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Gluten-free products are everywhere: Food retailers carry numerous brands and restaurants have added gluten-free menu items. The once small U.S. gluten-free market is now a $10.5 billion industry, which is expected to grow to $15.6 billion by 2016.
But gluten-free products aren’t just the latest fad; for the 18 million Americans who suffer from gluten intolerance, gluten sensitivity or celiac disease, they are a necessity. To help assure customer confidence, the FDA issued a final rule last August that defines gluten-free label claims across the food industry. Food manufacturers have until August 5, 2014 to bring their labels into compliance with the new requirements.
The rule requires that foods labeled “gluten-free,” “without gluten,” “free of gluten,” or “no gluten” contain no wheat, rye, barley, or crossbreeds of these grains and no more than 20 parts per million (ppm) gluten. In addition, the rule contains the following details.
- Foods inherently containing no gluten (like raw carrots or grapefruit juice) may use the claim.
- Foods with ingredients of any whole, gluten-containing grain (such as spelt wheat) may not use the claim.
- Foods with ingredients of gluten-containing grains that are refined but still contain gluten (such as wheat flour) may not use the claim.
- Foods with ingredients of gluten containing grains that have been refined to remove the gluten (such as wheat starch) may use the claim as long as the food contains less than 20 ppm gluten.
- Foods that contain 20 ppm or more gluten as a result of cross-contact with gluten containing grains may not use the claim.
The final rule applies to all FDA-regulated foods and beverages, including dietary supplements. It does not currently apply to foods regulated by the USDA (such as meats, poultry, and egg products) or the Alcohol and Tobacco Tax and Trade Bureau (such as distilled spirits and malt beverages). Restaurants using gluten-free claims on menu items should also follow the rule.
As of August 5, FDA may use its full range of routine post-market monitoring activities to enforce the final rule, including periodic inspections of food manufacturing facilities, food label reviews, follow-up on consumer and industry complaints, and gluten analyses of food samples.
If a manufacturer uses a gluten-free claim on its packaging, but fails to meet the requirements of the FDA rule, the product may be deemed misbranded. FDA regulatory action against misbranded products includes monetary penalties, no-sale orders, product seizures, and/or injunctions. It’s important for companies at every stage of the supply chain manufacturers, packers, distributors, and retailers to have processes in place to assure they are not dealing in misbranded products, including components and packaging.
What Companies Need to Do Before Deadline
Before the final rule goes into effect on August 5, manufacturers must bring package labels, suppliers, and testing and quality systems into compliance. Retailers and specifiers have the same timeframe to establish purchasing and labeling expectations and disseminate them to their suppliers so the products they carry on store shelves comply with the FDA gluten-free final rule.
Considerations for Manufacturers and Suppliers. The FDA gluten-free definition of 20 ppm or less is clear, but the pathway to accomplish this has not been defined. Testing alone is not sufficient to ensure gluten-free compliance. Investing in a quality management system that evaluates supplier assurance, good manufacturing practices (GMPs), and ongoing training is the best option to demonstrate that products reproducibly meet the requirements of the rule.
In order to credibly support gluten-free claims, companies must control for gluten at every step in the supply chain. Suppliers must be able to produce, deliver, and document consistently gluten-free ingredients. This could involve assessments of processes and sub-ingredients, supplier certification, a supplier internal monitoring program, pre-shipment verification testing, and certificates of authenticity.