TIPS FOR THE COLA PROCESS BY MARC E. SORINI
lmost every distiller, from the smallest to the largest,
Marc E. Sorini is a partner in the law firm of McDermott Will & Emery LLP, based in the Firm’s Washington D.C. office. He leads the Firm’s Alcohol Regulatory & Distribution Group, where he concentrates his practice on regulatory and litigation issues faced by supplier-tier industry members. His practice for distillers includes distribution agreements, distribution counseling and litigation, product formulation, labeling, promotional compliance, compliance strategy, and federal and state tax and trade practice enforcement defense.
Products containing a manufactured flavor require even more
must navigate the Certificate of Label Approval (“COLA”) diligence, as TTB requires that flavors and extracts used in the
process administered by the federal Alcohol & Tobacco Tax & production of a distilled spirit obtain TTB approval before such Trade Bureau (“TTB”). Federal law requires that the labels of flavors and extracts can be used to produce a distilled spirit. all distilled spirits (excepting spirits for non-beverage use) be The major flavor companies (such as Givaudan, IFF, Syrmise and reviewed and pre-approved by TTB before a distiller can lawfully others) generally have substantial experience with this process use such labels in “interstate commerce.” As the law considers and routinely obtain TTB approval of their formulas before any commerce between states (at least) to qualify as “interstate offering them to customers like distillers. But, as with the need commerce,” as a practical matter for distillers this requirement for a beverage formula itself, the failure to obtain a formula for a to obtain a COLA is nearly universal. Because the process can flavor to be used in, for example, a flavored whiskey, will impose frustrate marketing objectives and/or cause delays in product additional delays in the process if TTB rejects a beverage formula introduction, a distillery would do well to learn the process and due to its use of an unapproved flavor. work to minimize surprises and problems.
For products requiring formulas, the formula approval process can have a significant impact on labeling decisions.
NECESSARY PREREQUISITES – FORMULAS If, for example, the distiller wants to make a label claim about A subset of distilled spirits must have their recipe and method a particular ingredient in the spirit, the formula should clearly of manufacture reviewed and approved by TTB before TTB will identify this ingredient in order to substantiate the ingredient even consider a review of the product’s label. For domestic claim during the COLA process. Similarly, if a distiller wishes to products, the approval is called a “formula,” while imported label a product as a particular TTB “class” or “type” of product, products must obtain a “pre-import approval”, PIA. Distillers, the formula application should be crafted to obtain this class/ then, should become familiar with which products require type designation during the formula approval process. In short, formulas. If a COLA application is submitted to TTB, it may take distillers should keep labeling and marketing considerations in weeks or even months before TTB reviews it, and a rejection the forefront during the formula application process. based on the failure to obtain a necessary formula (or PIA) can waste significant time before the legal introduction of a product. Domestic distilled spirits requiring formula approval prior to even starting the COLA process include:
Today, the vast majority of formulas are submitted online through TTB’s COLAs Online system. While there remain a few
• Flavored vodkas, whiskeys, brandies, and other flavored instances where a distiller (or its counsel) should consider an products.
old-fashioned “paper” filing, online COLA applications generally
• Any product not recognized as falling within one of TTB’s receive faster review than paper applications. To use COLAs class/type designations (often known as “distilled spirit Online, however, a filer must establish a COLAs Online account. specialty” products).
• All liqueurs. • Certain whiskeys.
This involves an application and requires the filing of Signing Authority or Power of Attorney documentation for the actual persons authorized to submit COLA applications on behalf of the
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