Labeling of wines is an important topic regardless of the wine’s alcohol content. Wine labeling is filled with regulations, black letter laws, policies, and rulings. It is no wonder that regulations governing wine labels can be filled with nuances and intricacies.
Perhaps once of the greatest nuances in the world of wine labeling is the regulation of wines that fall under 7% alcohol by volume. To many unsuspecting folks, they may not realize there is a significant regulatory difference between wines that are under 7% alcohol by volume and wines that are at or above 7% alcohol by volume.
Labeling of wines under 7% alcohol by volume can cause significant challenges for wineries, importers, and brand owners because the regulations governing these products are often unfamiliar territory. Traditional table wines and other vinous beverages with an alcohol content falling below 7% are subject to the labeling jurisdiction of the Food and Drug Administration (“FDA”). The FDA’s labeling regulations are found at 21 CFR Part 101.
For industry members who are familiar with the TTB, submitting COLAs, and similar processes, FDA labeling can be daunting. Lindsey Zahn P.C. is very familiar with the differences between labeling requirements for TTB-regulated and FDA-regulated products and can help your alcohol beverage business with the regulatory requirements of either agency.
Is my wine subject to the labeling jurisdiction of the TTB or the FDA?
How does an industry member know if its wine is subject to the labeling jurisdiction of the TTB or the FDA? What are the major differences between the label requirements of the TTB and the FDA?
For wines, it is relatively simple to determine which agency will have primary jurisdiction over the labeling of the product. A wine with an alcohol by volume content under 7% is subject to the labeling requirements of the FDA. Wines that are at or above 7% alcohol by volume are subject to the primary labeling jurisdiction of the TTB and typically will require a COLA or—if applicable—a COLA Exemption before the product can be sold at market. If an industry member is not certain of the alcohol content of their wine, a third party lab analysis can help determine the alcohol content and shed light on which agency has primary jurisdiction for labeling purposes.
FDA labeling regulations can be exceptionally overwhelming. Typically, FDA labeling will require a product in the agency’s jurisdiction to include items like a Nutrition Facts Panel, ingredients statement, statement of identity, and net quantity of contents (not an exhaustive list). Perhaps the most intimidating requirement for alcohol industry members is the Nutrition Facts Panel, which generally has font size and style requirements, horizontal line weight requirements, and restrictions on rounding numbers. The Panel is generally not required on TTB-styled labeling (at least, not at the time of this writing).
While there are major differences between to the two agencies, there are also some spillovers (such as, for example, the required Government Warning Statement, sulfites statement, etc.). However, folks should keep in mind that the text of the FDA regulations is very different from and quite dense in comparison to 27 CFR Part 4 or the federal TTB regulations that govern wine labeling.
Is a COLA required for wines that are under 7% alcohol by volume?
Wines under the 7% alcohol by volume threshold are subject to the FDA’s labeling jurisdiction. Generally speaking, the TTB does not have regulatory authority over the labeling of the wine. From our experience, if an industry member tries to submit a label to TTB for a wine that is under 7% alcohol by volume, the TTB will reject the label application. (This is not to suggest that a formula approval is not required; it is possible that a formula could still be required by the TTB for a wine under 7% alcohol by volume depending on the specifics of the product.)
As of the date of this writing, the FDA does not offer a pre-market approval or review of a label similar to TTB’s COLA system. Instead, the industry member is responsible for ensuring that its label complies with the FDA labeling regulations before the wine is sold at market. This is an important point as it will require significant regulatory review of the label prior to printing the label.
FDA labeling may sound like an enticing option for folks who are familiar with TTB’s COLA application system. However, it should not be taken lightly. The absence of a pre-market approval system shifts a burden to the industry member to ensure its product complies with 21 CFR 101 and subsequent guides, policies, and similar documentation.
Consequently, while the market is home to many wines under 7% alcohol by volume that some folks may want to use as a guide or a model, this can be risky. Because the FDA does not have a pre-market approval system, unfortunately there is no guarantee that labels in the market comply with FDA requirements. Additionally, products can certainly vary and even a slight difference could trigger a different requirement or disclose under the FDA regulations.
For those reasons, it is highly recommended that wine companies heading to market with a wine under 7% alcohol by volume work with a professional familiar with the labeling regulations of both the FDA and the TTB and have the label reviewed prior to entering the market.
How can Lindsey Zahn P.C. help you with a wine that is under 7% alcohol by volume?
Lindsey Zahn P.C. works closely with both alcohol beverage and food companies to review proposed labels for compliance with federal food labeling and alcohol beverage labeling regulations. Given our experience working with both traditional alcohol beverages and food products, we can offer a unique perspective for products that fall within the primary jurisdiction of the FDA but may still present some crossover issues with the TTB. We can also assist U.S. wineries and importers that wish to produce or import both traditional wines as well as wines under 7% alcohol by volume and advise on what implications this may bring to your business with respect to permitting and/or other important compliance considerations.
Contact Lindsey Zahn P.C. to schedule an introductory meeting to discuss your needs and products and to learn more about how we can help: info@zahnlawpc.com or (929) ZAHNLAW (929-924-6529).