Navigating TTB and FDA Regulations to Advance Sustainable Wine Production

Wine producers face increasing pressure to deliver quality wine with distinctive character while simultaneously reducing environmental impact. With sustainability now a core business priority for wine producers, new and improved processing aids are available to help winemakers meet these sustainability goals. As a result, embracing new processing aids has become a strategic necessity. Since new processing aids must have a suitable regulatory status before being permitted on bonded wine premises, winemakers and processing aid manufacturers benefit from understanding the applicable regulatory framework, which involves navigating two different regulatory agencies: the Alcohol and Tobacco Tax and Trade Bureau (TTB), which has primary jurisdiction over wine and the Food and Drug Administration (FDA), which provides TTB with scientific expertise regarding the use of processing aids in alcoholic beverages. 

Approved Processing Aids 

Processing aids are wine and juice treating materials used in "the process of filtering, clarifying, or purifying wine and may remove cloudiness, precipitation, and undesirable flavors and odors" but "may not change the character of the wine."¹ Processing aids permitted for use in winemaking fall into two categories:

• materials that are administratively approved as acceptable in good commercial practice under TTB's authority in § 24.250, pending the outcome of notice and comment rulemaking; and
• authorized materials that have undergone notice and comment rulemaking.

Administratively approved substances appear on the TTB website until they are the subject of formal notice and comment rulemaking required under the Federal Alcohol Administration Act (FAAA). Provided this notice and comment rulemaking process does not preclude a listing, substances are then listed as authorized for use in Table 1 in 27 C.F.R. § 24.246 ("Materials authorized for the treatment of wine and juice").

Experimental Use Applications

If a processing aid is not already approved for use, TTB regulations provide a mechanism to request approval. TTB provides general advice regarding the approval process in its publication, Wine and Juice Treating Materials and Processes for Domestic Wine Production.²

When establishing TTB approval for a new processing aid, a winemaker must first file a request for experimental use of the substance. The request must demonstrate that experiments can be conducted in a manner that does not jeopardize the revenue (owed to the TTB), conflict with wine operations, or contradict any law.³ These requests also must include details of the experiment, list the facilities and equipment to be used, and provide information on how wine that has undergone experimentation will be segregated from regular wine operations.⁴ Winemakers may not begin conducting experiments until TTB has approved the experimental use application, and any segregated wine must be disposed of in accordance with TTB's experimental use approval. If, however, a winemaker would like to receive approval to market the segregated wine, the experimental use application must also contain documentary evidence of FDA's authorization of the processing aid for the intended use.

Continuous Use Applications

TTB generally considers approval of new processing aids for continual use after several experiments have been conducted. Applications for the use of a new processing aid must generally show that the processing aid is a cellar treatment consistent with good commercial practice, and also must specifically include:

• The name and description of the material.
• The purpose, manner, and extent to which the material is to be used together with any technical bulletin or other pertinent information relative to the material.
• A sample of the proposed material.
• Documentary evidence of FDA’s authorization of the material for its intended purpose in the amounts proposed for the particular treatment contemplated.
• The test results of any laboratory scale pilot study conducted by the winemaker in testing the material and an evaluation of the product and of the treatment, including the results of tests of the shelf life of the treated wine.
• A tabulation of pertinent information derived from the testing program conducted by the chemical manufacturer demonstrating the function of the material.
• A list of all chemicals used in compounding the treating material and the quantity of each component.
• The recommended maximum and minimum amounts, if any, of the material proposed to be used in the treatment and a statement as to the volume of water required, if any, to facilitate the addition of the material; and
• Two 750-milliliter samples representative of the wine before and after treatment.⁵

Documentary Evidence of a Suitable FDA Status

As discussed above, TTB requires documentary evidence of a suitable FDA status for use of the material in wine for a continuous use submission and for an experimental use submission if the winemaker would like to receive approval to market the wine that has been the subject of the experimental use. TTB consults directly with FDA to establish the clearance. Documentary evidence of an FDA clearance may be based on an applicable Food Additive Regulation,⁶ effective Food Contact Notification (FCN),⁷ applicable Threshold of Regulation (TOR) exemption,⁸or relevant Generally Recognized as Safe (GRAS) Notice.⁹  

Concluding Thoughts

The multi-step TTB process can seem daunting. In our experience, applications that address the applicable TTB data requirements, demonstrate a suitable FDA status, and point out the public policy and industry benefits of the new processing aid most effectively navigate the approval process. As a result, a shared understanding of the regulatory process can help winemakers and processing aid manufacturers work together toward more sustainable practices. 

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¹ See 27 C.F.R. § 24.246 ("Materials authorized for the treatment of wine and juice").

² See TTB's Wine and Juice Treating Materials and Processes for Domestic Wine Production, available at: https://www.ttb.gov/regulated-commodities/beverage-alcohol/wine/treating-materials.

³ See 27 C.F.R. § 24.249 ("Experimentation with new treating materials or process").

⁴ Id.

⁵ 27 C.F.R. § 24.250 ("Application for use of new treating material or process").

⁶ See 21 C.F.R. Parts 172 to 186.

⁷ See Inventory of Effective Food Contact Substance (FCS) Notifications; available at https://hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=FCN.

⁸ See Threshold of Regulation (TOR) Exemptions; available at https://hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=TOR.

⁹ See GRAS Notices; available at https://hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices.

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About the Steptoe StepLadder Series

Steptoe LLP is pleased to publish the StepLadder series of articles for our clients, prospective clients, and interested companies as a way of educating attorneys and non-attorneys alike about legal and regulatory principles related to food packaging in meaningful ways. While there are many sources of information available online, the StepLadder series is intended to be accessible to, and understandable by all, to help support business decisions related to food packaging compliance.

This information is provided for educational purposes only, is not legal advice, and does not establish an attorney-client relationship with Steptoe. Our lawyers made us write that. If you have legal questions, please consult an attorney. Preferably from a team well-versed in food packaging regulation – and definitely from a group of attorneys that have a good sense of humor. Because you are what you eat… unless your food packaging isn't a 'food additive,' in which case you’re not food packaging.