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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, April 12, 2012

Are Oats Gluten Free?

 For anyone that has struggled or is struggling with a dietary lifestyle change, such as going gluten-free it’s not always an easy task. Gluten is hidden in a variety of things; anywhere from condiments to meat-glue to alcohol.  As the changes begin to sink in, and avoiding the said ingredients becomes second nature a new detour comes into sight; cross contamination (insert scary music here). 

So what exactly is cross contamination and why did the scary music start? 

Cross contamination can be found in a variety of non-gluten grains; the most common being oats. But, as I already mentioned oats are a gluten-free grain, so what is the deal? 

There are several different ways cross contamination can affect gluten-free gains. Cross contamination can occur any time during the planting of the oat seed to the packaging of the grain for sale, and anywhere in between.  First of all oats are a seasonal crop, so many farmers will alternate growing oats with other grain crops such as wheat or barley. Leaving behind contaminates when the oats are planted.  Secondly, if neighboring farms are growing wheat, the wind can carry the wheat spores over to the oats, contaminating them. Then you need to know where the oats are processed. Are the machines that pick the oats and process the oats shared with any other type of grains? Then, even if they are processed in a gluten-free facility how are they being transported once they are harvested? 

I remember hearing a speaker at a seminar mention that a lab called Cyrex labs had done a study to see how much of the oats on the market were contaminated with gluten. The surprise that they found was that oats that were labeled as “gluten-free,” were at times more contaminated with gluten than were just regular Quaker oats! 

An incident at Whole Foods market brought this to consumers' attention when several children with gluten allergies were sent to the hospital after consuming products sold exclusively at Whole Foods that claimed to be “gluten-free.”

Another study published in the New England Journal of Medicine, took 12 containers of oats; 4 different batch numbers from 3 different brands (Quaker, Country Choice, and McCanns). Scientists tested all 12 containers for gluten contamination and found that:
  • 3 of the 12 containers contained gluten levels of less than 20 ppm
  • 9 of the 12 had levels that ranged from 23 to 1,807 ppm
  • All brands that were tested had at least 1 container of oats that tested above 200 ppm gluten
Although the FDA has not set criteria for what a “gluten-free” claim can be, they have proposed that any product that claims “gluten-free” must be tested to have less than 20 ppm of gluten detected. As of now there is no set regulation that requires products to guarantee that their claims of “gluten-free” are accurate. Sadly, as consumers we must merely trust that the food manufactures are complying with the voluntary guidelines that have been set, without truly knowing if the claims that they have made are 100% accurate or what degree of testing they have undergone. 

My advice to you if you know that you have a gluten allergy or intolerance, is to avoid manufactured products that claim to be gluten-free until an enforced standard is in place. You can also look for the Gluten Free Certification logo on packaging, which proves that the product has gone through testing to certify the gluten-free claim. The Gluten Intolerance Group of North America® (GIG) is a non-profit support organization that was founded by the Gluten-Free Certification Organization (GFCO). “Products that earn Gluten-Free Certification by the GFCO contain less than 10 ppm; half the gluten levels that the FDA has proposed as levels allowable in foods labeled gluten-free.” 

Then there are guidelines that go above and beyond that of the FDA and GFCO. The Celiac Sprue Association has determined their own guidelines for what they consider to be gluten-free. In order to help those with celiac disease choose uncontaminated food products, they have determined the following criteria:
  • Gluten-free products can not contain any form of gluten grain; this includes all species of wheat, barley, rye, and oats (WBRO). (Oats are not a risk-free choice for all celiacs. In vivo and in vitro studies indicate that some celiacs have an immune response even to pure, uncontaminated oats. Presently there are no indicators available to predict which celiacs may have such a response.) CSA
  • Source ingredients and additives can not be from WBRO grains
  • Ingredients that have been “specially processed” to remove gluten are not allowed.
  • All products must be tested to contain less than 5 ppm of gluten
  • ELISA testing to determine the level of cross contamination
To view a comparison against the different gluten-free definitions, click here

It’s not only oats that you need to be aware of, other non-gluten grains have been shown to be contaminated as well. Rice and Corn are ones that I would suggest to also be wary of. 

For a list of products that have been guaranteed gluten-free according to the Celiac Sprue Association standards, click here.  

