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

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 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

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

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

The U.S. Food and Drug Administration (FDA) issued a press release on the evening of Monday, November 25 concerning its recent enforcement actions and a regulatory decision concerning products that contain cannabidiol (CBD).  The Warning Letters follow FDA’s trend of focusing its CBD product enforcement on unapproved drug claims.  The regulatory decision stated in the press release concerns FDA’s decision that CBD is not generally recognized as safe (GRAS) for use as a food additive.

Continue Reading FDA States CBD Is Not GRAS for Use in Food, Issues More Warning Letters