Determine If and How Ingredients May be Used in Your Beverage
Here is some information to help you determine if and how certain substances may be used as ingredients in your alcohol beverage products. Note that this is offered as guidance only; please refer to the complete text of 21 Code of Federal Regulations as the final authority.
Learn more about:
- Substances that are Generally Recognized as Safe
- Food/color additives and limitations on their use
- Substances prohibited from use in human food
Substances that are Generally Recognized as Safe (GRAS)
You may use any substance that is “generally recognized as safe” (GRAS) by the U.S. Food and Drug Administration (FDA) in making your beverage.
Criteria for Determining if a Substance is GRAS
Per the FDA, "Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.
- Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive. General recognition of safety through scientific procedures is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
- Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers."
FDA Lists of GRAS Substances
The FDA has several lists of substances that can be used in food based on the GRAS provision. Per the FDA, “Importantly, these lists are not all-inclusive. Because the use of a GRAS substance is not subject to premarket review and approval by FDA, it is impracticable to list all substances that are used in food on the basis of the GRAS provision.
- 21 CFR Part 182 contains the remnants of a list, which FDA established in its regulations shortly after passage of the 1958 Food Additives Amendment. The list is organized according to the intended use of these substances. As part of the agency's comprehensive review of GRAS substances in the 1970s, FDA affirmed that the use of some of the ingredients on this original GRAS list is GRAS, and moved the affirmed uses of the substance to 21 CFR Part 184.
- 21 CFR Part 184 contains a list of substances that FDA affirmed as GRAS as direct food ingredients for general or specific uses. This list derives from the agency's 1970s comprehensive review of GRAS substances and from petitions that FDA received to affirm the GRAS status of particular uses of some food ingredients.
- 21 CFR Part 186 contains a list of substances that FDA affirmed as GRAS for certain indirect food uses.
- FDA's Internet site also contains a list of substances that have been the subject of a notice to FDA - i.e., when a firm has notified FDA about its view that a particular use of a substance is GRAS. You can access this summary of GRAS notices, along with FDA's response, from the GRAS Notification Program page.
Can the use of a substance be GRAS even if it is not listed by FDA? Yes…The use of a substance is GRAS because of widespread knowledge among the community of qualified experts, not because of a listing or other administrative activity.”
To learn more about GRAS, see FDA’s:
Contacting FDAFor any questions regarding how GRAS determinations are made or the particular GRAS status of an ingredient, please contact the FDA's Center for Food Safety and Applied Nutrition.
Food/Color Additives and Limitations on their Use
Food and color additives can be used in alcoholic beverages assuming the ingredient is approved for its intended use, at appropriate use rates, by the FDA.
To find out if and how a food or color additive can be used, consult:
- TTB’s list of limited flavoring substances, acceptable colors, and label implications
- FDA’s Food Additive Status List
- 21 CFR Part 172 (Food Additives Permitted for Direct Addition to Food for Human Consumption)
- Substances Added to Food (formerly “EAFUS” - FDA’s Everything Added to Food in the United States)
- FDA’s Color Additive Status List
Substances Prohibited from Use in Human Food
Some food ingredients have been prohibited from use in human food by the FDA. Use of any of these substances causes the food involved to be adulterated and is in violation of the regulations.
Here is the list of prohibited substances:
- 21 CFR Part 189 (Substances Prohibited from use in Human Food)