ALCOHOL LAW ADVISOR
ALCOHOL LAW ADVISOR
Regulatory and Distribution Law Updates for the Alcohol Industry
ALCOHOL LAW ADVISOR
Regulatory and Distribution Law Updates for the Alcohol Industry
FDA
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Non-Alcoholic Beer Regulation 101

As part of the general move to better-for-you beverages, non-alcoholic (NA) options have been and will likely continue to be on the rise. However, how NA is treated, or not treated, as “beer” has significant impact on its potential route to market. The below summarizes the overall treatment of NA beer under US federal law, as well as examples of restrictions on direct-to-consumer (DTC) shipments imposed by certain states. FEDERAL TREATMENT OF NA BEER Tax Treatment: The Alcohol and Tobacco Tax and Trade Bureau’s (TTB) regulations define “beer” as a fermented beverage containing 0.5% or more alcohol by volume (ABV) and brewed or produced from malt, wholly or in part, or from any substitute for malt. (See: 27 C.F.R. § 25.11.) The regulations refer to a malt beverage containing less than 0.5% ABV as a “cereal beverage.” (See: 25.11.) Because NA beer contains less than 0.5% ABV, TTB will not treat it as a “beer” under the Internal Revenue Code (IRC), and...

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Importing and Exporting Beer

Importing and exporting beer or other alcohol beverages involves multiple levels of government regulation and taxation. Some regulations, taxes, and reporting requirements mirror your existing compliance obligations as a brewery. Other obligations are unique and include government agencies that are not involved in regulating domestic producers, such as US Customs and Border Protection (CBP) and the Commerce Department. The nations you target for selling or importing can have layers of regulations just as daunting as they are in the United States. Multinational trade agreements, treaties and laws at the national, state, provincial or municipal levels may apply to your activities and govern critical topics, including: Excise and other taxes Product classification and tariffs National support for domestic producers and exports Impediments to trade In addition to government regulation, entering new import or export agreements with businesses requires diligence....

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

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. The case started when Florida resident Uri Marrache purchased a bottle of Bombay Sapphire gin at a Winn-Dixie store in Florida. After consuming the gin, Marrache filed suit under Florida’s Deceptive and Unfair Trade Practices Act, claiming that Bacardi (the producer of Bombay Sapphire) and Winn-Dixie had engaged in...

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EPA Approves Use of 10 Pesticide Products on Hemp

Yesterday, the Environmental Protection Agency (EPA) announced its approval of 10 new pesticides for use on hemp products. EPA’s approval of nine biopesticides and one conventional pesticide provides greater certainty to hemp farmers in time for the 2020 planting season. The hemp industry awaits further guidance from other federal regulatory agencies. In December 2018, Congress passed the Agriculture Improvement Act of 2018 (2018 Farm Bill), which explicitly removed hemp from the definition of marijuana in the Controlled Substances Act. The 2018 Farm Bill directed the US Department of Agriculture (USDA) to establish a regulatory framework for hemp production in the United States. USDA recently released its interim final rule including proposed rules and regulations regarding USDA’s approval of hemp production plans submitted by States and Indian Tribes, and the establishment of a Federal Plan for hemp growers in States without a USDA-approved plan. Comments...

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What to Know About FDA’s Recent Statements on CBD

Last week FDA issued a public release on CBD titled, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis derived Compounds, Including CBD.” The FDA document does not break much new ground, though it emphasizes again FDA’s concern with the safety of CBD, some of which comes from FDA’s review of the CBD-based epilepsy drug Epidiolex. FDA does not believe it has enough information about certain aspects of CBD, such as what happens if someone takes CBD daily for sustained periods. In addition, FDA specifically identifies as a potential harm the use of CBD with alcohol because of the increased risk of sedation and drowsiness, which can lead to injuries. FDA, in addition to issuing this document, sent 15 warning letters to companies marketing CBD products that FDA views as unapproved drugs primarily because of the drug like claims made for such products. FDA appears to be on a path toward considering a...

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USDA Publishes Long-Awaited Interim Regulations Governing the Production of Legalized Hemp

Yesterday, the United Stated Department of Agriculture (USDA) released its interim final rule setting forth the proposed rules and regulations regarding the production of hemp under the provisions of the Agricultural Improvement Act of 2018, or the “2018 Farm Bill.” As mandated by the 2018 Farm Bill, the proposed regulations outline provisions for both the approval by the USDA of State or Indian Tribe proposed plans as well as the development of its own federal plan for the production of hemp in the absence of an applicable approved State or Tribal program. While the draft rule is still subject to further comment, it provides the first official guidance from the USDA regarding the lawful production of hemp under the 2018 Farm Bill. In general, each of the approved State, Indian Tribe or Federal Plans include requirements for documenting and reporting, such as: Land descriptions, including geospatial location identifiers and total crop acreage Sampling and...

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Cannabis and Hemp Update

Cannabis legalization receives widespread popular support. According to opinion polls, more than two-thirds of Americans support full legalization—a steep rise in support considering that as recently as 2005, almost two-thirds of Americans opposed legalization. The country appears on the path to full cannabis legalization, but until that time, citizens and companies should be aware of the legal risks involved in entering the cannabis space. Access the full article. Originally published in The New Brewer, July/August 2019.

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FDA CBD Docket Closed, Agency to Soon Provide Status Report

The Food and Drug Administration (FDA) has increased its efforts to follow through on its commitment to provide guidance to stakeholders on the regulatory landscape for products containing CBD. On May 31, 2019, the FDA held a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds. Following the hearing, the FDA established a docket to allow the public to submit additional comments, research and information to the Agency. The docket closed on July 16 and received nearly 5,000 comments. On July 12, FDA Chief Information Officer and Principal Deputy Commissioner Dr. Amy Abernethy confirmed via Twitter that the Agency is “expediting its work to address” questions surrounding CBD and plans “to report on [its] progress around end of summer/early fall.” Due to the significant number of comments to the docket, it remains to be...

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

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. This hearing must be viewed as part of the FDA’s information-gathering process. The agency made no pronouncements regarding its regulatory approach toward cannabis and cannabis-derived compounds. In announcing this hearing in early April, former Commissioner Scott Gottlieb cautioned that the questions surrounding possible legal pathways for cannabidiol (CBD) and other cannabis-derived compounds will take...

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USDA Issues Opinion on Several Hemp-Related Provisions of the 2018 Farm Bill

On May 28, 2019, the United States Department of Agriculture (USDA) issued a legal opinion to address questions raised by several hemp-related provisions of the Agricultural Act of 2018, better known as the 2018 Farm Bill. The USDA opinion clarifies four areas of the 2018 Farm Bill: the removal of hemp as a controlled substance and schedule I drug became effective upon enactment of the 2018 Farm Bill; following the publication of implementing regulations, states and Indian tribes cannot prohibit interstate transportation and shipment of hemp and hemp-based products, and the USDA confirmed that this preemption also covers hemp produced under the 2014 Farm Bill; pending certain exceptions, individuals with certain controlled substance felony convictions will be barred from producing hemp; and following the enactment of the 2018 Farm Bill, states and Indian tribes still retain the ability to regulate hemp production, including the ability to grow or cultivate...

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