Gluten Free Labeling is Coming - But, First, FDA Wants to Hear From YOU!!!!

Imagine a world where a manufacturer’s claims that their products are “gluten free” could be trusted by U.S. consumers.  Imagine a world where U.S. consumers were promised a definition of “gluten free” by the U.S. Food and Drug Administration (FDA), and the FDA held all manufacturers and importers to the same stringent standard….

Good news, we’re getting close!!

As of August 2, 2011, FDA has re-opened the comment period so that they can hear from YOU.  Yes, YOU!  FDA wants to hear from Celiacs, gluten sensitive consumers, et al. in the U.S.  Why, you ask?  Well, the FDA is firming up their definition of “gluten free”; and wants to know that the gluten free community is satisfied with the FDA’s finalized definition.  So, let’s make sure we tell the FDA what's important to us.  FDA has proposed a definition of "gluten free" in order for the term to be used on labeling of food products.

FDA’s proposed rule defines “gluten free” as products that do not contain:

1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
2. an ingredient derived from these grains and that has not been processed to remove gluten
3. 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) gluten
4. 20 ppm (parts per million) or more gluten

FDA wants to hear from the public and industry. The public comment period on the proposed rule will officially open after noon on Aug. 3, 2011, and will remain open for 60 days (until October 3, 2011). FDA prefers electronic comments, go to http://www.regulations.gov/ and

1. choose “Submit a Comment” from the top task bar
2. enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. select “Search”

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is tasked with making this happen, check out FDA's webpage which shows the safety assessment done to confirm 20 ppm is the correct standard to use.   

FDA held a conference call with industry, where the FDA allowed questions on opening up the comment period, and hopefully bringing truthful gluten free labeling to U.S. consumers soon.  Some questions asked where the methods in which FDA would test manufacturer’s products (answers were the Elisa R5 Mendez method, and Morinaga Method (currently used by the Japanese government for allergen labeling).  Presently, the Food Service and Products industry doesn't have to use these methods, but these are the methods FDA will use for enforcement.  

FDA is well aware that 20 ppm may not protect everyone, FDA wants your comments on this issue, what would truthful gluten free labeling be to you??  I was thinking about a range, 0-5 ppm, 5-10 ppm, 10-15 ppm, etc. to be included with “gluten free.”  FDA was also thinking about low/very low gluten labeling – but, what would be considered low?  What would be low or very low to you?  Tell the FDA!!

As far as timing goes, FDA will review the comments received, and is targeting the 3rd quarter of 2012 to publish a final rule.   

Yours truly asked the FDA about enforcement because I want to know how FDA will check on these products once these standards are implemented.  FDA advised there will be a compliance program set with the new rule, which will likely entail inspections, label review, (although I was hoping to hear about more lab testing of products).  Further, I asked about the size of FDA’s budget to assist in enforcement (once we all agree on definitions and a final rule comes to be…) but, there was no comment from the FDA on the budget to enforce (only a chuckle...).

We all think of the monsters out there who have preyed on Celiac’s/gluten free consumers, and did not in fact sell a gluten free product.  FDA will issue warning letters, seize products, issue injunctions, issue mandatory recalls, etc., when faced with manufacturers who are selling gluten free product that is NOT truly gluten free.

Let’s get to it, let’s tell the FDA you agree with 20 ppm, don’t agree, want low/very low standards (explaining what your tolerances are), or whatever your prospective may be.  FDA is listening, they want to hear from you, speak now!  You have until October 3 to have your voice heard before the final rule, and then, the hope is you will trust the products on your shelves that state, “gluten free”.