“We are the United States of America. There is nothing beyond our capacity!”
-- President Joe Biden
President Joe Biden recently gave my 9 year old son Jax a couple of boxes of his POTUS M&Ms! Jax was so excited when he showed us the M&Ms in their special box featuring the "Seal of the President of the United States" and President Biden's signature! So cool, right? For most kids, they would have ripped the box open and gobbled up the M&Ms on the spot. Well, not so fast for those kids like Jax in the Celiac world with a potentially life-threatening food allergy to Gluten.
"Mom, can I eat the President's M&Ms? Does it have Gluten in it?" -- Jax Bari
Fear, Uncertainty, Doubt & Danger
My wife and I quickly saw Jax's smile vanish when the fear and uncertainty with the potential for danger once again arose with the voluntary labeling of Gluten in the U.S., including on the POTUS M&Ms. "Does this product have Gluten in it?" has been the daily refrain in our lives ever since Jax was diagnosed in 2018 with Celiac Disease.
Step 1 - Let's check the label and see if POTUS M&Ms have Gluten in them:
"M&M's Milk Chocolate Candies INGREDIENTS: Milk Chocolate (Sugar, Chocolate, Skim Milk, Cocoa Butter, Lactose, Milkfat, Soy Lecithin, Salt, Natural Flavor), Sugar, Cornstarch; Less Than 1% of: Corn Syrup, Dextrin, Colors (Includes Red 40 Lake, Blue 2 Lake, Blue 1 Lake, Yellow 6 Lake, Blue 1, Red 40, Blue 2, Yellow 6, Yellow 5, Yellow 5 Lake), Carnauba Wax, Gum Acacia. ALLERGY INFORMATION: CONTAINS MILK AND SOY.
MAY CONTAIN PEANUTS."
Hmm... or Should I Say Hm&m?
If you have an allergy to Milk and Soy, then one cannot eat these M&Ms. Ok, that makes sense, and the label is clear. If you have an allergy to Peanuts, then you may also want to avoid these M&Ms since it "MAY CONTAIN PEANUTS."
While managing potentially life-threatening food allergies to Milk, Soy and/or Peanuts is certainly not easy, the mandatory labeling of those food allergens makes it a lot easier to know whether a particular food product is safe to consume for someone with those respective food allergies. However, the Gluten guessing game for those with Celiac is caused by the voluntary labeling scheme of Gluten in the U.S., and this is epitomized by POTUS M&Ms.
Importantly, unlike food allergies with IgE-Mediated mechanisms, there is no rescue medicine (i.e., adrenaline or antihistamine) to treat the accidental ingestion of Gluten and the start of the auto-immune cascade in food allergy with Non-IgE-Mediated mechanisms such as Celiac Disease. Additionally, those with a Non-IgE-Mediated food allergy to Gluten cannot outgrow their food allergy – Celiac is lifelong (until such time as a cure may be developed). As Jax told President Biden, insulin is to Diabetics as Gluten Free food is to Celiacs.
"The time has come to end the Gluten guessing game with voluntary labeling and require that Gluten be labeled as a Major Food Allergen, including on POTUS M&Ms. Secretary Xavier Becerra has existing statutory authority to label Gluten now as a Major Food Allergen!" -- Jon Bari
Step 2 - Contact the Manufacturer & Decipher Confusing Responses from M&M Mars
According to the FDA, "If you have any doubts about a product’s ingredients and whether or not the product is gluten-free, the FDA recommends that you should contact the manufacturer or check its website for more information." The FDA also advises that "consumers who are allergic to particular foods to ask questions about ingredients and preparation when eating at restaurants or any place outside the consumers home."
The FDA's guidance is an inherently impossible task for consumers, and a recipe for inadequacy with the voluntary labeling scheme for Gluten!
