Could it possibly be? At long last, there’s some movement on the behalf of the gluten-free labeling movement. This is REALLY big news for people who are gluten-free in the U.S.! The FDA has re-opened a comment period for 60 days to solicit opinions from health professionals, scientists and the public on a potential ruling for defining gluten-free as less than 20 ppm.
Why 20 ppm? According Michael Taylor at the FDA at stakeholder teleconference on Aug 2nd, it’s the lowest amount that can be accurately quantified (quite a surprising comment, since many companies test to lower), and many leading experts believe it is a safe amount. Europe has used it for 20 + years. Several prominent researchers, including Dr. Alesso Fasano and Dr.Stefano Guandalini, spoke in favor of the new proposed legislation. “This is a standard that has been in use in Europe for almost two decades, & the science supports the U.S. adopting it as well,” commented Dr. Fasano. FDA also published a safety assessment as well regarding the safety level.
A final ruling is due out in the 3rd quarter of 2012, and per speakers “the FDA is committed to moving quickly” This regulation will only cover food for human consumption and will not cover medications, etc.
There were lots of fantastic questions about cross contamination, low gluten designations, symbols and much more. In most cases, FDA responded by encouraging people to comment.
I know this is a very, very hot topic and I hope anyone and everyone who has a vested interest in eating a gluten-free diet will take this opportunity to make your voice heard!
The comment period starts Aug 3rd around noon, and you can submit your comment here:
www.regulations.gov and entering Docket No. FDA-2005-N-0404
For more information and a statement from the FDA, please see:
My take: I think reflexively we all want the standard to be at zero, but first, we can’t get below what machines can detect (general consensus is around 3ppm). I also think the danger of not having a law is greater than the danger of the 20ppm, and at the point, best case scenario, we’ll have a law in effect in 2013. I want them to get on with it! I like the idea of having something uniform, standard and most of all, enforceable.
However, I feel like the most important job of the FDA is to explain the gap between the proposed 20 ppm and the safety report’s recommendation of 1 ppm. According to the Federal Register: “Currently, analytical methods that can reliably and consistently detect gluten at levels lower than 20 ppm do not appear to be available. In addition, it may be difficult or infeasible for food manufacturers to meet a lower gluten threshold level or that meeting a lower level could increase their food product costs. As a result, fewer and/or more expensive GF-labeled foods would be available to individuals with CD, placing them at higher risk of developing serious health complications from CD and other related diseases.”
Huh? There are still other programs out there which will certify foods at 5 and 10 ppm, such as CSA, GIG and NFCA, so it appears we have the technology. Also, by all accounts the GF marketplace is booming. I hope FDA provides a clearer answer AND expresses how they determined 20ppm was safe level for almost all Celiacs.
The rest of my wish list includes:
- Incorporate newer research, such as the studies that came out on gluten free grains and flours and cross contamination.
- Take this opportunity to define the “made in a factory” statements.
- Look closely at the issue of considering oats gluten-free, since there is still a good deal of controversy on the issue.
- I truly hope they do NOT go down the path of “low gluten”, which seems excessively confusing to people.
- I would love it if they would label gluten in medications, even though they were pretty clear it’s not on the table at this point
Agree? Disagree? What’s on your wish list? Whatever your view, I hope everyone who has a vested interest in this legislation takes the time to write into the FDA.
A very big thank you to the FDA for hosting this discussion and taking this next step, and to 1 in 133, American Celiac Disease Alliance, University of Maryland Center for Celiac Research and many, many others for getting this legislation moving again.