FDA to Issue Gluten-Free Allergy Labeling Rule in 2012 - Celiac.com

[Scott Adams]

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FDA to Issue Gluten-Free Allergy Labeling Rule in 2012 Celiac.com Celiac.com 04/26/2012 - A recent statement by the FDA announces that the agency is gathering data to respond to calls for an "alternative approach" to determining a specific gluten threshold level other than the proposed level of under 20 parts per ... Open Original Shared Link

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[Em314]

Not to revive a dead topic, but I've been hunting through threads- does anyone know the status of this? The FDA web didn't seem to explain this to me very well (I did dig around- found some stuff but nothing substantial).

[psawyer]

I will believe it when it actually happens.

In 2004, FALCPA said, in part:

SEC. 206. GLUTEN LABELING. Deadlines. Regulations. 21 USC 343 note.

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall issue a proposed rule to define, and permit use of, the term "gluten-free" on the labeling of foods. 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.

Um, the dates in question were 2006 for the proposal, and 2008 for the final rule. Still waiting. Yawn.

[Takala]

This article was from April.....

If you read it again, it says FDA intends to issue rules by the end of fiscal year 2012. The fiscal year for the Federal government of the U.S. does not match the calendar year. It runs from Oct 1 of one year to Sept 30 of the year it is named for, so Fiscal Year 2012 ran from Oct 1, 2011, to Sept 30, 2012.

However, when I clicked on the pdf link, "FDA," it looks to be a copy of the Dept of Health and Human Services Fiscal year 2013 on the page header. It says Food and Drug Administration page 138, Gluten Allergy Labeling. summary: Conducted safety assessment of gluten exposure in individuals with celiac, and published a Federal Register notice in August 2011, reopening the comment period for the proposed rule. But it says they intended to finish and issue the rule, by the end of Fiscal year 2012.

Open Original Shared Link

So they intended to have finished this process, 2 and half months ago.

LOL.

I think they are still in the process of "discovering" that there are more than 40,000 celiacs in the United States, and this continues to surprise them.

[Em314]

I know it was from April, but I wasn't able to find anything in the forum (or many other places, except what was already linked) on this topic since. I did look. And the FY2012 deadline was why I was wondering if anyone had any news- seems like there would at least have been UPDATES since April if they're behind their deadline (which always happens with such things, I know).

On a semi-cursory search, there also seems to be an alarming lack of really good research being used in the FDA's decision-making process. Studies seem to often have very small n's, high attrition (of course, when you think about it), and a lot of them are not only not double-blind, but also not single-blind (which is mind-boggling). Someone please correct me and link if I am wrong; Open Original Shared Link is the primary document I'm drawing that conclusion from. However, it's kind of alone the lines of common issues with medical research at large, unfortunately, so I can believe a lot of the research in the decision-making process is like this.

[kareng]

The reason you haven't seen anything lately is that it was not approved and it was set aside. That is what Takala and Peter were trying to say.

Here's a thread from Oct about a petition to try to get a vote/resolution on the bill.

https://www.celiac.com/forums/topic/97190-petition-for-gluten-free-labeling-on-white-house-website-celiaccom/page__st__15__hl__+fda#entry833685

[GFinDC]

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32,410 signatures now, and room for a few more.

[Takala]

If I am remembering correctly, they (FDA) outsourced the first commentary period on the rule change to a private company, it was not done on the FDA website, and the comment acceptance time period was short, and they did not want to be bothered unless the person was officially diagnosed as celiac, which, for technical reasons beyond our control, knocks some of us out of their persons of interest, because, as I said above, they're still surprised by the concept that there just may be more than 40,000 celiacs in the United States. If you are "just" gluten intolerant, you are in a less respected category to certain interests (except to the celiac and gluten intolerant researchers, whom have been trying to correct this misconception that you don't really exist with a real medical condition). This may be why you are not finding the answers to any customer/consumer/patient input surveys on the FDA website. This means.... I have no idea what the FDA did after they contracted out those surveys! They did send the former chemical industry FDA official to speak to some celiac groups working on the labeling, sort of like sending the ambassador to the next galaxy, we come in peace, just don't expect anything.

This contains a list of FDA Guidance of Regulatory Information, including the Gluten Category, in Topic - Specific Labeling Information

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  Quote

Gluten-Free

• 
  

  Federal Register Notice of Reopening of the Comment Period on the Proposed Rule:

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  • Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten May 2011
    Open Original Shared Link
    
  • External Peer Review of the FDA/CFSAN Draft Health Hazard Assessment for Gluten in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten December 2010
    Open Original Shared Link
    
  • Open Original Shared Link
    
  • Open Original Shared Link
    
  • Press Release 8/2/2011 - Open Original Shared Link
    

  [*]

  Open Original Shared Link January 23, 2007
  • Open Original Shared Link January 23, 2007
    

  [*]

  Open Original Shared Link July 19, 2005
  • Open Original Shared Link
    
  • Open Original Shared Link
    

There may be more information on their website, but this was the obvious list.

The press release from Aug 2, 2011, includes this:

_______

“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.”

_______

Then there has been a bit of push-back from certain lobbying groups on this, of course, all jockeying for Federal dollars for medical research, for the Farm Bill, for the export industry, etc. But I think they (FDA) are watching the expanding sales in the food industry of "gluten free foods" and seeing if it becomes a large enough industry faction to be forced to actually issue a voluntary labeling rule. If they set up their rule- needs criteria (accidentally) as to automatically weed out a lot of celiacs and gluten intolerants, or if they are behind in reading what the medical researchers claim, and what food sales seem to indicate is a real, growing amount of gluten free people, then they can be less motivated to be in any sort of hurry.

I have read an article recently in some business journal that I must not have bookmarked, I'm still looking for it, it was pretty funny. The author noted that gluten free foods were selling at an increasing rate, (maybe they based it on this story here, by Jefferson Adams,

https://www.celiac.com/articles/23103/1/Gluten-free-Market-to-Top-66-Billion-by-2017/Page1.html "Gluten Free Market to top $6.6 billion by 2017" ) but complained that the items were being purchased by people who were not diagnosed celiac, so it must be a waste. It had numbers it claimed were the number of undiagnosed purchasing gluten free food, I would love to see where they got that figure from. To me, this says the opposite, that there must be a large proportion of people out there who are not diagnosed with anything, but are self selecting foods that agree with them, in spite of what some magazine thinks about their shopping habits.

Now, HERE is a food reaction that is taken seriously, it's gone from about .4% of children reacting to 1.4% from 1997 to 2008. It is claimed that 1.3% of adults have the same problem, yet you would never see a serious "science" writer telling someone with a peanut allergy that they were just neurotic attention seekers making it up, or on a fad diet.

Open Original Shared Link

We likely have a lot more people with a "gluten problem," but because exposure doesn't kill you quickly, it isn't getting respected in the media. Yet.