• Jon Bari

Readout of White House Meeting on Labeling Gluten as a Major Food Allergen to Protect Celiacs


Jax Bari visiting the White House to meet with Domestic Policy Council staff on the labeling of Gluten as a Major Food Allergen to better protect 3.3 million Americans with Celiac Disease, 11-10-22, "It's me, hi, I'm the problem, it's me!" -- Taylor Swift
Jax Bari at the White House

"It's me, hi, I'm the problem, it's me!"

-- Taylor Swift


As a follow up to 9 year old Jax Bari meeting President Joe Biden on October 20, 2022 and asking for the President's help to protect him and 3.3 million American Celiacs by labeling Gluten as a Major Food Allergen (like it is done in 85 other countries worldwide), Jax took his case to the White House. On November 10, 2022, Jax, along with his parents Leslie and Jon Bari, met with staff from the White House Domestic Policy Council ("DPC") to share their lived experience presentation with the DPC on the Celiac community's request for help.

Jax Bari visiting the White House to meet with Domestic Policy Council staff on the labeling of Gluten as a Major Food Allergen to better protect 3.3 million Americans with Celiac Disease, 11-10-22
Jax Bari at the West Wing of the White House

Sharing Their Lived Experience with Celiac Disease and the Dangers with the Voluntary Labeling Scheme of Gluten

Jax, Leslie and Jon discussed the complexities of managing Celiac Disease which is a potentially life-threatening and life-debilitating food allergy, auto-immune disease and digestive disease that is triggered by eating Gluten, a protein found in Wheat, Barley, Rye and most Oats. The participants also discussed that a strict Gluten Free diet is the only treatment that has ever been historically available for Celiac Disease. The Baris shared the science that unlike IgE-Mediated food allergies (i.e., Peanuts or Milk), there is no rescue medicine (i.e., epinephrine or adrenaline) available in the case of accidental ingestion of Gluten, and one cannot outgrow Celiac.

Jax Bari Shared His Lived Experience with Celiac Disease at the White House, 11/10/22
Jax Bari Shared His Lived Experience with Celiac Disease at the White House

Celiacs Face a Permanent State of Food Insecurity in the Absence of Required Labeling of Gluten in the U.S.

The participants also discussed that the reliance on food labels is the only way that Celiacs and their parents/caretakers know what foods are safe to eat. Jon shared that whereas sufferers of the current top 9 Major Food Allergens (Sesame as of January 1, 2023) rely on what ingredients are included in required labeling disclosures of packaged foods, Celiacs must rely only on what ingredients are excluded in voluntary Gluten Free labeling disclosures on packaged foods. Leslie and Jon discussed this perplexing paradigm of consumer protection and how that endangers Celiacs. Jax illustrated this consumer confusion using POTUS M&Ms as an example of how voluntary labeling of Gluten is inadequate, and how the voluntary labeling scheme causes fear, uncertainty, doubt and frustration with trying to read incomplete food labels.

What is Food Allergy? The Similarities and Differences Between Non-IgE-Mediated Mechanisms with Celiac Disease & Typical IgE-Mediated Mechanisms
What is Food Allergy? The Similarities and Differences Between Non-IgE-Mediated Mechanisms with Celiac Disease & Typical IgE-Mediated Mechanisms

Jon discussed his research findings as to how the voluntary labeling of Gluten has been conflated with the voluntary adoption of a Gluten Free lifestyle diet, and that this has made it much more difficult for Celiacs to have their medical requirements of a strict Gluten Free diet taken seriously. Leslie shared how the voluntary labeling of Gluten has also created a premium marketplace for Gluten Free foods, and how the price for Gluten Free foods is 2x-6x more than their Gluten containing counterparts (see White House DPC presentation (pages 29-37). If there is one thing that the Celiac community knows all too well, it is inflation and the high cost of food products.


White House Conference on Hunger, Nutrition and Health

The Baris expressed gratitude to Ambassador Susan Rice and her entire DPC team for inviting the Baris to attend the White House Conference on Hunger, Nutrition and Health in Washington, D.C. on September 28, 2022, and they shared their takeaways from the Conference.

