Following up on last year’s “gluten-free” labeling rule, the FDA has now published guidance to help industry interpret and apply the rule. All food products claiming to be “gluten-free” must comply with the rule by August 5, 2014. At its essence, according to the FDA, “gluten-free” means that the food does not contain an ingredient made from a gluten-containing grain unless that grain has been processed to remove the gluten and the remaining gluten in he ingredient does not exceed 20 parts per million. Food containing unavoidable amounts of gluten, such as from cross-contact, must still be below the 20 ppm threshold to use the “gluten-free” claim. The rule does not require testing of gluten levels, but a company using the claim is responsible for ensuring that its product meets the established threshold to avoid product being adulterated and/or misbranded.
Interestingly, FDA has specifically stated that the “gluten-free” claim can also be used on foods that do not inherently contain gluten. This conclusion seems somewhat at odds with other determinations that a technically factual statement can be used in a misleading manner, especially where all similar products share the same characteristic. For example, placing “gluten-free” on a package of raw carrots could mislead a consumer into thinking that other packages of raw carrots without the “gluten free” claim do contain gluten.