Rejection for major food allergen

Hello all, we are having to reject a large quantity of a dietary ingredient due to the fact we found a single soybean in the shipment.  The supplier is wanting to test it for the soy allergen concentration.  We are mentioning to them the United States Code regarding misbranding and allergens, and that any exposure to a major food allergen means we have to reject it, but what other regulation or statement would you rely on to justify and stand by this rejection?  We are getting ready for a lot of 'push-back' as this is an expensive lot.  The supplier does not seem to realize that the exposure means it is irreversibly rejected and that it doesn't depend on test results now. 

We are manufacturing dietary supplements in the United States and have certifications for GMP (NSF) and SQF for food safety.

Thank you,

Matthew

As a customer you can reject it for whatever reason. 

A single soybean was found in your product or loaded with your shipment during transport? 

It was in the actual dietary ingredient, in contact with it.

As a customer you can reject it for whatever reason. 

A single soybean was found in your product or loaded with your shipment during transport? 

How was your supplier approved? Were you aware of allergens at their facility? Was RA done? 

You are correct.  Once a product has tested "bad"  you cant test until you get the result that you like.   

How you convince a customer of that, is a different issue.  I dont know if a specific regulation that states this.  Its always just been given in my mind.   

Somewhat cynical of me, but im guessing they will just turn around and send it back to you as different lot if they are that convinced that its good.  

They were approved by site visit, review of food safety/certification documents, test results, performance, FDA supplier website resources, and other documents.  We were not aware of allergens at their facility, and in fact their regulatory book of information says they have no soy allergens (and no other major food allergens) in their product, on the same line, or in the same manufacturing plant, so it looks like the soy exposure is from their supplier.  We are working on trying to obtain return authorization (RA).

How was your supplier approved? Were you aware of allergens at their facility? Was RA done? 

Did your purchasing specifications say zero tolerance for undeclared allergens or specifically X,Y, or Soy?  They have had a critical failure in their safety program if soy isn't even supposed to be present on the same equipment.

The FDA does not currently recognize any acceptable threshold for undeclared allergens.  It does not matter how much testing is done, it is not zero because contamination has been observed.

Like kingstudruler1 I would be suspicious of subsequent shipments from them.

Hi Matthew,

I think you are being more than fair by just rejecting the lot. You should be considering delisting the supplier.

What level of testing is going to be done by the supplier to provide enough assurance that the lot is soy free?

How can you and the supplier be sure it won’t happen again? They should be breaking their necks to investigate the source of this soya bean given the supposed absence of allergens in their products and at their facility.

Kind regards,

Tony

They can't prove this load is safe with random sampling for concentrations of the allergen.  Random sampling is obviously not 100% accurate to the entire load, no matter how randomized.  Then if you have accepted it after testing, another soybean found in an untested case of product derails everything all over again.

The fact it's an allergen in a scheme that presented itself to you as allergen free ups the stakes significantly here.  I'd be fully rejecting this load.  I'd be blacklisting this lot number, possibly the supplier for your supplier unless they agree to a site visit and inspection.  Screw their "push back", I'd be pushing them to accept treat my complaint to a full root cause investigation with corrective actions.

No, our specifications do not say that.  I don't think I have ever seen that on a specification in our industry.  Does it really have to be stated, since this is something that, in our view, would make it misbranded, if not adulterated?  Also, I thought 21 CFR 117.136 [https://www.ecfr.gov...section-117.136] would obviate that specification requirement, would it not?  Is that something that happens in the food industry? 

Did your purchasing specifications say zero tolerance for undeclared allergens or specifically X,Y, or Soy?  They have had a critical failure in their safety program if soy isn't even supposed to be present on the same equipment.

 

The FDA does not currently recognize any acceptable threshold for undeclared allergens.  It does not matter how much testing is done, it is not zero because contamination has been observed.

 

Like kingstudruler1 I would be suspicious of subsequent shipments from them.

If your supplier "guaranteed" that the item was free of said allergen then they failed to comply. 

Those are all great questions.  I am trying to get our Purchasing to arrange a call with the supplier so we can discuss all the remaining unresolved issues.  They want us to sample and test for allergens though.  Part of the problem is that we had the lot for a while before finding the soybean--I think up to three months, and we should have examined it within a more reasonable time, such as within 30 days.

Hi Matthew,

 

I think you are being more than fair by just rejecting the lot. You should be considering delisting the supplier.

