Earlier this month, FDA issued its final rule on foods claimed to be  gluten free, settling on a definition of less than 20 parts per million (ppm) of gluten. That rule will apply to products with claims including “gluten free,” “without gluten,” “free of gluten” and “no gluten,” eliminating uncertainty over foods’ gluten content and providing peace of mind for those with Celiac disease or gluten allergies.

“This is a tool that has been desperately needed,” says Andrea Levario, head of the American Celiac Disease Alliance. “It keeps food safe for this population, gives them the tools they need to manage their health and obviously has long-term benefits for them.”

Food Engineering asked class action defense attorney Kristen Polovoy of Montgomery, McCracken, Walker and Rhoads, for a legal perspective on the new gluten-free rule and its potential impact on food production operations.

Got gluten-free questions? Here are the answers.
Class action defense attorney Kristen Polovoy answered our questions on FDA's new gluten free standard.


FE: Do you think manufacturers will welcome FDA’s definition of gluten free?

Polovoy: Food manufacturers will either love or loath the FDA definition when it comes to competition issues. Companies that can satisfy the 20 ppm of gluten definition will love the standardized definition as “leveling the playing field” among manufacturers when it comes to eligibility to affix the gluten-free label to one’s product—i.e., everybody has to “earn” the label under the rules now.

But companies that do not even aim to manufacture gluten-free products in the first place may feel competitive pressure from the definition because many consumers in today’s health-focused marketplace—even those without celiac disease—equate “gluten-free” as somehow “better” than non-gluten-free and tend to buy gluten-free food over other choices.


FE:  How many manufacturers currently labeling their products “gluten free” are likely to have to reformulate (or risk litigation) due to a gluten content above 20 ppm?

Polovoy:  Technically, the answer to that question is that no companies will “have” to reformulate products. This is because the new FDA regulation defining gluten free is for voluntary food labeling. It is up to a manufacturer as to whether it wants to: (1) affix a gluten-free label to its product by reducing gluten levels to 20 ppm or less or (2) keep its over-20 ppm product as is but without gluten-free labeling. Whether manufacturers will reformulate their products’ ingredients to come in under 20 ppm is dependent upon the particular company’s marketing plan—such as whether it believes consumer demand for gluten-free products in its given industry is strong enough to warrant product reformulation to contain under 20 ppm and satisfy the new FDA definition. 

Bottom line: The FDA’s gluten-free labeling rule provides a uniform national definition for voluntary labeling, but does not mandate the use of gluten labels. Manufacturers have until August 5, 2014 to remove “gluten free” or similar claims from their labels on products that don’t meet the FDA’s definition.


FE: What penalties will manufacturers face if they are found not to meet FDA’s new gluten-free definition?

Polovoy: Since manufacturers aren’t required to test their products to ensure that they meet the 20 ppm standard in the new definition, we’re likely to see a spike in class actions  from the new definition, as plaintiffs’ lawyers might do their own independent lab checks of food gluten levels and then bring suits that allege that “gluten-free” labels on foods with over 20 ppm are false and misleading under state consumer protection statutes. 

Even if industry observers think the new definition doesn’t have real teeth in it because FDA is too overstretched in resources to police the market, I think we will see sufficient private policing by the plaintiffs’ bar, using state consumer protection statutes and gluten-free labels on foods over 20 ppm.


FE: What foods must adhere to the new definition?

Polovoy: Foods regulated by the USDA (most meat, poultry, eggs) aren’t covered by the new FDA definition, but all FDA-regulated food products and dietary supplements are. Companies should know the category into which they fall.