The Food & Drug Administration (FDA) is preparing to release a regulation on the labeling of “gluten-free” food by the end of 2012. Although the regulation will provide much needed guidance to consumers and food manufacturers, it will also establish a standard that food manufactures will need to follow in order to use a “gluten-free” label. If food manufacturers use the “gluten-free” label without properly following the regulation, they could face lawsuits from consumers purchasing their products.
An increasing number of people in the U.S. follow a gluten free diet. Gluten is a protein contained in grains such as wheat, barley, rye and triticale. Packaged Facts, a Maryland based research firm, estimates that U.S. retail sales of gluten-free products in 2010 was $2.3 billion dollars, up from $1 billion dollars in 2006. The firm projects retail sales of gluten-free food to reach $2.6 billion in 2012, and $5.5 billion in 2015.
Although the recent increase in dollars spent in the gluten-free market presents opportunities to businesses, it also presents risks. People choose to follow a gluten-free diet for a variety of reasons, and some individuals require that food they consume be prepared in a completely gluten-free environment. If individuals with Celiac disease consume gluten, they may suffer symptoms ranging from gastrointestinal issues to neurological problems and cancer (PDF download). According to a 2010 study, 10% of gluten-free consumers purchase gluten-free products because they or a member of their household have Celiac disease or an intolerance to gluten, wheat or other ingredients. Scientists estimate that approximately 18 million Americans have some degree of gluten sensitivity. This requires that businesses take food labeling and food handling procedures seriously.
Confusion over what is gluten and what type of special handling is required to comply with a “gluten free” label has made the universe of food labels confusing to both gluten-free consumers and manufacturers. Food labels range from being marked “gluten-free,” “made with no gluten ingredients,” and “manufactured in a gluten-free environment.” Currently, a company can label a product as gluten-free regardless of whether the food has been tested for the presence of gluten.
McDonalds received a great deal of negative publicity in 2006 when the company admitted that the fries they had previously claimed were gluten-free, are actually prepared with an oil that uses hydrolyzed wheat bran. After an outcry from gluten-free consumers, McDonald’s removed fries from their list of gluten-free options and began labeling them as containing the allergen wheat. Although lab results indicated that no gluten was present in the fries, McDonald’s has not relabeled the fries as gluten-free (and appears to no longer have a gluten-free list at all) possibly out of fear of more lawsuits.
The FDA has twice opened the comment period for the public to weigh in on the agency’s proposed rule on how to label food as gluten-free. The proposed rule may require, among other criteria, that food bearing the claim of gluten-free cannot contain 10 parts per million (ppm) or more of gluten (available testing methods cannot reliably detect the amount of gluten in a food when the level is less than 20 ppm). 76 Fed. Reg. 46671, 46673 (August 3, 2011). This is also the rule in many European countries. Adopting the same rule in the U.S. could make the process of exporting U.S. manufactured gluten-free products to these countries easier for U.S. manufacturers. U.S. gluten-free consumers could benefit by a broader and easier to navigate market for gluten-free foods, which would include gluten-free food from European countries bearing the same label as U.S. manufactured gluten-free food.
The FDA has set a goal of establishing the regulation on the labeling of “gluten free” food by the end of 2012. Until then, manufacturers are left to decide which label is best to use—leaving gluten-free consumers and manufacturers confused.
We will continue to monitor and report on this issue as well as any further FDA developments. Should you have a specific question, please feel free to contact us.
Brian D. Gross is a partner at Cooley Manion Jones who has extensive experience in a broad spectrum of litigation. He is also a member of several corporate defendants’ national trial teams. 
Jonathan Tabasky has defended product liability and toxic tort claims throughout New England. Jon represents an array of companies, including those that manufacture prescription drugs, protective clothing, fittings, heating devices, wire and cable, trucks, aircraft and turbines. 
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Sarah M. Knoff is an associate with Cooley Manion Jones. She is a civil litigator who focuses her practice on commercial disputes and toxic tort litigation. 
Michael R. Brown is an associate in the Boston office of Cooley Manion Jones, where his practice focuses on commercial disputes and products liability actions. 
Peter J. Faben is an associate and a member of the Product Liability and Complex Tort Defense team in Cooley Manion Jones’ Delaware office. His practice focuses on toxic tort defense, as well as general commercial litigation. 
Carrie Lin is an associate in Cooley Manion Jones' San Francisco office. Her civil litigation practice focuses on tobacco and asbestos matters as well as the prosecution of employment class action matters. 
Daniel P. McCarthy is an associate in the Boston office of Cooley Manion Jones. Daniel’s practice focuses on civil litigation, toxic torts, professional liability, products liability, and business and commercial disputes. 
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Shaina Rasmussen is an associate in Cooley Manion Jones’ Products Liability and Complex Tort Defense Practice Group. Prior to joining CMJ, Shaina worked as a Direct Claims Manager and Mass Tort and Environmental Litigation attorney. 
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