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"May Contain" Allergen Labeling

Quick answer

May contain allergen labeling is optional: no federal law requires a "may contain" statement, and no FDA rule defines one. Advisory lines like "may contain peanuts" or "made on shared equipment with tree nuts" are voluntary. FDA's position is clear: they must be truthful and not misleading, and they are never a substitute for good manufacturing practices that keep allergens out.

May contain allergen labeling example: side-by-side of a required "Contains: milk, wheat" statement and a voluntary "May contain peanuts" advisory line on a cookie package
Required versus voluntary: two different allergen lines
01

"Contains" versus "may contain"

The two lines look alike but play by different rules. One is the law. The other is your call.

"Contains" statement"May contain" statement
Required?Yes, or name allergens in the ingredient listNo, voluntary
CoversAllergens in the recipePossible traces from cross-contact
Set by21 U.S.C. 343(w)No specific rule; must be truthful
ExampleContains: wheat, milk.May contain peanuts.
FDA Allergen Q&A, Edition 5 (D.12)The allergen labeling law does not address advisory statements. They must be truthful and not misleading under section 403(a)(1) of the FD&C Act.
02

What cross-contact means

Cross-contact is when an allergen gets into a food that was never meant to have it. FDA names typical causes:

  • Shared equipment and the order products run on it
  • Rework added back into the wrong product
  • Allergenic product passing above an open product line

The allergen labeling law does not apply to these unintended traces. The manufacturing rules do: good manufacturing practice, and for facilities covered by them, preventive controls that include allergen controls.

21 CFR Part 117 · 117.135(c)(2)Good manufacturing practice and the food allergen preventive controls that protect against cross-contact.
03

When an advisory line is acceptable

FDA has said a "may contain" line could be considered truthful and not misleading when low levels of an allergen end up in a food through cross-contact, despite strong manufacturing practices.

The order matters. First you control cross-contact. Then, if a real risk remains, an advisory line tells allergic shoppers about it. FDA was asked whether a "may contain" label alone is enough. Its answer: no.

FDA Allergen Q&A, Edition 5 (D.15)Labeling is not a substitute for good manufacturing practice or allergen preventive controls.
04

Four combinations to avoid

Don't printWhy
"Contains milk" and "may contain milk"The advisory line implies milk isn't an ingredient, which misleads
"Milk-free" and "may contain milk"A free-from claim means none at all, including from cross-contact
"Contains peanuts" when there are noneListing an allergen that isn't present does not comply with FDA rules
Possible traces inside the Contains lineThe Contains statement is reserved for allergens in the food
FDA Allergen Q&A, Edition 5 (D.10, D.13, D.14)FDA's answers on free-from claims, mixing advisory and Contains statements, and what the Contains statement is for. FDA has also cited listing absent allergens in a warning letter.
05

How to word it

There is no required wording. Pick a line that describes your real situation, and keep it apart from the Contains statement. Common versions:

  • May contain peanuts.
  • Made on shared equipment that also processes tree nuts.
  • Produced in a facility that also handles sesame.

Our tool writes the Contains line from your recipe, with the specific nut, fish or shellfish named. The advisory line depends on your kitchen, so that one is yours to decide.

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06

"May contain" decision checklist

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Questions

Questions

No. The federal allergen labeling law covers allergens that are ingredients. Advisory statements about possible traces are voluntary.

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