The Regulation of Wine Processing Aids in the U.S.

Louis Pasteur’s 19th-century discovery that different types of yeast convert sugar into alcohol radically changed our understanding of the winemaking process. Armed with this new knowledge, winemakers began to control the quality of wine by intentionally adding different yeasts, resulting in some of the first processing aids used to control fermentation. Today, many different types of processing aids may be used by winemakers in a variety of applications, such as to control the alcoholic and malolactic fermentation processes, to clarify wine, or to treat off-flavor or odor. Notably, use of these processing aids in the United States for winemaking must be authorized by regulation for the intended use. Thus, it is important to understand the regulatory framework underpinning the regulations --- whether choosing the appropriate processing aid as a winemaker or bringing a new processing aid to market in the United States.

Wine is regulated in the United States by two federal agencies: the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) under the Federal Alcohol Administration Act (FAAA) and the U.S. Food and Drug Administration (FDA) according to the Federal Food, Drug, and Cosmetic Act (FD&C Act). While TTB has primary jurisdiction over wine, the bureau relies on the scientific and public health expertise of FDA, including when considering the approval of processing aids used in wine. 

A list of processing aids currently authorized by TTB, along with limitations on their use, can be found in Title 27 of the Code of Federal Regulations (C.F.R.) Section 24.246 (“Materials authorized for the treatment of wine and juice”). TTB also provides a list of permitted processing aids with administrative approval on its website. Administrative approvals represent TTB’s initial determination that use of a material is consistent with good commercial practice before the lengthier formal notice and comment rulemaking that is required under the FAAA occurs, which ultimately results in the listing of the material as a processing aid in 27 C.F.R. § 24.246. 

TTB’s regulations also provide a framework for the approval of new processing aids. Based on TTB guidance, processing aids for wine and juice are intended “for filtering, clarifying, or purifying wine and may remove cloudiness, precipitation, and undesirable odors and flavors,” but processing aids may not “change[s] the character of the wine.”[1]  Manufacturers who wish to request approval of these sorts of processing aids must demonstrate that use of the processing aid is a cellar treatment consistent with “good commercial practice,” including “addressing the reasonable technological or practical need to enhance the keeping, stability, or other qualities of the wine, and achieving the winemaker's desired effect without creating an erroneous impression about the character and composition of the wine.”[2]

The regulatory process for establishing clearance for a new processing aid begins with at least one winemaker filing a request for experimental use of the substance to demonstrate the experiments can be conducted in a manner that does not jeopardize the revenue, conflict with wine operations, and is not contrary to law prior to granting approval.[3]  These requests must include details on the experimentation to be conducted and list the facilities and equipment to be used, as well as information on how wine that has been undergone experimentation will be segregated from regular wine operations.[4] Winemakers may not begin conducting the experiments until TTB has approved an experimental use application and any segregated wine must be disposed of in accordance with any conditions noted by TTB in its approval letter.[5] If a winemaker wishes to request the ability to market segregated wine, the experimental use application must also contain documentary evidence of FDA’s clearance of the processing aid for the intended use. If the request does not include this information, TTB may require destruction of the segregated wine.

TTB generally considers approval of new processing aids for continual use after several experiments have been conducted with the processing aid. Applications for the use of a new treating material (i.e., processing aid) must include:

• The name and description of the material;
• The purpose, manner, and extent to which the material or process is to be used;
• A sample, if a proposed material;
• Documentary evidence of the FDA's clearance of the material for its intended purpose in the amounts proposed for the particular treatment to be used;
• The test results of any laboratory scale pilot study conducted by the winemaker;
• Pertinent information derived from the testing program conducted by the chemical manufacturer;
• A list of all chemicals used in compounding the treating material and the quantity of each component;
• Information on the of proposed materials; and
• Two 750-milliliter samples representative of the wine before and after treatment.[6]

With respect to components that are generally recognized as safe (GRAS), under the FD&C Act, TTB relies on and consults with FDA as to their use.  It is our understanding that, in addition to GRAS substances, TTB will also rely on substances that FDA confirms are cleared for use in the winemaking process. This may be by way of applicable food additive regulations, effective Food Contact Notifications, and relevant Threshold of Regulation exemptions.

We acknowledge that the TTB process can be long and feel cumbersome, but, in our experience, experimental use and continuous applications that address relevant data areas up front and highlight public policy benefits of the new processing aid can often impact how long and how smoothly the process proceeds. 

Armed with an understanding of the regulatory framework around processing aids, winemakers and manufacturers can make good business decisions about processing aids used in winemaking. 

This article is reprinted with permission of Wine Business. It was first published by Wine Business on June 6, 2024. 

[1]See TTB publication, “Wine and Juice Treating Materials and Processes for Domestic Wine Production,” available at: TTBGov - Treating Materials). 
[2]Id.
[3]See 27 C.F.R. § 27.249 (“Experimentation with new treating material or process).
[4]Id.
[5]See 27 C.F.R. § 27.249(b)-(c).
[6]See 27 C.F.R. § 27.250 (“Application for use of new treating material or process”).