Bipartisan Blueprints for Funding Celiac Research & Labeling Gluten: ACT for ALS & FASTER Act

My family has turned our pain into purpose - eating without fear. We want to change the trajectory of the lives of 3 million Americans with Celiac Disease, including for our 8 year old son Jax. To that end, Jax's two primary goals are:

1. increasing Federal funding for Celiac Disease research, and

2. requiring that Gluten be named as a Top 10 Food Allergen and Gluten be labeled on all packaged foods in the US, just like it is in 85 countries around the world including in Canada and across Europe.

To accomplish those goals, it is instructive and moreover uplifting to learn from the bipartisan blueprints established with the Accelerating Access to Critical Therapies for ALS Act ("ACT for ALS") and the Food Allergy Safety, Treatment, Education, and Research Act of 2021 ("FASTER Act"), both of which were signed into law by President Biden in 2021. Interestingly, both the ACT for ALS and the FASTER Act were written in plain English (not legalese), are concise and address long overdue health challenges. In summary, the ACT for ALS legislation will provide $600 million in funding for ALS research and patient-focused programs over the next six years. The FASTER Act named Sesame as the 9th Major Food Allergen and will require that Sesame be labeled on all packaged foods in the U.S.

Celiac Disease is relentless. So are we! Let's learn, let's go and let's get funding and labeling done! Here's how...

Bipartisan Blueprint 1 - Accelerating Access to Critical Therapies for ALS Act

The Accelerating Access to Critical Therapies for ALS Act was signed into law by President Biden on December 23, 2021.

In his remarks, President Biden stated,

"As we enter this Christmas and New Year, the bill I’m about to sign into law truly represents the spirit of the season, in my view ­a season of hope and light, goodness and grace, and the power of unity in everyday Americans doing extraordinary things. That’s Accelerating Access to Critical Therapies for ALS Act... ALS, known as Lou Gehrig’s disease, attacks the nervous system and weakens the muscles, making it hard to lift up a spoon to eat or to take a step to walk. It leads to paralysis and ultimately leads to death within an average of two to five years of diagnosis. Since Lou Gehrig, the Hall of Famer from New York Yankees, announced his retirement from baseball in 1939 because of the disease, no cure has been found. Treatments are still limited, and the outcomes are still the same. That’s 82 years with hundreds of thousands of lives lost. But today, we’re finally closer than ever to new treatments and hopefully, hopefully ­God willing ­a cure. And it’s because of the movement led by the patients and caregivers and members of Congress of both parties, many of whom are joining us today virtually. Patients like Brian Wallach and his wife, Sandra."

The Accelerating Access to Critical Therapies for ALS Act (H.R. 3537 and S.1813) will make $100 Million available each fiscal year from 2022-2026 to build new pathways to fund early access to ALS investigational therapies, accelerate ALS and neurodegenerative disease therapy development through a public-private partnership, and increase research on and development of interventions for rare neurodegenerative diseases through a new Food and Drug Administration (FDA) research grants program.

According to Politico's insightful article, "He Was Given 6 Months to Live. Then He Changed D.C.", "Brian Wallach was diagnosed with ALS the day his daughter came home from the hospital. In the time since, he's radically changed how medical advocacy works and how the government approaches medical research."

The ACT for ALS bill has established:

1. "An Expanded Access grant program that funds research on and provides access to promising investigational treatments to people living with ALS who are not eligible for clinical trials.

2. A public-private partnership for rare neurodegenerative diseases jointly led by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). This will be the first federal effort explicitly charged with speeding the development and approval of therapies for ALS and other rare neurodegenerative diseases.

3. A rare disease grant program at the FDA that will fund research on and the development of interventions to prevent, diagnose, treat or cure ALS and other rare neurodegenerative diseases."

Legislative History

Given that there is not a lot of good news out of Washington, D.C. these days, it is really inspirational to see the speed with which this bipartisan legislation moved through the House and Senate.

