Innovative designs for packaging wine have taken off in recent years. Although the proverbial bag-in-box design has been around for more than 20 years, the use of PET as a replacement for glass bottles for wine has been around for less than a decade. And the newest innovation just came about last fall, with the introduction by Truett-Hurst Inc., Healdsburg, CA, of a paper “bottle,” which consists of a molded outer shell made from recycled paperboard and a plastic liner.
No matter what the packaging materials used, however, there is a need for a fundamental understanding of the way that wine is regulated in the U.S. to ensure that such packaging materials are found acceptable for their use by the proper authorities—in this case, the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) and the U.S. Food and Drug Administration (FDA).
The Federal Alcohol Administration Act (FAAA), which is administered by the TTB, provides for the federal regulation of wine. The Act defines wine as products containing not less than 7 percent alcohol, and sake. Thus, wines with 7 percent alcohol or more are subject to packaging and labeling requirements imposed by the FAAA, although all beverages containing more than 0.05 percent alcohol are taxed by TTB.
Wines that contain less than 7 percent alcohol, such as wine coolers, are subject to the packaging and labeling requirements of the Federal Food, Drug and Cosmetic Act (FFDCA) and the Fair Packaging and Labeling Act, and are under the jurisdiction of FDA.
In the regulation of wine packaging, just as in the case of packaging for beer and spirits, TTB has two primary concerns: the safety and integrity of the packaging. On the first score, TTB has the responsibility to ensure safety with respect to additives that are used in its production and materials that are used in the processing and packaging of wine. While TTB has primary jurisdiction over wines, the bureau has consistently utilized the expertise of FDA to ensure the protection of consumers of alcoholic beverages and regularly consults with FDA regarding the safety of ingredients added to wines and in assuring that the packaging materials used are safe.
Packaging materials are considered food additives. Under the FFDCA, additives for wines are treated like all other food additives, that is, they must be cleared by FDA as safe prior to their use in wine, and for those additives that have been explicitly cleared by FDA, TTB allows their use without further clearance. However, although the FFDCA also allows the use of additives without FDA pre-clearance if they are considered “generally recognized as safe” (GRAS), the bureau will not accept a self-determined GRAS status without written confirmation from FDA.
For new packaging, TTB requires producers to obtain an "opinion" from FDA stating that the uncleared material is not expected to become a component of the wine or is otherwise acceptable for use. However, since FDA will rarely issue such opinion letters, this means that manufacturers may need to file a Food Contact Notification (FCN) with FDA. Once an FCN becomes effective, TTB will concur with FDA's determination on the safe use of the material by issuing a letter to the producer stating that the substance may be used to produce the bottle or package of interest.
While unconventional forms of packaging may attract the attention of TTB, the bureau has found certain materials acceptable for use with alcoholic beverages. TTB’s predecessor, the Bureau of Alcohol, Tobacco and Firearms (BATF), addressed the use of specific types of packaging in a number of rulings. For example, in BATF Ruling 82-12, the bureau held that polyethylene terephthalate (PET) is an approved consumer packaging material for alcoholic beverages.
The FAAA also focuses TTB's attention on whether the packaging affects the alcohol proof of the wine product. TTB may raise questions about alternative wine packaging if the container does not comply with "standard of fill" requirements, thus making the bureau's job of calculating and collecting excise taxes more difficult.
Alternative packaging is also a concern to TTB because of the potential for misleading consumers as to the nature of the product.
Also, for new packaging materials, TTB will typically require data to demonstrate that the proof of the wine is not significantly affected over time.
As alternative packaging for wine continues grow in popularity—in part, due to reduced cost, lighter weight and resistance to breakage—manufacturers will need to make sure the packaging is in compliance with regulations governing its usage.
Author George Misko is partner at Keller and Heckman. Founded in 1962, the respected law firm has a broad practice in the areas of regulatory law, litigation and business transactions, serving both domestic and international clients. Reach him at [email protected].