But manufacturers should be just as concerned about restoring confidence among the 21 million Americans eating gluten-free for medical reasons, as most of them worry about contamination, according to the nonprofit National Foundation of Celiac Awareness (NFCA).
Gluten-free labeling isn’t mandatory, but companies that voluntarily make this claim whose food products are FDA-regulated have to meet the agency’s definition, meaning the food must contain less than 20 parts per million (PPM) of wheat, rye, barley and their derivatives unless they’re processed to remove gluten. Currently, about 5% of manufacturers making gluten-free claims are not in compliance with the FDA’s definition, the agency found.
The FDA issued a final guidance last August under the Food Allergen Label and Consumer protection Act following a mandate issued in 2007 to create a standardized definition for gluten-free. (Read the final rule in the Federal Register.) The agency has also said it will examine independent claims not specifically spelled out in the guidance, such as “gluten friendly” and “low gluten”, reviewing them on a case-by-case basis to ensure they aren’t misleading.
“There’s still a lot of fear in the gluten-free community about ingredients containing wheat,” NFCA vice president Jennifer North told attendees of a webinar hosted by the United Natural Products Alliance on Thursday. “As I like to say, you almost have to have a PhD to navigate a gluten-free diet, which is why so many people live in fear of being contaminated. Most people get sick from it on a regular basis.”
Up to 70% of celiacs on gluten-free diets exposed to gluten and have intestinal damage
Based on doctor interviews, the NFCA found that upwards of 70% of celiac patients on gluten-free diets continue to get gluten exposure.
Moreover, a 2011 NFCA-administered consumer survey found that 99% of people with celiac disease are somewhat or very concerned about gluten contamination in food, beverages and supplements. More than three-quarters (77%) look for certification on labels and (68%) will call manufacturers to double check the status of gluten-free products, which can place a huge burden on manufacturers’ customer service lines, according to North.
“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,” she said.
Gluten-free consumer inquiries the second most requested ingredient question
That isn’t likely to subside anytime soon, either. SPINS estimates the market (including supplements) is currently worth about $20 million, with researchers forecasting gluten-free sales growth of at least 10% until 2018, North said.
Nearly a third (30%) of American adults are looking to either eliminate or reduce gluten in their diets—some for medical reasons, though many more because of perceived benefits. About 1% of the US population has celiac disease, though just 17% (500,000) have been diagnosed. About 6% of people have non-celiac gluten sensitivity (though there’s no currently no diagnostic test for this), and less than 1% suffer from related disorders such as wheat allergy and the neurological disorder gluten ataxia.
The remaining 23% of people who avoid gluten are doing so largely because of perceived benefits (this number includes gluten-free dieters and those reporting anecdotal relief from symptoms of MS, autism, ADHD, etc.). For those who perceive gluten-free food to be cleaner, easier to digest and generally healthier, much of that is unproven and North expects some of it will fall away. (Read more about celiac disease, gluten sensitivity and cultural wheat bashing.)
“A lot of the perceived benefits are not really attributable to eliminating gluten,” she said. “They’re attributable to other things coinciding with a gluten-free diet, such as eliminating sugar and dairy.”
Gluten testing not mandated; self-testing should only be supplementary
FDA regulation doesn’t mandate gluten testing, though the agency recommends ingredient verification, finished product testing and third-party certification to ensure compliance.
Although wheat and its derivatives can be denoted on labels in a variety of ways (i.e., einkorn, Kamut, durum flour, farina, etc), rye and barley (malt) are trickier because they’re not required to be labeled.
Moreover, numerous dietary supplements use wheat-containing inactive ingredients as fillers and binders—including modified wheat starch, pregelatinized starch, dextrates and caramel coloring. Other hidden sources include: oats (70% of the supply is contaminated with wheat), herbs, spices, spice blends, wheat starch (which can be separated from grain, but there’s a high risk for contamination), brewers, hydrolyzed yeast, and yeast extract.
Even pure ingredients can be exposed to gluten at certain points on the supply chain, making traceability key, North said.
“For products testing high coming out of dedicated facility, it can be like finding needle in hay stack. We had a customer—a supplement manufacturer—who had to turn away orange peel because it was often contaminated with gluten. Tracing that supply is very important, regardless of what happens inside your plant,” she added.
North expects to see robust demand for third-party certification from suppliers and manufacturers wanting to minimize risk, particularly because gluten testing requires such specialized knowledge. (There are extraction test kits for self-testing of products, though NFCA recommends manufacturers use them as supplements to third-party testing.)
NFCA endorses the Canadian Gluten Free Certification Program, an internationally recognized certification program that’s managed and administered by the Allergen Control Group. The GFCP uses a single process to certify products for distribution in the US and Canada, and manufacturers can select their own auditors. See more information here.