Could you still be subject to a recall (due to allergen mislabeling) even if you have an advisory statement on the label?

Good Day,

I have been trying to get a clear-cut answer to this and I haven't found anything so far. I have been looking through both the FDA and CFIA literature.

For example, if we have a product that is labeled with precautionary statement May Contain [X], a Customer purchases the product, consumes it, and has an allergic reaction to X. Could the FDA/CFIA issue a recall? 

Is the company liable any way. I would think it would make sense at the least to issue a voluntary recall but I am curious if there is any clear guidance

Regardless, I was just looking for a clear documented answer, or if any has any first hand knowledge of a similar scenario, any insight would be appreciated 

Precautionary statement is made to worn allergic or sensitive people that this particular product may contain the allergen they're susceptible to. It's a consumer responsibility to read a product label. Sorry, I don't have a reference document, only this link (CFIA): https://inspection.c...52326591?chap=4

I've been reviewing CFIA recall warnings and never seen recalls issued due to the abovementioned case scenario.

from the link

"Cross contamination statements may be declared by food manufacturers and importers when, despite all reasonable measures there is the unintended presence of food allergens in the food. Cross contamination statements are not a substitute for Good Manufacturing Practices."

so you can infer that if there was an adverse reaction to your product, the onus is on you to prove that your GMPs were adequate and did not contribute to the issue

IMO the rationale is that, although "May Contain..." labeling does alert the consumer of the potential risk from unintentional cross-contamination, it does not absolve manufacturer of taking reasonable precaution to eliminate or reduce the known allergen hazard risk to an acceptable level. The “May Contain..” statement is voluntary, and therefore, does not cover for any known allergen cross-contamination. Both CFIA and FDA have clear positioning around allergen labelling and that the use of may contain statement is not sufficient replacement for allergen management program that includes all reasonable precautions to control allergens. Therefore, the onus is ultimately on manufacturer to protect the consumer.

P.S Interesting read “May Contain” Labelling: Adequate Consumer Warning or Unnecessarily Defensive Manufacturer Behavior? at link below

https://link.springe...0603-009-9095-8

IMO the rationale is that, although "May Contain..." labeling does alert the consumer of the potential risk from unintentional cross-contamination, it does not absolve manufacturer of taking reasonable precaution to eliminate or reduce the known allergen hazard risk to an acceptable level. The “May Contain..” statement is voluntary, and therefore, does not cover for any known allergen cross-contamination. Both CFIA and FDA have clear positioning around allergen labelling and that the use of may contain statement is not sufficient replacement for allergen management program that includes all reasonable precautions to control allergens. Therefore, the onus is ultimately on manufacturer to protect the consumer.

 

P.S Interesting read “May Contain” Labelling: Adequate Consumer Warning or Unnecessarily Defensive Manufacturer Behavior? at link below

https://link.springe...0603-009-9095-8

Hi isprout,

Thks for the link.

i think the topic in OP has been previously discussed here. Yr link focuses mainly on European market. IIRC There is at least one similar article aimed at US scenarios which is of equal or even greater length but i forget the link.

I noted that link in Post 4 is (a) quite old (2009), (b) totally speculative. (Afai could see from a quick skimming no reference to actual cases is made). The US article referred above is also not recent  but IIRC includes some actual legal events and their consequences. I daresay this reflects a higher litigious tendency in US.

I anticipate the current US situation is as per Post 2, inferred from the numerous recalls based on labelling  absence of subsequently detected allergens.