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FDA Conference Call Summary – GF Labeling Standards

August 2, 2011 by  
Filed under News

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.”

To submit your thoughtful and substantiated comments (August 3 – October 2, 2011) electronically:

USE THIS DIRECT LINK to find the proposed rule and other pertinent documents. “Submit comment” is a button on the top right: http://www.regulations.gov/#!documentDetail;D=FDA-2005-N-0404-0135

To submit your comments to the docket by mail, use the following address:

The Division of Dockets Management
HFA-305
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.

Comments

6 Responses to “FDA Conference Call Summary – GF Labeling Standards”
  1. Nancy says:

    Some comments on this post from our Facebook page -

    34 people like this.

    Wendy Butler: Let’s do this right for once FDA! AND let us know what is GMO! We know you CAN do it but, WILL you?

    Damon Saylor: Nice summary. Thank you.

    Michelle Watson: Is 20 ppm low enough? I don’t want to get sick and don’t want my kids to get sick.

    Jill Bradshaw: So, nothing that requires manufactures to lable gluten in products like with wheat is proposed unless gluten is added to the top 8 allergians list?

    Gluten Freeville: Jill -Doesn’t sound like it. These regulations are for Gluten free labels, not for gluten containing labels. Send in your comment beginning tomorrow that you want it in the allergen list! ~nancy

    Wanda Starr: Thank you for keeping us informed.

    Deanna McMillan: Michelle, 20ppm is the industry standard because it’s nearly impossible to detect lower levels of gluten than that.

    April Long: ‎20 ppm is not enough, it should be 0, traces of gluten makes my daughter sick.

    Ac Wood: Other Countries (Australia 3ppm), as well as the Gluten free certification board (10ppm)

    Debra Riedesel: Very nice summary

    Cassi Friz: we need lower than 20ppm- more than one serving could definitely affect a sensitive individual at those levels. plus, even with minimal levels, I would like to know if the food was manufactured in a facility w/ wheat/gluten-ingredients. no matter how low their levels, an individual should be allowed to choose either dedicated gluten-free or risk cross-contamination with the awareness that it is possible.

    Darlene Manz: This is serious!!!

    Anthony D’Annunzio: I think its a start in the right direction….a start….and if more people used fresh, organic, ingredients in cooking and things made from scratch you would not need to be staring at labels all day…..if their is a question whether something may contain gluten in it, research the product or just don’t eat and you will not get sick

    Shaunna Heibeck: I think there needs to be more FDA consideration for prescription drugs.. i can’t count how many times I’ve gotten more sick from taking medicine that is cross contaminated than it healing me. There needs to be dedicated gluten free medication manufacturers… even cross contamination is a HUGE problem bc I am so sensitive

    Bonnie J. Messenger: I can see problems with cross-contamination. When formerly safe products make me sick, it’s major. How will the standard address this? Will it be random testing of batches to prove 20ppm–which, without supervision, could be done at the end of a run of a product, instead of at the beginning when the previous item made on that line contained gluten…e.g. sun chips vs. lays potato chips,and hershey’s cookies and cream bars vs. regular milk chocolate bars, to name two situations that have led to cross-contamination issues for me. Manufacturers basically don’t WANT to change their methods. I believe that they’ll take any loophole and exploit it.

    Gluten Freeville: They said on the call that oversight will involve a combination of studying label accuracy, random testing by 2 methods that must agree and random on site inspections. There will be protocols put in place that companies have to abide by if they choose to label their products gluten free. Some will probably just remove the claim if they don’t fit the requirements, but if they choose to label, they will have to comply with the set limits. Consequences of violations are in the link above. ~nancy

    Darlene Manz: well I am very senstive and I do not like to be sick..I cannot function wen this happens.this is serious!!

    Darlene Manz Anthony: I eat raw foods diet..some times I want something..and i should be able..in this day and age to make something..and not have to worry..I get sic from something near a wheat item..it is crazy!!]

  2. Leisha Tringali says:

    I have Celiac Spru and Gluten Ataxia. It is important to know what ingredients are in the food products so that I don’t poison myself. Putting Labels on food products would prevent me from eating food with hidden gluten and could save my life.

  3. Claudia says:

    I don’t like this… any litte gluten contamination is devastating for me! How many doses of 20ppm would my body tolerate before having to suffer another contamination episode?

  4. Sarah says:

    I dont think its OK for people with a Disease and need GF in order to be health 20PPM is ok at all! Just because it does not kill me instantly its OK? What is the allowed PPM for Peanut??? I would be interested to know that comparison.

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  1. [...] Click here for my summary of the FDA’s announcement, conference call, and a link for submitting yo… [...]

  2. [...] wrote a post which outlines the substantive points of the FDA’s proposed guidlines.  You can read that here. To submit your comments on the FDA’s proposed guidelines on gluten-free labeling, go to [...]



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