Pura Vida!
Alica Ryan, NTP

Saturday, November 26, 2011

Day 271- FDA Nutritional Supplement Actions

The FDA has presented a troubling issue regarding nutritional supplements. A GUIDANCE issued by the FDA calls for such incredible constraint on the supplement industry that, if enacted, could truly have a profound effect on the availability of a vast array of products. Since virtually all of us, including myself, use dietary supplements, I urge you to take immediate action by sending the attached letters to your representatives. A text version is also at the end of this email – you may cut and paste it into an email to your elected representatives in Washington, but you will need to fill out a brief contact form first. I believe faxing is the best way to be heard. Feel free to change the letters and personalize them.

Follow this link for Website address for government contact information including mailing addresses and fax numbers for your Senators and Representatives. www.usa.gov/Contact/Elected.shtml

DEADLINE IS DECEMBER 2, 2011 FOR COMMENTS – The FDA is proposing certain regulations to impede, restrict, and ban dietary supplements. This has happened in Europe and other countries. Please help to stop it from happening in America!

The following are a few highlights of the Guidance document:

The FDA’s draft Guidance requires companies to possess exorbitant amounts of information concerning their existing dietary supplements to prove that New Dietary Ingredient (NDI) notifications are not required for the products they are currently marketing. In many cases, it will be impossible to gather such information, thereby threatening the future availability of numerous dietary supplement products on the market today.

In order to market a product that contains a new dietary ingredient, manufacturers will be required to submit a tremendous amount of information concerning historical use of the ingredient or conduct a multitude of animal and human studies which are overly burdensome and costly. Establishing such excessive requirements is both contrary to Congressional intent and unnecessary given the safety record of dietary supplements over the past few decades.

Any change in the manufacturing process of a dietary ingredient that results in chemical alteration of such ingredient or a change in specifications of the ingredient,regardless of how insignificant the alteration or change is, will require the submission of a NDI notification. This will discourage manufacturers from using the most advanced and efficient manufacturing technologies and pursuing methods that can improve the safety and effectiveness of dietary supplement products.

Any increase of the amount of a dietary ingredient in a dietary supplement or any change in formula of a dietary supplement, regardless of how minute or insignificant, will require the submission of a NDI notification. This will discourage the innovation of new products.

……………………………………………………… SAMPLE LETTER BELOW

November , 2011

To My Elected Representative:

My name is , and I am a constituent in your District. I am deeply concerned about the Food and Drug Administration’s (FDA) recently issued Draft Guidance document entitled New Dietary Ingredient Notifications and Related Issues.

Dietary supplements are an important part of my and my family’s health-maintenance routine. We consider access to affordable supplements to be a crucial part of our healthy lifestyle to mitigate the need for expensive medical procedures and promote good health to improve and extend our lives.

The FDA’s issuance of its draft Guidance is very troubling because it signals a dramatic shift in its policy towards dietary supplements, and I believe the FDA is attempting to establish a system of pre-market approval for these products. It has been nearly two decades since enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Back then the industry was in a fight for its life because of the FDA’s insistence on using the vague standards in the food additive provisions as a means of removing from the marketplace ingredients it disapproved of even for reasons unrelated to safety. The FDA abused its authority, and through a lot of hard work, we won the battle.

Now we find ourselves having to defend the very existence of this industry once again. While DSHEA purposely had drafted in it, a sensible and reasonable system by which the agency must be notified of the marketing of a new dietary ingredient and the basis for which the manufacturer believes that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe, the FDA has taken positions in its draft Guidance that indicate that it intends to treat dietary ingredients as food additives once again. Even more disturbing, is FDA’s insistence that any change in the formula of a dietary supplement that contains a new dietary ingredient will require the submission of a NDI notification. The agency has announced its intention that all dietary supplements containing new dietary ingredients be pre-cleared by the FDA. This is contrary to Congressional intent in passing DSHEA. If the FDA deems it necessary to make such drastic changes in the way dietary supplements are regulated, I think it should have to go through Congress. This is a bureaucracy that is out-of-control. It would needlessly restrict access to safe dietary supplement products, and is a job killer for the dietary supplement industry.

As a concerned constituent in your District, I am requesting that you do everything in your power to stop the FDA from enforcing DSHEA in a manner that is contrary to Congressional intent and in a manner that has the potential to destroy an industry that has brought so much good to so many people.


If you would like to send a letter to your representative to help stop this from going into affect, you can download the customized letter, here. Please help to keep our rights when it comes to nutritional supplements. I truly believe in the benefit of nutritional supplements and don't know where I would be without them, I hope I never have to find out.


If you would like to read more about this issue, click here.


Pura Vida!