• May 25, 2020 - U.S. Representative Mike Quigley (D, IL-5), Chairman of the House Appropriations Subcommittee on Financial Services and General Government, and Representative Jeff Fortenberry (R, NE-1), Ranking Member, House Appropriations Subcommittee on Agriculture, Rural Development, and Food and Drug Administration (FDA), with Senator Chris Coons (D, DE), co-chair of the Senate ALS Caucus, and Senator Lisa Murkowski (R, AK), re-introduced the bipartisan, bicameral Accelerating Access to Critical Therapies for ALS Act (ACT for ALS). This legislation was designed to create the infrastructure necessary to fund early access to promising clinical trial therapies for patients suffering from fast-progressing rare neurodegenerative and terminal diseases such as ALS.

• December 8, 2021 - The ACT for ALS Act legislation led by U.S. Representatives Mike Quigley (IL-05) and Jeff Fortenberry (NE-01) passed the House of Representatives with overwhelming bipartisan support. The ACT for ALS was designed to help people living with ALS get early access to promising treatments and help researchers gain a better understanding of neurodegenerative diseases.

• December 9, 2021 - The U.S. House of Representatives passed the ACT for ALS, the bipartisan, bicameral legislation introduced by U.S. Senators Chris Coons (D, DE) and Lisa Murkowski (R, AL) and U.S. Representatives Mike Quigley (D, IL) and Jeff Fortenberry (R, NE). The passage of the bill in the House came just as the companion bill reached 55 cosponsors in the Senate, with Senators Deb Fischer (R, NE) and Martin Heinrich (D, NM) having been the 50th and 51st co-sponsors.

• December 26, 2021 - The U.S. Senate unanimously passed the ACT for ALS Act legislation that was introduced by U.S. Senators Chris Coons (D, DE) and Lisa Murkowski (R, AK) and U.S. Representatives Mike Quigley (D, IL) and Jeff Fortenberry (R, NE).

A Personal Note of Gratitude to Brian Wallach and Sandra Abrevaya

Congratulations to Brian Wallach and Sandra Abrevaya (Brian's wife, voice and caregiver) and the I AM ALS team on getting the ACT for ALS through Congress and signed into law! I am in awe of your accomplishments and so thankful for all that you have done to change the trajectory of the lives of Americans suffering from neurodegenerative diseases and their loved ones.

Our worlds crossed paths in Room 2358C of the Rayburn House Office Building in April 2019... While eagerly awaiting the testimony on Celiac Disease to the Labor, Health and Human Services Committee on Appropriations from Marilyn Geller of the Celiac Disease Foundation, I distinctly recall listening to Brian's riveting testimony on ALS, and I got choked up. It stuck with me how Brian shared his lived experience in such a meaningful and mindful manner. My mom has Parkinson's, and I am hopeful that ALS research can help unlock the mystery of neurodegenerative diseases for Brian, my mom and all others similarly situated.

Bipartisan Blueprint 2 - The FASTER Act for Naming Gluten as 10th Major Food Allergen Requiring That Gluten Be Labeled on All Packaged Foods

Until such time as there is a treatment for Celiac Disease other than a strict Gluten Free diet for life, or better yet a cure, Jax and 3 million Americans need Gluten to be named as the 10th Major Food Allergen and labeled on all packaged foods, just like it is in 85 countries across the world, including across Europe and in Canada. Labeling Gluten will also be in accordance with the legislative intent and original language in what became the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

To that end, it is instructive and inspirational to review how the FASTER Act of 2021 became law to protect about 1.6 million Americans who are allergic to Sesame. This marked the first time since 2004 that a new major food allergen has been added to the top 8 allergens in the U.S. as set forth in the FALCPA. With the FASTER Act, the U.S. has joined 46 other countries around the world where Sesame must be labeled on packaged foods including in Canada and across Europe.

Legislative History

Given that there is not a lot of good news out of Washington, D.C. these days, it is again really inspirational to see the lightning speed with which this bipartisan legislation moved through the House and Senate because eating without fear is something that is non-partisan.

