Gluten-free products abound in the marketplace. While consumers might select gluten-free products for several reasons, the manufacturers of gluten-free products must protect the segment of those consumers who are highly sensitive to the ingestion of gluten. Consumers with celiac disease must avoid completely avoid gluten and will respond to ingestion of trace levels of gluten. Consumers with wheat allergies are similarly susceptible to the ingestion of trace levels of gluten from wheat. While wheat-allergic consumers may be able to safely ingest barley and other sources of gluten, these consumers also likely rely on gluten-free products.
Accordingly, FDA regulates gluten-free label claims with the aim of protecting consumers with celiac disease or a wheat allergy. FDA definition of gluten-free is less than 20 ppm gluten or 0.002 percent. Manufacturers of gluten-free products must take appropriate steps to assure that products bearing gluten-free label claims have less than 20 ppm gluten. Similarly, ingredient manufacturers who sell ingredients to the gluten-free industry are expected to comply with the specification of less than 20 ppm gluten.