6 replies to this topic

[Marisa_Nardones]

Hello all,

 

I am currently dealing with a situation that I have never dealt with before and in my research, cannot find a concrete answer on for the owners of my company. Can anyone help me with labeling regulations regarding putting a "may contain" allergen statement on a product that DOES NOT contain said allergen?

 

Here's the back story-

 

We used to purchase bagels from a supplier who also makes sesame bagels., Prior to 2023, not a problem. With sesame becoming a major allergen, we faced a new problem. Our plant does not have the time or capabilities to do an allergen clean-up during production hours. We save our one controlled allergen (egg) at the end of the night; sanitation works 3rd shift to perform cleaning of all production lines. During the transition, they put a "may contain sesame" statement on all bagel products. I told them we must switch as there is a cross contamination concern and they informed me that they cannot continue to run bagels at only the end of the night. They started purchasing a sesame free bagel from another supplier, everything was fine.

 

We recently got a new nutritionist (the spot was empty for a couple of months) and one of the first things I wanted to do is have her remove that statement from the labels. FF a couple of months and there are issues with the new supplier. They cannot fulfill the quantity we need and short us a lot. The informed me of this when I asked if I could have her remove the statement. They said they may still have to use the old supplier from time to time if need be. I again explained allergen concerns, their answer was to have us just keep the "may contain sesame" statement on the label. Even though at the current time, we are only purchasing a sesame free bagel. I know we may be questioned by our USDA inspector or during SQF audit (in one month is our audit) and I need to know if this is allowed. Mind you, they will not be doing a cleaning or waiting until end of shift since it does not actually contain or possibly contain sesame. I tried to google info and could not find anything on this. Are we allowed to do this? If I make a statement saying we keep the statement on the label due to the use of 2 different vendors. In the even we use the old vendor, we will place bagel product at the end of the shift. 

Basically, can we have a "may contain sesame" statement on a product that DOES NOT contain sesame, with no cleaning after? Does anybody have any regulation or something they can cite, that I can show to the owners of my company? 

TIA! 

[kingstudruler1]

I'm not 100% sure i understand your situation.  

 

Does the bagel actually contain sesame or is it just produced in a facility that has sesame?  Originally, i thought you were using an advisory statement in place of required allergen labeling.   I don't think that is the case.   

 

 

 

"Some foods carry a voluntary “may contain” label statement (e.g. “May Contain Peanuts”) because there is a chance that a food allergen is present. FDA guidance says these statements should not be used as a substitute for following current good manufacturing practices, and must be truthful and not misleading."

 

"FDA notes that allergen advisory statements such as “may contain [allergen]” may be used to alert consumers to the possible presence of a major food allergen due to cross-contact. FDA continues to reiterate that advisory statements are not a substitute for adherence to CGMPs and preventive controls. In a footnote, however, FDA states that the “presence of allergen advisory statements may be considered a health risk mitigating factor when allergen cross-contact is appropriately managed consistent with CGMPs, preventive controls, or other controls (e.g., HACCP).” These statements appear to be among the few explicit, public statements FDA has made about when allergen advisory statements may be appropriate, though the advisory statements’ value would still be assessed on a case-by-case basis retrospectively."

[jfrey123]

If I'm reading this right, no actual allergen cross contact for sesame is happening in your facility:  you're only buying sesame free bagels from the vendor and they're putting out a "may contain" warning on their packages?  I'd say the risk is low, but you'll want to review their allergen control and sanitation programs and get COA's for the products.  The justification in my mind would be that your vendor isn't allowed to substitute poor GMP when using the "may contain" warning, and too many companies are putting it as an artificial CYA instead of standing up proudly behind their practices.  Probably be worth getting some tests on the questionable bagels to verify they are sesame free as your vendor is claiming, perhaps verify a few different times throughout the year to be sure.

[Marisa_Nardones]

We have NO SESAME at our facility. Our old bagel supplier WAS placing a may contain sesame statement in lieu of proper sanitation practices, and for some reason is able to get away with it. I do know it is a bakery and I do know wet cleaning is not recommended in bakeries. 

We switched to a new vendor who does NOT have sesame in their facility/bagels.

 

I was going to have our new nutritionist remove all "may contain sesame" statements from our bagels, but first wanted to check with our president to ensure we will no longer purchase from the old bagel supplier. He stated that he does not know since new bagel supplier has been having issues keeping up with our bagel demand. He wants to keep the "may contain sesame" statement on all of our bagel products even though current supplier is a sesame free facility. His justification being, if he does need to switch back to the old vendor, he does not need new labels declaring possible sesame contamination. 

