The U.S. food industry finally has a gluten-free rule to follow. Heeding the rule may involve trusting ingredient suppliers, or those who pay attention to farmer contracting, certification, handling practices and transportation issues. As evidenced by increasing sales and national surveys, reasons to enter the gluten-free category remain plentiful.

The Food and Drug Administration on Aug. 2 published a new regulation defining gluten-free for voluntary food labeling. It requires for a food with the gluten-free term on its label to contain less than 20 parts per million (p.p.m.) of gluten. The F.D.A. ruled gluten refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of those grains.

According to the F.D.A., gluten must be avoided by people with celiac disease, a chronic inflammatory auto-immune disorder estimated to affect up to 3 million Americans.

People without celiac disease are buying gluten-free products, too. According to Packaged Facts, the U.S. gluten-free market reached $4.2 billion in 2012 after experiencing a compound annual growth rate of 28% from 2008 to 2012.

According to a Mintel report issued in September of this year, the $10.5 billion gluten-free food and beverage industry in the United States grew 44% from 2011-13. About 24% of consumers currently eat, or have someone in their household who eats, gluten-free foods, according to Mintel.

“Perceptions of gluten-free foods have moved from being bland, boring substitutes for gluten-containing products to everyday items that appeal to those with and without a gluten allergy,” Mintel said.

Mintel predicts the gluten-free food and beverage market in the United States will grow 48% between 2013 and 2016 and reach $15.6 billion.

Patrick O’Brien, marketing manager, bakery and snacks, for Ingredion, Inc., Westchester, Ill., gave a reason for the differences in gluten-free market projections during an Oct. 24 webinar put on by Sosland Publishing and Baking & Snack, a sister publication of Milling & Baking News. Mr. O’Brien said Packaged Facts tracks traditional products that normally include gluten. Other reports may include gluten-free products that traditionally are gluten-free.

“All signs show that the (gluten-free) trend is going to continue,” Mr. O’Brien said.

He added four types of consumers buy gluten-free products: those with celiac disease; those with gluten intolerance or wheat allergies; those with health concerns such as irritable bowel syndrome, multiple sclerosis or ADHD; and those who have a “free-from” lifestyle and want to avoid certain items, not only gluten.

The gluten-free category, while offering sales opportunities, comes with potential consequences. Failing to meet the 20 p.p.m. mark may not only draw the F.D.A.’s attention. It also may sicken consumers. For people with celiac disease, a tiny bit of gluten may cause a reaction with symptoms that last for hours or days, said Alice Bast, president of the National Foundation for Celiac Awareness, Ambler, Pa., during a presentation July 16 in Chicago at the Institute of Food Technologists’ annual meeting and food exposition.

Gluten may enter the supply chain at many points.

Unexpected sources of gluten include spices, especially from international sources, and fermented ingredients like enzymes and bacterial cultures, said Joe Baumert, Ph.D., a professor in the Department of Food Science and Technology at the University of Nebraska in Lincoln, when he spoke July 16 at the I.F.T. event.

Ms. Bast said airborne flour in bakeries may lead to gluten cross-contact as might utensils and toppings in the preparation lines at delis.

Good manufacturing practices should be followed in the laboratory, said Jennifer Williams, senior applications scientist at Penford Food Ingredients, Centennial, Colo., at the I.F.T. event. Gluten-free items should be in sealed containers and kept on separate shelves. Documentation should be required from ingredient suppliers. Penford offers gluten-free starches for use in grain-based foods.

Didion Milling, Cambria, Wis., achieved certification for its corn products from the Gluten-Free Certification Organization, Auburn, Wash. The G.F.C.O. requires companies to have no more than 10 p.p.m. of gluten in the gluten-free products, which is half the amount tolerated by the F.D.A. ruling, said John Deininger, quality assurance manager at Didion Milling.

“The certification simply provides another level of confidence to guarantee that our products are gluten-free,” he said.

Didion does not process any gluten-containing grains. Didion Milling purchases locally grown whole corn, Mr. Deininger said. The corn is delivered using transportation vessels that are free of any other grains. Didion Milling has the ability to track batches of whole corn from farm to finished product.

“Corn products are a gluten-free alternative with a flavor and texture profile that consumers already enjoy,” Mr. Deininger said. “It is also label-friendly and available at a value-added price compared to specialty alternatives.”

