FDA Conference Call Summary – GF Labeling Standards
On August 2, the FDA held a conference call to announce the reopening of the comment portion of the FDA gluten free labeling for 60 days.
Summary - My feeling after participating on the call is that the FDA officials on the call understand the critical importance to the health of consumers that the labeling be done right. They are soliciting thoughtful and substantiated comments from researchers, heath practitioners and gluten free consumers to help finalize the ruling, which it sounds like they will seriously consider. I would advise against emotional, derogatory, or unsubstantiated comments, so that they have serious information to consider.
Here are the main important points that were made:
- <20 parts per million of gluten as the proposed amount of gluten allowed in GF labeled foods was reached by a combination of studies, available reliable testing methods, and looking at other countries’ rules, but it is still open for comment
- These rules will pertain to food for human consumption only – not drugs, lotions, etc.
- It will not be mandatory to label products gluten free, but if you choose to, you will have to meet the guidelines (proposed <20 ppm)
- The research shows a likelihood that that <20 ppm meets the criteria of helping those with celiac avoid the health consequences but also make it feasible for companies who provide goods to be able to do so.
- The comments are open for 60 days, August 3 – October 2 and the final ruling is targeted for 3rd quarter next year.
- Oats will probably be allowed to list as gluten free assuming they have less than the proposed amount of gluten
- Corn products will be allowed to list as gluten free assuming they have less than the proposed amount of gluten
- Cross contamination is addressed only in that every product that labels gluten free will have to meet the proposed criteria for ppm.
- They are accepting comments on whether a standardized gluten free symbol should be used
- Both doctors that called in, including celiac guru Dr. Alessio Fasano at the Center for Celiac Research at University of Maryland indicated they are happy with the <20ppm number. Read the Center for Celiac Research’s paper “How Much Gluten Is Safe?”
- They are accepting comments on whether gluten should be added to the top 8 allergen list
- There is a broad range of consequences for those who don’t comply with the ruling – warning letter, injunction, seizure, detention, mandatory recall authority
- The pertinent scientific research and safety assessment that indicates <20ppm is safe will be made available to the public on the FDA website
“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”
The Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Include docket number FDA-2005-N-0404 on each page of your written comments.
If you missed today’s conference call, it was recorded and will be available for replay until September 2, 2011. To hear the replay, callers can dial 866-415-8391. International callers will need to dial 203-369-0700.