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Slow rising loaf: After 6 years, FDA publishes final rule on gluten free labeling

By Hank Schultz , 05-Aug-2013
Last updated on 05-Aug-2013 at 15:44 GMT

After years in the draft stage, the US Food and Drug Administration has finalized its rule defining the term “gluten free” for voluntary food labeling. The final version contains no surprises, but will bring certainty to a market in which many firms have already been adhering to the standards proposed in the draft rule first published in 2007.

“I think that’s the big news, that they finally made it final,” Antonio Gallegos, a Denver-based attorney with the firm Greenberg Traurig told FoodNavigator-USA. “I don’t think industry forgot about it, but they may have thought that FDA did.”

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.” 

This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. It requires that, in order to use the term "gluten-free" on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.” 

Many already in compliance

In a press release that announcing the move, FDA said that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements. 

The term "gluten" refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains.  In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.  

Rooting out imposters

Gluten is ubiquitous in the North American food market, said food consultant Kantha Shelke, PhD. Shelke, who is the principal in the food consultancy CorvusBlue LLC, said it is one of the multifunctional food ingredients like salt, fat and sugar that formulators find it difficult to do without, and it may make its way into a “gluten free” product through a side door during processing. The final regs will clean that aspect up, she said.

“Gluten along with wheat and its by-products may appear in practically any prepared food or beverage.  Celiac patients and sensitive gluten-intolerant people avoided not only bread, pasta, couscous, bran, crackers, and foods made with flour, but also foods with obscure gluten-based thickeners and additives such as hydrolyzed proteins, beta-glucan, seitan, natural flavorings, and soy and hoisin sauces—minor ingredients that easily slipped through the cracks in labeling rules,” Shelke said.

“The new regulations expose these ingredients and other processing aids derived from wheat, oats, barley and rye. The gluten-free limits declared by the FDA will now banish the imposters off the gluten-free aisles and force product developers to be more mindful of their formulations and labels,” she said.

It could also help bring certainty to certain food service situations, Shelke said.

“Under the Americans With Disabilities Act, schools are supposed to make reasonable accommodations for kids on gluten-free diets.  The new regulation provides a guideline to institutional foodservice including school and college cafeterias and to help them separate fact from fiction,” she said.

If it's gluten free, why can it have some gluten?

A key portion of the final rule, one that has raised some controversy, is the 20 ppm level.  Some of the estimated 3 million Americans who suffer from celiac disease may react to gluten even at very low levels.  In the discussion portion of the final rule, FDA addresses this concern: “An important consideration is that, as the comments suggest, lowering the gluten level below 20 ppm will make it far more difficult for manufacturers to make food products that could be labeled as "gluten-free," thereby reducing food choices for individuals with celiac disease. . . Given the various factors we have to consider and the data available to us, we decline to revise the rule to adopt a safety assessment-based approach at this time.”

“The 20 ppm level is a reflection of reliable detection limits in the commercial market today.  With the development of more sensitive methods, this regulation is bound to be amended, and likely in the very near future,” Shelke said.

Another section of the final rule addresses the status of oats.  Oats are not on the list of “prohibited grains,” so the mere presence of oats will not disqualify the product from make a gluten free claim.  But FDA is encouraging manufacturers to disclose the presence of ingredients derived from oats on the label.

The real benefit of gluten free

With the certainty brought by the final rule, a level playing field is laid out that will support a growing market, Shelke said. And it may help separate fact from fiction when it comes to the real benefits of a food being gluten free.

“People lacking the basics of food and nutrition education (including the likes of Ms Gwyneth Paltrow) may continue to believe ‘gluten-free’ to be synonymous with ‘better for you’ and not realize that they are essential for a group of people with celiac sprue, a genetic condition, and for those with gluten-intolerance, an auto-immune condition.

“The educated type, who understand food science and nutrition, can easily separate the wheat from the chaff (no pun intended) and continue to rely on fruits, vegetables, meats, fish, eggs, beans, nuts and potatoes—foods that are naturally gluten free, as are some other grains and seeds such as rice, amaranth, quinoa, chia, flax, etc.,” she said.

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