Coronavirus (COVID-19)

On February 22, 2021, the Hawaii Senate passed SB No. 65, a measure allowing direct-to-consumer shipping of distilled spirits in original containers. The bill was passed in response to the legislature’s finding that the COVID-19 pandemic and the governmental responses to contain the spread of COVID-19 have disproportionately affected certain local liquor producers. With the frequent closure of bars, clubs, and in-person dining, local liquor producers have struggled to find alternative methods of serving their customers, resulting in drastic revenue losses.
Continue Reading Hawaii Senate Passes Bill Allowing Direct-To-Consumer Shipping of Distilled Spirits

On January 21, 2021 at 3:00 PM in Eastern Time, the Centers for Disease Control and Prevention (CDC) will host a joint webinar to provide updates on COVID-19 vaccine implementation for food and agriculture essential workers. The webinar will also cover vaccine safety and confidence as well as recommendations for vaccine prioritization.

The panelists for

On December 29, 2020, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice the 2021 fee schedule for its Over-the-Counter Monograph Drug User Fee Program.  That user fee program was an addition made in the Coronavirus Aid, Relief, and Economic Security (CARES) Act and authorized FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests.

These user fees concern over-the-counter (OTC) monograph drugs, which are nonprescription drugs without an approved new drug application which are governed by the provisions of section 505G of the Federal Food Drug and Cosmetic Act (21 U.S.C. 355h).  Under the new fee schedule, FDA will assess a fee for certain facilities registered with FDA and for the submission of an OTC monograph order request (OMOR).  An OMOR is an industry request for an administrative order to add, remove, or change an OTC drug monograph, which is submitted under section 505G(b)(5) of the Federal Food Drug and Cosmetic Act (21 U.S.C. § 355h(b)(5)).

The announcement took some by surprise, particularly those in the craft distilling industry that shifted production to FDA regulated hand sanitizers, a type of OTC monograph drug, during the COVID-19 public health emergency.  By December 31, 2020, the Department of Health and Human Services (HHS) took action over FDA’s fee schedule.  In a post on Twitter, the HHS Chief of Staff, citing the small businesses who stepped up to provide hand sanitizer in the face of the pandemic, announced that HHS had “directed FDA to cease enforcement of these arbitrary, surprise user fees.”  HHS Office of Public Affairs (Dec. 31, 2020), at https://twitter.com/SpoxHHS/status/1344782160084037639.
Continue Reading Holiday Confusion for the Over-the-Counter Drug Industry: FDA Announces OTC Fee Schedule That HHS Quickly Withdraws

Last week, the U.S. Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) issued a checklist to assist human and animal food operations during the COVID-19 public health emergency. The checklist is useful for persons growing, harvesting, packing, manufacturing, processing or holding human and animal food regulated by FDA when assessing or

U.S. trademark owners must file regular maintenance documentation with the U.S. Patent and Trademark Office (“USPTO”) to show that the owner is still using its trademark “in commerce” during the period leading up to the maintenance deadline. The COVID-19 crisis has disrupted businesses and some owners may have had to shut their doors or stop selling products. How do trademark owners maintain their trademark registrations if their businesses have been disrupted?

Continue Reading How to Maintain Trademark Registrations in a Pandemic

Despite the best of intentions to comply with the myriad of laws, orders and recommendations and to “do right” by employees while dealing with the current pandemic and recession, employers remain vulnerable to a whole host of potential COVID-19-related claims. Husch Blackwell’s Labor & Employment team is closely following the ever-changing guidance and return-to-work orders

Recently, the Centers for Disease Control (CDC) and Occupational Safety and Health Administration (OSHA) jointly issued an interim guidance to meat and poultry processing companies to facilitate continued operations and mitigate the risk of spreading COVID-19.  This interim guidance document marks the first time the federal government has issued comprehensive recommendations to a specific industry on safe operation of a facility during the COVID-19 public health emergency.
Continue Reading CDC issues Guidance for Meat and Poultry Processors with OSHA, President Issues Executive Order to Reopen Facilities

The U.S. Food and Drug Administration (FDA) announced updated plans for conducting routine inspections of domestic and foreign inspections during the COVID-19 public health emergency.  In March, FDA announced that it was temporarily suspending routine inspections of domestic and foreign facilities, except “mission critical” inspections, as well as conducting remote inspections of food importers subject to the Foreign Supplier Verification Programs.  FDA intends to continue suspending routine inspections for the time being and states that it will resume those inspections when local, national, and international conditions warrant.
Continue Reading FDA Provides Updated Plan on Inspections During COVID-19

The  issued Industry Circular 2020–3 on May 8, 2020 which clarifies the applicability of the trade practice provisions of the Federal Alcohol Administration (FAA) Act and TTB regulations during the COVID-19 public health emergency.  The guidance is in effect only from March 1, 2020 through September 30, 2020.
Continue Reading TTB Relaxes Certain Trade Practice Rules During COVID-19

The U.S. Food and Drug Administration (FDA) and Alcohol and Tobacco Tax and Trade Bureau (TTB) have issued new and updated guidance documents in addition to those previously published in order to address the decreased market supply of hand sanitizer products resulting from the rapid spread of the COVID-19 pandemic.
Continue Reading FDA and TTB Issue Additional Guidance on Hand Sanitizer Manufacturing, CARES Act Provides Tax Relief