Sometimes you need one and sometimes you don’t. Regardless, it is best to find out before you apply for your Certificate of Label Approval (COLA) or you will not be allowed to receive your COLA – rather, you will be directed to submit a request for Pre-COLA Product Evaluation – otherwise known as formula approval.
You don’t always need a formula approval, but rather, TTB regulations require formulas most commonly when flavoring or coloring materials are added to an alcohol beverage product. If you are putting something in the wine bottle other than juice from a grape, we suggest you don’t assume that a formula is not needed. This is a better safe, than delayed, decision!
The actual regulations relating to formulas only shed a bit more light on the requirements, making it all the more important to contact TTB if you have any questions about whether or not a formula is required. The regulations state that a “proprietor shall, before production, obtain approval of the formula and process by which special natural wine, agricultural wine, and other than standard wine (except distilling material or vinegar stock) are to be made.” This begs for some definitions. Some of these terms are in fact defined in the regulations as follows:
• Special natural wine. A product produced from a base of natural wine (including heavy bodied blending wine) to which natural flavorings are added, and made pursuant to an approved formula in accordance with [these regulations].
• Agricultural wine. Wine made from suitable agricultural products other than the juice of grapes, berries, or other fruits.
• Standard wine. Natural wine, specially sweetened natural wine, special natural wine, and standard agricultural wine, produced in accordance with [these regulations].
Of course, no special natural wine, agricultural wine, or, if required to be covered by an approved formula, wine other than standard wine may be produced prior to approval by the appropriate TTB officer of a formula covering each ingredient and process (if the process requires approval) used in the production of the product. Basically, you are stuck until the formula is approved.
On application, the proprietor shall on each formula filed designate all ingredients and, if required, describe each process used to produce the wine. The addition or elimination of ingredients, changes in quantities used, and changes in the process of production, or any other change in an approved formula, will require the filing of a new application. After a change in formula is approved, the original formula must be surrendered to the appropriate TTB officer.
TTB has a chart known as “Pre COLA Product Evaluations for Wine Products.” This chart is designed to show a listing of numerous products and whether or not those products require a formula, for example. Though the chart is useful, keep in mind that it is limited by the following statement on the chart: “This chart is provided as general guidance. Particular circumstances may dictate the need for a pre-COLA product evaluation for a specific product even though no such requirement is indicated on the chart.” A helpful tool, but you certainly can’t totally rely on it. If you have questions regarding whether or not your product needs a formula approval prior to application for your COLA, please don’t hesitate to contact our office. While we’ll be happy to comment on our thoughts about whether or not you need a formula approval, but we’ll make sure we contact TTB for final determination prior to assisting you with your formula and COLA application.