We have until April 23, 2007 to have our voice heard by the FDA. They have issued its proposed definition of "Gluten-Free" as required by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
PLEASE speak up! The proposed definition is not simple. There are 95 pages in the docket. But in summary, the proposed, voluntary use of the term "gluten-free":
1. Does not contain wheat, rye, barley or cross bred hybrids of these grains.
2. Does not contain an ingredient derived from one of the above grains if use of that grain results in greater than 20 ppm gluten in the food.
3. Does not contain greater than 20 ppm gluten in the food.
4. Does not contain 20 ppm or more of gluten.
1. All oats cannot be claimed to be "gluten-free".
2. Oats products with 20 ppm or greater of gluten cannot be claimed to be gluten free.
The FDA is seeking comments and scientific info from the public regarding:
1. Appropriateness of 20 ppm gluten as the proposed threshold level as determined using an ELISA based method.
2. Effect the adoption of a lower threshold level would have on celiacs and on industry.
3. Scientific data or other info about whether the adoption of the lower threshold would be of benefit to celiacs.
4. Effect of a lower threshold level on the availability in the US of foods labeled gluten-free and whether that reduced availability could negatively impact individuals with celiac.
5. Proposal to restrict the types of gluten-free labeling claims that can be made for oats.
Comments are accepted until APRIL 23, 2007. To read the docket, link from www.csaceliacs.org.
IMPORTANT NOTE: while this FDA definition uses ppm limits to DEFINE the product, the CSA Recognition Seal schedules tests at 3 ppm to VERIFY that the Product, Process and Packaging are as "risk-free" as possible for eliminating wheat, rye, barley and oats, their crosses and their derivates from the diet.
NOTES ABOUT PPM:
1 part per million is equal to:
1. One penny in $10,000.
2. One minute in two years.
3. One dime in one-mile-high stack of pennies.
4. Four drops of ink in a 55-gallon barrel of water.
5. 1 milligram per 1000 grams or 0.001 milligram per 1.0 gram or 0.000001 gram per 1.0 gram (1000mg = 1 gram; One roasted peanut weighs about 1 gram. Now imagine dividing that into 1000 equal pieces. One of those pieces would weigh 1mg.)
The FDA has not issued a final ruling - but indications are that they will most likely choose LESS THAN 20 ppm. It also looks like they will not include oats in the definition! (YIKES)!
International standards use the Codex Alimentarius Commission standards, which are set at 200 ppm.
Canada sets a definition of less than 20 ppm for foods that make label claims of gluten free.
The Celiac Sprue Association (CSA) for the CSA Recognition Seal Program: assure to less than 3 ppm gluten!
The Gluten Free Certification Organization (a program of GIG): assures to less than 10 ppm gluten.
Less than 10 ppm = less than 0.01 milligram per 1.0 gram.
Less than 20 ppm = less than 0.02 milligram per 1.0 gram.
Less than 200 ppm = less than 0.20 milligram per 1.0 gram.
For example (ficticious numbers used for example): say you ate 1 slice of gluten free bread which weighed 47 grams. If it had less than 10 ppm, you'd ingest less than 0.47mg. If it had less than 20 ppm, you'd ingest less than 0.94mg. If it had less than 200ppm, you'd ingest less than 9.4mg.
A study at the U of MD School of Medicine, published in American Journal of Clinical Nutrition (vol 85, No 1, 160-166, Jan 2007):
49 biopsy proven celiacs went on a 90-day trial.
They were tested at 0 mg gluten, 10 mg gluten, or 50 mg gluten per day. One celiac was "challenged" at 10 mg gluten per day and developed clinical relapse.
CONCLUSION: Ingestion of contaminating gluten should be kept to lower than 50 MG per DAY!
Research by Carol E. Semrad MD, currently with U of Chicago, prev. w/Columbia Med Center, on the amount of gluten that actually causes intestinal damage: Damage is dose related, and Results indicated that it takes only as little as 1/8 tsp of wheat flour to cause damage.
[Note: 1/8 tsp of all purpose wheat flour contains about 25-30 mg of gluten. Wheat flour is anywhere from 8-14% protein depending on whether it's cake flour, all purpose or bread flour. High gluten flour is milled to be high in protein and low in starch. It's about 40-45% protein. According to Don Kasarda, former research chemist with the USDA, about 80% of the protein in wheat flour is gluten.]
Here's a question: if the CSA says they can detect gluten to 3ppm, why can't we have products labeled by this method? Personally, I want my food to have the least amount possible. I don't want to have to count/add my "ppm" all day now too.
PLEASE WRITE A LETTER TO:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm. 1061, (HFA-305)
Rockville, MD 20852
(It's important to write the docket and RIN numbers to be forwarded to the correct department and not the trash!)
When you write a letter, you speak for 300 celiacs. I hope we can make a difference.
fyi: my MIL almost just died from ingesting gluten by accident. I am not as sensitive, but maybe I will be by the time I get congestive heart failure at 70 yrs old, I dunno. She cannot afford 20 ppm a day. Please speak for sensitive celiacs and children who accidently ingest gluten (via dog foods, medications, beauty products).
Edited by: DOTSLADY at: 3/16/2007 (09:32)
KNOWLEDGE = POWER. BODY = TEMPLE. FOOD = MEDICINE. PREVENTION IS THE CURE. YOU ARE WHAT YOU ABSORB!
One person's food is another person's poison.
Celiac Disease: An autoimmune reaction from eating gluten grains: wheat, rye, barley and contaminated oats=nutrient deficiency=cancer. Have 1 of 300 symptoms? bit.ly/cdsymptoms
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