The Food and Drug Administration (FDA) recently issued a draft guidance on the agency’s voluntary recall process and announced the agency’s intention to notify the public faster when a product is recalled.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 Notably, the draft guidance does not specifically address recalls of alcohol beverage products regulated by the Federal Alcohol Administration (FAA) Act or the primary role of the Alcohol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 Comments on the draft guidance are due by March 20, 2018. Continue Reading FDA Releases Draft Guidance on Public Warnings and Notifications of Recalls
Vanessa K. Burrows counsels clients on health care law and regulatory issues, with an emphasis on drug, medical device, food, beverage, and pharmacy law. Her broad-based experience also includes the Health Insurance Portability and Accountability Act (HIPAA) compliance, health privacy and security, alcohol beverages and public health. She advises health care entities and their contractors on compliance, regulatory, data sharing, licensing, and enforcement matters. She also counsels clients on compliance with Food and Drug Administration (FDA) regulations and guidance. Read Vanessa Burrows' full bio.
Today, Attorney General Jefferson B. Sessions announced, in a memorandum to all US Attorneys, the immediate revocation of five Obama Administration policies on federal marijuana enforcement, including Guidance Regarding the Ogden Memo in Jurisdictions Seeking to Authorize Marijuana for Medical Use, Guidance Regarding Marijuana Enforcement and Guidance Regarding Marijuana Related Financial Crimes. These three Obama-era guidance documents were drafted by then Deputy Attorney General James M. Cole in response to state legalization initiatives. Continue Reading Cannabis Chaos: Justice Department Revokes Obama-Era Guidance on Marijuana Enforcement
In the past three years, TTB has approved an increasing number of certificate of label approvals (“COLA”) for hemp-flavored vodka, from Mill Six’s hemp, white tea and ginger flavored vodka to Olde Imperial Mystic’s hemp infused vodka. Distillers have designed labels with green smoke-like images and psychedelic sixties-style lettering to hint at their cultural connection to marijuana. As more states have legalized recreational cannabis, distillers have been thinking more ambitiously about combining their distilling business with one or more aspects of the emerging marijuana business.
Originally published in Artisan Spirit: Winter 2017.
It’s hard to deny that marijuana has a cultural connection with craft beer, or at least with substantial segments of the craft brewing community. Many craft brewers have signaled to their fans that they know a thing or two about the rituals and lingo of marijuana consumption. But with the legalization of recreational cannabis by several states since 2012, many brewers have been thinking more ambitiously about combining their brewing business with one or more aspects of the emerging marijuana business.
This article originally appeared in The New Brewer November/December 2017.
Two consumer advocacy groups recently sued the Food and Drug Administration (FDA) for delaying the compliance deadline for the agency’s 2014 menu labeling rule for a fourth time. The menu labeling rule requires menu items offered for sale in restaurants with 20 or more locations to disclose nutritional information and the number of calories in each standard menu item. FDA and Congress previously extended or delayed compliance with the menu labeling rule three times in 2015 and 2016. Before the latest delay, the most recent “compliance date” for the menu labeling rule was May 5, 2017.
The incoming Trump Administration may usher in a more hostile climate to state efforts to legalize the sale and distribution of marijuana and products that contain the drug. The Obama Administration opposed the federal legalization of marijuana, but its enforcement approach, which focused on persons and entities whose conduct interferes with eight drug enforcement priorities, is outlined in a memorandum. This guidance does not have the force and effect of law, which means that the incoming Administration may replace it with a new guidance addressing prosecutorial discretion in marijuana cases. Below we examine the positions taken by President-elect Trump and his nominee for Attorney General, Senator Jeff Sessions, on (1) medical and recreational marijuana, (2) states’ rights, (3) attitudes toward marijuana use, and (4) enforcement of federal drug laws.
Most breweries have numerous dealings with the Alcohol and Tobacco Tax and Trade Bureau (TTB) and understand the need to comply with TTB regulations; this includes preparation for TTB audits and inspections. But the TTB is not the only federal agency with the authority to conduct a brewery inspection.
The Food and Drug Administration (FDA) also inspects food facilities, including breweries, to ensure they comply with FDA regulatory requirements. The FDA may conduct inspections as the result of routine surveillance, product quality issues, consumer complaints, or recalls. The agency also may conduct inspections to follow up on a previous inspection or an FDA enforcement action. The FDA also contracts with state and local food protection programs to conduct inspections and provide certification and training.
