How does the FDA regulate beverage products?

The U.S. Food and Drug Administration (www.fda.gov) regulates all food products in the US which includes beverages. Specific regulations govern what ingredients can be used in beverages, the production process, how beverages can be labeled (including the ingredients and nutritional information), and how beverages can be marketed. More details can be found on the FDA website, in the Federal Food, Drug, and Cosmetic Act and in the Code of Federal Regulations.
Alcoholic beverages are subject to much more specific regulations provided by the Alcohol and Tobacco Tax and Trade Bureau (www.ttb.gov). See “What is the Role of the TTB?”

What is the role of the Alcohol and Tobacco Tax and Trade Bureau (TTB)?

The TTB provides specific regulations that govern alcoholic beverages. Many of these regulations concern who can manufacture and sell alcoholic beverages as well as the collection of federal potable alcohol taxes.
These regulations govern which ingredients can be used in each class of alcoholic beverage (beers, wines, distilled spirits, etc.) as well as the production process, labeling and taxation. As an example of the complexity, the formula and exact label for all distilled spirits products must be approved in advance by TTB. Furthermore, these products can only be produced by facilities inspected and licensed by the TTB.
For more information, see the TTB Website .

What is a Beverage Formula?

A recipe or ingredient list which includes the amount of every ingredient and all of the processing steps required to manufacture a beverage is referred to as the “formula”. Usually, the ingredients can be broken down into basic categories – water , bulk ingredients like sweeteners and acidulants, alcohol-based products such as rum or neutral grain spirits (if required), flavoring ingredients, colors, and preservatives. Most products sold in the US are required to list the ingredients on the product label. However, this list does not specify the detailed information given in the formula.
For example, a typical soft-drink might include the following ingredients listed on the product label: water, sugar, ascorbic acid, natural and artificial flavors, sodium benzoate for preservative. However, this simple list can belie the complexity of the beverage. For example, the “natural and artificial flavors” ingredient may include several dozen individual ingredients. See “What are Flavors?”

What are Flavors? What is a Flavor System?

A beverage flavor system consists of all the flavor ingredients combined and ready to dose into a finished beverage. Flavors are usually very concentrated and are generally used at very low levels in a beverage, often < 0.2%. The individual ingredients within a flavor system are NOT required to be listed on the product ingredient statement. A flavor system is often a very complex mixture that may contain several dozen ingredients. These ingredients may be individual flavor chemicals such as vanillin, or complex natural products like lemon oil. Carrier solvents such as ethanol or propylene glycol are also often used to ease handling and solubility. If a flavor system consists consists of only natural ingredients, excluding the carrier solvents, it is referred to as a Natural Flavor. If both natural and artificial ingredients are used, the flavor is referred to as a Natural and Artificial Flavor. A list of ingredients, specifications and the process necessary to make the flavor is referred to as the Flavor Formula. The flavor formula is generally proprietary property of the flavor supplier and is not disclosed to the beverage manufacturer, bottler or the final consumer.

My flavor supplier won’t tell me what’s in the flavor. Is this a problem?

US Law protects the content of beverage flavors from disclosure provided that all ingredients are approved for use in food products. This long-standing legal status protects the flavor supplier’s intellectual property in lieu of patent protection which is not available for flavors. Even so, the flavor supplier must certify that their flavor complies with US law.
The design of flavoring systems for food and beverage products is a very complex and expensive process. Flavor companies must specialize in the flavor and chemical attributes of over 2000 approved flavoring ingredients as well as the special regulatory requirements for specific finished products (e.g. fruit juices, beers, etc.). Companies which sell flavor systems in almost all cases DO NOT DISCLOSE the ingredients to the purchaser. These remain proprietary trade secrets of the flavor company.
Supply and exclusivity agreements can be used to protect beverage companies which use these proprietary flavors if necessary.