health and Human Services has been directed to come up with a concrete definition of the term “gluten-free” by the deadline year of 2008.
Currently in the United States, there has been no legislation passed which would require the FDA to regulate the term “gluten-free” listed on the label of food products. Although the FDA has published a proposed rule that defines the food labeling term “gluten-free”, the rule still has not been made final. This proposal was published in 2007, and despite a number of public-comment periods having been opened up for consumers and food manufacturers to weigh in on the proposal, no final decision has been made to legitimize the rule. Another meeting will be held in March, 2013 by the FDA where this topic will be discussed once again with the possibility of a consensus being reached. If so, under the current proposed definition of the term “gluten-free”, any food baring this label will not be allowed to contain any of the following:
- an ingredient that is a “prohibited grain,” referring to any species of wheat (such as durum wheat, spelt wheat, or kamut), barley, rye or their crossbred hybrids;
- an ingredient (such as wheat flour) that is derived from a “prohibited grain” and that has not been processed to remove gluten;
- an ingredient (such as wheat starch) that is derived from a “prohibited grain” that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 micrograms or more gluten per gram of food (20 ppm),
What is the reason for the delay?
It is possible that one of the reasons for the delay on finalizing the proposed “gluten-free” rule is because there is controversy surrounding the question as to what the upper allowable limit should be for the presence of gluten in a product labeled “gluten-free”. Since 2007, analytical methods used to detect the presence of gluten have improved, now being able to detect even lower levels than the previous 20 ppm. As a result of the various comment periods open to the public on the issue over the last five years, the FDA has taken into consideration opinions from consumers, doctors, researchers, and food manufacturers and noticed there are a number of people and some doctors who feel now that it is possible with advance analytical techniques to detect lower levels of gluten, the maximum allowable level should thus be lowered.
Is 20 ppm too high?
According to the Gluten Intolerance Group (GIG), while there is evidence that shows most people who have gluten sensitivities will not have reactions from consuming food that contain up to 20 ppm of gluten, there is also evidence showing there are some who are extremely sensitive to gluten and can have reactions to the presence gluten at even lower levels. However, this seems to be rare.
What’s the likelihood of lowering the ppm bar?
Due to the fact that a number of food products sold within the U.S. are imported from other countries it doesn’t seem likely. Countries have different food governing organizations which have conflicting definitions of what is allowable for the term “gluten-free” to be listed on the label. In Canada, the term “gluten-free” means that a food product must not contain wheat, spelt, kamut, rye, barley, oats, trilicate or any ingredients extracted from those grains. Whereas in Australia and New Zealand, in order for a food product to bare the gluten-free label, that food cannot contain more than 5 ppm of gluten. In European nations, the allowable threshold was lowered from 200 ppm to 20 ppm in 2008. It seems likely that until most of these food governing organizations jump on the same page and share a similar definition of what the label “gluten-free” should mean or at least lower the bar to that which Australia and New Zealand hold, it is likely that the allowable threshold for a “gluten-free” label for food products in the U.S. will be set at a maximum of 20 ppm when the FDA has finally legitimized their proposed rule.