Alica Ryan, NTP

Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, April 12, 2012

Are Oats Gluten Free?

 For anyone that has struggled or is struggling with a dietary lifestyle change, such as going gluten-free it’s not always an easy task. Gluten is hidden in a variety of things; anywhere from condiments to meat-glue to alcohol.  As the changes begin to sink in, and avoiding the said ingredients becomes second nature a new detour comes into sight; cross contamination (insert scary music here). 

So what exactly is cross contamination and why did the scary music start? 

Cross contamination can be found in a variety of non-gluten grains; the most common being oats. But, as I already mentioned oats are a gluten-free grain, so what is the deal? 

There are several different ways cross contamination can affect gluten-free gains. Cross contamination can occur any time during the planting of the oat seed to the packaging of the grain for sale, and anywhere in between.  First of all oats are a seasonal crop, so many farmers will alternate growing oats with other grain crops such as wheat or barley. Leaving behind contaminates when the oats are planted.  Secondly, if neighboring farms are growing wheat, the wind can carry the wheat spores over to the oats, contaminating them. Then you need to know where the oats are processed. Are the machines that pick the oats and process the oats shared with any other type of grains? Then, even if they are processed in a gluten-free facility how are they being transported once they are harvested? 

I remember hearing a speaker at a seminar mention that a lab called Cyrex labs had done a study to see how much of the oats on the market were contaminated with gluten. The surprise that they found was that oats that were labeled as “gluten-free,” were at times more contaminated with gluten than were just regular Quaker oats! 

An incident at Whole Foods market brought this to consumers' attention when several children with gluten allergies were sent to the hospital after consuming products sold exclusively at Whole Foods that claimed to be “gluten-free.”

Another study published in the New England Journal of Medicine, took 12 containers of oats; 4 different batch numbers from 3 different brands (Quaker, Country Choice, and McCanns). Scientists tested all 12 containers for gluten contamination and found that:
  • 3 of the 12 containers contained gluten levels of less than 20 ppm
  • 9 of the 12 had levels that ranged from 23 to 1,807 ppm
  • All brands that were tested had at least 1 container of oats that tested above 200 ppm gluten
Although the FDA has not set criteria for what a “gluten-free” claim can be, they have proposed that any product that claims “gluten-free” must be tested to have less than 20 ppm of gluten detected. As of now there is no set regulation that requires products to guarantee that their claims of “gluten-free” are accurate. Sadly, as consumers we must merely trust that the food manufactures are complying with the voluntary guidelines that have been set, without truly knowing if the claims that they have made are 100% accurate or what degree of testing they have undergone. 

My advice to you if you know that you have a gluten allergy or intolerance, is to avoid manufactured products that claim to be gluten-free until an enforced standard is in place. You can also look for the Gluten Free Certification logo on packaging, which proves that the product has gone through testing to certify the gluten-free claim. The Gluten Intolerance Group of North America® (GIG) is a non-profit support organization that was founded by the Gluten-Free Certification Organization (GFCO). “Products that earn Gluten-Free Certification by the GFCO contain less than 10 ppm; half the gluten levels that the FDA has proposed as levels allowable in foods labeled gluten-free.” 

Then there are guidelines that go above and beyond that of the FDA and GFCO. The Celiac Sprue Association has determined their own guidelines for what they consider to be gluten-free. In order to help those with celiac disease choose uncontaminated food products, they have determined the following criteria:
  • Gluten-free products can not contain any form of gluten grain; this includes all species of wheat, barley, rye, and oats (WBRO). (Oats are not a risk-free choice for all celiacs. In vivo and in vitro studies indicate that some celiacs have an immune response even to pure, uncontaminated oats. Presently there are no indicators available to predict which celiacs may have such a response.) CSA
  • Source ingredients and additives can not be from WBRO grains
  • Ingredients that have been “specially processed” to remove gluten are not allowed.
  • All products must be tested to contain less than 5 ppm of gluten
  • ELISA testing to determine the level of cross contamination
To view a comparison against the different gluten-free definitions, click here

It’s not only oats that you need to be aware of, other non-gluten grains have been shown to be contaminated as well. Rice and Corn are ones that I would suggest to also be wary of. 

For a list of products that have been guaranteed gluten-free according to the Celiac Sprue Association standards, click here.  

