September 12, 2019
The Alcohol and Tobacco Tax and Trade Bureau (TTB) must evaluate the ingredients and additives of certain wines, distilled spirits, and beers before the product can be made or imported, and before the importer or bottler may apply for a Certificate of Label Approval (COLA).
When is TTB Formula Approval necessary?
This “formula approval” is usually required when flavoring or coloring materials are added to a beverage, and usually not required when the product is produced using industry-standard procedures and ingredients. Although the TTB formula review process can be a bit lengthy and convoluted, failing to obtain TTB formula approval when required can result in significant delays in your production and rollout schedules. Therefore, it is important to understand exactly when a product requires formula approval.
TTB Label Requirements for Beer & Spirits
In its simplest terms, TTB formula approval is required when an alcoholic beverage is produced using non-traditional methods or ingredients.
The TTB requires formula approval so that it can:
- Verify that ingredients used meet FDA requirements and are considered safe
- Assign an appropriate tax classification
- Ensure that proposed labels will identify the product in a non-misleading way
The TTB label maintains three lists of formula approval requirements for different beverages, one for wine, one for distilled spirits, and a final one for malt beverages. Additionally, the TTB regularly exempts non-traditional ingredients commonly used by brewers from triggering TTB formula approval requirements, such as certain fruits and spices.
What all this means is that some alcoholic beverages, like a blend of straight bourbon whiskeys or a beer brewed with pumpkin, do not require formula approval, while other alcoholic beverages, like a pumpkin beer brewed with nutmeg extract (nutmeg extract is not an exempt ingredient) or a flavored whiskey, do require formula approval. Although TTB formula approval can be relatively straightforward in some situations, manufacturers should be aware of the situations where they may encounter resistance.
TTB Label Requirements for CBD Infused Beers
Cannabidiol’s (CBD) recent surge in popularity has sent several brewers across the country scrambling to develop CBD infused beers. Unfortunately for those brewers, the TTB released an industry circular on April 25, 2019 stating that they would not approve any applications for formulas containing hemp ingredients other than those derived from hemp seeds or hemp seed oil.
And while hemp seeds can produce a fragrant and interesting beer like New Belgium’s Hemperor HPA, hemp seeds do not contain any CBD, and therefore cannot be used to develop a CBD infused beer. The TTB requires a laboratory analysis for any applications containing hemp ingredients, even if the ingredient is derived from hemp seeds or hemp seed oil.
For its part, the TTB notes that brewers may resubmit any formula approval applications for products containing hemp ingredients other than hemp seeds or hemp seed oil, or their derivatives, if they receive a favorable individual determination from the FDA on the regulatory status of their ingredients.
Although the FDA recently reiterated its position that CBD is not a permitted ingredient in food or dietary supplements under federal law, it is beginning the process of reevaluating this position and is currently holding public hearings to gather scientific data on CBD’s safety. So, while not totally impossible for brewers to develop and obtain formula approval for a CBD infused beer, it is going to take a few extra steps, and could add significant time and cost to the formula approval process.
Obtain your TTB Label & Formula Approval
If you need help obtaining formula approval, or have questions about the approval process, our experienced team of Minneapolis craft beer attorneys can help. Contact us today to get started.