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Hi Everyone,
I hope that the CD community will take action to make sure that FDA doesn't 
get away with allowing contaminated oats to be included in foods labeled as 
gluten-free under the FDA's Proposed Rule.   (Keep in mind that Congress 
required the FDA to come up with this definition as part of the 2004 law 
that protects American people with allergies and with celiac disease)

I am absolutely appalled that the FDA Proposed Rule does not designate oats 
as one of the prohibited grains.  The FDA notes in the Proposed Rule that   
“3 of the 4 major celiac associations in the United States  … take the 
position that oats are not an acceptable food for individuals with celiac 
disease.”  Why did the FDA choose to ignore the majority opinion about oats 
in the celiac community?  This is totally unacceptable.

Please take a few moments and make comments to FDA about this issue.  The 
comments that I’m sending to FDA are provided below for your information - 
please feel free to use any of the language in your own comments.    As 
other emails have noted recently, we can make comments via email or snail 
mail to the FDA for 90 days.
Diane

*******************************************************************************
To: Food and Drug Administration, HHS
Re: Docket No. 2005N-0279] RIN 0910-ZA26
Proposed rule, Food Labeling; Gluten-Free Labeling of Foods

I am extremely concerned that oats are not included in the FDA rule’s list 
of “prohibited grains.” As the grandmother of a child with celiac disease, I 
am worried about how this will increase the risks to my granddaughter’s 
health.

Since my granddaughter was diagnosed with celiac disease at the age of 18 
months, our family has carefully avoided any product with oats, based on the 
advice of doctors and literature regarding the disease.

Contamination of Oats with Prohibited Grains
The reason why we don’t want our granddaughter to take any risk of eating 
oats is clearly identified in the FDA Proposed Rule:

“…a major obstacle impeding general acceptance of oats in the diet of 
individuals with celiac disease is the concern about the commingling of oats 
with wheat, rye or barley that can occur during grain production, transport, 
storage, or processing” (excerpt from FDA proposed Rule, Background)

The FDA admits that contamination is a serious problem with current 
agricultural practices.   However, the FDA resorts to wishful thinking that 
these agricultural practices will change.  Where is the data to support the 
idea that the rule will serve as “an incentive for more manufacturers to 
produce such (gluten-free) oats?” (excerpt from FDA Qs&As)

The FDA’s vague hope for changes in agricultural practices would be 
laughable, if it weren’t for the threat this represents to the health of 
people with celiac disease.   We need protection from the FDA, not vague 
hopes.  The cross-contamination of oats with “prohibited grains” is a fact 
of life in agriculture and should not be treated so lightly in the FDA rule.

Irrelevance of Studies Regarding Oats
The FDA mentions recent studies showing that people with celiac disease can 
tolerate gluten-free oats.   These studies are not relevant because they 
were carefully controlled so that the oats were not contaminated by 
prohibited grains.  These studies do not prove that people with celiac 
disease can tolerate oats contaminated with prohibited grain; therefore, it 
is irresponsible for the FDA to rely on these studies in the Proposed Rule.  
The FDA should make oats a prohibited grain until studies prove that 
gluten-free oats are available and being used by manufacturers.

Need to Designate Oats as Prohibited Grain
I support the implementation of the FDA’s Option Seven, which is specified 
as follows in the proposed rule:

“Option Seven : Take Proposed Action, Except Include Oats in the List
of Grains That We Propose to Prohibit in Foods That Firms Label as
Gluten-Free” (excerpt from FDA proposed Rule)

The FDA’s analysis of Option 7 does not provide a reasonable basis for 
dismissing it:

“We could also expand the list of prohibited grains to include oats. Some 
consumers with celiac disease may be unable to tolerate some of the proteins 
that naturally occur in oats and may prefer to avoid oats in addition to 
avoiding the proposed prohibited grains and ingredients people make from 
those grains discussed in Option Two. However, other consumers with celiac 
disease may be able to tolerate the proteins that naturally occur in oats 
and, therefore, may wish to consume oats when following a diet that does not 
include gluten ….”  (excerpt from FDA proposed Rule, Background)

Obviously, any consumer who wants to eat oats can choose from a wide variety 
of oat products.   However, people with celiac disease who wish to avoid any 
oats in their diet depend on the labels indicating that a product is gluten 
free.

Our family knows that my granddaughter should not eat oats.  If the FDA 
implements Option 7, we will be able to trust that she is safe eating a 
product marked gluten-free.  If not, we will not know how to evaluate a 
product and its potential risk for my granddaughter.

I am outraged that the FDA Proposed Rule is ignoring that   “3 of the 4 
major celiac associations in the United States  … take the position that 
oats are not an acceptable food for individuals with celiac disease,” 
(excerpt from FDA proposed Rule, Background)

I urge the FDA to reconsider the Proposed Rule and select Option 7 and 
provide the protection that was intended when Congress passed the Food 
Allergen Labeling and Consumer Protection Act (FALCPA) in 2004.

Diane Meier

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