"If a parent cannot feed a child, there's nothing else that matters for that parent. If you look at your child and you can't feed your child, what the hell else matters?" -- President Joe Biden

Leslie shared that President Biden's remarks as to "what the hell else matters" unfortunately hit home for us since that has been our lived experience (as well as that of many people in the Celiac community), including when eating out of the house, because of the lack of required labeling of Gluten as a Major Food Allergen.


Leslie discussed Celiac Journey's policy objective from the White House Conference of reducing diet-related disease by labeling Gluten as a Major Food Allergen on all packaged foods in the U.S., like it is done 85 countries around the world. Labeling Gluten is in alignment with the conclusions of international food safety authorities and expert committees comprised of scientists, regulators, physicians, clinicians, individuals and risk managers from academia, government and the food industry including:

  • Food and Agriculture Organization of the United Nations/World Health Organization. "Summary report of the Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. Part 1: Review and validation of Codex priority allergen list through risk assessment" 2021 ("2021 FAO/WHO Expert Consultation"). The 2021 FAO/WHO Expert Consultation was chaired by the FDA's Dr. Lauren Jackson, and in 2022, the complete report was published, "FAO and WHO 2022 Risk Assessment of Food Allergens. Part 1 - Review and validation of Codex Alimentarius priority allergen list through risk assessment. Meeting Report. Food Safety and Quality Series No. 14, Rome."

  • 1,576 Comments Submitted to the FDA on the Public Health Importance of Labeling Gluten as Major Food Allergen in Summer 2022. On April 19, 2022, the FDA published “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act: Guidance for FDA Staff and Stakeholders – Draft Guidance,” April 19, 2022, Docket number: FDA-2021-N-0553 (“FDA’s Draft Guidance”). It is instructive to read some of the comments submitted including from: Dr. Virginia Stallings, a board-certified nutrition pediatrician, Professor of Pediatrics and Director of the Nutrition Center at the Children’s Hospital of Philadelphia; Beyond Celiac; Celiac Journey; Celiac Disease Program at Children’s National Hospital; Davis Family (Shannon, Brian and Joshua); National Celiac Association; Gluten Free Watchdog; University of Chicago Center for Celiac Disease, etc.. In total, we helped to generate a total of 1,903 comments submitted to the FDA on Docket FDA-2021-N-0553, and of those, 1,576 comments (82.8%) mentioned Celiac and/or Gluten as a food allergen.

"Based on systematic and thorough assessments which used all three criteria (prevalence, severity and potency), the Committee recommended that the following should be listed as priority allergens: Cereals containing gluten (i.e., wheat and other Triticum species, rye and other Secale species, barley and other Hordeum species and their hybridized strains), crustacea, eggs, fish, milk, peanuts, sesame, specific tree nuts (almond, cashew, hazelnut, pecan, pistachio and walnut)." -- 2021 FAO/WHO Expert Consultation
Jax Bari, Leslie Bari, and Jon Bari, Meeting at the White House with the Domestic Policy Council staff to discuss the labeling of Gluten as a Major Food Allergen, 11/10/22
Jax Bari and Leslie Bari at the White House Meeting with Staff from the Domestic Policy Council

President Biden's Executive Order 13985, "Advancing Racial Equity and Support for Underserved Communities Through the Federal Government"

Informed by their lived experience and stories shared with them over the years by thousands of members of the Celiac community, Jon stated that he believes that in accordance with President Joe Biden’s Executive Order 13985, advancing equity requires a systematic approach to embedding fairness in the decision-making processes that all FDA functions are routed through. Using that lens and framework, the Baris shared that the FDA’s Draft Guidance released on April 19, 2022 suggests systemic food privilege that contributes to food insecurity, and the Biden-Harris Administration can work to redress historical inequities in various agencies’ policies and processes towards the Celiac community, including with HHS/FDA declaring that Gluten is a Major Food Allergen and that Gluten must be labeled on all packaged foods.


Section 2(a) of Executive Order 13985 provides that,


“The term ‘equity’ means the consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.” Further, section 2(b) provides that, “the term ‘underserved communities’ refers to populations sharing a particular characteristic, as well as geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life, as exemplified by the list in the preceding definition of equity.” (emphasis added)


The Celiac community represents an underserved community which shares a particular characteristic including a chronic disability under the ADA [1] and a potentially life-threatening and life-debilitating food allergy to eating Gluten with numerous adverse health consequences associated with the ingestion of Gluten.