Pura Vida!
Alica Ryan, NTP

Saturday, November 26, 2011

Day 271- FDA Nutritional Supplement Actions

The FDA has presented a troubling issue regarding nutritional supplements. A GUIDANCE issued by the FDA calls for such incredible constraint on the supplement industry that, if enacted, could truly have a profound effect on the availability of a vast array of products. Since virtually all of us, including myself, use dietary supplements, I urge you to take immediate action by sending the attached letters to your representatives. A text version is also at the end of this email – you may cut and paste it into an email to your elected representatives in Washington, but you will need to fill out a brief contact form first. I believe faxing is the best way to be heard. Feel free to change the letters and personalize them.

Follow this link for Website address for government contact information including mailing addresses and fax numbers for your Senators and Representatives. www.usa.gov/Contact/Elected.shtml

DEADLINE IS DECEMBER 2, 2011 FOR COMMENTS – The FDA is proposing certain regulations to impede, restrict, and ban dietary supplements. This has happened in Europe and other countries. Please help to stop it from happening in America!

The following are a few highlights of the Guidance document:

The FDA’s draft Guidance requires companies to possess exorbitant amounts of information concerning their existing dietary supplements to prove that New Dietary Ingredient (NDI) notifications are not required for the products they are currently marketing. In many cases, it will be impossible to gather such information, thereby threatening the future availability of numerous dietary supplement products on the market today.

In order to market a product that contains a new dietary ingredient, manufacturers will be required to submit a tremendous amount of information concerning historical use of the ingredient or conduct a multitude of animal and human studies which are overly burdensome and costly. Establishing such excessive requirements is both contrary to Congressional intent and unnecessary given the safety record of dietary supplements over the past few decades.

Any change in the manufacturing process of a dietary ingredient that results in chemical alteration of such ingredient or a change in specifications of the ingredient,regardless of how insignificant the alteration or change is, will require the submission of a NDI notification. This will discourage manufacturers from using the most advanced and efficient manufacturing technologies and pursuing methods that can improve the safety and effectiveness of dietary supplement products.

Any increase of the amount of a dietary ingredient in a dietary supplement or any change in formula of a dietary supplement, regardless of how minute or insignificant, will require the submission of a NDI notification. This will discourage the innovation of new products.

……………………………………………………… SAMPLE LETTER BELOW

November , 2011

To My Elected Representative:

My name is , and I am a constituent in your District. I am deeply concerned about the Food and Drug Administration’s (FDA) recently issued Draft Guidance document entitled New Dietary Ingredient Notifications and Related Issues.

Dietary supplements are an important part of my and my family’s health-maintenance routine. We consider access to affordable supplements to be a crucial part of our healthy lifestyle to mitigate the need for expensive medical procedures and promote good health to improve and extend our lives.

The FDA’s issuance of its draft Guidance is very troubling because it signals a dramatic shift in its policy towards dietary supplements, and I believe the FDA is attempting to establish a system of pre-market approval for these products. It has been nearly two decades since enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Back then the industry was in a fight for its life because of the FDA’s insistence on using the vague standards in the food additive provisions as a means of removing from the marketplace ingredients it disapproved of even for reasons unrelated to safety. The FDA abused its authority, and through a lot of hard work, we won the battle.

Now we find ourselves having to defend the very existence of this industry once again. While DSHEA purposely had drafted in it, a sensible and reasonable system by which the agency must be notified of the marketing of a new dietary ingredient and the basis for which the manufacturer believes that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe, the FDA has taken positions in its draft Guidance that indicate that it intends to treat dietary ingredients as food additives once again. Even more disturbing, is FDA’s insistence that any change in the formula of a dietary supplement that contains a new dietary ingredient will require the submission of a NDI notification. The agency has announced its intention that all dietary supplements containing new dietary ingredients be pre-cleared by the FDA. This is contrary to Congressional intent in passing DSHEA. If the FDA deems it necessary to make such drastic changes in the way dietary supplements are regulated, I think it should have to go through Congress. This is a bureaucracy that is out-of-control. It would needlessly restrict access to safe dietary supplement products, and is a job killer for the dietary supplement industry.

As a concerned constituent in your District, I am requesting that you do everything in your power to stop the FDA from enforcing DSHEA in a manner that is contrary to Congressional intent and in a manner that has the potential to destroy an industry that has brought so much good to so many people.


If you would like to send a letter to your representative to help stop this from going into affect, you can download the customized letter, here. Please help to keep our rights when it comes to nutritional supplements. I truly believe in the benefit of nutritional supplements and don't know where I would be without them, I hope I never have to find out.


If you would like to read more about this issue, click here.


Pura Vida!

Alica Ryan, NTP