Ah! Now that is a somewhat different question. I would say that the situation you describe of being able to reattach the seal with something as simple as regluing the liner back on the bottle would be something that likely is not going to pass muster as tamper evident. I think I would agree with your manufacturer on this point (and honestly in my opinion it is generally sound decision-making to defer to the manufacturer in instances like this because they know their product far better than you ever could or will) and would likely want to find another way to manage the tamper evident requirements. Something as simple as a cap sleeve would be sufficient and then the induction seal is to protect either the product from the elements or from leaking out of the container. Not sure that I could come up with a way to justify that a seal which could be reattached to the bottle being sufficient as the tamper evident component. Unless there is a way for the induction seal to be somehow "damaged" by the removal whereby regluing of the seal back to the bottle would be impossible. Say for instance if you had a seal that "breaks" along the inner edge of the bottle or in some way that would show even if it were glued back on that the seal had been broken. Or something like a color change that occurs once someone touches the seal itself to break it or if it were broken and air got to the underside of the seal somehow that you had an indicator in the seal. Obviously none of these match your situation but that would be the only way I could think of that would work in your situation.
Sorry for the misunderstanding of your original question and sorry I can't come up with a way to make this one any easier on you...
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 20-Sep-2019 12:12
From: Tanya Nachreiner
Subject: Tamper Evident Lining Material
Thank you Victor,
The reason why I ask is because the manufacturer of this particular lining material is stating they do not believe it be tamper-evident because it does not leave any residue on the bottle which would allow someone the ability to manually glue the liner back on.
That is why I was hoping for feedback if anyone had any success with submitting this type of liner to the FDA to demonstrate tamper-evidence. Because yes, to your point if it is broken or missing then one is left to believe the product has been tampered. But what would be the reasonable expectation when considering all of the ways a product could be tampered with and resealed?
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Tanya Nachreiner
Naperville IL
United States
Original Message:
Sent: 19-Sep-2019 15:55
From: Victor Mencarelli
Subject: Tamper Evident Lining Material
Hi Tanya.
Let's look at this pragmatically - the purpose of the tamper-evident seal is to show the consumer that the product has been or could have been tampered with. As such, if the seal is there and intact then the assumption is that the product has not been disturbed since the production process was completed and the seal was applied. If the seal is broken or in your case missing, that would lead to the assumption that the product either (1) has not been through the complete production process thereby leaving the seal unattached; (2) has been or could reasonably have been tampered with post-production; or (3) is counterfeit. In your case I think this would work fine. Only suggestion would be to remember to include the "Do not use if tamper-evident seal is broken or missing" somewhere on the outer package so it is obvious to the consumer that a seal should be intact on the inside of the cap.
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Victor Mencarelli
Director Regulatory Affairs
United States
Original Message:
Sent: 19-Sep-2019 08:59
From: Tanya Nachreiner
Subject: Tamper Evident Lining Material
Dear All,
We are in the process of identifying different induction seal liners that could be considered tamper-evident.
Does anyone have any experience with the approval/rejection of their container system that used an induction seal liner that could be cleanly removed from the bottle without leaving any residue?
The liner will not be destroyed in the process of opening the bottle, but because the liner is an induction seal, it would could not be re-adhered to the bottle.
Thank you,
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Tanya Nachreiner
Naperville IL
United States
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