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.
However, even the best supplier program in the world can be quickly undermined if the manufacturer doesn’t follow GMPs and cross-contaminates or comingles gluten-free ingredients with others. Gluten-free products, ingredients, and processes must be segregated. This includes separate ingredient storage, product warehousing, distribution, preparation, and processing as well as personnel, equipment, and smallwares dedicated only to gluten-free processing.
All employees, including supervisors, should receive training that covers ingredients and processing as well as compliance with internal label controls and verification procedures. Employees who handle, formulate, process, and package gluten free products must receive specific training on awareness and proper procedures.
Considerations for Retailers and Specifiers. Like manufacturers and suppliers, retailers and specifiers must also have confidence in their sources of gluten-free products. A structured and well-managed supplier qualification program and approval process is essential. Verification through supplier certification or internal verification testing is a good approach. Separation and hygiene rules also apply in-store, especially for products that are exposed in merchandising.
Verification through supplier certification or internal verification testing is a good approach.
Third-Party Gluten-Free Certification
The final rule does not specifically require manufacturers to test for gluten in their ingredients or finished foods labeled gluten-free. However, manufacturers are responsible for ensuring that any gluten-free claim it makes is truthful and complies with FDA regulations. Quality control tools to accomplish this include conducting in-house gluten testing of ingredients and/or finished foods, employing a third-party laboratory to conduct gluten testing, requesting certificates of gluten analysis from ingredient suppliers, and participating in a third-party gluten-free certification program.
“Third-party gluten-free certification shows that companies have the right processes in place (including a quality management system, good manufacturing practices, supply chain assurance, and employee training) to prevent gluten contamination and to consistently stay below 20 ppm gluten,” says Jim Bail, director of food safety consulting at NSF International.
NSF International has seen a big increase in inquiries from companies about gluten-free certification since the FDA rule was announced. To earn certification under the NSF program, companies must have a gluten-free compliance plan and undergo onsite inspections of their production and handling facilities. Certification also requires ongoing compliance through annual manufacturing facility inspections and product testing.
NSF analyzes product labels for compliance, examines a company’s processes for shipping, receiving, storing, and handling raw ingredients and finished products, and verifies procedures for sanitation, quality control, testing, record retention, and product recalls.
During the onsite audit, an accredited inspector collects random product samples, verifies the company conducts appropriate raw ingredient testing or sources raw ingredients from a certified gluten-free supplier, and confirms that the manufacturer and its suppliers and handlers have procedures to prevent contamination and comingling.
NSF’s gluten-free certification program is ISO/IEC Guide 65 accredited and verifies that products contain 20 ppm or less of gluten in ISO/IEC 17025 accredited labs. NSF microbiologists test food samples using scientifically valid methods for replicable and reliable results. This includes a step-by-step, systemic approach and duplicate methods and controls for test validity.
Scientists use an analytical biochemistry assay with antibodies and a spectrometer to detect and quantify the presence of gluten. Specifically, NSF uses a sandwich-based enzyme-linked immunosorbent assay, or ELISA, kit from R-Biopharm, one of the same methods the FDA uses. The kit and recommended test procedures, which NSF follows, are performance tested by the AOAC Research Institute.
Global Food Safety Initiative (GFSI) standards (such as SQF and BRC) do not have specific requirements for gluten, but do require training, supply chain assurance, and GMPs. Companies with these procedures in place can combine GFSI and gluten-free audits, and companies already certified to a GFSI standard will likely already meet some of the requirements for gluten-free certification. Likewise, training, supply chain assurance, and GMPs are also core pillars of not only gluten-free compliance, but also of the Food Safety Modernization Act.
Gluten-Free Labeling Globally
Regulations for gluten-free labeling don’t stop at the U.S. border. Companies looking to export need to be aware of other regions’ requirements. In general, the 20 ppm requirement of the FDA rule is consistent with international standards, including Codex Alimentarius Commission’s revised Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten, European Commission Regulation No 41/2009 that concerns the composition and labeling of foodstuffs suitable for people intolerant to gluten, and Health Canada’s Food and Drug Regulations.
A difference is that the Codex Standard, European Commission Regulation, Australia New Zealand Food Standards Code, and Health Canada include oats as gluten-containing grains, whereas the U.S. final rule does not.
The Australia and New Zealand Food Standards Code is more stringent and requires foods labeled “gluten free” to have no detectable gluten. The code doesn’t define “detectable,” but current technology can test accurately to 3 ppm.
Some areas allow more than one level of “gluten-free” claim. In Europe, foods containing less than 100 ppm can bear the term “very low gluten” and in Australia and New Zealand, food containing less than 200 ppm of gluten can be labeled “low gluten.”
Bowen is general manager of NSF International Agriculture and QAI (Quality Assurance International). Reach her at 858-792-3531.
References Furnished Upon Request
According to a 2013 gluten-free report from Mintel, the $10.5-billion gluten-free food and beverage industry has grown 44 percent from 2011 to 2013 as the rate of celiac disease diagnoses and interest in gluten-free foods increase. Some 24 percent of consumers currently eat, or have someone in their household who eats, gluten-free foods. Perceptions of gluten-free foods have moved from being bland, boring substitutes to everyday items that appeal to those with and without a gluten allergy. In fact, three quarters (75 percent) of consumers who do not have celiac disease or sensitivity to gluten eat these foods because they “believe they are healthier.” —FQ&S