Food Safety
TECH FLASH

Got gluten-free questions? Here are the answers

FDA released its new rule for gluten-free labeling earlier this month.

August 28, 2013
/ Print / Reprints /
ShareMore
/ Text Size+

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.

Did you enjoy this article? Click here to subscribe to Food Engineering Magazine.

Recent Articles by Shane O'Halloran

You must login or register in order to post a comment.

Multimedia

Videos

Image Galleries

Fabulous Food Plant: Paramount Citrus

Learn more about this fabulous food plant in Food Engineering's article, found here.

Podcasts

Burns & McDonnell project manager RJ Hope and senior project engineer Justin Hamilton discuss the distinctions between Food Safety and Food Defense as well as the implications for food manufacturers of the Food Safety Modernization Act.
More Podcasts

What was your favorite part of FA&M 2014?

View Results Poll Archive

THE MAGAZINE

Food Engineering Magazine

Food engineering magazine 2014 april cover

2014 April

Catch a preview of the Powder and Bulk Show in this April 2014 edition of Food Engineering. Also, be sure to check out a coffee stick making a real stir and a major advancement in the the pet food industry.
Table Of Contents Subscribe

THE FOOD ENGINEERING STORE

Food-Authentication-Flyer-(.gif
Food Authentication Using Bioorganic Molecules

This text provides critical tools and data needed to augment routine food analysis and enhance food safety by aiding in the detection of counterfeit, and potentially deleterious, foods.

More Products

Clear Seas Research

Clear Seas ResearchWith access to over one million professionals and more than 60 industry-specific publications,Clear Seas Research offers relevant insights from those who know your industry best. Let us customize a market research solution that exceeds your marketing goals.

Food Master

Food Master Cover 2014Food Master 2014 is now available!

 

Where the buying process begins in the food and beverage manufacturing market. 

Visit www.foodmaster.com to learn more.

STAY CONNECTED

FE recent tweets

facebook_40.pngtwitter_40px.pngyoutube_40px.pnglinkedin_40px.png