Area of focus #2

Food

Additional areas of focus

Drugs and medical devices

Education

Research and epidemiology

Prevention

Goal

Ensure that people affected by alpha-gal syndrome (AGS) have equitable access to safe food options

Priority #1

Formally recognize alpha-gal as a major food allergen

Challenge

Prevalence

  • According to CDC estimates, alpha-gal syndrome (AGS) affects up to 450,000 people in the U.S., making it the 10th most common food allergen in the U.S.8,9
  • Up to 3% of some populations are affected by AGS, including large areas of the South, Midwest, and East Coast.13,14,15
  • Alpha-gal syndrome is the most common adult-onset food allergy throughout these regions.16

Severity

  • Evidence-based criteria for defining a food or food ingredient as a “major food allergen” requires consideration of both the prevalence and severity of allergic reactions to a food or food ingredient in order to establish that such food or food ingredient is an allergen of public health concern, as outlined in the FASTER Act. 19.
  • Allergic reactions to alpha-gal are, on average, severe. This is due in part to the delayed nature of AGS reactions. Unlike protein allergies, there is no immediate reaction that signals people with AGS to stop eating.
    • 60-75% of people with AGS have anaphylactic reactions, a higher percentage than even peanut allergy.1,2,3,133
    • A third of all anaphylactic reactions in some adult populations are caused by alpha-gal, more than all other food allergies combined.17
    • Reactions to alpha-gal are often life-threatening and have resulted in fatalities.5
  • AGS disproportionately affects adults, who are more likely to experience severe anaphylaxis with cardiac complications than children.
    • AGS is the number one cause of both adult-onset allergy and adult and adolescent anaphylaxis in much of the South, Midwest, and East Coast.16,17
    • A number of people with AGS report heart attacks in conjunction with anaphylactic reactions to alpha-gal.
    • 30-40% of people with AGS experience cardiac symptoms.20

Disproportionate risk of exposure

  • Alpha-gal in the form of meat products, lard, dairy, gelatin, hundreds of mammalian byproducts, and carrageenan is ubiquitous in foods, drugs and medical products, personal care, and household products.
  • Due to the ubiquitous presence of alpha-gal and the difficulty of identifying mammal-derived ingredients, AGS imposes a disproportionate risk of exposure for those affected by it.
  • Compared to other allergens, mammal-derived ingredients are much more difficult to identify. There are hundreds of mammal-derived ingredients with obscure names like lipase, diglyceride, and oleic acid.21
    • Virtually nobody is familiar with all of these ingredients.
    • No comprehensive list of these ingredients exists.
    • Many of these ingredients can be mammal or plant-derived, leading to further consumer confusion.
  • As a result, lack of transparent disclosure of mammal-derived ingredients in foods results in a disproportionate impact on people affected by AGS relative to those with allergies to more easily identified allergens.

Equity

  • An equity-centered approach requires consideration of inequities in the burden of allergic disease.
  • AGS disproportionately affects resource-poor rural populations whose members are farther from emergency and specialty care, have less access to healthcare, are less likely to have health insurance, and have lower levels of education and income.8,18,31,32,34
  • The most affected states, including Arkansas, Oklahoma, Missouri, Kansas, Tennessee, Kansas, and North Carolina,8,18 are among the least affluent, according to data from the U.S. Bureau of Economic Analysis.

    OPPORTUNITY

    • Amend Section 201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)) to add galactose-α-1,3-galactose (alpha-gal) to the definition of “major food allergen.” For the purposes of this amendment, “alpha-gal” should include ingredients derived from non-catarrhine primate mammals, red algae in the Gigartinales order, and other known sources of alpha-gal. Mammal-derived ingredients for which there is compelling data documenting no alpha-gal above an established, detectable limit shall be exempt, e.g. ingredients made from GalSafe pigs.

    ALIGNMENT WITH NATIONAL PUBLIC HEALTH STRATEGIES AND EXPERT RECOMMENDATION

    • In his 2020 paper “Diagnosis & management of alpha-gal syndrome: lessons from 2,500 patients,” expert Scott Commins, MD, PhD identified the lack of adequate labeling for mammalian-derived sources in foods, medications, and vaccines as a challenge to the management of AGS.13
    • In its 2020 and 2022 reports to Congress, the Congressionally mandated Tick-Borne Disease Working Group called for thelabeling of foods and beverages that contain non-primate mammalian ingredients (active or inactive).129

    Due to the ubiquitous inclusion of mammal-derived materials in foods, medications, personal products and stabilizing compounds, full avoidance is difficult to achieve.

    As with management for any food allergy, AGS management is based on allergen avoidance. For patients with AGS, however, this tenet of self-protection is made difficult by the lack of adequate labeling for mammalian-derived sources in foods, medications, and vaccines. 

    Scott Commins, MD, PhD

    UNC

    In summary, this report demonstrates that AGS is both a severe allergy, with nearly 75% of patients meeting criteria for anaphylaxis, and also distinct from other food allergies in its symptom profile. 

    Binder AM, Cherry-Brown D, Biggerstaff BJ, et al.

    CDC