|September 18, 2018||Number: 2018 - 6|
TTB Industry Circular
Guidance Regarding Formulas for Certain Alcoholic Beverages
To: Proprietors of Bonded Wineries, Bonded Wine Cellars, Taxpaid Wine Bottling Houses, Beverage Distilled Spirits Plants, Breweries, Importers, and Others Concerned.
This circular supersedes, in its entirety, Industry Circular 2007- 4, "Pre-COLA Product Evaluation," dated September 11, 2007. Formula guidance may now be found on the Formula Home Page of the TTB website, so that the guidance can be updated more easily to reflect changes to formula and laboratory evaluation requirements.
As part of its review of applications for Certificates of Label Approval (COLAs) for distilled spirits, wine, and malt beverages under the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), TTB requires the submission of formulas for, and samples of, certain alcohol beverage products prior to the issuance of a COLA. Furthermore, TTB regulations require the submission of formulas prior to the production of certain domestic alcohol beverages. These requirements are issued under TTB's authority under the FAA Act, the Internal Revenue Code of 1986 (IRC), or both.
In some cases, TTB's evaluation of the product requires the submission of a sample so that TTB can conduct a laboratory analysis of the product sample. The type of product evaluation required for a particular product depends on that product's formulation and origin.
3. Changes Since the Issuance of Industry Circular 2007- 4.
Industry Circular 2007- 4 provided background on TTB requirements for "pre-COLA product evaluation" of certain alcohol beverage products. The types of "pre-COLA product evaluation" included formulas and pre-import letters, as well as the submission of samples for laboratory analysis. However, TTB updated this terminology in 2011, when we launched Formulas Online, our online system for the submission and tracking of formulas. In Formulas Online, the term "pre-import letter" is replaced by "formula," and the term "laboratory analysis" is replaced by "formula with laboratory sample analysis."
Attached to Industry Circular 2007- 4 were three commodity-specific charts that indicated which products required a pre-COLA product evaluation. In Industry Circular 2016-1, "Elimination of Certain Pre-COLA Product Evaluation Requirements (Formulas or Laboratory Analysis) for Certain Alcohol Beverage Products," dated September 29, 2016, TTB separated the commodity-specific charts from Industry Circular 2007- 4 and published them as discrete guidance documents. These documents are updated periodically to reflect changes to which products require formula approval or formula approval with laboratory sample analysis. (See TTB G 2016-1A, TTB G 2016-2, and TTB G 2016-3.) Thus, it is no longer necessary to refer to Industry Circular 2007- 4 for this information. To determine if your product requires formula approval or formula approval with lab sample analysis, you may also use the formula approval tools found on the TTB Website.
You should also note that TTB may require submission of samples or laboratory reports for certain alcohol beverages as part of the label approval process, even though no formula is required for the products. For example, a sulfite waiver may be required to substantiate certain statements that are made on (or omitted from) some wine labels. These requirements are not set forth in the above-referenced guidance documents.
4. Submission of Formulas.
As previously mentioned, TTB launched Formulas Online in 2011, several years after the issuance of Industry Circular 2007- 4. TTB has designated Formulas Online for the receipt of electronically transmitted formula applications. See 27 CFR 73.31, which allows the submission of an electronic form through an electronic document receiving system that TTB has designated for the receipt of that specific form and for which the applicant has registered, if so required.
Formulas Online is a web-based application that supports the online submission of applications and offers the submitter a number of advantages, such as being able to check the status of the submission in real time and viewing your application online. Accordingly, TTB encourages you to use Formulas Online. However, you may, if you wish, continue to submit paper applications for formula approval.
In Industry Circular 2007-4, TTB advised industry members that they could use TTB F 5100.51, Formula and Process for Domestic and Imported Alcohol Beverages in lieu of the formula forms prescribed in the TTB regulations. Industry members may continue to choose to use this form as an alternate procedure authorized under the applicable alternate method or procedure provision in 27 CFR 19.26, 24.22, 25.52, 26.331, or 27.221, and no approval from TTB is necessary in order to use this form. Alternatively, industry members may choose to submit the paper forms (or, in the case of brewers, letterhead applications) referenced in the regulations.
Questions. If you have any questions concerning this industry circular, please contact the Regulations and Rulings Division at 202-453-2265 or use the contact us form.
John J. Manfreda