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
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Winds of Change Blowing for Craft Brewers

For those who follow developments in the law and craft brewing with equal passion, every year has its share of substantial issues. This year has been no exception, with a pending Supreme Court case; a substantial upswing in federal trade practice enforcement activity; a massive rewrite of US Tax and Trade Bureau (TTB) labeling and advertising regulations; and prospects for extending the biggest cuts in the excise tax on beer since the repeal of Prohibition. As these developments play out over the next year, we may see changes translate into the marketplace. Find out what you can expect. Access the full article. Originally published in The New Brewer, May/June 2019.

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TTB’s Take on Alcohol Beverages Infused with Cannabidiol

On April 25, 2019, TTB published Industry Circular 2019-1. It addresses the hot topic of alcohol beverages (especially beer) infused with hemp-derived ingredients–with cannabidiol (CBD) as the clear focus of industry interest. While hardly surprising, the Industry Circular takes or reiterates the following positions: TTB will require a formula for any product containing a hemp-derived ingredient TTB will not approve a formula for any product containing a Schedule I controlled substance under the Controlled Substances Act TTB will not approve a formula for any product containing CBD until FDA changes its current position towards CBD as a food ingredient. FDA currently views interstate commerce in any food containing CBD as a violation of the federal Food, Drug & Cosmetic Act TTB will continue to approve formulas for alcohol beverages containing ingredients derived from hemp seeds and hemp oil TTB will not approve a formula for any product containing a hemp...

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FDA Releases Warning Letters to CBD and Hemp Oil Companies

Last week the Food & Drug Administration (FDA) made public three new warning letters to Cannabidiol (CBD) and hemp oil product companies sent by FDA and the Federal Trade Commission (FTC). FDA has previously targeted cannabis product companies. The new warning letters are consistent with FDA Commissioner Scott Gottlieb’s recent statements that the FDA will go after manufacturers of CBD products that make health and wellness claims that FDA views as egregious. For example, the CBD companies in question allegedly marketed their products for Alzheimer’s disease, fibromyalgia, inflammation, skin conditions, autoimmune disorders, anxiety, cancer pain, PTSD and depression, to name a few symptoms. These companies are making food, dietary supplements, and cosmetic products, as well as products for pets (CBD for dogs). Some highlights: One letter specifically calls out a CBD isolate product (blue CBD crystals isolate 1500 mg). Some have advanced arguments that a...

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FDA Issues Guidance on Hops and Wine Grapes

The FDA recently issued Guidance announcing its decision to exercise enforcement discretion with regard to the Produce Safety Rule for entities growing, harvesting, packing or holding hops and wine grapes, as well as almonds and pulse crops (dry, edible seeds in the legume family harvested solely in dried form). More specifically, while the FDA considers rulemaking to address the unique circumstances of these four crops, the FDA does not expect entities growing, harvesting, packing or holding these commodities to meet any of the Produce Safety Regulation requirements with respect to these commodities. Hops: The FDA’s rationale for exercising enforcement discretion for hops is that hops used in the making of beer receive adequate pathogen reduction through means other than a cook step (e.g., pH, alcohol content and fermentation) and hops are not used outside of the brewing process. Wine Grapes: For wine grapes exclusively grown for use in winemaking, the FDA...

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FDA Announces Public Hearing on Products Containing Cannabis or Cannabis-Derived Compounds

On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing on cannabis products. The hearing seeks to obtain scientific data on cannabis and cannabis-derived compounds, along with additional information regarding health and safety risks, manufacturing and product quality, marketing, labeling and the sale of such products. The FDA’s notice announcing the hearing recognizes that the regulatory landscape surrounding cannabis continues to evolve at both the federal and state levels. At the state level, 33 states and Washington, DC, allow for the medical use of marijuana and 14 additional states have medical programs limited to cannabidiol (a/k/a CBD) products. Moreover, 10 states and Washington, DC have legalized marijuana for recreational use, while 13 additional states have decriminalized recreational marijuana possession in some form. At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334 (often called the 2018...

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DEA Schedules a FDA-Approved CBD Drug

As beverage manufacturers mull the creation and distribution of cannabidiol (CBD)-infused products, the US Drug Enforcement Administration’s (DEA) recent actions regarding an approved CBD drug merit exploration. CBD is one of many chemicals in the cannabis plant, and the US Food and Drug Administration (FDA) has stated that CBD does not produce the same euphoric effect as tetrahydrocannabinol (THC), marijuana’s psychoactive component. In June, FDA approved the first drug comprised of an active ingredient (CBD) derived from marijuana, Epidiolex. FDA approved the CBD oral solution for patients two years of age and older who have seizures associated with two forms of severe epilepsy. According to DEA and FDA, the CBD in Epidiolex is extracted from the cannabis plant and is a purified drug substance. Though it is derived from the cannabis plant, the FDA-approved drug has no more than 0.1 percent residual THC. Last week, DEA announced an order scheduling Epidiolex...

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FDA Extends Compliance Date for Updated Nutrition Facts Label

The Food and Drug Administration (FDA) is extending the compliance dates for updating the familiar Nutrition Facts labels, from July 26, 2018 to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will receive an extra year to comply – until January 1, 2021. FDA explained that after considering a range of stakeholder comments, there was a need for manufacturers to have additional time to make required label changes. The approximately 18-month extension accomplishes this goal and will provide sufficient time to transition to the new version of the Nutrition Facts label. Finally, FDA said it is committed to ensuring that all manufacturers have guidance to help implement the required label changes by the upcoming compliance dates and the additional time will help FDA achieve that objective.

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FDA Releases Draft Guidance on Public Warnings and Notifications of Recalls

The Food and Drug Administration (FDA) recently issued a draft guidance on the agency’s voluntary recall process and announced the agency’s intention to notify the public faster when a product is recalled. The guidance aims to assist and provide recommendations to industry and FDA staff regarding the use, content and circumstances for issuance of public warnings and public notifications for firm‑initiated or FDA‑requested recalls. In addition, the guidance discusses what information to include in a public warning, as well as the parties responsible for issuing it. Notably, the draft guidance does not specifically address recalls of alcohol beverage products regulated by the Federal Alcohol Administration (FAA) Act or the primary role of the Alcohol and Tobacco Tax and Trade Bureau (TTB) in seeking and monitoring recalls of such beverages. Comments on the draft guidance are due by March 20, 2018. The draft guidance, “Public Warning and Notification of Recalls...

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FDA Publishes Supplemental Guidance on Menu Labeling for Chain Restaurants

On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu labeling and nutrient disclosure regulations applicable to chain restaurants (Draft Guidance). FDA guidance documents are advisory in nature and represent the views of the FDA at a given point in time. Accordingly, guidance is subject to change, but is useful for developing a compliance plan for retail establishments covered by the menu labeling regulations. Changes are usually incremental and based on agency experience and input from regulated industry members. The FDA established a 60-day period for comments on the draft menu labeling and nutrient disclosure guidance. The comment period ends on January 6, 2018. The current compliance date for menu labeling and nutrient disclosure regulations is May 7, 2018. Implementation of federal menu labeling and nutrient disclosures by chain restaurants is a study in...

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FDA Proposes to Extend Compliance Dates for Nutrition and Supplement Facts Labels and Serving Size

On September 29, 2017, the US Food & Drug Administration (FDA) announced a proposal to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule. For manufacturers with $10 million or more in annual food sales, the date will change from July 26, 2018, to January 1, 2020.  Manufacturers with less than $10 million in annual food sales would receive an extra year to comply—until January 1, 2021. FDA’s proposal addresses only the compliance dates. The FDA is not proposing any other changes to the Nutrition Facts Label and Serving Size final rules.  While this rulemaking is being completed, FDA intends to exercise enforcement discretion with respect to the current July 26, 2018, and July 26, 2019, compliance dates. A copy of the public inspection version of the proposed rule can be found here.

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