Todd Giesfeldt, R.&D. senior product manager at Didion Milling, said, “Corn flour brings protein and starch to the recipe, making it a great ingredient for pasta applications. Viscosity-controlled corn flour provides a more uniform product in kneading machines and automated dough processing equipment. Our pre-gels — corn flour that’s been heat- and moisture-treated to give it specific properties — have great binding properties and provide stabilizing functionality. It all depends on the formula you’re putting together.”

Ingredion, Inc. showed how its ingredients may be used in gluten-free products through a cranberry oatmeal breakfast cookie prototype that uses Homecraft GF 20, a tapioca flour and rice flour system. Novation 4600 corn starch provides batter viscosity and moisture retention. Hi-Maize 260, a resistant corn starch, delivers 2.5 grams of fiber per serving.

Ms. Bast, who has celiac disease, said the quality of gluten-free products has improved over the past 20 years, back when the pasta’s texture was gummy and the bread was crumbly. Nutrition also has improved.

“It’s incredible,” she said. “We have come a long way.”

What about oats?

The simple answer is yes, oats may be used in gluten-free products in the United States. Complexity appears in the forms of cross-contact and exports.

According to the Food and Drug Administration’s gluten-free rule issued Aug. 2, grains such as rice, buckwheat or oats may be labeled gluten-free if the presence of any unavoidable gluten due to cross-contact situations is less than 20 parts per million (p.p.m.). Oats do not have to be certified gluten-free to be labeled gluten-free, according to the F.D.A. rule.

It’s not the same case up north. Health Canada, Ottawa, in June 2012 issued its position on gluten-free claims. It lumped oats in with barley, rye, triticale, or wheat, Kamut and spelt as ingredients that may keep a food product from achieving a gluten-free claim.

Oats, while naturally gluten-free, in some instances are grown on the same farms as wheat and harvested at the same time of the year, said Joe Baumert, Ph.D., a professor in the Department of Food Science and Technology at the University of Nebraska in Lincoln, during a July 16 presentation in Chicago at the Institute of Food Technologist’s annual meeting and food exposition. He added the same trucks and grain elevators may handle both oats and wheat.

“It’s fairly common to see wheat in oat products,” he said.

Some doctors recommend that patients, after being diagnosed as having celiac disease, not eat oats for 3 to 6 months after the diagnosis, said Alice Bast, president of the National Foundation for Celiac Awareness, Ambler, Pa., during the I.F.T. event.

Oats do offer nutritional benefits. They are high in protein and fiber content, said Rajen Mehta, senior director of specialty ingredients for Grain Millers, Inc., Eden Prairie, Minn. They are also high in selenium, magnesium, manganese, zinc and phosphorous, he said. Steel-cut oats have a glycemic index of 51.5. An F.D.A. allowed health claim says consuming soluble fiber from whole oats may reduce the risk of heart disease.

Gluten-free oats from Grain Millers, Inc. are certified to have less than 10 parts per million (p.p.m) of gluten, which is more stringent than the Food and Drug Administration requirements of 20 p.p.m., Dr. Mehta said.

Grain Millers offers a full line of gluten-free oat products, including oat flakes, oat bran, oat flour, oat groats and oat fiber and is GFSI Certified.

NSF International, a global public health organization based in Ann Arbor, Mich., certified ingredients, including oats, from Grain Millers as gluten-free. While oats are certified at less than 10 p.p.m., many other Grain Millers ingredients are available at less than 20 p.p.m. gluten.

NSF International’s gluten-free certification program meets the F.D.A.’s new regulation defining the term “gluten-free” for voluntary food labeling.

Grain Millers produces certified gluten-free oats through proprietary technical milling and specialized origination methods to ensure the oats stay below 10 p.p.m. for gluten, Dr. Mehta said. Extensive sampling and testing throughout the entire system from grain receiving to the pack lines assures every pallet is compliant with requirements.

A Grain Millers’ mill in Yorkton, Sask., handles only oats, including conventional, organic and gluten-free oats, Dr. Mehta said. Grain Millers also has a dedicated corn mill in Marion, Ind., and a flax mill in Newton, Wis.

