Precautionary Major Allergen Labeling Not Sufficient Disclosure
GMPs and label controls are the foundation of safety
As we close out this year, taking a pause and reflecting is a good thing. This WLW marks my 232nd consecutive weekly WLW post! When I mentioned this number the other day, someone said to me, “You must really enjoy writing those posts,” which is true. It is not always easy, as I rarely pre-write posts, which means I’ve written WLWs while on international flights, after long days at trade shows, when I was sick as a dog, when I was floating on the Mekong River in Laos, and much more. This is a labor of regulatory love, and I am grateful for all of your support!
Precautionary allergen labeling are statements like “Made in a facility that also processes wheat” or “May contain peanuts.” I’m sometimes asked whether this is sufficient for major allergen disclosure, and the answer, of course, is “no.”
A recent FDA recall highlighted this issue. Let’s see what we can learn.
The issue was due to an inadvertent mislabeling that was thankfully discovered by a retail store employee who noticed walnuts (the undisclosed allergen) in the product. As a fellow label reader and regulatory geek, I applaud this employee for identifying this issue before it could lead to safety or legal issues.
When precautionary allergen labeling is appropriate. Learn more.
Precautionary allergen statements are voluntary and should be used only to communicate residual, unavoidable cross-contact risk after strong allergen controls are in place. FDA indicates advisory statements may be appropriate when manufacturers follow GMPs and take every reasonable step to prevent cross-contact. FDA also acknowledges that the advisory statement may be permitted when trace unintended allergens still occur despite those controls.
When a precautionary allergen labeling is NOT appropriate:
Not a substitute for controls: “May contain” statements don’t replace GMPs or preventive controls and must be truthful/non-misleading.
Not for added ingredients: If an allergen is an ingredient, it must be declared in the ingredient list and/or “Contains” statement, and PAL can’t replace required disclosure.
Don’t use both formats for the same allergen: Avoid stating both “Contains X” and “May contain X” for the same allergen; FDA says this can be misleading. This is a good one that I see every once in a while.
Read the recall here.
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