Today FDA issued the finalized rule for gluten-free labeling and thereby standardized the meaning of this claim. This claim is essential for those with Celiac disease. Gluten is a protein found in grains, such as wheat, barley, and rye. Those suffering from Celiac disease must avoid gluten, as the protein causes an immune response that damages the small intestine’s lining and can cause other health consequences, which are sometimes severe. It is estimated that up to 3 million Americans have Celiac disease.
Those with Celiac disease have been waiting a long time for FDA to establish this rule. When Congress passed the Food Allergen Labeling and Consumer Protection Act (signed into law on August 3, 2004), they instructed FDA to finalize a rule for gluten-free claims in four years. Nine years later, FDA issued the final rule – only five years late.
FDA has provided the industry a year to revise its packaging/manufacturing practices to ensure compliance with the new rule. We expect FDA to be testing the products to survey the industry’s current compliance with the rule, and to being estimating how many resources to allocate to enforcement when the rule becomes a legal requirement. For products that fail to comply with the rule, FDA will issue at least an Untitled Letter (if not a Warning Letter) to the manufacturer.
When a label makes no claim about gluten, FDA will likely take the approach that the consumer needs to assume the product has gluten regardless of whether it contains a grain with gluten. However, when a product takes the affirmative step to claim that it is “gluten-free” FDA will require, among other things, that the product does not contain a gluten grain and that it tests below 20 parts-per-million for gluten.
If a product fails the gluten-free rule, then, beyond issuing an Untitled Letter or Warning Letter, we anticipate that FDA will pressure the manufacturer/distributor to recall the product in order to protect consumers, who have a reasonable expectation to rely on the gluten-free claim.
Now is the time for manufacturers to ensure compliance with the rule, to avoid the risk of FDA enforcement. The team at FDAImports.com can assist your business in compliance with this new requirement, as well as all aspects of food labeling and manufacturing.
