FDA’s New Gluten Free Labeling Rule: What you need to know

The celiac and gluten free community are abuzz over the new Gluten-Free Labeling rule (check out #GFis20PPM on social media) today and they have every reason to be!

The voluntary gluten-free labeling rule should have been issued by the Food and Drug Administration in 2008 as a result of the Food Allergen Labeling and Consumer Protection Act of 2004   But there were delays and now 10 years after FALCPA went into effect, today we in the gluten-free community now have a gluten-free labeling standard on our food.

Today Congresswoman Nita Lowey (D-NY), author of FALCPA, sent me a statement about the announcement: “These new consumer protections are an important, if long-overdue, step and a victory for families coping with celiac disease.”  Rep. Lowey also said, “I am pleased that our federal government has finally set clear uniform standards that will rein in a fast growing, unregulated market and provide consumers and families the tools they need to protect their health.”

What does the FDA’s Rule for Gluten-Free Labels mean?

There are a lot of nuances here and I just went through the 100-page rule and I wanted to give you some highlights:

1. Companies who choose to label their products gluten free will have to abide by the requirements by the FDA.  This is a voluntary rule, meaning companies will choose whether they want to label their products gluten free then if so they are REQUIRED to meet the FDA’s standards.  This is not a requirement for all companies to label their foods gluten free or not.
2. Companies who choose say “no gluten” or “free of gluten” must still follow the FDA’s rule for the “gluten-free” label.
3. To attach a gluten-free label, the food must be inherently gluten free, like fresh fruit or vegetables; not contain wheat, barley, rye or a derivative of that; cannot be from a gluten-containing grain that has been processed to remove the gluten (like some wheat starch), it must test below 20 parts per million of gluten.
4. Labeling must happen by August 5, 2014.  The FDA actually made an exception to move this deadline up.  Normally they have a uniform compliance date for any FDA food labeling changes between January 1, 2013-December 31, 2014. That compliance date is January 1, 2016.  But the FDA felt that “waiting until the FDA’s next uniform compliance date…would create an unnecessary delay in the enforcement of this final rule.”
5. The FDA is not requiring companies to say if a gluten free food is processed in a facility with wheat, barley and rye.
6. The FDA felt 20 PPM should be the standard criteria for measurement, rather than 10, 5 or zero.  It said good, reliable scientific testing methods are not currently available for testing for less than 20PPM.  Plus, the FDA stated, “celiac disease researchers and epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of gluten in foods (including levels that are less than 20 PPM) without causing adverse health effects.”
7. The FDA explained how it will monitor compliance:  The information states, “The manufacturer is responsible for ensuring that any gluten-free claim it makes on its food labels is truthful, not misleading and complies with FDA regulations.”  It says the FDA will use the “full range of its routine post-market monitoring activities to enforce the final rule on gluten-free food labeling”, including periodic inspections of facilities, food-label reviews and follow up on consumer and industry complaints.
8. USDA and the TTB (which oversees most alcohol) has been in contact with the FDA regarding the rules and what their plan will be.  Additional information will come out at a later date for beer that is overseen by the FDA.

I am happy this has finally come.  My family has been dealing with gluten free and reading confusing labels for 13 years when it was a zillion times more vague than it is even today.

Finally, the manufacturers have a standard they need to follow.  I know this standard may not help everyone with celiac or a gluten intolerance.  Plus, not everyone will be happy with the rules.  But it is a vast improvement to help us get safe food and hold companies, who want our business, accountable for their gluten free claims!

For additional information:  

FDA’s News Release

Questions and Answers: Gluten-Free Labeling Final Rule

Tags: celiac, FDA, gluten-free, labeling