Lindsey Zahn P.C. drafts TTB formula applications, checks every ingredient for GRAS status, and works with TTB until the formula is approved. Getting the formula right first keeps your label approval and launch date on schedule.
Some wines, beers, and distilled spirits need formula approval from the Alcohol and Tobacco Tax and Trade Bureau (TTB) before their labels can be submitted and the product sold. A formula works like a recipe: a list of ingredients, their use rates, and a short description of how the beverage is made. Lindsey Zahn P.C. drafts formulas and labels that comply with federal regulations and still support your marketing goals.
TTB’s Formulation Division checks whether the ingredients fit the product classification you are seeking and whether they are Generally Recognized as Safe (GRAS). GRAS status is governed by the Food and Drug Administration (FDA) under Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act. TTB cannot grant GRAS status, but it does review ingredient lists to confirm that industry members use GRAS ingredients.
When an Ingredient Is Not GRAS
A non-GRAS ingredient can stall a launch. The firm reviews ingredients before submission to identify potential problems and, where an ingredient is not GRAS, works with your team on possible pathways to market.
How the Firm Helps
- Review draft formulations for wines, malt beverages, distilled spirits, meads, and hard ciders
- Identify required label statements based on your formula and ingredients
- Develop a compliant label based on ingredients and the claims you want to make on labels or in advertising
- Write the formula and manage the application from drafting through TTB feedback
Process and Timeline
- Scoping call. You describe your products, ownership, and plans. The firm confirms which TTB formula you need and what documents to gather.
- Preparation. The firm drafts the TTB formula and supporting documents and flags any issues before filing.
- Filing and follow-up. The firm files, answers agency questions, and keeps you updated until a decision.
- Approval and next steps. You get the approval and a list of the follow-on filings and deadlines that come with it.
TTB publishes its current average processing times online. The firm checks them when it files and tells you what to plan for, so your launch date accounts for agency review.
Recent Representations
- Reviewed formulas for a co-packer’s clients and advised on compliance issues for distilled spirits products
- Counseled a domestic distillery on a non-GRAS ingredient in a proposed cocktail product
- Worked with an importer and its supplier to develop an ingredients list and method of manufacture covering items typically requested in formulation
- Guided brand owners on drafting new formulas to support preferred label statements
Prior results do not guarantee a similar outcome.
Frequently Asked Questions
Which products need a TTB formula?
Products with added flavors, colors, or other ingredients beyond the standard for their class often need formula approval before label submission. The firm can tell you whether yours does.
What does GRAS mean for alcohol beverages?
GRAS (Generally Recognized as Safe) is an FDA status. TTB allows ingredients that are GRAS and checks ingredient lists during formula review, so a non-GRAS ingredient can delay or block approval.