The Gluten guessing game goes on every day in the absence of mandatory labeling of Gluten as a Major Food Allergen. The efforts made and anxiety endured by parents and caretakers is palpable. Social media groups are replete with the Celiac community trying to decipher lots of confusing consumer information, and it is not just limited to Halloween or other candy-oriented holidays. One Celiac mom posted about M&Ms, "I do not understand how so much conflicting information is out there. Every time I reach out to Mars, call or email, this is the inconsistent information I get." Hm&m. Here are some examples:
January 4, 2021 "Thank you for contacting Mars Wrigley. We appreciate your interest in M&M’S® Milk Chocolate. Although our M&M’S® Milk Chocolate do not contain gluten, we do not have a gluten free statement on our packaging because this product is made in a facility where other products that do contain gluten are manufactured. We understand that people with food allergies have to be careful with the food they eat. Moving forward please feel free to check the back of the package for allergen information." (Response to Michele H. from Mars Wrigley, 1/4/21)
March 16, 2022
"Hello Kelly... Any ingredient which contains gluten, such as wheat, barley, rye, and oats, is listed on the ingredients list on the pack.
In areas where gluten may be present, we always provide a statement (i.e. May contain wheat, etc.). There are really strict controls in our factories surrounding gluten and other allergens. We make sure that sufficient cleaning structures are in place to avoid any cross-contamination.
Although the product does not contain gluten, we do not have a gluten-free statement on our packaging because this product is made in a facility where other products that do contain gluten are also manufactured.
At this time, we do not have a list of gluten free products for chocolate. All our chocolate products either have gluten or could be made on machinery that does. We hope that this information has been helpful." (Mars Wrigley North America Email to Kelly P. From Chris, Mars Customer Care, 3/16/22, ref:_00D0Y34dhp._5008d480m3:ref)
October 28, 2022
"Thank you for contacting us about M&M'S. We do not label our Chocolate products as gluten-free. This is because all our Chocolate products either have gluten, are made on machinery that also makes products containing gluten, or is made in a facility that uses gluten in other products. Whether or not the product includes a “may contain” statement, it is never labeled as gluten-free because we cannot guarantee that it is gluten-free despite the cleaning and other protocols that we use at our sites. We hope this information has been helpful. If you have further questions or concerns, please don’t hesitate to reach out to us." (Email to Jon Bari from Jaja, Mars Customer Care, Case ID: 03036440,10/28/22)
Perplexing Paradigm of Consumer Protection for 3.3 Million Celiacs: Included vs. Excluded
With the mitigation of the burden of chronic disease in mind, it is instructive to understand the following current perplexing paradigm. Unlike the Food Allergen Labeling and Consumer Protection Act ("FALCPA") labeling scheme for the top 9 Major Food Allergens in the U.S. (including Sesame as of January 1, 2023), Gluten Free labeling is permissive (not mandatory) in the U.S. In other words, whereas sufferers of the current top 9 Major Food Allergens 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.
M&Ms Does Only the Bare Minimum: Unfortunately M&MS Are Not Really For All Funkind (Yet?)
In the case of M&M's, Mars Wrigley elects to not label their products Gluten Free. The bottom line is that in the absence of mandatory labeling schemes, Mars Wrigley reverts to doing the minimum. In other words, Mars Wrigley only does what is legally required. That leaves consumers like my son Jax vulnerable to the dangerous ingestion of Gluten, a potentially life-threatening food allergen, and as such, Mars Wrigley fails in its promise "to use the power of fun to include everyone" in its mission of "for all funkind." In other words, by failing to label their candy Gluten Free, Mars Wrigley has failed in its mission to "create a world where everyone feels they belong."
It is instructive to view research published in the Academy of Management, “The Effects of Mandatory and Voluntary Regulatory Pressures on Firms' Environmental Strategies: A Review and Recommendations for Future Research.”
“This article presents an in-depth review of scholarship on how mandatory and voluntary regulatory pressures on firms affect their environmental strategies and performance. Although mandatory regulation typically has a strong and positive influence on firms’ environmental performance, studies of the effects of voluntary pressures demonstrate that by themselves they are unlikely to bring about significant improvement in environmental outcomes.”
