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

The U.S. Food and Drug Administration (FDA) belatedly responded Wednesday to Wine Industry Insight’s weeklong efforts to gather information for its article regarding wine corks containing TDI.

Diam also issued a statement (reproduced in its entirety below).

The EPA has not responded to the status of corks in their TDI rulemaking process.

Wine Industry Insight has requested comment from Sintesi on whether they anticipate further actions.

FDA: Exemptions Must Be Obtained; No Enforcement Action Anticipated; Safety Issues Not Identified

The complete email is reproduced below with additional paragraph breaks to aid clarity.

In terms of background, TDI-based PU is authorized under 21 CFR part 175.105 (Adhesives) for use in adhesives used in food packaging, but, as the letter indicates, clearance under 21 CFR 175.105 does not include clearance for use as a binder (adhesive) in agglomerated cork stoppers for wine and beverages. 

“Agglomerated” is not a trade name but is the type of cork stopper at issue:  agglomerated cork is granulated cork that is bound together by an adhesive.  There is no regulation in 21 CFR that covers this specific use. 

We have the names of some firms (not necessarily all) that are or may be involved in manufacture of the agglomerated corks. FDA has been in contact with certain firms involved and has obtained data from them on this use of TDI-based PU. 

We have conveyed to them that TDI-based PU, the usage of which is reasonably expected to result in substances becoming components of food (wine or beverages), is subject to regulation as a food additive.

Such use should comply with FDA regulations, and 21 CFR 175.105 does not cover this use.

This usage is neither generally recognized as safe (GRAS) nor prior-sanctioned or otherwise exempt from the definition of food additive. 

If, then, the usage is reasonably expected to result in the migration of substances to food, the TDI-based PU is a food additive under the Federal Food, Drug and Cosmetic Act (FFDCA) and must be authorized by a regulation under 21 CFR for this use.  Authorization may be in the form of an effective food contact notification (FCN) or a threshold of regulation (TOR) exemption.      

Based on the data and information available to us, we have identified no safety issues with this use of TDI-based PU in agglomerated corks.  

Accordingly, FDA is not contemplating any enforcement action against the agglomerated corks or wine, is not recommending that wines already sold or in the supply chain with agglomerated cork closures or agglomerated corks be recalled, and is not recommending a cessation of the marketing and purchasing of the agglomerated corks for use with wine and beverages at this time.  

However, we are currently planning a communication with agglomerated cork manufacturers and suppliers on the need to submit an FCN or TOR exemption to obtain FDA authorization for this usage wherein migration of substances to food is reasonably expected (e.g., in the absence of a physical barrier that prevents such migration), including the time frames for such submissions.  The wine industry may contact FDA on any questions concerning this matter.      

Diam Issues Statement

Diam sent the following statement to its customers:

Diam Corks in Full Compliance with FDA Requirements

Independent Tests Confirm TDI Cannot Be Detected in Cork or Wine
Diam Bouchage, a world-leading manufacturer of technical cork closures, today issued the following statement about the company’s compliance with U.S. Food & Drug Administration regulations.

Dominique Tourneix, Diam’s Chief Executive Officer, said:

“Diam makes very safe, high-quality corks. They are all in full regulatory compliance in both Europe and the United States. Their safety has been verified by several independent labs, and they have been in the marketplace for 10 years without a single credible safety issue.

“TDI, or 2,4-toluene diisocyanate, is a compound used to produce the adhesive in Diam’s food grade stoppers. Independent tests confirm that after production of the corks and polymerization of the binder, TDI is not detectable in our corks and, therefore, will not leach into the wine. Because there is no detectable TDI in the cork, the substance is not considered a ‘food additive’ and, therefore, is permitted for use under the applicable FDA laws and regulations.

“Diam has provided FDA with data on our closures, which confirm that TDI is not expected to migrate to wine or other beverages. FDA has never questioned these data or had any follow-up requests for more information.

“Diam remains committed to working with FDA and regulatory agencies around the world to demonstrate our products are safe and in regulatory compliance.”

Wine Industry Insight has asked both Diam and the FDA whether the studies mentioned have been published in any peer-reviewed scientific journals, and if they have been submitted to the FDA.

For previous WII article, please see: Micro-Agglomerates: 350 Million Illegal Corks Per Year?

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Additional Wine Industry Insight Coverage:

• FDA Update: Assessing Safety Of Agglom Corks Needs More Work

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