TTB Formulas

Some wines, beers, and distilled spirits require the submission of a formula application to the Alcohol and Tobacco Tax and Trade Bureau (“TTB”). This must happen before the product’s label can be submitted and sold at market. 

A formula is similar to a product’s recipe, which typically requires the submission of a list of ingredients, their use rates, and a short summary detailing how the beverage is made.

When TTB’s Formulation Division reviews formula submissions, the specialists check for several things. First, the Division will review the ingredients against the product classification. This is important in ensuring that a proposed product meets the requested classification. Lindsey Zahn P.C. has significant experience advising clients how to draft formulas and/or labels that comply with federal regulations and align with your marketing goals.

The TTB also reviews formulas to ensure that ingredients are safe for use in alcohol beverage products or what is commonly known as Generally Recognized as Safe (“GRAS”). TTB takes the position that industry members can use any substance that is GRAS for alcohol beverages. GRAS is a status that is actually regulated by the Food and Drug Administration (“FDA”). Under Sections 201(s) and 409 of the Food, Drug, and Cosmetic Act (“FDC&A”) and FDA’s implementing regulations, an ingredient can be GRAS for use in food though scientific procedures or for a substance that was used in food prior to 1958 (through experience based on common use in food). While TTB is not authorized to grant GRAS status to an ingredient, the agency does review the ingredients list of formulated products to ensure that industry members use ingredients that are GRAS.

If the TTB finds that a product’s ingredient is not GRAS, it can cause significant delays for your product’s market launch. Lindsey Zahn P.C. works with clients to review ingredients before products are submitted to TTB for formulation to determine whether or not the proposed product contains potentially problematic ingredients. In addition, Lindsey Zahn P.C. can work with your company to propose potential pathways to market in the instance that ingredients are not found to be GRAS.

TTB Formulas: Services

Among other services, the firm can also assist with the following:

• Review proposed draft formulations for wines, malt beverages, distilled spirits, meads, and hard ciders for compliance with federal regulations
• Provide insight on required label statements based on proposed formulas and/or use of specific ingredients
• Guide clients through developing a compliant label based on ingredients used and/or specific claims companies wish to assert on labels or advertising
• Work with your team to write a formula for submission to TTB and oversee the formula application from drafting to submission to feedback from TTB

Recent Representations

Some recent representations include:

• Assisted a co-packer with reviews of formulas for its clients, advising of potential compliance and legal issues on various distilled spirits products
• Counseled a domestic distillery on the use of a non-GRAS ingredient in a proposed cocktail product
• Served as outside counsel for an importer of alcohol beverages and worked with the importer and supplier to develop an ingredients list and method of manufacturer that included items typically requested during the formulations process
• Guided brand owner companies on options for drafting new formulas to obtain an approval that would line up with specific labeling statements preferred by the company

For more information about how Lindsey Zahn P.C. can help your company, please contact us at lindsey@zahnlawpc.com.

Prior results do not guarantee a similar outcome.