FDA Friday A.M. Update: Assessing Safety Of Agglom Corks Needs More Work

Just received at 7:55 a.m. Friday in response to Wine Industry Insight’s request for further information.

This makes clear that the safety issue of TDI in agglomerated corks is still up in the air and needs more work.

No conclusive proof they are not safe. Some indication that they may be.

A rush to judgement in either direction as has been seen in other wine industry publications is unwarranted.

The FDA statement in full: (bold annotations have been added by WII)

This is in response to your questions on data FDA obtained from Diam and their statements that have been released concerning this data. 

FDA did receive several study reports from Diam indicating no detection of the analytes (the substances analyzed for) including toluene diisocyanate (TDI), in wine or in food simulant extracts and the agency did not question this data nor has subsequently requested further information from Diam as of the release of Diam’s statement.

The reports received were not from published studies.  We agree that if the use of a substance in contact with food is not reasonably expected to become a component of or otherwise affect food, it is not a food additive requiring authorization under 21 CFR. 

However, non-detection of an analyte is not conclusive as to whether the analyte is present in food or food simulant; it still may be present below the limit of detection of the method employed. 

The reports provided by Diam did lend support to their conclusion that the substances they analyzed for were not expected in food at levels that would indicate a safety issue. FDA has not evaluated these reports as a basis for obtaining authorization under 21 CFR for this use.

FDA cannot make a complete determination of safety without reviewing a complete data package on the identity and manufacture of the PU binder material, which would include an accounting for all potential migrating substances from the material, and support for data results provided including standard curves, representative spectra or chromatograms, example calculations, validation methods and results.

FDA’s position is that all manufacturers/suppliers should, in the absence of a physical barrier preventing the migration of components of the PU binder to cork, submit an FCN or TOR exemption request that fully demonstrates the safety of their usage of PU binders in agglomerated corks as soon as possible.

We are planning a communication to all manufacturers of these products to this effect, as we have already indicated.

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Previous Wine Industry Insight Coverage:

• FDA, Diam Respond To WII Request For Comment On Agglom Corks

• Micro-Agglomerates: 350 Million Illegal Corks Per Year?