This week, the Food and Drug Administration’s (FDA) Director of the Center for Food Safety and Applied Nutrition (CFSAN) formally announced that the agency will delay enforcement of its final rule entitled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.” The statement marked the second time the agency extended the compliance deadline. Enforcement of the menu labeling rule was scheduled to take effect on December 1, 2016. The date that the FDA will begin enforcing menu labeling provisions is unknown at this time. The delay is the result of a provision in a federal appropriations law that prohibits the FDA from using funds to implement, administer, or enforce the menu labeling rule until one year after the agency issues its final, Level 1 guidance on nutrition labeling of standard menu items in restaurants and similar retail food establishments. FDA has yet to issue that final guidance.
The “successorship” provision of Ohio’s franchise law for alcohol beverages has spawned much litigation over the past two decades. Premium Beverage Supply, Ltd. v. TBK Production Works, Inc. represents the latest chapter of this saga, providing further clarity on several issues in the Ohio Alcoholic Beverage Franchise Act (Franchise Act).
In Premium Beverage Supply, the Court of Appeals for the Tenth Appellate District of Ohio considered whether The Brew Kettle Production Works (Brew Kettle) could terminate an agreement appointing Premium Beverage Supply (Premium) as the sole distributor of TBK craft beers after Brew Kettle purchased all of TBK’s assets. The trial court held that Brew Kettle could not terminate or cause the termination of Premium’s franchise. The trial court reasoned: (1) the terms of the distribution agreement controlled, as opposed to a provision in the Franchise Act permitting a successor manufacturer to terminate or fail to renew a distributor’s franchise in certain situations; and (2) Brew Kettle was not a successor manufacturer within the meaning of the Franchise Act. The Ohio Court of Appeals reversed the lower court and remanded the case to address Premium’s claim for compensation due to the termination of the distribution agreement.
First, the appellate court examined whether the statutory provisions in the Franchise Act permitted Brew Kettle to terminate or not renew Premium’s distribution franchise. The Franchise Act generally prohibits a manufacturer from terminating or failing to renew a distribution franchise without prior consent unless the manufacturer has “just cause” and provides sixty days prior notice. The Franchise Act provides an exception to the usual just cause requirement for termination if “a successor manufacturer acquires all or substantially all of the stock or assets of another manufacturer through merger or acquisition or acquires or is the assignee of a particular product or brand of alcoholic beverage from another manufacturer.” In such a case, the successor manufacturer has ninety days to give written notice of termination of the franchise to the distributor. In Esber Beverage Co. v. Labatt USA Operating Co., the Supreme Court of Ohio upheld this exception to the usual just cause requirement and concluded that a written franchise agreement did not override the statutory exception. Citing Esber, the Ohio Court of Appeals held that the trial court erred in finding the distribution agreement prevented Brew Kettle from terminating Premium’s franchise.
Second, the Ohio Court of Appeals reviewed the definition of the term “manufacturer” under the Franchise Act, because the act does not define the phrase “successor manufacturer.” The appellate court held that neither the law nor the asset purchase agreement required Brew Kettle to hold all necessary production licenses in order to be considered a successor manufacturer within the meaning of the Franchise Act. The court then evaluated Premium’s argument that Brew Kettle was not a successor manufacturer under the provision of the Franchise Act that defines situations that do not constitute “just cause,” because the owner of TBK also owned a minority interest in Brew Kettle. Noting the asset sale was an arms-length transaction, the court weighed the totality of the circumstances and held that Brew Kettle was not controlled by the individual with the minority interest.
Finally, the Ohio Court of Appeals considered whether the case should be remanded to address whether the statutory exception to the usual just cause requirement resulted in an unconstitutional taking. Premium argued that the termination of its distribution franchise was a state-sanctioned taking for private use. The U.S. District Court for the Southern District of Ohio previously determined that a taking did not occur when a private party used the statutory exception to the usual just cause provision to terminate a distributor’s franchise agreement. The Ohio Court of Appeals agreed and held that the termination of the distributor’s franchise agreement did not constitute a taking.
On December 28, 2015, the U.S. Food and Drug Administration (FDA) extended by 90 days the public comment period on the use of the term “natural” in food and beverage labeling. As discussed in an earlier post, the FDA is interested in receiving comments on the use of the term “natural” for foods that have been genetically engineered or contain ingredients produced using genetic engineering. In addition to food processing, production and manufacturing methods, the FDA may also consider whether the term “natural” implies any nutritional or health benefit. The FDA has received over 3,000 comments to date and will accept comments until May 10, 2016.