Flavors Purchased From Another Manufacturer
TTB regularly receives formulas containing compounded flavors as ingredients without supporting information. This delays formula processing and causes frustration for the submitter.
The following information is required for compounded flavors contained in a formula:
- Predominant ingredients must be identified and quantified on the formula. This is especially important when the component may be the only source of the name of your flavor or when it is the reason that your product is unfit for beverage purposes.
- All limited ingredients must be listed and quantified. If none please state that.
- Colors must be listed. If none please state that.
- If the product contains ethanol, the ethanol content in volume must be provided.
- Please be sure to provide the manufacturer and TTB number of the product (if it has been submitted to TTB).
- A specification or ingredient data sheet may be submitted (see example), but it must provide the information mentioned above. The manufacturer of the product may be directed to fax the information directly to us, referencing your TTB number.
- Follow documentation guidelines and flowchart for purchased products. **NEW**
Note: It is important to point out that information on limited ingredients, ethanol content, and the TTB number of your product are not proprietary and must be provided to customers when requested. In situations where disclosing the quantities of FDA or TTB limited ingredients would reveal the majority of the product, the information may be provided directly to the Nonbeverage Products Laboratory. This can be accomplished by the manufacturer of the intermediate submitting the formula on TTB Form 5154.1.