• March 3, 2021 - The FASTER Act, S. 578 was introduced by Senator Tim Scott (R, SC) along with 8 Cosponsors including Sen. Chris Murphy (D, CT), Sen. Susan Collins (R, ME), Sen, Kirsten Gillibrand (D, NY), Sen. Thom Tillis (R, NC), Sen. Richard Blumenthal (D, CT), Sen. Tammy Baldwin (D, WI), Sen. Roger Marshall (R, KS) and Sen. Raphael Warnock (D, GA). On that same day, the FASTER Act was passed by Unanimous Consent in the U.S. Senate!

• April 14, 2021 - The House overwhelmingly approved the FASTER Act in a bipartisan manner in a vote of 415 voting "yea" and only 11 voting "nay." The U.S. House of Representatives passed the FASTER Act to add Sesame as 9th top allergen! This was a truly remarkable moment for the food allergy community especially this early in the 117th Session of Congress as more than 2,150 bills had already been introduced in Congress and the FASTER Act was only one of seven that had passed the Senate.

• April 23, 2021 - President Joe Biden signed the FASTER Act into law which added Sesame as the 9th Major Food Allergen that is required to be labeled on packaged foods in the U.S.

HHS/FDA Could Have Acted Independently to Require the Labeling of Sesame Based on Existing Language in FALCPA and Without the FASTER Act

Notwithstanding the FDA's authority under FALCPA's Section 203(b) and 403(w) which enables the Secretary of Health and Human Services to require labels or labeling changes for other food allergens that are not major food allergens, Congress still passed the FASTER Act to name Sesame as a Major Food Allergen. This was done in large part since it appears that the FDA believed that voluntary labeling of Sesame was sufficient.

According to the Food & Drug Law Journal's seminal article in 2006 that was entitled, "When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004,"[1] FALCPA does not preclude HHS Secretary from expanding via regulation the list of major allergens requiring identification under the FALCPA's labeling scheme.[2] 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."[3]

"When Food is Poison" was written by Laura Derr when she was a student at Harvard Law School, under the supervision of Lecturer on Law Peter Barton Hutt, Partner at Covington & Burling, 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.

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 or through legislation, it is instructive to look at the Congressional Budget Office ("CBO") Cost Estimate for H.R. 2117, which was the predecessor to the FASTER Act. The CBO's estimate, including for the Federal government and private sector, with labeling Sesame may likely be similar to the costs involved in naming 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)."

At age 8, Jax recruited 9 bipartisan members of the U.S. House of Representatives to join the new Congressional Celiac Caucus in 2021. In addition to Jax's two legislative priorities (funding research and labeling Gluten), the Celiac Caucus can improve the lives of those with Celiac by using a "Whole of Government" approach and working on issues with different government agencies including the National Institutes of Health, Health and Human Services, Food and Drug Administration, Centers for Disease Control and Prevention, Department of Education, Department of Defense, etc.

Inspired by these two bipartisan blueprints, I drafted a proposed FASTER Act of 2022 Bill to name Gluten as the 10th Major Food Allergen. This will better protect Jax and 3 million Americans with Celiac Disease, so they can avoid getting violently ill as Jax did in California this past Summer when the chef at the restaurant thought a product was Gluten Free because it did not have wheat in it, but the product did have unlabeled Gluten in it.

Epilogue on the FASTER Act (November 1, 2023) - Some Manufacturers Intentionally Adding Sesame to Their Products

As discussed, Celiac Journey advocated as allies in the food allergy community for passage of the FASTER Act to get Sesame labeled on all packaged foods in the US.

Prior to the FASTER Act taking effect on January 1, 2023, it was being reported that there was an untended effect whereby some food manufacturers had started to intentionally add Sesame to products that previously did not have Sesame in them, and then label those products as having Sesame.

