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
US Food and Drug Administration
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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 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On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu labeling and nutrient disclosure regulations applicable to chain restaurants (Draft Guidance).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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Implications of EU Ingredient Labeling Proposal for US Suppliers

On March 13, the European Commission approved a report that calls on members of the alcohol beverage industry to develop a comprehensive self-regulatory system of ingredient and nutritional labeling for beer, wine, and distilled spirits. The Commission is composed of representatives of each member nation of the European Union (EU) with a range of administrative responsibilities and authority to develop and propose legislation for consideration by the European Parliament. The European Commission characterizes access to ingredient and nutrition information as a right of EU consumers, and called on industry members to develop a self-regulatory proposal over the next year. Current EU policy on alcohol beverage labeling is analogous to US policy. The EU regulation on food labeling exempts alcohol beverages containing more than 1.2 percent alcohol-by-volume. The European Commission proposal warrants careful attention by US alcohol beverage suppliers across all...

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FDA Releases Final Guidance Regarding the Food Labeling Term “Evaporated Cane Juice”

The US Food and Drug Administration (FDA) has released final guidance stating its view that sweeteners derived from sugar cane should not be declared in the statement of ingredients as “evaporated cane juice.”  FDA’s view is that the term “evaporated cane juice” is false or misleading because it suggests that the sweetener is fruit or vegetable juice or is made from fruit or vegetable juice, and does not reveal that the ingredient’s basic nature and characterizing properties are those of a sugar. FDA’s guidance recommends that ingredients currently labeled as “evaporated cane juice” be relabeled to use the term “sugar,” optionally accompanied by a truthful, non-misleading descriptor to distinguish the ingredient from other cane-based sweeteners.  Such a descriptor could be a coined term, and can be used to distinguish the ingredient from white sugar and other sugars by describing characteristics such as source, color, flavor or crystal size.  FDA would expect...

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FDA Announces Availability of Final Guidance on Menu Labeling

On May 5, 2016, the US Food and Drug Administration (FDA) announced the availability of its final menu labeling guidance, “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11).” The guidance is designed to help businesses comply with the menu labeling final rule. Under a law signed late last year, FDA’s enforcement of its menu labeling final rule cannot begin until one year after FDA published this notice of availability. As a result, enforcement of the final Menu Labeling regulations will start on May 5, 2017. FDA’s guidance responds to many frequently asked questions that it has received. It differs from the draft guidance by providing additional examples and new or revised questions and answers on topics such as covered establishments (pages 6, 12–17), alcohol beverages (pages 50–55), catered events (page 14), mobile vendors (page 16), grab-and-go...

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