Comments Submitted by Gluten Free Watchdog, LLC: FDA draft guidance: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act￼Tricia Thompson
To everyone who must follow a gluten-free diet for medical reasons or loves someone who does, please comment on this draft guidance.
You can access the guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-fda-staff-and-stakeholders-evaluating-public-health-importance-food-allergens-other
You can comment at https://www.regulations.gov/commenton/FDA-2021-N-0553-0005
You can view comments posted to date at https://www.regulations.gov/docket/FDA-2021-N-0553/comments
This draft guidance is taking the preemptive position that FDA will NOT consider a petition asking FDA to establish regulatory requirements for gluten-containing grains under FALCPA standards because FDA will only consider regulating allergens that cause acute and sometimes life-threatening immune responses, and because FDA implies in Footnote No. 42 that consumers with celiac disease are already protected under FDA’s gluten-free labeling rule (20 CFR. § 101.91).
Please read the text of the comment posted by Gluten Free Watchdog, LLC. Please feel free to use any of the text in your personalized comment or simply state you support the comments submitted by Gluten Free Watchdog, LLC. See https://www.glutenfreewatchdog.org/news/wp-content/uploads/2022/05/CommentGlutenFreeWatchdogFDA-2021-N-0553-0005.pdf
There is a basic problem with getting gluten included in the FALCPA allergen list: it’s not an allergen. What we need is for the Federal Food, Drug, and Cosmetic Act to be amended with something parallel to the FALCPA, some sort of “Gluten Labeling and Consumer Protection Act”, or perhaps something broader that encompasses other substances that can destroy a person’s health over a period of time. (Things like glyphosate, lactose, and arsenic come to mind, but glyphosate and arsenic are probably potentially covered by existing law, although not yet adequately by regulations, and affect everyone, not just a portion of the population.)
I can see the point of trying to get the FDA to follow the practice of other countries and include gluten as if it were an allergen, or at least adding barley, rye, etc. to the allergen list. It’s certainly important enough for those of us with celiac disease. But perhaps a parallel effort to get gluten treated in a category of its own would be appropriate.
Thanks for your comment. Much appreciated. You are correct of course about gluten-containing grains not being allergens. The issue with a “parallel FALCPA” is that it requires a new law. Simply adding “gluten-containing grains” under FALCPA standards is the most straight forward path. Adding gluten-containing grains to FALCPA is part of the Food Labeling Modernization Act of 2021 but we most likely will have to pull out this provision and go for a stand alone bill (the FLMA is quite large and unlikely to pass as is). More on all of this later.
I think that If the FDA public response that undeclared gluten is not a safety concern, there is a problem in understanding that for celiac and gluten sensitive people it is a safety issue. If not, then consumers have no reasonable protection under gluten-free labeling rule unless a gluten-free claim is made which is not mandatory but a voluntary claim.
This is contrary to the overall spirit of FSMA. Under FSMA, there is a requirement to have a food safety plan in place that is delivered and effective. Hazard analysis and preventive controls are at the core. Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food). (see https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food). Clearly, undeclared gluten is a chemical hazard and if not controlled is a safety concern for a significant segment of the population.
If one looks at food recalls, risk assessments are conducted by FDA to examine known or potential adverse health effects resulting from human exposure to a hazard; quantify the levels of risk associated with specific exposures and the degree of uncertainty inherent in the risk estimate. They have three levels or classes of recalls:
Class I: Recalls for products which could cause serious injury or death;
Class II: Recalls for products which might cause serious injury or temporary illness;
Class III: Recalls for products which are unlikely to cause injury or illness, but that violate FDA regulations.
At the very least, undeclared gluten in levels above 20 ppm would qualify for a Class II recall.
Here is my recommendation. I believe the hazard for undeclared gluten should not be under FALCPA but be handled the same way as the hazard for undeclared sulphites if over 10 ppm as per TITLE 21–FOOD AND DRUGS, CHAPTER I–FOOD AND DRUG ADMINISTRATION, CHAPTER I–FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER B – FOOD FOR HUMAN CONSUMPTION, PART 130 — FOOD STANDARDS: GENERAL, Subpart A – General Provisions, Sec. 130.9 Sulfites in standardized food. This is what happened in Canada under its Food and Drug Regulations where allergens, sulphites and gluten are handled separately. The Safe Food for Canadians Regulations parallel FSMA for hazard analysis and preventive controls. Failures can lead to recalls in the similar three classes as those of the FDA.
Hope that this helps. Contact me oif you have any questions.
Thanks so much, Frank. We have several prongs in the fire. The most important thing is to not require a new law. Gluten-containing grains must be able to fall in lock step with whatever law it is placed. At the moment, that is FALCPA because we are asking only for gluten-containing grains to be declared as wheat, barley, or rye on the label. Because FALCPA required FDA to issue a proposed rule that defined and permitted the voluntary use of the term “gluten free” on the labeling of foods this is the most likely place for this additional group of proteins. BUT we will certainly consider all options!
Hello Tricia. IMO the battle to get gluten added to the list of priority allergens may already be lost based on FDA comments to GFWD. Strategically, moving on the sulphite-model is more feasible like Canada and other nations that progressively recognize that the level of protection for undeclared gluten needs to be set in regulation and enforced. They did not add gluten to their allergen list for the same reasons FDA resists. The sulphite-model regulation for undeclared gluten would have as key elements like:
• a definition for gluten (already exists in the gluten free rule)
• a limit (>20 ppm) where there is recognized harm to consumers needing to avoid gluten which would trigger a contains gluten statement; and
• official methods for the appropriate matrix (e.g., fermented/non-fermented, hydrolyzed/non-hydrolyzed)
Keep up the good work. I hope that the above comments help add another path to a solution.
