Formula approvals from the Alcohol and Tobacco Tax and Trade Bureau (“TTB”) are a core part of compliance for producers and importers of alcoholic beverages. A frequent question is whether TTB formula approvals expire—and the short answer depends on whether the product is domestic or imported.
The Short Answer
- Domestic product formulas: Generally do not expire so long as the product continues to be manufactured in accordance with the approved formula and current TTB rules (see discussion below).
- Imported product formulas: Typically expire ten (10) years from the date the formula was approved. Importers should track those approvals and take steps to renew or refile before expiry to avoid compliance problems.
Below, we explain the differences, when re-approval is required, and best practices for maintaining compliance.
Domestic Products: When Re-Approval Is Required
Domestic formulas remain valid so long as production matches the approved submission and TTB has not changed governing policy that affects the formula. You must submit a new formula (or an amended formula) if you make any material change, such as:
- Changing ingredients or ingredient proportions.
- Altering the production process in a way that affects composition.
- Switching to a new raw materials supplier whose ingredient composition differs materially.
- Adding or removing colorings, flavorings, or other non-beverage ingredients.
- Changing the base spirit or other primary alcohol source.
If you make any such change, do not rely on the old approval—submit an updated formula before producing or labeling the revised product.
Imported Products: Ten-Year Expiration
Imported formulas are treated differently. As a practical rule, TTB approvals for imported product formulas generally expire ten years after the approval date. This means importers should not assume indefinite validity; instead, they should:
- Track the approval date for each imported formula.
- Plan to renew or refile before the ten-year anniversary if the product remains unchanged.
- Provide updated documentation from the foreign producer if requested (for example, confirmations that the recipe, ingredient sources, and production methods remain identical).
- Resubmit promptly if the foreign producer changes the composition, process, or ingredient sources—such changes will require a new approval regardless of the ten-year clock.
Failure to renew or to confirm that an imported product still conforms to its approved formula can result in enforcement risk, delays at U.S. ports, or rejection of label approvals (COLAs) tied to the formula.
When TTB Policy or Ingredient Classifications Change
Even outside the ten-year rule for imports or the general resubmission rules for domestic products, TTB may revise guidance or reclassify ingredients. In those situations, TTB can request updated information or require new submissions. Producers and importers should monitor TTB notices and industry guidance so regulatory changes do not catch them by surprise.
Practical Steps to Maintain Formula Compliance
Staying on top of TTB formula compliance requires organization and proactive review. Producers and importers should maintain a clear system for tracking their formula approvals, particularly for imported products that expire after ten years.
First, maintain an internal formula register that lists each approved formula, its approval date, and—if applicable—its expiration date. This register should also include supporting documentation such as ingredient statements, process descriptions, and correspondence with TTB.
Next, review your formulas on a regular basis, ideally once a year, to confirm that your current production methods and ingredient sources still match what was approved. This step helps prevent inadvertent compliance issues caused by recipe adjustments or supplier changes.
For importers, obtain periodic written confirmations from your foreign producers to verify that the product’s composition and production methods remain the same as those described in the approved formula. If any changes occur, you should be prepared to refile with TTB before continuing to import the product.
Additionally, plan ahead for renewals by setting reminders several months before an imported formula’s ten-year expiration date. This will allow sufficient time to gather updated documentation and submit renewal materials without disrupting import operations.
Finally, consult with legal counsel or compliance professionals before making any significant changes to a product’s ingredients or production process. Even minor adjustments can trigger the need for a new formula submission, and advance review can help avoid costly production or labeling delays.
How Lindsey Zahn P.C. Can Help
We assist both domestic producers and importers with all aspects of TTB formula compliance, including:
- Determining whether your product requires a formula approval.
- Preparing and submitting formula applications, amended applications, and renewals through TTB’s online systems.
- Managing ten-year renewals for imported product formulas and coordinating documentation with foreign producers.
- Reviewing proposed production or ingredient changes and advising whether a new submission is required.
- Responding to TTB inquiries or requests for additional information during review.
If you produce or import alcoholic beverages and want to confirm whether your formulas remain valid—or need help preparing a renewal or new submission—contact Lindsey Zahn P.C. to schedule a consultation. We can review your formula register, prepare filings, and help reduce the risk of delays or enforcement issues.
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