The Gluten-Free Clock Is Ticking. FDA Labeling Rules Take Effect Next Week.

Starting next Tuesday, August 5, 2014, FDA will enforce its gluten-free labeling rule. Companies will no longer be able to call their products “gluten-free” unless foods are free of wheat, barley, rye, and their derivatives-or unless ingredients have been specifically processed to remove gluten-and unless foods contain less than 20 parts per million (ppm) of gluten.

Although the “gluten-free” designation is voluntary, companies are increasingly denoting gluten content in response to rising demand for gluten-free products. According to Jennifer North, vice president of the National Foundation for Celiac Awareness (Ambler, PA), speaking during a webcast today hosted by the United Natural Products Alliance (UNPA; Salt Lake City), market researcher SPINS estimates that the U.S. gluten-free market reached $20 billion in February (including all product segments, such as supplements). Researchers, she says, predict a 10%-plus growth of gluten-free food sales through 2018.

“Gluten-free consumer inquiries are the second-most requested ingredient question across food industry sectors-and, as you all know, it can be very expensive for manufacturers and suppliers to field those questions and field them appropriately,” North said.

How many products are currently in danger of non-compliance with FDA’s gluten-free regulation-that is, foods labeled as “gluten-free” that don’t meet FDA’s gluten-free criteria? Up to 5% of products, according to FDA estimates, North said.

And what of cereal grasses-wheat grass, alfalfa grass, barley grass, and oat grass-which are increasingly popular in the healthy foods industry due to their wealth of vitamins, essential fatty acids, and antioxidants? FDA’s regulation covers wheat grain, but where do cereal grasses fall within the scope of FDA’s regulation?

Because cereal grasses are harvested before they mature and form gluten, these grasses should not contain the gluten that the mature grains contain. However, in order to use the “gluten-free” designation, manufacturers should still ensure that their cereal grasses meet the FDA’s threshold of 20 ppm. “Wheat grass might require a different testing method than barley grass would require,” North said.

“But,” she added, “I can tell you that the gluten-free consumers that we represent, which again are those who follow the gluten-free diet out of medical necessity, they are very skeptical about any wheat-based products. They don’t want them. You can talk about testing, and you can talk about the difference between the grain and the grass. There are still fears in the gluten-free community about ingredients that are derived from gluten-containing grains-even though the grass, again, is different from a grain. My understanding, and I would like to confirm this, is that wheat grass will be allowed if it’s verified, but whether or not the celiac consumer is one that would purchase is another question.”

FDA also permits “gluten-free” claims for products that “inherently do not contain gluten,” such as raw carrots and grapefruit juice. But North said such ingredients should still be tested.

“Typically, it’s the flours and grains that are highest at risk,” she said. “But that’s not always the case. Sometimes it’s surprising. Sometimes it’s like trying to find a needle in a haystack when you’re trying to verify ingredients, especially ones that seem like they’re low risk. For example, I was talking to a supplement manufacturer about 18 months ago. They test all of their incoming ingredients because they’re labeled gluten-free, and they’ve found that they’ve had to turn away orange peel several times. They find it often contaminated with gluten. It’s just pure, straight orange peel without any other ingredients in it. So, really, tracing the supply is very, very important.”

In its regulation, FDA says that it considers beta-glucan, derived from barley and often used in the dietary supplements market for supporting immune health, to be an ingredient in which gluten has been removed in the process of extracting desired polysaccharides. But other dietary supplement and healthy food ingredients will likely not be considered gluten-free, including modified and pregelatinized starches, dextrates, dextrin, and dextrimaltose and caramel coloring if barley malt is used.

As for “low gluten” or “very low gluten” claims that manufacturers may still independently to make, FDA says it will evaluate those on a case-by-case basis to ensure they are truthful and not misleading.

How long will the gluten-free trend last? According to North, 23% of Americans are looking to follow a gluten-free diet for reasons beyond medical conditions such as celiac disease. However, North said, many consumers still misunderstand what gluten and a gluten-free diet is. “A lot of the perceived health benefits of the gluten-free diet are really not attributable to eliminating gluten; they’re attributable to other things that are being done coinciding with a gluten-free diet,” such as eliminating dairy or sugar. As a result, North said she expects that some of the mainstream gluten-free demand will eventually “fall away.”

“We hope as an organization to drive awareness of what is healthy food, period, and what is the gluten-free diet. They are not one and the same,” she said.

Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine jennifer.grebow@ubm.com

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