The Celiac community has been systemically denied a full opportunity to participate in important aspects of daily economic, social and civil life. For someone with Celiac Disease, eating, sleeping, thinking and learning are major life activities that can be impacted on a daily basis, and there are various bodily systems which can be impacted through the ingestion of Gluten including: gastrointestinal (digestive), nervous (anxiety, ataxia and neuropathy), skeletal, reproductive (infertility) and integumentary.

Jax Bari, Leslie Bari, and Jon Bari, Meeting at the White House with the Domestic Policy Council staff to discuss the labeling of Gluten as a Major Food Allergen, 11/10/22
Jon, Jax and Leslie Bari at the White House to Meet with Staff from the Domestic Policy Council

Celiacs Have Been Historically Underserved by the Federal Government

Therefore, with respect to the Celiac Disease community, which has been historically underserved and marginalized by our Federal government, including by way of example and not limitation:

  • Underfunding NIH biomedical research for Celiac Disease over many years (on average, the Federal government spent about $3.4 million annually on Celiac research from 2011-2020, which is about $1.00 per American with Celiac per year, and that is way too low). Funding for Celiac research has been disproportionately low as compared to NIH funding research for food allergies, digestive diseases, auto-immune diseases and/or foodborne illness, especially when evaluating the various amounts spent with regard to disease prevalence, treatment burden and other available treatment options . According to a Congressionally mandated report "Enhancing NIH Research on Autoimmune Disease" published in May 2022 from the National Academy of Sciences, Engineering and Medicine, "There is a lack of long-term (20 years or more) population-based epidemiology studies on autoimmune disease, the committee found. Such studies would allow for, among other things, assessing trends, risk factors, and costs of disease; identifying differences among population subgroups; and determining the prevalence of under-researched autoimmune diseases, such as celiac disease.”

  • Labeling Gluten only with a voluntary scheme since 2014 (Under the Food Allergen Labeling and Consumer Protection Act ("FALCPA"), mandatory labeling of the top 8 Major Food Allergens started on January 1, 2006. In contrast, the FDA delayed action on the FDA's final rule for Gluten Free labeling until August 5, 2014, in spite of a FALCPA deadline of August 4, 2008, and that on January 23, 2007, the FDA published its proposed rule on the voluntary labeling of Gluten Free products that for all intents was the final rule ultimately enacted on August 5, 2014.)

  • Disqualifying Celiacs from service in the military [2]

  • Excluding Celiac Disease from the CDC’s Index of Diseases & Conditions

  • Excluding Celiacs from Medicare coverage for medical nutrition therapy (MNT) which is currently limited to patients with diabetes and kidney failure, leaving millions of older Americans with leading diet-related diseases, without access to nutrition counseling.

  • Excluding Celiac Disease (through June 2022) from the NIH’s "Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC)" that provides research and funding data on how NIH allocates its financial resources. Celiac was finally added to the RCDC list in July 2022 following the House Appropriations Committee distributing its FY2023 Budget Report which included the following language about Celiac Disease: “The Committee thanks NIH for establishing a Research Condition, Disease Categorization (RCDC) for celiac disease.”

  • Excluding representation from Celiac Disease advocacy organization(s) on the National Institute of Allergy and Infectious Diseases ("NIAID") Autoimmune Diseases Coordinating Committee ("ADCC") from 1998-2020.[3] As of May 29, 2020, there were 17 members from patient advocacy organizations represented on the ADCC. "NIAID chairs the NIH Autoimmune Diseases Coordinating Committee (ADCC), which was established in 1998 at the request of Congress. The purpose of the ADCC is to facilitate coordination of research across the National Institutes of Health (NIH), federal agencies, professional societies, and patient and advocacy organizations with an interest in autoimmune diseases. It was not until after the “Celiac Disease-Focused Autoimmune Disease Coordinating Committee Meeting” on May 29, 2020 that the Celiac Disease Foundation and Beyond Celiac were invited to join as members of the ADCC.

  • Funding various agencies, facilities, schools, programs, etc. that exclude Celiacs from full and equal participation in life’s daily activities that involve food, etc..

