- A bill (H.R.9988) was introduced into the House on July 30th which would amend the definition of “major food allergen” in Federal Food, Drug, and Cosmetic Act (21 U.S.C 321(qq)) by replacing “wheat” with “gluten-containing grain.” The term “gluten-containing grain” is defined in the bill to include wheat, rye, barley, oats and crossbreeds of such grain (e.g. triticale). Major food allergens are subject to allergen labeling requirements.
- The bill would also require the Department of Health and Human Services to prepare a report addressing various issues related to celiac disease, including the collection of data related to its prevalence and severity, the development of effective diagnostics and treatments, and methods for preventing its onset and reducing risks related to the disease.
- Symptoms of celiac disease are triggered by ingestion of gluten proteins. Celiac disease affects an estimated 1% of the U.S. population, and, if not diagnosed and treated, can have devastating effects, including damage to the lining of the intestine and poor absorption of nutrients. Gluten avoidance is critical for those with celiac disease.
- While celiac disease is similar to an allergic reaction in certain respects, it is an autoimmune disorder and not an allergic response. For example, celiac disease is not mediated by immune specific antibodies like IgE, and celiac symptoms typically develop 48-72 hours after ingestion of gluten. Gluten can also cause non-celiac gluten sensitivities, but these reactions also are not allergic reactions.
- Currently, there is not a requirement that gluten be affirmatively disclosed in food labeling for the benefit of individuals with celiac disease. There is allergen labeling applicable to wheat-derived ingredients, and FDA has established criteria for voluntary gluten-free claims, 21 CFR 101.91.
- We will continue to monitor developments in this area.
