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

The U.S. Food and Drug Administration (FDA) has announced it will begin conducting remote inspections of importers under the Foreign Supplier Verification Program (FSVP) during the COVID-19 Public Health Emergency.  Continue Reading FDA to Conduct Remote FSVP Inspections during COVID-19 Public Health Emergency

Over the last several days, the U.S. Food and Drug Administration (FDA) has updated its recommendations for food manufacturers and food retailers during the COVID-19 public health emergency.  While FDA continues to underscore that there is no evidence of food or food packaging being associated with the transmission of COVID-19, FDA as updated its recommendations based upon updated guidance provided by the Centers for Disease Control and Prevention (CDC). Continue Reading FDA Updates Recommendations on Social Distancing and Use of PPE for Food Companies

The U.S. Food and Drug Food and Drug Administration (FDA) has issued two guidance documents intended to assist restaurants and other retail food establishments during the COVID-19 public health emergency. Continue Reading FDA Announces Guidance for Food Retailers During COVID-19 Pandemic

The U.S. Food and Drug Administration (FDA) announced a new policy to provide flexibility for restaurants and food manufacturers that have products on hand that are not labeled for retail sale (i.e. labeled for foodservice). To facilitate food distribution during the COVID019 pandemic, FDA released a guidance document, Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency, which allows restaurants and food manufactures to sell food products without nutrition labeling under certain circumstances. FSIS provided similar flexibility for FSIS regulated products last week. Continue Reading Following FSIS Lead, FDA Announces Flexibility on Nutrition Labeling Requirements for Foodservice Products Diverted to Retail

As with all businesses, franchise systems are dealing with challenges from COVID-19 that are new and unexpected. Franchisors and franchisees will have to work together, communicate and support each other to overcome these challenges and allow their brands to survive and thrive in the future. Below are some key considerations for both franchisors and franchisees as they move forward into uncharted territory.

Continue Reading COVID-19 Considerations for Franchise Systems

COVID-19 (Coronavirus) has drastically impacted all facets of everyday life, including the way in which alcohol sales can be conducted. Though most jurisdictions have banned dine-in customers at restaurants, bars and tap rooms, many have permitted on-premise licensees to temporarily sell to consumers through delivery, curb-side pickup, or off-premise sales. It is imperative to contact legal counsel to identify and navigate the changes and additional approvals that may be necessary to continue to operate during the outbreak.

Husch Blackwell is experienced navigating the licensing requirements of state, city, and county alcohol laws and regulations. Our Alcohol and Beverage lawyers are available to discuss these developments and how companies can appropriately comply with new requirements that can develop opportunities for continued sales. Contact Caroline O’Connell, Emily Lyons, or your Husch Blackwell attorney.

The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19 outbreak.

The FDA issued two guidance documents to increase the supply of alcohol-based hand sanitizers. The first indicates that FDA will not take action against manufacturing firms that produce alcohol-based hand sanitizers for consumers and healthcare workers. The second allows pharmacists to compound alcohol-based hand sanitizers without a patient-specific prescription.

The guidance only applies to production that uses the United States Pharmacopoeia or Food Chemical Codex grade ingredients listed in the guidance. There is also additional information about product labeling, manufacturing methods, and reporting requirements as Drug Registration and Listing System (DRLS) information will have to be prepared and submitted to FDA.

The TTB announced that the agency is allowing distilled spirits permittees (DSPs) and alcohol fuel plants (AFPs) to more easily participate in the hand sanitizer market as well.  DSPs do not have to obtain authorization to produce hand sanitizer or distilled spirits for use in hand sanitizer.  AFPs and beverage DSPs are also exempted from obtaining additional permits or bonds to manufacture hand sanitizer or supply ethanol for other TTB permittees to manufacture hand sanitizer. AFPs and beverage DSPs must continue to maintain records of their operations.  Many states have announced similar flexibility for distilled spirits manufacturers, but manufacturers should check with their local licensing authority prior to supply ethanol for or producing hand sanitizer.

Husch Blackwell is experienced navigating the regulatory requirements of FDA and TTB. Our FDA and Alcohol and Beverage lawyers are available to discuss these developments and how companies can a comply with this new guidance, including the preparation of DRLS information that will have to be submitted to FDA as well as navigating state and federal alcohol beverage requirements.  Contact Seth Mailhot, Emily Lyons, or your Husch Blackwell attorney.

On March 17, 2020, the U.S. Food and Drug Administration (FDA) issued guidance to food manufacturers and importers in response to the COVID-19 pandemic.  In the guidance, FDA stated it will temporarily not enforce supplier verification onsite audit requirements for receiving facilities and importers under the Food Safety Modernization Act (FSMA) so long as other supplier verification methods are used instead.

Continue Reading FDA Issues Temporary Policy for Food Manufacturers and Importers in Light of COVID-19 Outbreak

Companies directly and indirectly regulated by the U.S. Food and Drug Administration (FDA) face specific challenges separate from other businesses in dealing with the recent outbreak of coronavirus disease 2019 (COVID-19).  At the time of this writing, FDA has not offered specific recommendations on measures that regulated industries should take.  However, good manufacturing practice (“GMP”) requirements and the Federal Food, Drug and Cosmetic Act (“FDCA”) impose obligations on regulated industry to monitor and control employee health and sanitation practices as they relate to product quality and safety.  Beyond the risk of state and federal enforcement, there are reputational risks associated with inadequate management of COVID-19.

Continue Reading Coronavirus in FDA-Regulated Industries