Non-Beverage Alcohol Archives - ALCOHOL LAW ADVISOR

Non-Beverage Alcohol

Growing Regulatory Focus on ‘Crossover Alcohol Products’

by Alva C. Mather | Jul 10, 2024 | Advertising and Marketing, Beer, Malt Beverages and Cereal Beverages, Distilled Spirits, Non-Alcoholic Beverages, Non-Beverage Alcohol, Wine and Cider

As more companies – including businesses with and without experience producing alcoholic beverages – move to leverage their brands and brand equity across the beverage spectrum, regulators, trade associations and the companies themselves are focusing on ways to responsibly label, advertise, market and display these products to avoid consumer confusion and potential sales to minors.

Crossover alcohol products are generally categorized as alcohol beverages that use the products and intellectual property (e.g., brand names, logos) of a preexisting non-alcohol brand. While not legally defined (yet), such products include Dunkin’ Spiked Original Iced Coffee, Eggo Brunch in a Jar, Lipton Hard Iced Tea and SunnyD Vodka Seltzer, among others. As illustrated by these examples, products such as Lipton Hard Iced Tea leverage the non-alcoholic Lipton Iced Tea branding for a new product in the alcohol space.

As crossover alcohol products have become more prevalent across the market, state regulators have started taking notice and providing guidance to alcohol producers as to how to assure these products are not “false or misleading,” as defined by alcohol regulations, or tend to induce minors to drink the alcoholic product either through the products’ labels, packaging or store-display locations. The Commonwealth of Virginia, in particular, has taken the lead through the issuance of Circular Letter 23-01, which provides guidelines for alcohol producers as they develop these products. These guidelines focus on the following, among other issues:

Ensuring that the crossover product clearly indicates the type of alcohol it contains, with such information visible in at least three to six different locations.
Ensuring that the sizes of the alcohol references and warnings are sufficiently large and noticeable in comparison to other writings on the product label.
Ensuring that any and all changes to product labels, containers and secondary packaging clearly distinguish the crossover products from the original non-alcoholic products so as to prevent consumer confusion; such changes may involve the color palette, font type, imagery, placement of words, images and descriptions, or background elements.
Ensuring that secondary closures, such as foil lids, plastic wrapping, lip guards, stickers or other “child-proof” packaging, are present, to prevent accidental consumption by a minor.

Recently, a coalition including the Distilled Spirits Council of the United States (DISCUS), Wine & Spirits Wholesalers of America (WSWA), FMI – The Food Industry Association, and the National Association of Convenience Stores (NACS) (representing the three tiers of the industry: suppliers, wholesalers and retailers), issued a joint commitment related to the responsible marketing and merchandising of crossover alcohol products. Similar to Virginia’s guidance, the coalition is focused on assuring that these products are not confused for their non-alcohol counterparts and do not appeal to those under the legal purchase age, based on the appeal of the underlying brand. Accordingly, the coalition looks to alcohol producers to commit to responsible production, packaging and marketing of crossover alcohol products by:

Adhering to responsible advertising codes, such as the Distilled Spirits Council Code, to ensure these [...]

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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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Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

by Alva C. Mather | Apr 1, 2020 | Alcohol Excise Taxes, Food Safety and FDA, Legislation, Non-Beverage Alcohol, TTB COLAs and Formulas

To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have been rapidly updating and providing guidance for alcohol manufacturers interested in producing or supplying alcohol for the production of these important products. The below neatly summarizes the key issues surrounding the production of alcohol for use in or production of hand sanitizers for distilled spirts plants (DSPs).

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TTB and FDA Relax Restrictions on the Production of Hand Sanitizers by Alcohol Manufacturers

by Alva C. Mather | Mar 23, 2020 | Food Safety and FDA, Non-Beverage Alcohol, TTB COLAs and Formulas

With the increasing pace of the spread of the Coronavirus (COVID-19) and the related emergent need to increase the available supply for hand sanitizer products across the United States, the Alcohol and Tobacco Tax and Trade Bureau (TTB), followed by the Federal Drug Administration (FDA), have relaxed requirements for certain alcohol producers to produce these products without first amending their existing permits or obtaining prior formula approval.

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TTB Publishes New Nonbeverage Product Formula Form

by T. Marshall Fawley III and McDermott Will & Emery | Aug 19, 2019 | Alcohol Excise Taxes, Non-Beverage Alcohol, TTB COLAs and Formulas

On August 12, 2019, the Alcohol and Tobacco Tax and Trade Bureau (TTB) published its updated Formula and Process for Nonbeverage Product, TTB Form 5154.1. The Nonbeverage Product approval process is critical to obtain “drawback” (a refund) on most of the alcohol excise tax on distilled spirits used to make such products deemed “unfit for beverage purposes.” The Nonbeverage Formula Form accordingly is important to producers of flavorings and extracts, soft drink concentrates and other non-beverage products made using potable alcohol. (more…)

Additional Rum Cover Over for Puerto Rico and the US Virgin Islands Approved in 2018 Budget Legislation

by Arthur J. DeCelle | Feb 9, 2018 | Alcohol Excise Taxes, Import/Export, Legislation, Non-Beverage Alcohol, TTB COLAs and Formulas

Early this morning, both houses of Congress approved the “Bipartisan Budget Act of 2018,” complex legislation that includes important modifications to an arcane law known as the “rum cover over,” which is an important revenue source for the Commonwealth of Puerto Rico and the US Virgin Islands (USVI).