In response to the FDA's Draft Guidance, Dr. Stallings opined,


"While a Non-IgE-Mediated food allergy does not trigger anaphylaxis and is not immediately life-threatening, people with Celiac Disease face potentially life-threatening and severe adverse health effects that can arise through gluten ingestion including by way of example and not limited to: anemia, cancer, heart disease, immunological scarring, intestinal damage and malnutrition…


A gluten free diet is not all that is needed to treat Celiac Disease; rather a gluten free diet is all that has ever been historically available to treat Celiac Disease. Additionally, with respect to labeling food products in the United States, the voluntary gluten free labeling scheme does not sufficiently protect consumers who are on medically required and very restrictive gluten free diets.


My strong recommendation is that gluten be labeled on all packaged foods in the United States, in accordance with the 2021 FAO/WHO Expert Consultation, just like it is in more than 85 countries around the world." (emphasis added)


Jon shared the findings of Celiac Journey, Bari Consulting Group and Gluten Free Finds that the FDA’s Draft Guidance presents an inequitable evaluation framework, as well as perpetuates flawed and ingrained scientific, governmental and societal biases including:

  1. A Gluten Free diet is all that is needed to treat Celiac Disease, as opposed to all that has ever been historically available to treat Celiac Disease.

  2. With respect to labeling food products in the United States, the voluntary Gluten Free labeling scheme [4] sufficiently protects consumers who are on medically required and very restrictive Gluten Free diets, as opposed to all that has ever been historically utilized labeling-wise.

  3. Othering the consumer protection needs for Celiacs in the United States with not evaluating the public health importance of Gluten as a food allergen because this Non-IgE-Mediated food allergy is not capable of triggering anaphylaxis and being immediately life-threatening, while seemingly ignoring that Celiacs face potentially life-threatening and severe adverse health effects that can arise through Gluten ingestion, including by way of example and not limitation: anemia, cancer, heart disease, immunological scarring, intestinal damage, malnutrition, etc.

The Baris shared their frustration that the FDA has othered the consumer protection needs of the Celiac community by lumping Celiac and lactose intolerance together, most recently in the FDA's Draft Guidance, "Immune-mediated mechanisms that are not IgE-mediated (such as mechanisms associated with celiac disease and contact dermatitis), and mechanisms that are not immune-mediated (such as lactose intolerance) typically are not associated with anaphylaxis or other immediately life-threatening conditions." According to the Cleveland Clinic, lactose intolerance is a non-immune-mediated foo sensitivity that "is inconvenient but not life-threatening."

Jax Bari visiting the White House to meet with Domestic Policy Council staff on the labeling of Gluten as a Major Food Allergen to better protect 3.3 million Americans with Celiac Disease, 11-10-22, East Wing of Eisenhower Executive Office Building
Jax Bari at the Eisenhower Executive Office Building Overlooking the West Wing Entrance of the White House on West Executive Avenue

Food Insecurity

It is also instructive to look at how the USDA defines food insecurity -- “Food insecurity is the limited or uncertain availability of nutritionally adequate and safe foods, or limited or uncertain ability to acquire acceptable foods in socially acceptable ways.” For those with food allergies such as Celiac Disease, we further define food insecurity as the limited or uncertain availability of food that is adequate, nutritious, safe and affordable, regardless of socioeconomic status, and limited or uncertain ability to acquire acceptable foods in socially acceptable ways.


The inequities in FALCPA and the FDA's Draft Guidance serve as barriers to the equal protection under the law and fair evaluation of the public health importance of adverse reactions to food due to a food hypersensitivity that is mediated by immune mechanisms, including for Gluten as a potentially life-threatening and life-debilitating food allergy with a Non-IgE-Mediated mechanism.


Economics of Inflation with Gluten Free Food - 2x-6x Greater Than

The Baris shared how the price for Gluten Free foods is 2x-6x more than their Gluten containing counterparts, and that this is often referred to as the "Gluten Free tax" (see White House DPC presentation (pages 29-37). For example:

  • Kraft Mac & Cheese Original (7.25oz box) costs $1.29 ($0.17/oz) versus Kraft Gluten Free Mac & Cheese Original (6oz box) which costs $4.79 ($0.80 oz). Really! The Gluten Free version of Kraft Mac & Cheese costs 4.7x greater than the regular version (as per prices at Target in Philadelphia, PA 19131).