In Canada, when undeclared gluten (>20 ppm) is reported or found in food products, these products can be subject to a recall after an appropriate risk assessment is conducted by Health Canada. A really good example of a recall is reported at https://recalls-rappels.canada.ca/en/alert-recall/arifoglu-brand-black-pepper-ground-recalled-due-undeclared-gluten where more details can be found for Arifoglu brand Black Pepper Ground recalled due to undeclared gluten. You will see that it is a Class III (i.e., a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences) as a result of the risk assessment which undoubtedly took into consideration the amount of gluten that would be consumed in what is usually a small portion of pepper. A contaminated product with higher serving size would likely raise the recall to Class II or Class I which is the highest concern. Regardless of the class of recall, the effect on retailers is very much the same who are forced to remove existing lots of the named product and receive returns from consumers. In this case, the product is imported from Turkey and the licensed importer would have to explain the failure of the preventive controls and corrective actions to the CFIA. If not satisfactory, CFIA can take further including seizure of future shipments to suspension or cancellation of the importer’s license. Obviously, Canada takes undeclared gluten seriously and effectively but not under regulations which apply to allergens but to gluten specifically beyond rules which apply to gluten free declarations. Hope that this helps with your strategy to influence the change needed to improve the level of protection for celiac and gluten intolerant persons. Good luck!!
Just a final word. Although gluten has a higher level of concern in Canada and more regulatory tools, the system is not perfect. Just ask Melissa Secord at the Canadian Celiac Association. Best regards, Frank
Thank you, Frank. I appreciate all the information and your experience in Canada. We (in the US) will eventually find a way!
Due to the lack of clear labeling of ALL gluten-containing ingredients, those with Celiac risk severe illness when consuming even basic foods. The result is harsh limitation of options (purchasing those items clearly labeled Gluten Free or Certified Gluten Free) to avoid sickness. This is both costly and can make finding a balanced meal a challenge, depending on the stocked options in a given area. If a family cannot afford the extra cost of labeled Gluten Free foods, they may continue consuming non-labeled foods. This affects adults and children with Celiac with ongoing symptoms across body systems: debilitating GI distress, diarrhea, neurological effects, including attention problems, brain fog, difficulty with recall and processing, depression, anxiety, joint pain, malnutrition/malabsorption, further increasing risk of additional autoimmune disorders being triggered (including: Type 1 diabetes, Hypothyroidism), increased risk of cancer. Please help us by simply calling out these ingredients which are a legitimate poison to the bodies of many many Americans
Hi Jessica, Did you post your comments to the docket? If not, please do. See https://www.regulations.gov/commenton/FDA-2021-N-0553-0006. Thank you!
I agree with Frank Massong. Gluten is a concern for many and should be on the labels of products as GLUTEN.
For regulation purposes, FDA defines gluten-containing grain and gluten as:
§ 101.91 Gluten-free labeling of food.
(1) The term “gluten-containing grain” means any one of the following grains or their crossbred hybrids (e.g., triticale, which is a cross between wheat and rye):
(i) Wheat, including any species belonging to the genus Triticum;
(ii) Rye, including any species belonging to the genus Secale; or
(iii) Barley, including any species belonging to the genus Hordeum.
(2) The term “gluten” means the proteins that naturally occur in a gluten-containing grain and that may cause adverse health effects in persons with celiac disease (e.g., prolamins and glutelins).
Labeling “gluten” versus labeling the gluten-containing grains wheat, barley, and rye could lead to confusion among manufacturers. Gluten is sometimes used in a more general sense to describe proteins found in many cereal grains. For example, you may hear or see reference to corn gluten or rice gluten, both of which are fine for folks with celiac disease to eat.
The Food Labeling and Modernization Act of 2021 would amend FALPCA*: If an FDA-regulated food product includes a gluten-containing grain, this would have to be disclosed in the ingredients list or separate Contains statement – just like for wheat and the other major allergens. This would be required regardless of whether the food was labeled gluten-free.
*The Bill would not add gluten to the list of major food allergens. It would add gluten to labeling requirements applicable to the major food allergen.
This is the provision that has been discussed with members of Congress and that appears to have support. Our efforts going forward with Congress directly (versus FDA) will likely stick with this approach. We may need a different approach when working directly with FDA (but we hope not). We are obviously open to whatever it takes!
Although celiac is not an allergic reaction, gluten has catastrophic effects on the a persons nutritional absorption. If a celiac patient is exposed to even a crumb of gluten their body is at risk for malabsorption of very important nutrients for 6 months to a year. This is why it is vital to a person living with celiac that the FDA adds malt/gluten as an allergen. Celiac disease may not cause immediate anaphylactic shock, but overtime can be threatening to a persons health, easing to cancer, infertility, and many other major health concerns.
Hi Tiffany, Please make sure you post your comments to the FDA docket. Thank you!
I am doing Gluten free diet due to Dermatitus heptiformis and have the biggest problem with medication . It is suppose to make you feel good but getting sick is just awful…thank you