It is indeed unfortunate that there have been various companies that responded to the FASTER Act by intentionally adding Sesame to their products that did not previously have Sesame, thus making it harder for people with a Sesame allergy to find safe foods to eat. While there have been some high profile cases of this bad faith practice, this appears to have been from just a subset of food companies. This is a downstream problem from the FASTER Act and the FDA's lax enforcement of existing laws and regulations under the Food Allergen Labeling and Consumer Protection Act.

That said, the Sesame allergy community is still better protected with the enactment of the FASTER Act because Sesame is now considered a Major Food Allergen which must be declared on all packaged foods. This also impacts the ways in which food service operators at schools and restaurants, for example, must address Sesame as a Major Food Allergen. The requirement to label Gluten is a foundational goal that we have for Gluten, just like Gluten is required to be labeled in 87 other countries.

On January 30, 2023, the Center for Science in the Public Interest ("CSPI"), filed a Citizen

Petition with the FDA "to Notify Manufacturers That They Cannot Mitigate Allergen Cross Contact Risks by Adding Sesame and other Major Allergens to Foods."

On May 2, 2023, U.S. Senator Ron Wyden (D, OR)., and U.S. Representatives Doris Matsui (D, CA), and Patrick McHenry (R, NC), led a letter urging bakers to stop unnecessarily adding sesame to baked goods and protect consumers with sesame allergies.

In a May 15, 2023 response letter to Congress, the American Bakers Association (ABA) argued that "Sesame is a uniquely challenging allergen to remove from the baking environment, and even the best practices cannot always remove traces of Sesame." The stated reason is that Sesame "is most typically used as a topping, rather than an inclusion (like Wheat, Eggs, Soy, or Milk are in many baked goods). The particulate nature of Sesame seeds makes them much more difficult to control in the baking production environment...)." The ABA has also stated that the "addition of Sesame would likely not be needed if FDA would establish allergen thresholds or otherwise set forth clear guidance as to when advisory or precautionary labeling (i.e., 'may contain' statements) may be used to alert allergic customers to the risk of cross-contact..."

With respect to our goals of getting Gluten labeled on all packaged foods in the US, just like Gluten must be declared in 87 other countries, Barley, Rye and Oats are more similar to the Top 8 Major Food Allergens rather than Sesame because those Gluten containing grains are an "inclusion" in baked goods rather than a topping like Sesame. In addition, the FDA and the Celiac community has established clear thresholds for Gluten free (i.e., < 20 parts per million), which would in theory enable the bakers to test and know if there is cross contact in their production lines and may likely prevent the intentional addition of Gluten like some bakers have done with Sesame.

On July 26, 2023, the FDA responded to CSPI's January 30, 2023 Citizen Petition regarding Sesame allergen labeling by denying two of CSPI’s petition requests and granting one request. In the conclusion to their response, the FDA stated that while the Agency is not taking action with respect to CSPI's Requests 1 and 2, they are "actively looking into and engaging on this practice of companies intentionally adding sesame to foods that, prior to the passage of the FASTER Act, did not contain sesame."

That said, in the US, we are also not aware of any of the top 8 Major Food Allergens just being added to foods by food manufacturers to avoid the labeling requirement of those Major Food Allergens under the Food Allergen Labeling and Consumer Protection Act of 2004. In addition, we are not aware of any multinational manufacturers in the 87 countries around the world where Gluten is required to be labeled intentionally adding Gluten to their food items.

While we would not want any food manufacturer to intentionally add Gluten to a product in the US like some have done with Sesame to circumvent the FASTER Act's intended disclosure purposes, that would be a "good" resulting problem to have knowing that Gluten was in fact declared a Major Food Allergen by the FDA.

Please join us in calling on the FDA to require the labeling of Gluten!

Notes

[1] Derr, Laura E. When Food Is Poison: The History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004. Food and Drug Law Journal, vol. 61, no. 1, 2006, pp. 65165. JSTOR, http://www.jstor.org/stable/26660870. Accessed 30 Sep. 2022.

[2] 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. https://www.congress.gov/108/crpt/srpt226/CRPT-108srpt226.pdf

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