 

What level of testing is going to be done by the supplier to provide enough assurance that the lot is soy free?

 

How can you and the supplier be sure it won’t happen again? They should be breaking their necks to investigate the source of this soya bean given the supposed absence of allergens in their products and at their facility.

 

Kind regards,

 

Tony

Those are all great questions.  I am trying to get our Purchasing to arrange a call with the supplier so we can discuss all the remaining unresolved issues.  They want us to sample and test for allergens though.  Part of the problem is that we had the lot for a while before finding the soybean--I think up to three months, and we should have examined it within a more reasonable time, such as within 30 days.

In my opinion, how long you have it for before you inspect it shouldn't have anything to do with it unless the lot was stored at your facility with soybeans around it and one could have possibly fallen in...

We received packing that was partly damaged, leading to our finished product being contaminated. We didn't notice the issue until we were almost done producing our finished goods, and still held the supplier accountable. We purchased the packaging with the belief that it was correctly manufactured and we can't possibly inspect every piece of packaging (they were trays).

We could have had the trays for months packaged up in the warehouse before we used them but that doesn't negate the fact that they were made improperly and at no fault to us.

I actually want a little more context on the contamination?

Was a single WHOLE soybean found within a tote of SEALED powered ingredient, was a soybean found in an open unit of raw ingredient?  does your supplier do anything to the product once they receive it from their supplier?  What is the agreement they have with them?

BEFORE you jump all the way down the rabbit hole here, what is the actual likelyhood that)

A.  did you confirm that it actually a soybean and not say, a white kidney bean?

B. if it is a soy bean and it's whole, how likely is it that ANY protein transferred to your raw material

C. if I were your supplier and you can at me months later without confirmation of it actually being a single soy bean on a high value ingredient, I'd probably tell you to take your business elsewhere

Not being argumentative, need much more detail AND trying to help you know what you'll be up against with your vendor

A single whole soybean was found within a tote of sealed whole root ingredient.  I don't know what the supplier is doing and what their agreement is their suppler.  Yes, the soybean is confirmed as soy using a lateral flow allergen test kit.  I don't know how likely it is that protein transferred to the raw material, but since the soybean was in contact with it, it seems likely; however, how to prove that analytically would be the difficult part, because we might or might not find traces of soy protein in the desired ingredient.  The fact that it was in contact with it makes it irreversibly adulterated, no?  But we would never contact the supplier about this issue unless we had confirmed that it was actually a soybean.  That would be silly if, after all this time, it turned out to be a kidney bean!  But no, we get confirmation of the presence of the major food allergen for decisions of this magnitude.

I actually want a little more context on the contamination?

 

Was a single WHOLE soybean found within a tote of SEALED powered ingredient, was a soybean found in an open unit of raw ingredient?  does your supplier do anything to the product once they receive it from their supplier?  What is the agreement they have with them?

 

BEFORE you jump all the way down the rabbit hole here, what is the actual likelyhood that)

 

A.  did you confirm that it actually a soybean and not say, a white kidney bean?

 

B. if it is a soy bean and it's whole, how likely is it that ANY protein transferred to your raw material

 

C. if I were your supplier and you can at me months later without confirmation of it actually being a single soy bean on a high value ingredient, I'd probably tell you to take your business elsewhere

 

Not being argumentative, need much more detail AND trying to help you know what you'll be up against with your vendor

What was the main ingredient that you purchased? What's your supplier's response to this incident?

The main ingredient we purchased is ashwagandha root, and the supplier's response is to ask us to test samples for soy proteins.  We find it strange that the supplier has had no real response in the weeks since we found a major food allergen, and we are still trying to set up a call with them.

What was the main ingredient that you purchased? What's your supplier's response to this incident?

Sounds like your supplier handles allergens at their facility and failed to control it.

If supplier refuses to comply and if I were you - I'd test random totes for soy allergen. I know soy is a major allergen, but in your case the risk is very little of contamination/adulteration. 

Good luck! 

The main ingredient we purchased is ashwagandha root, and the supplier's response is to ask us to test samples for soy proteins.  We find it strange that the supplier has had no real response in the weeks since we found a major food allergen, and we are still trying to set up a call with them.

They're paying for the allergen testing?

What is the proposed acceptable threshold, when the regulatory agencies don't recognize one?

Good questions.  If we could manage to set up a meeting with them, then we might work this out.

They're paying for the allergen testing?

 

What is the proposed acceptable threshold, when the regulatory agencies don't recognize one?