generally recognized as safe Archives

Don’t Assume Nonalcoholic Beverage Ingredients Are OK for Alcoholic Beverages

by Alva C. Mather and Alice Chung | Feb 5, 2024 | Food Safety and FDA, Non-Beverage Alcohol, TTB COLAs and Formulas

As we enter 2024, more and more brands are joining the nonalcoholic beverage space. An increasing variety of nonalcoholic, single-serve, ready-to-drink beverages are marketing the innovative use of indigenous botanicals, herbs or novelty ingredients found in other foods. This innovation has led to product development teams exploring the use of those ingredients for their alcoholic beverage products, but in many instances those ingredients have not been used in or approved for alcoholic beverages in the United States by the Alcohol and Tobacco Tax and Trade Bureau (TTB), leading to challenges with obtaining formula approvals.

BACKGROUND

As a reminder, the TTB requires that all ingredients added to an alcoholic product be determined generally recognized as safe (GRAS) for use in alcohol. If the TTB finds that a product’s ingredient is not GRAS, it can cause significant delays for your product’s market launch. Currently, the TTB’s GRAS determination relies directly on the advice and approval of the ingredient’s use in alcoholic beverages by the US Food and Drug Administration (FDA).

In line with the historic Memorandum of Understanding (MOA) between the two agencies, the FDA (not the TTB) is responsible for determining which ingredients are prohibited from use in food and/or beverage products under the US Federal Food, Drug, and Cosmetic Act. These include food additives, such as substances added intentionally to food, and color additives. The TTB is authorized by law to utilize the services of a government department or agency to carry out its powers and duties under the Federal Alcohol Administration Act. Pursuant to its MOA with the FDA, the TTB regularly consults with the FDA regarding the approval of ingredients in alcoholic beverages and the requirements of label disclosure for certain substances. The TTB’s Beverage Alcohol Laboratory also analyzes alcoholic beverage products for limited and prohibited compounds and enforces these restrictions for alcoholic beverages as per FDA guidance.

OUR GUIDANCE

In light of these challenges, we recommend that before submitting your formula, double-check to make sure all the ingredients and substances added are GRAS and allowable for use in alcoholic beverages specifically. This will help streamline the approval process and avoid potential delays. Below are some tips you should consider:

Check with the ingredient supplier or manufacturer for the regulatory status of the ingredient and ask for a Technical Data Sheet or Product Specification Sheet that likely contains the relevant information.
Refer to the TTB’s Limited Ingredients page, which contains both the “Flavoring Substances and Adjuvants Subject to Limitation or Restriction” and “Flavoring Substances and Adjuvants that are Used Only in Certain Situations.” These list many ingredients that may be used in alcoholic beverages only. It is not an exhaustive list of all substances that have limitations in foods or beverages but useful in determining whether a limit is exceeded in an alcoholic beverage product.
Search your ingredient on the FDA’s The Substances Added to Food inventory (formerly called Everything Added to Foods in the United States) to determine [...]

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Florida Federal District Court Rules GRAS Regulation Preempts Florida Statute Criminalizing Ingredient

by Alva C. Mather and Christopher M. Lahiff | Mar 9, 2020 | Food Safety and FDA, Legislation

In an important ruling dismissing a proposed class action, the US District Court for the Southern District of Florida ruled that the US Food and Drug Administration’s (FDA’s) generally recognized as safe (GRAS) regulation preempts a Florida statute that criminalized adding grains of paradise to liquor. More specifically, the Court in Marrache v. Bacardi USA, Inc., 2020 US Dist. LEXIS 13668 (January 28, 2020), ruled that the Florida statute was preempted because it conflicts with the Federal Food, Drug and Cosmetic Act (FFDCA) and the FDA’s regulations (21 C.F.R. § 182.10) which establish that grains of paradise are GRAS. 2020 US LEXIS 13668, at *4.

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Learnings from the FDA Hearing on Cannabis and Cannabis-Derived Compounds

by Noah Feldman Greene | Jun 7, 2019 | Cannabis, Food Safety and FDA

On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health benefits associated with cannabis products. More than 110 speakers, including academic researchers, trade associations and cannabis product manufacturers, presented to the FDA panel during the all-day hearing. Below we outline the notable points from the hearing, including statements by FDA officials and interesting speaker comments. (more…)

FDA Issues Final Rule on Food Ingredients that May Be Generally Recognized as Safe (GRAS)

by Christopher M. Lahiff | Aug 17, 2016 | Food Safety and FDA

The US Food and Drug Administration (FDA) has issued this final rule detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS). By way of background, if an ingredient is GRAS, food additive petition is not required and FDA does not have to approve the ingredient before it can be used in foods. FDA has been studying the existing process that currently results in a company conducting the GRAS assessment via a panel of experts and then either proceeding to immediately use the ingredient in foods, or submitting a GRAS affirmation petition to FDA before the ingredient is used in a food.

FDA’s new regulation provides the information FDA believes a company should have to make a GRAS determination or conclusion. Manufacturers remain free to conduct their own GRAS evaluations and then proceed to incorporate the substance into food. FDA’s final rule changes what had been a voluntary GRAS affirmation process into a voluntary “notification” process. Under this new process, if a company decides to use the notification process, the company conducts the requisite safety assessment and then prepares a notification submission to the FDA. The contents of the notification submission are detailed in the regulation. Once the voluntary notification had been submitted to FDA, the agency is supposed to respond within 180 days, though that can be extended for an additional 90 days (for a total of 270 days) before the substance can be included in a food, assuming FDA does not question the basis for the notifier’s GRAS conclusion.

Don’t Assume Nonalcoholic Beverage Ingredients Are OK for Alcoholic Beverages

Florida Federal District Court Rules GRAS Regulation Preempts Florida Statute Criminalizing Ingredient

Learnings from the FDA Hearing on Cannabis and Cannabis-Derived Compounds

FDA Issues Final Rule on Food Ingredients that May Be Generally Recognized as Safe (GRAS)

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