Its been five years of comment periods followed by radio silence coming from the White House since the statutory deadline for final rules on gluten-free labeling has passed. And this month round three begins.
For the one in 133 Americans who have celiac disease (CD) and have not been able to safely shop for gluten-free packaged food products, some type of label regulations have been beyond eagerly anticipated. To date there is no legal definition for the phrase "gluten-free." This means that food manufacturers can use and label with that phrase as long as, according to the U.S. Food and Drug Administration (FDA), it is not "misleading." Because of this loose definition, food products have been sold with gluten-free labeling despite the fact that they contain gluten ingredients. Exactly why people still get sick from eating foods even though they are labeled gluten-free.
So on December 14th, 2012, when the FDA issued a proposed rule titled "Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of a Docket," needless to say hopes have been raised…again. A comment period on the proposed rules was open until February 12th, 2013, and an FDA advisory committee meeting is scheduled for March 7th, 2013. But looking back on the history of this, it’s important to manage expectations.
Nine years ago, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCP) was set in place to create and implement final rules for gluten-free food labeling. It charged the FDA to have final standards for gluten-free labeling in place by 2008, no later than four years after the enactment of FALCP.
The first glimmer of hope sparked in 2007, when the FDA issued a proposed rule "Food Labeling: Gluten-Free Labeling of Foods." That proposed rule – which is the same as what is being commented on now - states that a food can be considered gluten-free if it does not contain the following:
- An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains.
- An ingredient derived from these grains and that has not been processed to remove gluten.
- An ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) of gluten.
This 2007 rule saw no action, and the next peep on the topic wasn’t muttered until 2011, when the FDA reopened the comment period on these same proposed regulations. That comment period also closed, and again no action was taken. Bringing gluten-free consumers to 2013, with still no regulations in place.
According to a reporter from The Hill newspaper’s “Regulation Blog” this regulation has been named “economically significant,” meaning it has a cost of $100 million or more to the economy. And no, it’s not next in line: The Hill reports that currently 143 rules and proposals are sitting at White House’s Office of Information and Regulatory Affairs, 84 of which have been sitting for more than the 90-day review limit imposed on the White House. So time will tell yet again if we get any ruling one way or another. Meanwhile stay tuned and keep reading ingredient labels!