FDA “Gluten-Free” Proposal: Why 20 PPM is NOT Acceptable

FDA Releases Safety Assessment on Gluten and Celiac Disease and Reopens Comment Period on “Gluten-free” Proposed Rule

August 2, 2011

The U.S. Food and Drug Administration (FDA) today reopened the comment period for its 2007 proposed rule that stated that one of the criteria for food labeled as gluten-free is that they could not contain 20 ppm or more of gluten.  In the proposed rule, the FDA is committed to performing a safety assessment of gluten exposure in people with celiac disease (CD). FDA has completed a health hazard assessment concerning gluten (PDF, 462KB), which includes the safety assessment, and a report about this work (PDF, 292KB) was also released today.

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I have looked over the proposed rule on the acceptable amount of gluten that a person with Celiac Disease can have in one’s diet before there is any harm to their bodies. I read the 20 ppm amount which to a person that does not have Celiac seems 100% reasonable. After all, our bodies can tolerate varying levels of many different toxins such as arsenic, radiation, lead, heavy metals, contaminated waters, PM 10 from factories and large commercial vehicles etc — Our bodies are incredibly resilient and are able to process many things to protect its self.

So let me ask you a question: What if it was your son, daughter, or husband, niece, nephew, mother, father, had Celiac Sprue? How would you feel if the Food and Drug Association had been paralyzed for years over the issue of how much gluten was acceptable for your loved one to eat? How comfortable would you be if there was no scientific documentation to support, “to a medical certainty”  that  the “acceptable” 20, 100, 200, or even 1000 ppm  of gluten  in the food you bought wasn’t going to hurt your children, husband or your family. How would you feel?

If you would like an example of one woman who found herself up to her neck in this very scenario, simply read my wife’s story.

According to their website, the FDA’s origins can be traced back to the appointment of Lewis Caleb Beck in the Patent Office around 1848 to carry out chemical analyses of agricultural products, a function that the newly created Department of Agriculture inherited in 1862. Though its name and functions morphed and shifted over the years, its purpose has remained the same: to protect the public from companies or individuals making false claims about the quality or contents of their food and later their cosmetics, and medical devices.

Only in 1906 did the government create a law dictating the make up of commercial products, a law which hopefully, “would put a stop to food adulteration and quack remedies — the two major evils and targets of a 20-year crusade for federal regulation of foods and drugs.”

However, this first act contained many gaps and problems — such as the clause stating that a defendant had only to show that he personally believed in his fake remedy to escape prosecution. In 1937 the FDA went on a mission to close these gaps and fix what had been previously badly broken for over three decades.

“With the election of Franklin Roosevelt and the death in 1930 of the embodiment of the 1906 act–Wiley–the FDA now had a receptive ear to petition for needed changes in the law: legally mandated quality and identity standards for foods, prohibition of false therapeutic claims for drugs, coverage of cosmetics and medical devices, clarification of the FDA’s right to conduct factory inspections, and control of product advertising, among other items. A new generation of muckraking journalists and consumer protection organizations aided in pushing a reluctant Congress to sponsor a bill to replace the old law. The FDA itself exemplified the state of affairs in the marketplace by assembling a collection of products that illustrated shortcomings in the 1906 law. It included Banbar, a worthless “cure” for diabetes that the old law protected; Lash-Lure, an eyelash dye that blinded many women; numerous examples of foods deceptively packaged or labeled; Radithor, a radium-containing tonic that sentenced users to a slow and painful death; and the Wilhide Exhaler, which falsely promised to cure tuberculosis and other pulmonary diseases. A reporter dubbed this exhibit “The American Chamber of Horrors,” a title not far from the truth since all the products exhibited were legal under the existing law” (U.S. Food and Drug Administration: FDA History – Part Two)

 Such was the birth of The Federal Food, Drug, and Cosmetic Act.

Once again we as the American Public must put our faith and hope in the FDA! You can not condone 20ppm of Gluten for the community that has Celiac anymore than the FDA could allow the continued use of Banbar, Wilhide Exhaler, eyelash dye that blinded many women; numerous examples of foods deceptively packaged or labeled; or a radium-containing tonic that sentenced users to a slow and painful death – The latter which  we could compare to the Gluten issues we all face now. Although Gluten is not radioactive like radium is, it will have a similar affect on a person.

Let me share with you my fate as told to me by the top doctors of the Mayo Clinic in Arizona.

After a week of poking and prodding, testing, x-rays, blood test, stress tests, MRI’s, CT Scans etc… the doctor finally was ready to speak to me about the results. He walked in, sat down stared at me and said, “Your Screwed!”

Uh..is that a medical term?

He went on to say, “because you were misdiagnosed for so long the damage to your body is extensive, irreversible, and progressive!!!”

I understood the first two it was the last one I was curious about. I was told that my Celiac had been put into motion and that it had in so way caused a sequence of events to occur that could not be stopped. (even eating Gluten free). He said that I would be in pain the rest of my life and eventually my organs would just start to shut down and I would die. Now we all die but the Doctor was quick to point out that my life would be shortened considerably.