 

We will not be cleaning after these bagels since there is no actual sesame or possible contamination and usually run in the beginning of production shift. He wants to keep the "may contain sesame" in the even we switch back to old supplier who does have a sesame warning.

 

Are we allowed to have a "may contain sesame" statement on a product that has no sesame/cross contamination concern, just in case we go back with our old supplier of the bagels? 

[G M]

...

Are we allowed to have a "may contain sesame" statement on a product that has no sesame/cross contamination concern, just in case we go back with our old supplier of the bagels? 

 

If you don't handle sesame and none of the ingredients you use carry that statement, including it on your label is potentially falling under "misleading" for FDAs determination.

 

https://www.fda.gov/...117410/download

 

 

AFAIK advisory statements like "may contain" are not allowed on USDA inspected product labels.

 

 

It is highly questionable how much advisory statements protect your company in any case, they are explicitly not a replacement for proper sanitation.  Their primary function is to let consumers judge how much risk they are taking on when deciding which foods to consume.

[Marisa_Nardones]

When we questioned the bagel supplier regarding the "may contain" statement in lieu of proper sanitation, they explained they are a dry environment and therefore a wet cleaning in between production practices is not advisable, which is how they are allowed to use a may contain statement. 

 

We do already have a "may contain soy" statement on some of our products. We manufacture mostly products that contain soy, very few without it. I found this on USDA inspected products- 

Allergens- Voluntary Labeling Statements | Food Safety and Inspection Service (usda.gov)

 

For reference we are a company that manufactures frozen pizza. The pizza bagels are plain cheese and some breakfast ones that include meat toppings. We also have a bakery on site, which does not get wet cleaned daily. Most of our crust contains soy, which is why they have a may contain soy statement on the 5% of products that do not contain soy. 

 

I have never been asked before to put an allergen warning on a product that DID NOT contain that allergen and figured it could be labeled as "misleading", but the owners do not agree. They understand not making a statement for an allergen that is present, but in their mind, they do not believe any auditor/inspector would have an issue with that statement being on there "just in case" they go back to the old bagel supplier.

 

Side note- If they do go back to the old supplier, they will only run that product at the end of the shift to precent potential cross contamination. 

 

 

[kingstudruler1]

When we questioned the bagel supplier regarding the "may contain" statement in lieu of proper sanitation, they explained they are a dry environment and therefore a wet cleaning in between production practices is not advisable, which is how they are allowed to use a may contain statement. 

 

We do already have a "may contain soy" statement on some of our products. We manufacture mostly products that contain soy, very few without it. I found this on USDA inspected products- 

Allergens- Voluntary Labeling Statements | Food Safety and Inspection Service (usda.gov)

 

For reference we are a company that manufactures frozen pizza. The pizza bagels are plain cheese and some breakfast ones that include meat toppings. We also have a bakery on site, which does not get wet cleaned daily. Most of our crust contains soy, which is why they have a may contain soy statement on the 5% of products that do not contain soy. 

 

I have never been asked before to put an allergen warning on a product that DID NOT contain that allergen and figured it could be labeled as "misleading", but the owners do not agree. They understand not making a statement for an allergen that is present, but in their mind, they do not believe any auditor/inspector would have an issue with that statement being on there "just in case" they go back to the old bagel supplier.

 

Side note- If they do go back to the old supplier, they will only run that product at the end of the shift to precent potential cross contamination. 

 

 I've used things like Alpet or dry san duo to remove allergens in dry environments.  It can be done.  Again, the may contains statement is not meant to take the place of proper practices.   But I guess that is an issue for your supplier.  

 

If you are confident that your supplier that does use sesame seeds is controlling the allergen and there is little to no risk, I would leave the statement off.   

If you feel like there is still risk some I would leave it on. 

 

I don't think either of you is "wrong" -  its a little gray area to me. I think you can justify that is not misleading because at anytime you could use the supplier that does have sesame on the same line as the bagels your are purchasing.    I see your side too.   In general i have always hated the voluntary precautionary statements.  I didnt think they offer much regulatory weight and really confuse the consumer.   They want to know if its there or not.   They want use to control our processes so that they can be confident they will not get sick.   no maybes 

 

Can you just ask your onsite inspector his/her opinion of leaving it on - in the event that you have to use that supplier?   

 

Or better yet find a third supplier that doesnt use sesame, and get rid of the supplier that does.