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FDA Issues Official Rule Defining Gluten-Free Foods

By Lucas Witman and Jazmine Woodberry

In August, the Food and Drug Administration issued an official rule defining specifically what it means for a product to be gluten-free. According to the newly minted standard, any product labeled “gluten-free,” “without gluten,” “free of gluten” or “no gluten” must contain no more than 20 parts per million of wheat, rye, barley or any other ingredient derived from these grains that has not been processed to remove gluten.

“This standard ‘gluten-free’ definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled ‘gluten-free’ meet a clear standard established and enforced by FDA,” said Michael R. Taylor, Deputy FDA Commissioner for Foods and Veterinary Medicine, in the official announcement from the FDA.

Gluten, the protein that occurs naturally in many grains, is detrimental to the health of many Americans, especially those with celiac disease. Celiac disease, an autoimmune disorder, causes the body’s natural defense system to react to gluten by attacking the inner lining of the small intestine. This can cause the body not to absorb necessary nutrients from the foods being consumed and can lead to nutritional deficiencies, osteoporosis, infertility, miscarriages, short stature, intestinal cancer and other maladies. It is estimated that 3 million Americans suffer from celiac disease, with another 18 million experiencing some degree of gluten sensitivity.

In recent years, awareness of gluten sensitivity and intolerance has exploded, resulting in a subsequent eruptive growth in the market for gluten-free products. According to market research firm, Packaged Facts, gluten-free product sales topped $4.2 billion last year. Thus, any change to the labeling standard for gluten-free products could have far-reaching industry-wide ramifications.

It is likely that most food companies that market gluten-free products will be largely unaffected by the FDA’s announcement, however, as the 20 ppm standard is already the unofficial one most companies currently employ. This is the figure most health officials agree upon as safe for those suffering from celiac disease, even for those who are severely sensitive to gluten. In fact, many gluten-free food producers actually adhere to an even stricter standard, ensuring that that their products contain no more than 10 ppm of gluten. Still, the FDA estimates that five percent of gluten-free products currently on the market currently contain over 20 ppm.

“This is great news for gluten-free consumers,” said Lucy Gibney, founder of gluten-free baked goods brand Lucy’s. Lucy’s markets a variety of cookies and brownies, all gluten-free, vegan, non-GMO and all-natural. “The U.S. FDA limit is about authenticity. Consumers now know what the ‘gluten-free’ claim really means, and manufacturers are held responsible for meeting the standard.”

Greg Vetter, CEO at Tessemae’s, a producer of all-natural, gluten-free dressings, spreads and marinades, expressed his pleasure with the FDA announcement as well. “It makes it a little bit easier for the consumer to have more trust in the products they are buying with the new FDA regulations,” Vetter said.

Although both Lucy’s and Tessemae’s already voluntarily conform to the FDA’s new 20 ppm or less standard, the companies support the rule as necessary for protecting the health of U.S. consumers and ensuring that those products with a gluten-free label are uniformly safe for consumption.

“When you are getting into all of these companies that are trying to create gluten-free products—cookies or pancakes—where things would historically have gluten in them, [it is important] that those people are doing what they need to be doing to protect those folks,” Vetter said.

“The new standard provides a definition, and it provides an expectation of accountability. Those two elements are reasonable when it comes to an important health matter for 21 million Americans,” Gibney said. “When this many people are affected, and the standard is so reasonable to meet, regulation is a good move.”

The FDA’s official regulation was published on August 5, and companies will have one year from the publication date to bring their labels into compliance.

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