My first thoughts were of my 7 children and wife at home worrying about their father and how I could POSSIBLY deliver the news.

“Hi kids, Daddy’s skrewed.”

Fortunately, I happen to have the most amazing wife and children in existence, who not only supported their ‘skrewed’ father but helped him start a bakery. 

Now, I am on oxygen every night and sometimes carry it with me. (I should carry it full time but I feel that I look so pathetic and sickly with it I leave it at home.) I fall down stairs and go through the wall at the base. I’ve gotten lost in my own neighborhood twice and got disoriented many times in the parking lot not knowing how I got there. My back is in pain always on a scale of 1-10 I live at a 5 with pain medication of which I hate to take. I have incontinence on a weekly basis and I forget to do simple things like take a pan of boiling water off the stove until it melts the lid and pan and causes large amounts of smoke and fumes.

I will be 37 this August 25^th. I am a echo of the shadow of the man I once was. I cannot run and play football with my boys, hike with my daughters, or even run up the stairs without taking a break at the top or even the middle to catch my breath. If my neighbors son Sam, gets the slightest amount of Gluten in his diet, it sends his physical, mental and emotional health into a tail spin. My daughters have side effects of irregular cycles of PMS, hives, migraines, face breaks out, loss of energy, GI problems, brain fog, ear infections, kidney infections, and the list goes on and on. Because Celiac Sprue is an “Auto-Immune” disease it affect the immune system in our bodies. When our immune systems are compromised we can be susceptible to a whole myriad of infections, diseases, and medical issues.

Why am I so emphatic about gluten free MEANING NO GLUTEN? Because I don’t want this to happen to you or any of your loved ones. Because I don’t want any of my celiac children to eat something that claims to be safe but is slowly poisoning them.

A few weeks ago I had an intern that went to their first day on the job at a grocery store making ice cream cones for the guests. Her first shift was 5 hours approximately and every time a guest would ask for a Kong Cone she would pull out of a box a cone and fill it with ice cream. Sarah has a very high sensitivity to gluten since she has full blown Celica’s Disease. When she got home she found she had hives from her wrist, down the left side of your chest, stomach and left leg almost to her knee. Just from some random dust that dropped out of the box when she pulled the cone’s out one by one. There are Great Harvest’s Stores out there seeing that the Gluten Free market is expanding aggressively and so some of the franchises are making a bread they call “Gluten Free!” Now, they make it in the same pans, the same kneading boards and in the same room and even at the same time as the other breads. There is no way that could be Gluten Free. However, because the FDA has chosen not to accept the rightful and legitimate meaning of Gluten Free to be 0ppm and only 0 ppm is truly Gluten Free, there are people out there that mistakenly trust the labels thinking that the FDA has got a tight grip on the reins and are being put in harm’s way because of it. Children and adults are eating breads that they are told by false advertising, “Gluten Free” when in reality it is not. We are all different. For me the Celiac disease ripped my body from the inside out, and gone a little longer just a few months I would not be here writing this email to you know.

History has a way of repeating itself if we don’t learn the lessons that life sends us.

I quote:

“Languishing in Congress for five years, the bill that would replace the 1906 was ultimately enhanced and passed in the wake of a therapeutic disaster in 1937. A Tennessee drug company marketed a form of the new sulfa wonder drug that would appeal to pediatric patients, Elixir Sulfanilamide. However, the solvent in this untested product was a highly toxic chemical analogue of antifreeze; over 100 people died, many of whom were children. The public outcry not only reshaped the drug provisions of the new law to prevent such an event from happening again, it propelled the bill itself through Congress. FDR signed the Food, Drug, and Cosmetic Act on 25 June 1938″ (U.S. Food and Drug Administration: FDA History – Part Two).

Don’t make history repeat its self. How many people have to die before someone up on Capitol Hill stops and says, “I think it’s time to overhaul the FDA, again!” I realize that most people feel that Celiac Sprue is just a fad or a neurotic issue. I even have family that try to tell me it’s all in my head. But I can promise you, my pain is real, my health is diminishing, and my mental faculties are slowly slipping away. This condition is as real as it gets. The pain that I am in is only second to my family that must stand by and watch my body deteriorate.

Allow us as Citizens to count on the FDA to do the right thing. If it says “GLUTEN FREE” then that means 0% Gluten. Simple, direct and to the point. Saying Low Gluten only serves to confuse the public and continue to perpetuate ignorance of this very real and deadly disease. New Grains Gluten Free Bakery is 100% Gluten Free! 0.0 ppm! That is the threshold or standard that I expect from my team for the safety of our clients that depend on us to be honest and provide a safe, nutritious, and wholesome alternative to its glutinous counterpart. I would hope and expect your organization to do the same thing. “GLUTEN FREE” MEANS 0ppm of Gluten in the food. I appreciate the time you spent reading this lengthy message and your thoughts on this very important matter would be very appreciated.

Timothy W. Lawson