From this analogy, one can glean from the Academy of Management Annals 2020 how these same findings on mandatory and voluntary regulatory pressures arguably apply to mandatory vs. voluntary labeling of potentially life-threatening food allergens by the food industry, including Mars Wrigley.
“Nearly all the literature works we have reviewed confirm that the mandatory powers of government are the most effective lever that society has to alter firm environmental strategies and performance. However, potential negative implications on competitiveness have generated a mixed and relevant debate. In this review, we have shown that voluntary programs have arisen to supplement mandatory regulation; however, research has found that often the results of these programs are disappointing.”
A Tale of Two Chocolatiers: Mars Wrigley vs. Hershey
In contrast to Mars Wrigley, it is instructive to look at how The Hershey Company clearly informs its customers in the United States that more than 280 of its products including favorites from Hershey's, Reese's, Kisses, Rolo, York, etc. are in fact Gluten Free.
A Tale of Two Chocolatiers With Ties to Warren Buffet: Mars Wrigley vs. See's Candies
In contrast to Mars Wrigley, it is also instructive to look towards See's Candies' "Allergen Information" page on which See's Candies clearly and plainly states,
"Candies produced in See’s Candies facilities do not contain gluten, and these products are the vast majority of those we sell. We sell a small amount of specialty candies that we purchase from other partner confectioners. Although these don’t contain gluten, they are manufactured in shared facilities or in shared equipment with gluten-containing products. These products are candy canes, peanut butter bites, lemon drops, apple pie bites, Hanukkah hard candy, hot cocoa, chocolate covered coffee beans sold in our retail shops and online at Sees.com." (emphasis added)
Hm&m?!? In 1972, Berkshire Hathaway purchased See's Candies. Maybe Warren Buffet and Berkshire Hathaway can share See's Candies' labeling and consumer protection best practices with Mars Wrigley (which Warren Buffet had formerly invested in)? Labeling Gluten can and should be done!
In the Lab - M&Ms Milk Chocolate Candy Tested to be Gluten Free
According to laboratory tests conducted by Gluten Free Watchdog in March 2021, M&M's Milk Chocolate Candies were tested to contain less than 5 parts per million of Gluten. While that was one batch of M&Ms tested on one day a couple of years ago, it suggests that M&Ms are in fact Celiac safe. That said, in the absence of a requirement to label Gluten as a Major Food Allergen, we are sensitive to the fact that ingredients, recipes and production may change over time, and therefore the Gluten Free Watchdog lab test results represent just one point in time and not a free pass for Celiacs to safely consume M&Ms. Note that the lab results are posted with permission of Tricia Thompson from Gluten Free Watchdog.
Labeling Gluten as a Major Food Allergen Will Provide Greater Consumer Protection & Choice for Celiacs
If the labeling of Gluten was mandatory on all products, it is our belief 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.
If Gluten was required to be labeled, then 3.3 million Celiacs including Jax would most likely be able to enjoy M&Ms and not be relegated only to the premium marketplace for foods labeled Gluten Free. If Gluten would be required to be labeled, then we could rely on labeling just like consumers with the other 9 Major Food Allergens currently rely upon. In the absence of Mars Wrigley labeling M&M Milk Chocolate Candies as Gluten Free, Celiacs, for example, pay a 4.8x multiple (price per ounce) to purchase a comparable candy to M&Ms that is labeled Gluten Free.
POTUS M&Ms Are a Big Deal - Don't Just Take Our Word For It!
POTUS M&Ms epitomize an all-American red, white and blue candy that Celiacs would love to enjoy, and that Jax would have loved to gobble up when the President gave him a few boxes of POTUS M&Ms! POTUS M&Ms are bipartisan and date back to President Ronald Reagan.