The temporary excise tax relief provided to distillers in the 2017 federal tax reform law will not diminish the amount of federal excise tax revenue covered over to the treasuries of Puerto Rico and the USVI. The 2017 tax reform law included a two year reduction in the federal distilled spirits excise tax rate from $13.50 per proof gallon to $2.70 per proof gallon on the first 100,000 proof gallons of distilled spirits, and $13.34 per proof gallon on the next 22,130,000 proof gallons produced by each distillery or each controlled group of distilleries. The 2018 Budget Act treats all rum subject to the rum cover over as if it is subject to the full $13.50 per gallon excise tax rate. (more…)

Additional TTB Tax Act Guidance

by McDermott Will & Emery | Feb 5, 2018 | Alcohol Excise Taxes, Import/Export, Legislation, Non-Beverage Alcohol

On Thursday evening, February 1, the Alcohol and Tobacco Tax and Trade Bureau (TTB) released additional FAQ guidance on the alcohol excise tax provisions of the 2018 tax reform (the Tax Act). (more…)

TTB Updates to the Semi-Annual Regulatory Agenda

by McDermott Will & Emery | Dec 27, 2017 | Advertising and Marketing, Alcohol Excise Taxes, Non-Beverage Alcohol, TTB COLAs and Formulas

Last week in its regular newsletter, Alcohol and Tobacco Tax and Trade Bureau (TTB) announced updates to the Fall edition of the semi-annual Unified Agenda of Federal Regulatory and Deregulatory Actions (Regulatory Agenda). Like other federal agencies, TTB uses the Regulatory Agenda to report on its current rulemaking projects.

In the updated agenda, a few new items have been added, and many expected publication dates of Notices of Proposed Rulemaking (NPRMs), Advanced Notices of Proposed Rulemaking (ANPRMs) and Final Rules have changed. As always, readers should recognize that TTB rulemaking moves very slowly, and the Agency often does not meet the aspirational dates published in the Regulatory Agenda. (more…)

Excise Tax Relief for Breweries, Wineries and Distilleries

by Arthur J. DeCelle | Dec 26, 2017 | Alcohol Excise Taxes, Distribution, Import/Export, Legislation, Non-Beverage Alcohol, Transactions, TTB COLAs and Formulas

This post does not constitute tax advice. It summarizes changes in alcohol beverage excise tax laws to assist industry members in planning to implement the changes. Excise tax calculations and liability must be determined for each taxpayer based on numerous variables.

The new tax law formerly referred to as the Tax Cuts and Jobs Act of 2017, provides a temporary reduction in alcohol beverage excise taxes for US brewers, winemakers, distillers and beverage importers. Temporary tax relief is available for beer, wine and spirits removed from a US manufacturing facility or released from Custom’s custody after January 1, 2018, and prior to December 31, 2019. Several provisions of the new law will require the Alcohol and Tobacco Tax and Trade Bureau (TTB) to quickly promulgate new regulations. (more…)

President Trump Issues Executive Order Aimed at Reducing Regulation and Controlling Regulatory Costs

by McDermott Will & Emery | Feb 13, 2017 | Advertising and Marketing, Alcohol Excise Taxes, Food Safety and FDA, Legislation, Non-Beverage Alcohol, Trade Practices, TTB COLAs and Formulas

On January 30, 2017, President Trump issued Executive Order No. 13771, entitled “Reducing Regulation and Controlling Regulatory Costs.” A link to Executive Oder 13771 appears here. The Order provides:

For Fiscal Year 2017 (which ends September 30, 2017):
1. For each new “regulation” published for notice and comment “or otherwise promulgated,” the agency in question must “identify” two existing regulations to be repealed. Notably, the Order does not require the repeal to be concurrent with the publication or promulgation of the new regulation.
2. For Fiscal Year 2017, each agency must ensure that the total incremental costs of all new and repealed regulations shall not exceed zero, unless otherwise required by law or as consistent with the advice of the Office of Management and Budget (OMB). The Order does not specify whether the costs in question represent costs to the agency, costs to the government or total societal costs. It also does not provide any guidance on how to calculate such costs.
3. To the extent permitted by law, the costs of any new regulations shall be offset by the elimination of costs associated with at least two existing regulations. Once again, the Order provides no guidance on what constitute costs of a regulation or how to calculate such costs.
4. The OMB is directed to provide agencies with guidance on how to implement the Order.
Beginning with Fiscal Year 2018 (which begins October 1, 2017):
1. The semi-annual Unified Regulatory Agenda for each agency must: (i) identify for each new regulation “that increases incremental cost,” two offsetting regulations; and (ii) provide an approximation of the total costs or savings for each new and repealed regulation.
2. Each regulation approved by the OMB shall be included in the Unified Regulatory Agenda.
3. Unless otherwise required by law, agencies may not issue new regulations that were not listed in the most recent Unified Regulatory Agenda.
4. During the budgeting process, the OMB shall notify agencies of the total costs per agency that will be allowed in issuing and repealing new regulations for the upcoming fiscal year.
5. The OMB shall provide agencies with guidance on implementing the Order’s requirements.

Executive Oder 13771 applies to each “executive department or agency,” but leaves a number of government regulatory functions outside of its scope. These include agencies involved in military, national security, and foreign affairs functions, as well as any government organization arising from the Legislative or Judicial branches. Nevertheless, the Order applies to a vast swath of the federal bureaucracy.

On its face, Executive Order 13771 could have a significant impact on the pace of federal rulemaking during the Trump Administration. The “two-for-one” requirement, in particular, appears to be a blunt instrument aimed at shrinking the Code of Federal Regulations. Moreover, the explicit requirement for cost estimates and “zero” total costs flowing from the rulemaking process plainly seeks to halt the growth and costs of the federal administrative state.

But the jury remains out on the practical impact of Executive Order 13771. Longstanding observers of the federal bureaucracy will, no [...]

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