Wednesday, June 19, 2019

FDA Gluten-Free Labeling, GF Certification & PPM

Disclosure: I am not an EXPERT. I am not a researcher or medical professional. I am simply a mom. A mom who wants to know MORE about gluten-free labeling, GF certification, PPM, cross contamination, in order to provide the best GF life for my kiddo. By doing research, and explaining it the way I have below, I hope you find it easier to follow and understand. Also, I HAVE NOT been compensated by any organization, website or person I mention below. If I was, I would be rich. ;) Let's get to it!

Understanding the gluten-free labeling laws and certifications can be confusing to say the least. My hope by sharing the information below, is that you will walk away more knowledgeable of the following:

  • What the FDA (Food & Drug Administration) considers "gluten-free"
  • What 20 PPM (parts per million) means and how the 20 PPM threshold was determined
  • Different organizations who provide GF certifications/seals and what the PPM threshold is for each one.
  • If the product just says "gluten-free", without a certification, what does that mean?
  • OATS - oats, oats, oats - what you need to know.
  • What does ALL this mean for those living with celiac disease?
  • Gluten-Free Testing Resources

(The following information is from

The rule specifies, among other criteria, that any foods that carry the label “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” must contain less than 20 parts per million (ppm) of gluten. 

Besides the limit of gluten to 20 ppm, the rule permits labeling a food “gluten-free, if the food does not contain:
  • An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains,
  • An ingredient derived from these grains that has not been processed to remove gluten, or,
  • an ingredient derived from these grains that has been processed to remove gluten, but results in the food containing more than 20 ppm of gluten.

PPM means "parts per million" and to explain this, I called on the experts! Ok, I didn't really call them, but I did some research, and I'm quoting them here:

Tricia Thompson, MS, RD of Gluten-Free Watchdog, LLC uses this example:
“If you bought a bag containing one million blue marbles, but the bag actually contained 999,980 blue marbles and 20 red marbles, you could say that the bag of marbles was contaminated with 20 ppm red marbles.”

How much 20 PPM of gluten in a day can you have?

"According to the latest research, ingesting 50 mg of gluten per day causes intestinal damage for people with celiac disease. That means you must eat at least five pounds of gluten-free food (with <20 ppm of gluten) per day for damage to occur." -

So, how did they come up with 20 PPM?? How was this number determined to be "safe" for those living with celiac disease??

The best person to explain this, is Dr. Alessio Fasano. Have you heard of this name? He is THE CELIAC DISEASE DOCTOR. 

Dr. Alessio Fasano is chief of Pediatric Gastroenterology and Nutrition at MassGeneral Hospital for Children (MGHfC). Dr. Fasano directs the Center for Celiac Research, specializing in the treatment of patients of all ages with gluten-related disorders, including celiac disease, wheat allergy and gluten sensitivity. ~ Massachusetts General Hospital

Dr. Fasano's letter, entitled, "In Defense of 20 Parts Per Million"  explains:

"For more than 30 years, millions of people worldwide have been following a gluten-free diet based on a safety level of 20 ppm or more (up to 100 ppm). The vast majority of those consumers have suffered no ill consequences."

"Setting a safe gluten-free threshold below 20 ppm could result in a drastic reduction in the amount and availability of gluten-free products in the U.S. market. Since the assay variability (margin of error of the ELISA) measurement of gluten in safety-based assessments can range from 10 to 20 percent, extremely low thresholds (like 5 ppm) do not give manufacturers enough flexibility to produce good-tasting and safe products. For instance, a batch of brownies tested today could measure 3 ppm. Keeping in mind the 10 to 20 percent margin of error inherent in assay measurement, that same batch tested tomorrow could measure 7 ppm. If the safety threshold was set at 5 ppm, a manufacturer could test the product as safe at 3 ppm, and it could be measured as unsafe at 7 ppm in a different test." 

Dr. Fasano shares other studies that brought them to the 20 PPM threshold and you can read that HERE. (please read the rest of this blog post first ;)

Below, are organizations who created gluten-free certification processes to help put some of us at ease when shopping for gluten-free products. These organizations have a PPM threshold LOWER THAN the FDA ruling of 20 PPM.  

When I see any of these logos below on gluten-free food, I personally, feel more comfortable with my son and husband eating the products that have a certification from one of these organizations below.