  • King Arthur Flour Unbleached All-Purpose Flour (5lb bag) costs $5.59 ($0.07/oz) in comparison with the King Arthur Gluten Free Measure for Measure Flour (48oz bag) which costs $9.99 ($0.21/oz). The Gluten Free version of King Arthur Flour costs 3x greater than the regular version (as per prices at Target in Philadelphia, PA 19131).

  • Wonder Round Top White Sliced Bread (20oz loaf) costs $3.19 ($0.16/oz). Wonder does not make a Gluten Free counterpart so we looked at Canyon Bakehouse Gluten Free Mountain White Bread (18oz loaf) as the comparable, and the Canyon Mountain White Bread cost $6.79 ($0.38/oz). The Gluten Free version of White Bread costs 2.4x more than its Gluten Containing Counterpart (as per prices at Target in Philadelphia, PA 19131).

"We are so proud of Jax for sharing his lived experience with Celiac and how hard it is reading food labels in the absence of Gluten being required to be labeled in the U.S. as an ingredient. Jax also shared how much easier and safer it is in Italy to read food labels since Gluten is required to be labeled as an allergen." -- Jon and Leslie Bari

Cost Estimates with Naming Gluten As A Major Food Allergen

In order to understand the costs involved with requiring that Gluten be labeled on all packaged foods in the U.S., whether this would be done by the Secretary as codified by FALCPA or through new legislation, it is instructive to look at the Congressional Budget Office ("CBO") Cost Estimate for H.R. 2117, which was the predecessor to the Food Allergy Safety, Treatment, Education, and Research Act of 2021 ("FASTER Act") for labeling Sesame as the 9th Major Food Allergen. The CBO's estimate, including for the Federal government and private sector, with labeling Sesame may likely be similar to the costs involved in declaring Gluten as a Major Food Allergen.


"H.R. 2117 also would add sesame to the definition of major allergens, would permit the Secretary of Health and Human Services to add food ingredients to that definition, and would require FDA to add a section to a report that the agency produces under current law. Using information from FDA, CBO expects the agency would require, on average, the equivalent of three additional full-time employees in each fiscal year from 2021-2025 to implement regulations and guidance that add sesame as a major food allergen and to evaluate whether new ingredients should be added to the list of major allergens. CBO estimates the new staffing and related expenses would cost about $5 million over the 2021-2025 period.


H.R. 2117 would impose a private-sector mandate as defined in the Unfunded Mandates Reform Act (UMRA) by requiring manufacturers of food products containing sesame to include additional information on the products’ label. Because the mandate would require a minor change to existing labels, CBO estimates that the cost of the mandate would not exceed the annual private-sector threshold established in UMRA ($168 million in 2020, adjusted annually for inflation)."


It is also instructive to read the following as reported in Food Safety Magazine on June 29, 2021,


"For most manufacturers, the addition of sesame or any other ingredient to the major food allergen list will not present much of a logistical challenge. It is likely that manufacturers are already listing other ingredients in compliance with the Federal Food, Drug, and Cosmetic Act and will only need to modify the labels to include sesame and any other ingredient that may be added to the major food allergens list." (emphasis added)


HHS Secretary Xavier Becerra Has Existing Statutory Authority to Label Gluten Now

According to the Food & Drug Law Journal's seminal article in 2006 that was published entitled, "When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004" ("When Food Is Poison"), FALCPA "does not preclude FDA from expanding via regulation the list of major allergens requiring identification under the FALCPA's labeling scheme."[5] Section 203(b) states that the labeling requirements established under new section 403(w) "do not prevent the Secretary from requiring labels or labeling changes for other food allergens that are not major food allergens."[6] (emphasis added)


When Food is Poison was written by Laura Derr Sim, Esq. when she was a student at Harvard Law School, under the supervision of Lecturer on Law Peter Barton Hutt, Partner at Covington & Burling in Washington, D.C., for Harvard Law School's Winter 2005 Food and Drug Law course. Mr. Hutt was also former Chief Counsel to the FDA from 1971-1975. When Food is Poison won First Place in the 2005 H. Thomas Austern Memorial Writing Competition (long papers) sponsored by the Food and Drug Law Institute.