If Gluten was required to be labeled as a Major Food Allergen, then we would know whether there was Gluten in the M&Ms because Mars Wrigley would clearly and adequately label their product, and not hide behind the voluntary labeling scheme that leads to the Gluten guessing game for those with a potentially life-threatening food allergy to Gluten.
POTUS M&Ms are not just a really big deal to Jax... On April 29, 2021, Ashley Williams, the Deputy Director of Oval Office Operations at the White House, tweeted that "POTUS M&Ms arrived just in time for the 100th day!"
Gisele Fetterman, the wife of U.S. Senator John Fetterman of Pennsylvania, recently posted about President Biden giving her POTUS M&Ms when she was flying with the President aboard Air Force One - "Here to confirm that m&ms are absolutely a real thing (and in my to-go bag)."
Even singer and actress Olivia Rodrigo shared with Jimmy Kimmel how President Biden gave her POTUS M&Ms, in addition to aviator sunglasses and a POTUS shoehorn, when she visited the White House on July 14, 2021.
"good 4 u" - Apathy is Our Obstacle!
When we met with staff from the White House Domestic Policy Council on November 10, 2022, they asked what we felt the biggest obstacle was in terms of getting Gluten labeled as a Major Food Allergen. We shared that our policy objective in labeling Gluten as a Major Food Allergen is in alignment with the 2021 FAO/WHO Expert Consultation from the Food and Agriculture Organization of the United Nations and the World Health Organization (which was chaired by the FDA's Dr. Lauren Jackson), and how 85 countries worldwide label Gluten as a Major/Priority Food Allergen.
We also shared Celiac Journey's findings that apathy was the largest obstacle which was fueled by flawed and ingrained scientific, governmental and societal biases including:
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.
With respect to labeling food products in the United States, the voluntary Gluten Free labeling scheme 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.
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.
Paradoxically, consumer ignorance about Gluten containing ingredients coupled with the Federal government's apathy towards the medically required needs of the Celiac community have been flourishing at a time when the number of diagnosed Celiacs has been increasing and consumers seem more interested than ever in food safety, ingredient labels, allergen declarations and nutrition.
Olivia Rodrigo's good 4 u lyrics speak to our lived experiences with how the Celiac community has been left to fend for ourselves when it comes to the voluntary labeling of Gluten in the U.S.
"Maybe I'm too emotional
Your apathy is like a wound in salt
Maybe I'm too emotional
Or maybe you never cared at all
Well, good for you, you look happy and healthy
Not me, if you ever cared to ask" -- good 4 u, Olivia Rodrigo
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."[1] 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."[2] (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.
The Bottom Line
We agree with President Biden that "there is nothing beyond our capacity," and that includes labeling Gluten as a Major Food Allergen to better protect 3.3 million Celiacs and help to more meaningfully include them in life's daily activities that involve food.
While we work on getting Gluten labeled from a regulatory side, we ask Mars Wrigley to reflect on its ethos, "the world we want tomorrow starts with how we do business today." To be clear, while we work towards getting Gluten declared as Major Food Allergen, Mars Wrigley can do the right thing now by labeling their products as Gluten Free, just like Hershey's does.
According to M&Ms parent company, "within Mars, we’re committed to fostering an environment where our more than 130,000 Associates feel valued and respected, regardless of any visible or invisible differences." To that end, greater than 1% of the population has Celiac Disease, and by estimate 1,300+ Mars employees suffer from Celiac and are allergic to Gluten like my son and 3.3 million Americans. For the record, Celiac is a recognized disability under the Americans with Disabilities Act, since Celiac impacts one of life's major activities, eating.
As much as Jax would love to eat M&Ms, including the really special ones which President Biden gave him, Jax cannot since Mars Wrigley is not required to label whether Gluten is an ingredient, and in the absence of that requirement, Mars Wrigley does not label any of its chocolate products as Gluten Free, yet!
Notes
[1] 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."
[2] H.R. Rep. No. 108-608, at 18. (2004), https://www.congress.gov/108/crpt/hrpt608/CRPT-108hrpt608.pdf