Gluten Intolerant Group (GIG) 

The GIG oversees the Gluten-Free Certification Organization (GFCO).  This the most popular certification program that you see often on gluten-free products.  They ensure that their products are at 10PPM or less.

    National Sanitation Foundation (NSF)
                                                                                                Also known as the Public Health and Safety   
    Organization, tests products at 15 PPM or less

   National Celiac Association (NCA)
  The Gluten-Free Manufacturing Program (GFMP)
  originated as the Recognition Seal Program operated     by the  Celiac Sprue Association, and later by the           National Celiac Association. THE GFMP tests their          products at 5 PPM or less. 

     Beyond Celiac (formerly NFCA)

      Beyond Celiac endorses the Gluten-Free 
      Certification Program (GFCP), a food safety-based         gluten management system for manufacturers, which         was created by the Allergen Control Group and the             Canadian Celiac Association. They 
      test their gluten-free products at 10 PPM or less.


"Unfortunately, the Food and Drug Administration under the gluten-free labeling rule is NOT requiring manufacturers to test their labeled gluten-free foods for gluten contamination." ~ Gluten-Free Watchdog

The following photo collage shows products labeled "gluten-free" and in doing so, THEY SHOULD be following the FDA gluten-free labeling law: that any foods that carry the label “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” must contain less than 20 parts per million (ppm) of gluten. 

So, what's the big deal? They say "gluten-free" and should be "gluten-free", right?

Right, they should. BUT, cross contamination is a possibility. 

When it comes to products like the ones above, there's a couple of ways I decide for for our family if they are acceptable gluten-free goods for Jack and his Dad:

1) Eat them. And, be aware the next 24 hours of any possible "glutened" signs. More visits to the restroom? Headaches? If so, DON'T EAT THAT PRODUCT.

2) Avoid them all together. If you want to play it SAFE - don't eat them. Jack has NEVER had Lucky Charms or Cheerios since his diagnosis, 10 years ago. I have a problem with "Oats" in general when it comes to being "gluten-free". If they haven't been "certified" gluten-free, we avoid them.

** OATS ** - Oats are OFTEN harvested along with wheat as they usually alternate fields. One year, they grow wheat, the next, oats - which means what?? HEAVILY CROSS CONTAMINATED.

Are ANY OATS SAFE?? YES! These oats fall in the category: "PURITY PROTOCOL" - which means, these particular oats are harvested and manufactured ONLY with OATS. Using the same fields to grow OATS, not alternating with wheat. Make sense?  

For a list of "Purity Protocol" Oats, click HERE. (BUT, please continuing reading the rest of my post first ;)

In a PERFECT world, we would try to achieve 0 PPM gluten as much as possible. But, we live in a NON-PERFECT, GLUTEN-FILLED WORLD.  

With that said, I am SO THANKFUL for the gluten-free organizations above, who provide gluten-free testing at PPM thresholds, that are LOWER THAN THE FDA threshold of 20 PPM. 

I feel COMFORTABLE with my son and husband eating these products that have been tested by these organizations. Anything being tested at less than 20 PPM is ACCEPTABLE for my family - again, I am speaking for my family. AND, we will eat naturally gluten-free as much as possible - vegetables, fruit, cheese, legumes, seeds, meat and poultry - this is eating as close to 
0 PPM as possible.

It's important to pass this information along to our children when they are old enough to comprehend all of it.  Having more knowledge of the FDA gluten-free labeling laws, what PPM is, and these organizations who provide gluten-free certification, is valuable to their health and their future.

"Gluten-Free Watchdog", I don't know why it has taken me SO LONG to subscribe, but man, don't wait folks, if you want to know about a certain product and it's gluten-free legitimacy, check it out! They have tested over 700 products.

GIG - Gluten Intolerant Group
CDF - Celiac Disease Foundation - don't hold the whole Cheerios debacle against them, they ROCK at raising awareness and funding research for celiac disease. AND, they provide very resourceful information.

PHEW! I feel like I just completed a research paper or I'm turning in a thesis...okay, more of a research paper, but still, it's been eye opening and I feel so much more knowledgeable about the logistics of gluten-free labeling and testing, and I hope it's beneficial to you as well.

If your kid is SMILING and NO LONGER suffering from undiagnosed celiac disease, than you're ALREADY AHEAD OF THE GAME. 


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