The Truth Prevails! FDA Issues Final Ruling on Gluten Free Labeling

Gluten free labeling just took a giant step forward towards consistency and truthfulness with a recent ruling by the U.S. Food and Drug Administration (FDA). On August 2, 2013, the FDA issued the final rule on the definition of “gluten free” for voluntary labeling of food products. The ruling is issued under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCAP). This was welcome news to the community of people who are gluten intolerant or have Celiac disease. The ruling means there are specific requirements that must be met before a food product can be labeled as “gluten free”, “free of gluten”, “no gluten,” or “without gluten.”

The final rule defines gluten free as meaning the food does not contain 20 parts per million (ppm) or more of:

• A gluten-containing grain (must be processed)
• An ingredient derived from a grain containing gluten that has not been processed to eliminate the gluten or
• An ingredient derived from a grain containing gluten that has been processed and the use of the ingredient does not exceed the maximum gluten level (20 ppm)

Any food product that does not inherently contain gluten or there is an unavoidable presence of gluten must still meet the requirement of having less than 20 ppm of gluten, if it is labeled as gluten free. Any product labeled as gluten free or any of the other labels indicating the food is free of gluten that does not meet the 20 ppm requirement is considered misbranded by the FDA. A food intentionally (key word: intentionally) manufactured with wheat, rye, barley or their crossbred hybrids cannot be labeled gluten free unless the ingredients are first processed. After processing, the amount of gluten in the product must be below 20 ppm.

The ruling goes even further. It says that a food label saying the ingredients include wheat, and also claiming to be gluten free, is considered misbranded unless the label also states the wheat has been processed to meet the FDA 20 ppm requirement.

The Truth Will Set You (Gluten) Free

For years, the FDA has allowed food manufacturers to use the term “gluten free”, and lack of agreement on specific guidelines has made enforcement difficult. This created a serious problem for people who cannot tolerate gluten because they had no way of knowing if the food labels were truthful. The fact the FDA has issued the rule is proof the hard science about the causes of gluten intolerance and Celiac disease is accepted across the board.

With the ruling in place, the FDA can now enforce product labels, take samples and inspect food manufacturer operations. The FDA recognized that many foods already labeled gluten free can probably meet the new rule requirements. However, consumers had no assurances when reading labels that food manufacturers were accurately labeling products.

The FDA label means consumers can shop for foods in a safer environment. The gluten free foods cannot contain wheat, rye, barely or crossbreeds of these gluten containing grains. The gluten free label will also specifically indicate that the food contains less than 20 ppm after processing of foods that do use ingredients naturally containing gluten. One of the questions asked concerns the application of the rule to restaurant foods. The FDA believes this rule suggests that menus using FDA-defined food labeling claims must also meet the rule requirements.

Remain Alert During the Transition Period

The ruling takes effect 30 days after the Federal Register is published. A year after that date, the manufacturers must comply with the rule concerning labeling. At that point, the FDA has the power to label a product as misbranded and take enforcement action.

Therefore, beginning September 2014, consumers can shop with more confidence that labels are truthful. However, a word of warning goes to the wise: Be aware there may still be some misbranded products on retailer shelves should they fail to remove or replace pre-ruling items. It is important to continue being a cautious shopper and to buy products from reliable vendors.