“They can also do gluten-free,” Dr. Mehta said. “Thus it is across the board. We can do oats and all grains (and flours) across the board gluten-free, the exception being grains like wheat that have gluten to begin with.”

Ancient grains and ancient grain blends such as those containing amaranth, quinoa and sorghum are inherently gluten-free and thus, unlike grains such as emmer and spelt, may be processed to be gluten-free.

Grain Millers is able to guarantee gluten-free oat fiber of less than 20 p.p.m.

Protocol and packaging allows the gluten-free ingredients to maintain that status once they leave the Grain Millers’ mills.

“The level of the cleanliness of the trucks is amazing,” Dr. Mehta said. “When it leaves our plant and is shipped in full truck loads, it continues to be completely gluten-free until arrival at destination.”

Other gluten-free ingredient options

Beans, peas, corn and eggs are just some of the ingredient options for companies wanting to create gluten-free products.

Ancient grains: Nutrition benefits may come from using certain ancient grains in gluten-free products. Amaranth, for example, offers 13.6 grams of protein and 159 mg of calcium per 100 grams, said Vanessa Klimczak, product applications technologist for Bay State Milling Co., Quincy, Mass., during a presentation at the International Baking Industry Exposition Oct. 6 in Las Vegas. Other gluten-free ancient grains include quinoa (14.1 grams of protein per 100 grams) and teff (13.3 grams of protein and 180 mg of calcium per 100 grams).

ConAgra Mills, Omaha, also offers a line of ancient grains, including gluten-free grains amaranth, millet, quinoa, sorghum and teff.

Bread mixes: Watson, Inc., West Haven, Conn., offers gluteNone gluten-free bread mixes that require only yeast, oil and water to be added at the bakery. Potential applications include sandwich bread, raisin and fruit bread, specialty bread, sandwich thins, hamburger and hot dog rolls, English muffins, bagels, hoagie rolls and wedges, and pizza shells.

Beans and peas: A gluten-free webinar put on June 20 by the USA Dry Pea & Lentil Council, Moscow, Idaho, listed the nutritional benefits of pulses. Dry peas offer 23.7 grams of protein and 16.6 grams of fiber per 100 grams, said Dan Best, president of Best Vantage, Inc., Northbrook, Ill., who ran the webinar. Other pulses include regular lentils (26.3 grams of protein and 13.6 grams of fiber) and chickpeas (24.4 grams of protein and 8.7 grams of fiber).

Archer Daniels Midland Co., Decatur, Ill., offers ingredients based on soybeans and other edible beans.

“Gluten-free products are often made using refined flours and starches from rice, tapioca, potato and corn,” said Cheryl Borders, ADM research manager, soy foods applications technical service, edible beans in Decatur. “These ingredients are often lower in protein and fiber. Other non-wheat ingredients such as soy proteins and edible bean powders can help improve the nutritional profile of the finished product.

“When using non-wheat proteins, gums and gum/starch blends are often used in the formulations to provide structure. Xanthan or guar gum is frequently found in gluten-free baked goods.”

Cassava flour: American Key Food Products, Closter, N.J., offers King Lion premium cassava flour, which has been shown to mimic the structure, texture and taste of numerous wheat-based products with a single ingredient. It thus may eliminate the need for complex formulations of flours, starches and hydrocolloids commonly used in gluten-free products.

Corn: Grain Processing Corp., Muscatine, Iowa, uses corn in its gluten-free ingredients, including Pure-Dent B700 corn starch and TruBran corn bran.

Eggs: A team of researchers from Kansas State University in Manhattan, Kas., found eggs showed a distinct impact on gluten-free bread roll quality, increasing volume and cell elongation.

Sorghum: ADM Milling offers Harvest Pearl white sorghum flour and Harvest Pearl white whole grain sorghum flour, which add fiber and protein levels, said Brook Carson, director of R.&D. at ADM Milling in Overland Park, Kas. ADM sorghum flour is produced in a dedicated facility that produces only sorghum, she said. The Gluten-Free Certification Organization, Auburn, Wash., certifies the ingredients.

Yeast: The Celiac Spruce Association, Omaha, has certified Bellarise yeast to be at or less than 5 parts per million (p.p.m.) of gluten, which is even more stringent than the Food and Drug Administration requirement of less than 20 p.p.m.