To amend the Federal Food, Drug, and Cosmetic Act to add alpha-gal to the definition of major food allergen.
Sponsors
Legislative Progress
IntroducedMr. Van Drew (for himself, Mr. Murphy, Mr. Davis of …
Summary
What This Bill Does
This bill requires food manufacturers to label products containing alpha-gal (galactose-alpha-1,3-galactose), a naturally occurring sugar molecule found in mammalian meat and certain red algae. Alpha-gal syndrome is a serious allergic condition triggered by tick bites that causes people to develop allergic reactions to red meat and other mammalian products. The bill adds alpha-gal to the federal list of major food allergens that must be disclosed on food labels, with an 18-month implementation period.
Who Benefits and How
Consumers with alpha-gal syndrome are the primary beneficiaries, as they will gain critical information to avoid potentially life-threatening allergic reactions. An estimated 450,000 Americans suffer from this tick-bite-induced allergy. Plant-based and vegan food manufacturers may see increased demand as consumers seek clearly-labeled alpha-gal-free alternatives. Biotech companies developing alpha-gal-knockout animal products (genetically modified to not produce alpha-gal) gain market advantages, as their products can be exempted if they meet FDA testing standards.
Who Bears the Burden and How
Food manufacturers using mammalian ingredients (meat, dairy, gelatin) face new compliance costs to reformulate labels and potentially reformulate products. Meat processors, dairy producers, and packaged food companies must update labeling systems within 18 months. Red algae processors that produce carrageenan (a common food additive) must also comply with the new labeling requirements. Restaurants and food service establishments will need to provide allergen information to customers. The FDA gains additional regulatory responsibilities for monitoring compliance and establishing detection thresholds.
Key Provisions
- Adds alpha-gal (galactose-alpha-1,3-galactose) to Section 201(qq) of the Federal Food, Drug, and Cosmetic Act as a major food allergen requiring mandatory labeling
- Defines alpha-gal to include ingredients from non-catarrhine primate mammals (most mammals except apes and Old World monkeys) and red algae in the order Gigartinales
- Exempts mammal-derived ingredients from alpha-gal-knockout animals if the Secretary determines alpha-gal levels are below detectable limits
- Provides an 18-month transition period before labeling requirements take effect
- Grants the FDA Secretary authority to establish testing standards and detectable limits for alpha-gal content
Evidence Chain:
This summary is derived from the structured analysis below. See "Detailed Analysis" for per-title beneficiaries/burden bearers with clause-level evidence links.
Primary Purpose
Adds alpha-gal (galactose-alpha-1,3-galactose) to the statutory definition of major food allergens under the Federal Food, Drug, and Cosmetic Act
Policy Domains
Legislative Strategy
"Expand FDA food allergen labeling requirements to protect consumers with alpha-gal syndrome, a tick-bite-induced allergy to mammalian meat and products"
Likely Beneficiaries
- Consumers with alpha-gal syndrome (tick-bite meat allergy sufferers)
- Allergy awareness organizations
- Producers of alpha-gal-free or plant-based food alternatives
- Producers of alpha-gal-knockout animal products
Likely Burden Bearers
- Food manufacturers using mammalian-derived ingredients
- Meat processors and packagers
- Red algae product manufacturers (Gigartinales order)
- Restaurants and food service establishments
- FDA (increased regulatory compliance monitoring)
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → Secretary of Health and Human Services (FDA)
Key Definitions
Terms defined in this bill
Commonly known as alpha-gal, a carbohydrate molecule that can trigger allergic reactions
Ingredients derived from non-catarrhine primate mammals and red algae in the order Gigartinales
Mammal-derived ingredients for which the Secretary determines there is no galactose-alpha-1,3-galactose above an established, detectable limit (such as ingredients made from alpha-gal-knockout mammals)
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology