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
Food Safety and FDA
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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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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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Bioengineered Food Disclosures

Earlier this year, the U.S. Department of Agriculture (USDA) proposed a new regulation that would require food manufacturers to disclose information about bioengineered (BE) food and BE food ingredients. The proposed rule is the result of a 2016 law that required the USDA to establish a National Bioengineered Food Disclosure Standard for all food. For purposes of the BE disclosure law, “food” includes alcohol beverages intended for human consumption as well as non-alcohol beverages. Read the full article. Originally published in The New Brewer, November/December 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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California Court of Appeal Holds That “Safe Harbor” Defense Precludes Suit Based on Presence of Inorganic Arsenic in Wines

Last month, the Court of Appeal of California, Second Appellate District, Division Four, issued an opinion in Charles v. Sutter Home Winery, Inc. (2018 Cal. App. LEXIS 418*; 2018 WL 2126987). The court considered the Plaintiffs’ appeal of their dismissed putative class action complaint brought under the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65. The appeal challenged the adequacy of the warning label that the Defendants, a group of wine suppliers, provided on wines that contained allegedly unsafe levels of inorganic arsenic, a chemical listed by the State of California as a carcinogen and a reproductive toxicant (a “listed chemical”). In a win for the wine industry, the Court of Appeal upheld the dismissal of the case. Proposition 65 requires that any person who knowingly and intentionally exposes another person to a “listed chemical” in the course of doing business must provide a “clear and reasonable” warning...

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