It has been a long road. The Food Allergen Labeling Consumer Protection Act (FALCPA) of 2004 has helped millions of people get better clarity in the ingredients in our food — for those who have issues with gluten — it has helped us identify sneaky wheat that had been hidden in “spices” and “natural flavorings” for years. But it doesn’t help with Gluten– even though it should by now.  And that’s why two US Senators stepped up this week to hold the FDA accountable for their inaction.

In 2004, FALCPA required the Food and Drug Administration to come up with a plan for voluntary gluten free labeling.  FALCPA states “Not later than 4 years after the date of enactment of this Act, the Secretary shall issue a final rule to define, and permit use of, the term “gluten-free” on the labeling of foods.”  Okay so that’s now three years past due.

This year the issue got a kick start again thanks to an awareness event spearheaded by Jules Shepard and John Forberger (founders of called the Gluten Free Labeling Summit. For a recap on this, you can read my post about the event, and a second post a few weeks after that included a follow-up interview with Shepard and Forberger.

Calling out FDA’s Inaction on Gluten Free Labeling

It was that renewed passion brought to DC this spring that has helped get these senators acting now.  This week, Senators Ron Wyden (D-OR) and Patrick Leahy (D-VT) sent a letter to the FDA commissioner asking what the holdup is.  According to, the letter stated,

“We ask that you provide us with an update on when FDA will promulgate a final rule, why FDA has taken so long to issue this rule, and if there are any legal or regulatory hurdles that have prevented the timely implementation of this legislation,” Letter to FDA Commissioner from Senators Wyden and Leahy

I believe the lack of  FDA guidance has led to companies feeling like they’re doing a good enough job of  “self-regulating” and testing their gluten free labeled products — which in many cases appears inadequate.  Without a standard who’s to know how gluten free a product really is?  The senators also pointed out that other organizations are taking it upon themselves to help guide food producers to a standard they deem safe.

“The regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of  ‘gluten free’ standards and labels provided by 3rd party groups.  This creates confusion for consumers, and hesitancy amongst producers on what their requirements will be,” the letter continued.

Many companies say their own standard is 20 ppm like the Codex guidelines in Europe, but this article points out the National Foundation for Celiac Awareness and Quality Assurance International’s partnership in creating new Gluten Free Certification label of 10 ppm.

The Food Navigator article, I think, unfairly characterizes the new program as a “scheme” (I think the word implies deception).  I believe there are organizations that have had enough with the delay and feel action needs to be taken.  But I also understand why the senators would say this creates confusion (10ppm or 20ppm?) among companies.  Clearly something needs to be done.

My take: the FDA’s foot-dragging hasn’t helped this situation.  Instead, it has created this kind of environment where gluten-free folks feel like they have to look out for themselves if the Government (who says they will look out for us) isn’t doing it’s job.

Thank you senators for the much needed support and push in this area.  We hope it moves things along.

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