“Precedent is a poor reason for decisions. It calcifies the status quo without a compelling rationale. It doesn’t matter how long a tradition has stood. If the old way is wrong, it should be challenged and changed. Progress lies in improving the future, not defending the past.” -- Adam Grant, The Wharton School, University of Pennsylvania

The Bottom Line

If the labeling of Gluten was mandatory on all packaged food products, our research and lived experience strongly suggest that the number of Gluten Free food products available to those who have Celiac Disease would greatly expand just by virtue of food products that do not contain Gluten being labeled as such. This would help to decrease food costs for the Celiac community.


With Thanksgiving upon us, the Baris are grateful for the opportunity to share our lived experience and inform public policy with the objective of better protecting 3.3 million American Celiacs by labeling Gluten as a Major Food Allergen, just like labeling Gluten is done in 85 other countries and in alignment with the 2021 FAO/WHO Expert Consultation.


#FEDup

Resources

  • Presentation to the White House Domestic Policy Council, Sharing Our Lived Experience: Jon, Leslie and Jax Bari, Celiac Journey & Gluten Free Finds, November 10, 2022

Notes

[1] In May 2019, in a case involving the disability rights of a child who has a severe allergy to Gluten, the U.S. Fourth Circuit Court of Appeals cited that "[t]he ADA [Americans with Disabilities Act] defines a 'disability' in pertinent part as 'a physical or mental impairment that substantially limits one or more major life activities' and that "[e]ating is a major life activity." J.D., by his father and next friend, Brian Doherty, Plaintiff-Appellant v. Colonial Williamsburg Foundation, Defendant-Appellee, National Disability Rights Network; Disability Law Center for Virginia; Scott Hayes; Virginia Food Allergy Advocates, Amici Supporting Appellant. Vacated and Remanded-Appeal from the United States District Court for the Eastern District of Virginia, at Newport News. Rebecca Beach Smith, District Judge. (4:17-cv-00101-RBS-RJK); United States Court of Appeals for the Fourth Circuit, No. 18-1725, Argued: January 29, 2019; Decided: May 31, 2019. See also "Colonial Williamsburg - Lessons Learned About the Civil Rights of the Celiac Community"


[2] U.S. Department of Defense, DoD Instruction 6130.03, Medical Standards for Appointment, Enlistment, or Induction into the Military Services, Section 5.12.c.(3), May 6, 2018


[3] As of July 1, 2020, of the 52 members of the ADCC, there were 17 members representing specific diseases. A full one third of the ADCC members came from patient advocacy organizations outside of the NIH. There were no representatives of any organization or physician/scientist representing the Celiac Disease community. However, there were multiple non-NIH employees on the ADCC including representatives for the following: Crohn’s/Colitis (3 people); Type 1 Diabetes (2 people), Juvenile Diabetes (1 person); Sjogren’s Syndrome (2 people), Lupus (1 person), Arthritis (1 person); Multiple Sclerosis (1 person), Psoriasis (1 person), Neuromyelitis Optica (NMOSD)/Devic disease (1 person).


[4] The FDA’s final rule defining Gluten Fee for food labeling became effective on September 4, 2013, and August 5, 2014 was the date when FDA-regulated foods labeled Gluten Free must comply with all requirements established by the final rule. https://www.federalregister.gov/documents/2013/08/05/2013-18813/food-labeling-gluten-free-labeling-of-foods , and https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-gluten-free-labeling-foods#


[5] When Food is Poison, Page 141, including footnotes 423-424: "See FALCPA 203(b), 21 U.S.C.A. 343(note); FALCPA 203(a), 21 U.S.C.A. 343(x). The Senate Committee Report states that it intends for any regulations issued by FDA requiring the identification of additional allergens to prescribe disclosure in 'a manner consistent with' the FALCPA. S. Rep. No. 108-226, at 10." "The legislation also adds a second misbranding provision to account for other food allergens. In particular, section 403(x) provides that FDA has the authority to require by regulation appropriate labeling of any spice, flavoring, coloring, or incidental additive ingredient that is, or includes as a constituent, a food allergen that is not a major food allergen. The committee does not intend the listing of all spices or flavorings in a product but intends that the Secretary will require the food allergen to be identified on the label in a manner consistent with this legislation."


[6] H.R. Rep. No. 108-608, at 18. (2004), https://www.congress.gov/108/crpt/hrpt608/CRPT-108hrpt608.pdf

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